Journal articles: 'United States. Commission on Nursing Services (Proposed)' – Grafiati (2024)

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The goal of accreditation is to ensure that the education provided by an institution of higher education meets an acceptable level of quality. This study developed standards and criteria for accreditation of baccalaureate nursing education programs, by comparing accreditation in South Korea and in the United States, and validating standards and criteria. A main comparative analysis was made between Nursing League for Nursing Accrediting Commission (NLNAC) standards, Commission on Collegiate Nursing Education (CCNE) standards for accreditation of baccalaureate nursing education programs, and Korean Accreditation Board of Nursing standards for accreditation of nursing education programs. The research team developed and validated standards and criteria for South Korean baccalaureate nursing education programs. Using the results of the analysis, revisions are proposed to standards for accreditation of baccalaureate nursing education programs, and categorized into 24 criteria and six domains: mission and governance, curriculum and teaching-learning practices, students, faculty, resources, effectiveness. Further studies are required to refine the standards and criteria and make them sophisticated enough to be applied globally.

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Objective To conduct a survey of the members of the Society for Maternal-Fetal Medicine (SMFM) to determine the practice patterns of maternal–fetal medicine (MFM) subspecialists in the United States and to estimate the likelihood that our work force is sufficient to support the proposed MFM staffing requirements for level III and IV maternity centers. Study Design All regular SMFM members in the United States were invited to answer a 26 question survey by email. The survey queried demographic characteristics, practice type, night call arrangements, and whether the respondent's hospital was currently equipped with the services and personnel described in the requirements for level III or IV centers. Results Of the MFM specialists working full time in what would be considered a level III or IV maternity center, only 47.5% took in-house call. Of those taking only call from home or back-up call, the majority reported that during call hours, MFM antepartum and laboring patients are cared for by generalist obstetrician gynecologists; only 6.4% work with MFM hospitalists. Respondents from level III or IV centers also reported that many of their centers did not meet the criteria for nursing support, anesthesia support, or intensive care services. Conclusion These data, if confirmed, indicate that work needs to be done to upgrade services and achieve appropriate staffing to meet the proposed level III and IV criteria for maternity care.

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Introduction:The past three years have included multiple Public Health Emergencies of International Concern (PHEIC) and dramatically impacted all facets of Emergency Medical Response. During this time, simultaneous crises have demonstrated the value of the non-traditional responder in mitigating complex incidents. Current geopolitical climate has proliferated nuclear power and increases the necessity for readiness and awareness for radiological incidents. These are complex incidents a responder may face and requires even the lowest skilled practitioner to be fully engaged before special operations intervention.Limited research exists to determine whether current emergency medical services (EMS) training supplies the competency necessary to ensure safety of the prehospital provider during a radiological incident. Forthcoming research will investigate the effectiveness of this current training within the United States.Method:Survey data will be collected from multiple providers across the United States to evaluate their confidence level on two primary objectives during a radiological incident: competency of personal protective equipment donning and doffing, and management of contaminated patients.Data analyses of survey responses help drive future proposed educational activities that will be compliant with best practices set forth by organizations such as the United States Department of Health and Human Services Radiation Emergency Medical Management (REMM), the National Fire Protection Agency (NFPA), and Radiation Emergency Assistance Center/ Training Site (REAC/TS).Results:Data will be collected by survey responses to evaluate a diverse range of EMS services. Details such as skill level, type of EMS service, catchment of communities served, and their impressions upon the training will be analyzed.Conclusion:This is an ongoing project that will embrace the perspectives of the diverse group of delegates of WADEM throughout and become enriched through the organization's wealth of knowledge. Gaps highlighted during roll-out of this research can also be used to address logistics, doctrine, and policy shortfalls.

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PURPOSE: The Commission on Cancer seeks to promote robust survivorship programs among accredited cancer programs. In practice, cancer programs' survivorship programs range from cursory (eg, developing care plans without robust services) to robust (eg, facilitating follow-up care). To inform cancer programs' future efforts, in this study, we identified the implementation strategies that cancer programs used to achieve robust survivorship programs, distinguishing them from cursory programs. METHODS: We sampled 39 cancer programs across the United States with approaches to survivorship program implementation ranging from cursory to robust on the basis of LIVESTRONG survivorship care consensus elements. Within sampled cancer programs, we conducted in-depth semistructured interviews with a total of 42 health care professionals. We used template analysis to distinguish implementation strategies used in cancer programs with robust survivorship programs from strategies that yielded cursory survivorship programs. RESULTS: Cancer programs with robust survivorship programs established clear systems survivorship care and formal committees to improve the survivorship care processes. They sought buy-in from multiple stakeholders to leverage cancer program resources and defined clear roles with shared accountability among multidisciplinary groups. By contrast, cancer programs with cursory survivorship programs reported less consistency in survivorship care processes and lacked buy-in from key stakeholders. They had limited resources, faced persistent structural concerns, and had insufficient clarity in roles among team members. CONCLUSION: Accrediting bodies may consider incorporating the implementation strategies that robust survivorship programs have used as guidance for supporting cancer programs in operationalizing survivorship care and evaluating the use of these strategies during the accreditation and review process.

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Since 2020, the world has been plunged into uncertain times. The world economy was significantly affected by the outbreak of the coronavirus disease of 2019 (COVID-19), which rapidly evolved and was quickly declared a global pandemic. As conflict in Eastern Europe raged from the beginning of 2022, the pandemic being far from over and inflation gripping the world economy, the financial stress individuals and entities were experiencing continued to escalate. At the time Australia and India signed the Comprehensive Economic Cooperation Agreement (AI-CECA) in April 2022. The signing of this economic partnership is a major step forward for both countries. The proposed economic benefits for both nation states are estimated to be significant, and will extend across many sectors including agriculture, financial services, science and innovation. This article will examine the AI-CECA and make the case that cross-border insolvency cooperation must be an ongoing priority for both countries to ensure strong economic management, and inserted into future amendment of this agreement. Problematic though is the fact that the current approach taken by Australia and India varies greatly. This article will also examine the United Nations Commission on International Trade Law , Cross-Border Insolvency Model Law, in the context of Australia and India. Australia, India, Comprehensive Economic Cooperation Agreement, Cross-Border Insolvency, Trade Agreement

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Continuing rise in health care costs in the United States, the Affordable Care Act (ACA), and a multitude of other regulations impact providers in 2013. Despite federal spending slowing in the past 2 years, the Board of Medicare Trustees believes that cost savings are only achievable if health care providers are able to realize productivity improvements at a quicker pace than experienced historically. Consequently, the re-engineering of U.S. health care and bridging of the divide between health and health care have been proposed beyond affordable care. Thus, the Medicare Payment Advisory Commission (MedPAC) envisions alignment of Medicare payment systems to eliminate variable rates for the same ambulatory services provided to similar patients in different settings, such as the physician’s office, hospital outpatient departments (HOPDs), and ambulatory surgery centers (ASCs). MedPAC believes that if the same service can be safely provided in different settings, a prudent purchaser should not pay more for that service in one setting than in another. MedPAC is also concerned that payment variations across settings encourage arrangements among providers that result in care being provided in high paid settings. MedPAC recommends that payment rates be based on the resources needed to treat patients in the most efficient setting, adjusting for differences in patient severity, to the extent the severity differences affect costs. MedPAC has analyzed the costs of evaluation and management (E&M) services and the differences between providing them in a HOPD setting compared to a physician office setting, echocardiography services, and multiple services provided in ASCs and HOPDs. MedPAC has shown that for an established patient office visit (CPT 99213) provided in a free-standing physician’s office, the program pays the physician 70% less than in HOPD setting with a payment for physician practice of $72.50 versus $123.38 for HOPD setting. Similarly, for a Level II echocardiogram, HOPD costs 141% more for the same service than a free-standing office ($188.31 versus $452.89). For interventional techniques, Medicare payments vary from physician office to HOPD setting, with $211.96 in an office setting, $407.28 in ASC setting, and $655.62 in HOPD for procedures such as epidural injections. The MedPAC proposal for changing HOPD payment rates for services would reduce program spending and result in beneficiary cost sharing by $900 million in one year. On average, hospitals’ overall Medicare revenue will decline by 0.6% and HOPD revenue would fall by 2.7%. Further, MedPAC provided a specific example that aligning payment rates between HOPDs and freestanding offices only for cardiac imaging services would reduce program spending and beneficiary cost sharing by $500 million in one year. In estimating the savings that would be realized by equalizing payment rates between HOPDs and ASCs for certain ambulatory surgical procedures, MedPAC have shown potential Medicare program spending and beneficiary cost savings to be about $590 million per year. The impact of the proposed policies that are discussed in this manuscript would result in savings of approximately $1.5 billion per year for Medicare. MedPAC also has recommended a stop-loss policy that would limit the loss of Medicare revenue for those hospitals. Key words: Medicare, health care delivery system, Medicare Payment Advisory Commission (MedPAC), hospital outpatient departments (HOPDs), ambulatory surgery centers (ASCs), physician office practices

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Background Although telemedicine intensive care unit (tele-ICU) nurses are integral to the tele-ICU model of care, few studies have explored the influence of tele-ICU nursing interventions on preventing failure to rescue in critically ill patients. Objective To determine how tele-ICU nurses characterize their interventions to prevent failure to rescue. Methods This qualitative interpretive study recruited a purposive sample from 11 tele-ICU centers across the United States for structured open-ended interviews. An inductive and deductive approach suitable for health services qualitative research was adapted to further explain and extend a relevant conceptual framework for tele-ICU nursing practice. Results Of 33 nurses practicing in tele-ICUs who responded to a recruitment email, 19 participated in this study. Findings included 4 major interrelated themes: (1) fundamental attributes of the tele-ICU nurse, (2) proactive clinical practice, (3) effective collaborative relationships, and (4) strategic use of advanced technology. Conclusion A conceptual framework extending the American Association of Critical-Care Nurses model of success for tele-ICU nursing practice is proposed to prevent failure to rescue. Tele-ICU nurses use systems thinking and integration of complex factors in their practice to prevent failure to rescue. Tele-ICU nurses’ perception of their role in preventing failure to rescue and emotional intelligence competence are key to building and maintaining effective relationships with the ICU. Tele-ICU nurses’ intentional use of advanced technology, rather than the technology itself, supports and enhances proactive tele-ICU practice to prevent failure to rescue.

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The proliferation of cryptocurrency transactions and the increase in their value raises the question of the need for a final solution to the problem of legal regulation of their circulation. The urgency of this task is exacerbated by the fact that leaving cryptoassets out of the legal field promotes their use in illegal activities and deprives the state of significant revenues from their proper taxation. The purpose of this article is to study the approaches to the legal regulation of the circulation of cryptoassets, which are recently formed in the world, to determine the positive experience and opportunities to borrow successful legislative decisions. The article analyzes approaches to the regulation of relations arising from cryptocurrencies in the United States, Canada, Great Britain, Germany, Austria, Estonia, China, Singapore and Australia. Particular attention is paid to the analysis of the European unified approach to the regulation of cryptocurrencies for all European countries, as well as cryptocurrency services. According to the results of the study, it is concluded that today the attitude to cryptocurrencies differs depending on the level of development of the country. However, recently there has been a tendency to focus efforts on the implementation of cryptoassets in the legal field and ensure legal regulation of their circulation. In general, 2020, the year of the pandemic and the transfer of life to the online format, was marked by special attention to the development of legal regulation of cryptocurrency circulation. Of particular concern to the authorities are features of cryptocurrencies such as decentralization and anonymity, which allow these assets to be used to launder criminal proceeds and finance terrorism. It is in this direction that government regulation of cryptocurrency circulation has been moving recently. Most countries in the world of cryptocurrency regulation focus on licensing cryptocurrency exchanges, identifying their users, taxing, and countering money laundering and terrorist financing. These principles are the basis of the unified approach to the regulation of cryptocurrency activities for all European countries proposed by the European Commission. It is noteworthy that both in the European unified approach to the regulation of cryptoassets and in their legal regulation in some European countries and the United States, it is proposed to classify cryptocurrencies and divide them into several categories depending on the functions they perform. These approaches to the classification of cryptoassets should be considered when determining the legal framework for regulating the circulation of cryptoassets (virtual assets) in Ukraine.

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U.S. hospitals are facing unprecedented margin compression and experiencing ongoing staffing issues, not only with nursing and ancillary services but with physicians as well. Looming physician shortages add to the vulnerabilities of acute care facilities to maintain normal operations. The traditional model of physician recruitment and retention may be inadequate to fill gaps, and novel approaches are needed. Vertical integration of medical education into health systems ecosystems may provide benefit to future stability. A recent uptick in proposed (and accredited) medical schools in the United States, particularly in Osteopathic Medicine, has seen many of these schools collaborating with community hospitals to provide the clinical training experiences required. Early reflection on this rapid growth (at least in one region) suggests that nascent physician education and training programs can have a significant synergy with community health/hospital systems that have not had such programming heretofore. Criticisms of such patterns are also addressed with a discussion of rebuttals and potential solutions. Hospitals that currently do not have medical education programs should consider the benefits of collaborating with medical education programs and seek to integrate their mission with local and regional providers of such programming.

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Background. Previous estimates of administrative costs in U.S. hospitals have been based on figures in California, and nationwide extrapolation has been controversial. If the costs of bureaucracy are high, major policy reforms may yield substantial savings. Methods. We obtained detailed data on hospital expenses for fiscal year 1990 from reports submitted to Medicare by 6400 hospitals. We calculated each hospital's administrative costs by summing expenses in the following Medicare cost-accounting categories: administrative and general, nursing administration, central services and supply (excluding the purchase cost of supplies), medical records and library, utilization review, and the salary costs of the employee benefits department. We classified costs in most other categories as clinical. Some small categories of expenses (e.g., gift shop) were excluded from both our clinical and administrative groupings, and for others (e.g., plant operations), a proportional share was allocated between the two groupings. Results. Nationwide, administration accounted for an average of 24.8 percent of each hospital's spending in fiscal 1990. Average hospital administrative costs ranged from 20.5 percent in Minnesota to 30.6 percent in Hawaii. Administrative salaries accounted for 22.4 percent of the average hospital's salary costs. Administrative costs were similar in states with high and low rates of enrollment in health maintenance organizations (HMOs). Conclusions. Hospital administrative costs in the United States are higher than previous estimates and more than twice as high as those in Canada. Greater enrollment in HMOs, with more competitive bidding by hospitals for managedcare contracts, an important element of proposed managed-competition health care reforms, does not seem to lower hospital administrative costs. N Engl J Med. 1993;329:400-3.

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Abstract In an effort to reduce the tax transparency and banking secrecy, the Organisation for Economic Co-operation and Development (“OECD”) has been taking the lead on the battle against cross-border tax evasion, seconded by the Internal Revenue Services (“IRS”) of the United States of America (“USA”), the G20 and the European Commission. Understanding the power that is brought by information and knowledge, the international community proposed adapting the exchange of information tools that were available to them and extending them to a worldwide level. As a result, the Common Reporting Standard (“CRS”) and the Foreign Account Tax Compliance Act (“FATCA”) reporting standards were born. This paper aims at analyzing the improvements in automatic exchange of information brought by the CRS and FATCA standards, together with its limitations. An important section of this paper shall be dedicated to the role that Romania plays in the international efforts of fighting tax evasion, together with the tools and procedures developed in order to sustain the reporting standards. In order to analyze the effects of the CRS and FATCA, it is essential to understand the pros and the cons of the international cooperation on tax matters and its available tools before the CRS and FATCA were created. As there is limited previous literature on the subject, the methodology of the research will consist mainly of analyzing the guidelines issued by the international public body representatives and of the current legislative framework. The main finding of the paper can be considered the fact that the new developments in the automatic exchange of information field can represent a huge step forward towards limiting the tax evasion activity, however, one should be reserved due to aspects such as compliance costs, protection of private information, data gathering and processing techniques and tax residency uncertainty. Further analysis is required when the automatic exchange of information results will be available in order to update the reservations of the paper.

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This study investigated the sustainability practices of two (2) selected publicly-listed higher education institutions in the Philippines that ensure health and well-being. Research and publication, course offerings leading to health professions, and collaborations and health services were used as variables to measure sustainable practices that ensure good health and well-being. On the other hand, sustainable development was chosen to assess the assurance of good health and well-being. This study is based on the theories of health, well-being, sustainable development, and stakeholder theory. The qualitative exploratory research design was used. Data were from the 2020 websites of the respective universities, which contained annual reports, sustainability reports, and other documents. The information from these sources was analyzed using an analytical method. According to the findings, publicly-listed higher education institutions have published several studies on health and well-being in peer-reviewed journals that are either locally or internationally referred locally or internationally or indexed in World of Science (WoS) or Scopus. Nursing, medicine, dentistry, optometry, medical technology, pharmacy, psychology, and social work are among the health-related courses available to train competent and dedicated health professionals. Graduates of these courses will be expected to promote, protect, and treat the physical, mental, social, emotional, environmental, and holistic well-being of others. The analysis of collaborations and health services revealed numerous programs and activities related to networking with other health institutions, health outreach programs, mental health support, and health care services. It develops solutions to improve the health and well-being of university stakeholders using the skills and resources at its disposal. To ensure good health and well-being, stakeholders should collaborate to ensure an integrated and holistic approach to higher education sustainability. To address the study’s limitations, it is proposed that research be conducted using a different approach that links SDG#3 to other SDGs applicable to a university setting.ReferencesAllardt. E. (1989). An updated indicator system: having, leaving, being. working papers 48, Department of Sociology, University of Helsinki.Aleixo, A., Azeiteiro, U., & Leal, S. (2020). Are the Sustainable Development Goals being implemented in the Portuguese higher education formative offer? International Journal of Sustainability in Higher Education, 21(2). https://doi.org/10.1108/IJSHE-04-2019-0150Aleixo, A. M., Azeiteiro, U., & Leal, S. (2018). 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Abstract:

The Medicare Program is the second-largest insurance program in the United States, with approximately 64 million beneficiaries and total expenditures of over $839 billion in 2021 [1]. There are two separate trust funds in the Medicare Program, namely the Hospital Insurance Trust Fund (HI Trust Fund) and the Supplementary Medical Insurance Trust Fund (SMI Trust Fund); both trust funds are held by the U.S. Treasury [2]. The first trust fund covers hospital in-patient expenses; and the second trust fund covers medically necessary services by medical doctors and doctors of osteopathy, preventive services, brand-name prescription drugs, and generic drug coverage [3,4]. Prior to the COVID-19 pandemic, the latest financial calculations projected that the HI Trust Fund would be insolvent by the year 2026. It is a fact that the Medicare HI Trust Fund has never been insolvent because there are no provisions in the Social Security Act that govern what would happen if insolvency were to occur. Ten of the last twelve years have witnessed expenditure outflows outpacing the HI Trust inflows, resulting in total Medicare spending obligations outpacing the increasing demands on the Federal budget as the number of beneficiaries and the per capita healthcare costs increase each year [5]. Uncompensated care refers to uninsured patients who receive care upon hospital emergency room admissions but not ever paying the hospital bill after discharge or death. Uncompensated care is the kryptonite of hospital financing because it is unpredictable and can easily destabilize the monies that hospitals depend on to cover overhead expenses. Nationwide, hospitals protect themselves against the uncertainty of uncompensated care by drastically overcharging prices to different patients receiving the same or similar medical procedures at the very same hospital locations. For all intents and purposes, the creation of Obamacare failed to address this kryptonite. However, it is a fact that the legal system places limitations upon what the federal government can do to deal with this Achilles’ heel of the American healthcare system. State governments truly hold the power to effect change towards the future of healthcare in 2030, both private healthcare and government-sponsored healthcare. Since 1970, one state has proactively protected its statewide healthcare system against the dangers of uncompensated care: Maryland. It is the only state in the entire nation to receive a federal waiver from the U.S. Centers for Medicare & Medicaid Services (CMS) because their specific design for accounting for a plethora of poor patients. This effort started with a group of hospital administrators meeting for coffee on a consistent basis to brainstorm the solution from their collective hospitals. Driven by the pride to help their communities, their involvement with the Maryland government led to the creation of the Maryland Health Services Cost Review Commission (Maryland HSCRC). This impartial government institution is backed by Maryland law that gives it the necessary legal powers to set stated singular hospital prices for all services statewide; these prices include the adjustments for uncompensated medical care that is distributed among all stakeholders equally. In fact, the Maryland HSCRC wrote the law that requires all stakeholders to comply with detailed auditing and data submission requirements for the purpose of providing the federal government with complete transparency regarding healthcare information without violating HIIPA federal patient privacy regulations. With this powerful information, the agency restricts hospital costs without limiting hospital profits, accurately measuring patient volume, and predicting the financial condition of all inpatient and outpatient services in Maryland. Because the Maryland HSCRC is both funded by resident’s money and accountable to the public, the hospital savings are as follows: Maryland markups for hospital services increased from 18 percent in 1980 to only 22 percent in 2008. During the same period, the average nationwide markup for hospital services skyrocketed from less than 20 percent in 1980 to over 187 percent by 2008. It is because of these significant savings to the Medicare Program that the Maryland HSCRC continues to receive a CMS waiver every year. In terms of prices, Maryland hospitals are prohibited from giving volume discounts and shifting costs to 4 other payers. The agency enforces a simple and clear mandate: same prices for the same medical services at the same hospitals, no exceptions! Before leaving office, President Trump instructed the CMS to enforce a price transparency rule though separate machinereadable prices as a protection against the kryptonite of uncompensated medical care. After the authors studied the CMS proposal, it became clear that single-handedly imposing penalties for noncompliance is only one factor in this multidimensional problem. Unlike the extremely efficient Maryland system, the CMS has threatened all hospitals with what will be shown below, to be ineffective measures that yield worthless results. The “Price Transparency Final Rule” penalizes hospitals with fewer than 30 beds at $300 daily for each licensed bed at small hospitals, and large hospitals (more than 30 beds) at $10 daily per licensed bed (cannot exceed the daily penalty of $5,500). Our financial analysis in a prior article on this point, focuses on Free Cash Flow because it represented the cash that a hospital can generate after disbursing the money required to maintain and pursue opportunities that enhance shareholder value. We argued that the proposed CMS civil monetary penalties imposed on hospitals was doomed from the start for failure. Our financial analysis focuses on business valuation, and specifically an accounting term called Free Cash Flows (FCF), which represents the cash that a company can generate after laying out the money required to maintain or expand its asset base; FCF is important because it allows a company to 5 pursue opportunities that enhance shareholder value [6]. At Pettingill Analytics, we looked at three publicly traded hospitals in the United States reported the following (Figure 1) [7].

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AbstractTreatment of mental illness in the United States is woefully inadequate. One-third of adults report having a mental health condition or substance use disorder, but less than half receive treatment for their condition.Access is the problem. The U.S. is short on mental health professionals: more psychiatrists are needed and psychologists and social workers are overextended. Proposed solutions are to (1) increase reimbursem*nt rates for psychiatrists and other mental health practitioners, and (2) use a wider range of providers, including nurses and family support specialists—all good ideas. My focus however is on two other forces that are moving into the behavioral health area, offering both financing and technologies to extend the reach of mental health services—private equity and telemental health.First, private equity firms see high demand in this market. Behavioral health is desperately needed but is highly fragmented and lacking in innovation. Private equity is attracted to outpatient programs that target specific conditions that have evidence-based clinical models—programs aimed at addiction, eating disorders, and autism; these areas require less capital. Federal and state reimbursem*nt is available, some regulations have been relaxed to allow remote prescribing of medicine; and innovative telehealth tools can be used. The problem is that private equity has a poor track record in both nursing home care and behavioral care for teens. The private equity model and its financial incentives are at odds with good care.Second, telemental health tools, already in use because of the need during the pandemic, appear attractive. These tools require less capital to treat a higher volume of patients and promise much improved access to mental health treatment for populations that could not get such care because of travel distance, costs, and time limitations. The problem is that the telemental health tools have yet to be subjected to evidence-based testing.My goal in this article is to test whether these two developments – private equity and telemental health —can improve access for patients at an acceptable level of quality. I conclude that both have substantial problems and I offer a range of regulatory approaches to control patient abuses and poor quality.

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Arthritis is the disease that kills the fewest but cripples the most. With the aging of the population in the United States and the antiquated DRG reimbursem*nt system for hospital surgical intervention, it is inevitable that the Medicare assistant will bankrupt itself prior to the proposed bankruptcy date of 2026 if changes are not made. It may change would be to insist that the system in Maryland for reimbursem*nt to hospitals for essential joint replacement surgery of the elderly be adapted nationwide. Medicaid expenditures are driven by a variety of factors, including the demand for care, the complexity of medical services provided, medical inflation, and life expectancy. The Medicare program has two separate trust funds – the Hospital Insurance (HI) Trust Fund and the Supplementary Medical Insurance (SMI) Trust Fund. Under the Hospital Insurance Trust, payroll taxes from workers and their employers go towards paying for the Part A benefits for today’s Medicare beneficiaries. In 2019, Medicare provided benefits to over 60 million elderly patients at an estimated cost of $796 billion [1]. While excluding the significant decrease in payroll taxes during the COVID-19 pandemic, the latest 2020 projections calculate Medicare Hospital Trust insolvency by 2026 [2]. The 2020 report declared that funds would be sufficient to pay for only 90 percent of Part A expenses at the time of this writing. Since inception, the Hospital Insurance Trust has never been insolvent, because there are no provisions in the Social Security Act that govern what would happen if insolvency were to occur. Ten of the last twelve years have witnessed expenditure outflows outpacing the Hospital Insurance Trust inflows, resulting in total Medicare spending obligations outpacing the increasing demands on the federal budget, as the number of elderly beneficiaries and the per capita health care costs continue to grow [2]. One of the principal goals of the following study is to determine how elderly patients, who often suffer from acute stages of arthritis and other orthopedic diseases, due in part to wear and tear, can continue to demand surgical intervention, in particular joint replacement surgery. Arthritis has been described as the disease that kills the fewest but cripples the most. With that in mind, the hospital systems ability to absorb the ever increasing number of elderly patients who demand joint replacement surgeries will continue to outstrip supply. The principal author of this study completed his PhD dissertation at the University of Manchester in 1977 by measuring the cost-benefit analysis of the treatment of chronic rheumatoid arthritis in Great Britain. Therefore, the author of this study aims to show the only reasonable method of payment for the imminent immeasurable demand for treatment for the elderly for age related diseases such as joint replacement surgery [3]. A recent Journal of Rheumatology article projects Medicare will finance approximately 2.67 million joint replacement surgeries by 2035, plus an additional 2.35 million joint replacement surgeries by the year 2040 [4]. The author believes that the current nationwide Diagnostic Related Groups (DRGs) system that helps determine how much Medicare pays the hospital for each “product” needs to be phased out as soon as possible. Our research shows that prior to Medicare implementing the DRGs payment system, Maryland proved that their total cost model of state-wide rewards and penalties compensated “efficient and effective” hospitals, providing care as defined by metrics set up by the Health Services Cost Review Commission (HSCRC). The Maryland legislature granted this independent government agency the broad powers to insulate the HSCRC from conflicts of interests, regulatory capture, and political meddling in the long term. In exchange, the HSCRC had the freedom to design a system that must deliver on three areas: cost reduction of hospital services, health improvement for all Maryland residents, and quality of life care improvements. Since inception of the HSCRC, all stakeholders are legally required to comply with robust auditing and data-submission requirements that allow the agency to collect data on the costs, patient volume, and financial condition of all inpatient, hospital-based outpatient, and emergency services in Maryland. This level of transparency allows the agency to set prices for hospital services, and hospitals must obey because it is Maryland law. Because of this methodology, HSCRC-approved average Maryland hospital markups ranged from 18 percent in 1980 to only 22 percent in 2008. During that same period, the average hospital markup nationally skyrocketed from 20 percent in 1980 to more than 187 percent in 2008 [5]. This strong evidence is the primary reason why the HSCRC has continued to receive a federal waiver from the Centers for Medicare and Medicaid Services, which requires both Medicare and Medicaid to pay the HSCRC-approved rates statewide. No discounts are given because of volume, nor any shifting of costs to other payers. There is a mandate: same price for the same service at the same hospital, no exceptions. Adjustments for uncompensated medical care are automatically bundled into the HSCRC-approved rates, as thus, this financial burden is shared by all hospitals in Maryland. This article explores the important milestones taken by the state of Maryland and how the lessons learned are responsible for the impressive results of their program today. This author believes that by applying the Maryland Total Cost of Care Model (Maryland TCOC Model) nationwide will yield financial savings of at least $227 billion by 2035, plus another $280 billion by 2040, exclusively from joint replacement surgeries reimbursed at HSCRC-approved rates and not any other method.

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Dear Editor, Nursing education consists of classroom and clinical training to demonstrate clinical competence based on theoretical concepts learned. However, there is a lack of clinical abilities demonstrated and theoretical knowledge gained from pre-qualified nursing education and the preparation of new graduates. Furthermore, graduates often believe that the lessons learned do not reflect the actualities faced in clinical fields. This discrepancy is known as the theory-practice gap among graduate nurses who are theoretically but not practically equipped to apply theory and knowledge to practice in the clinical environment. Graduate nurses working in high-risk fields can struggle to integrate theoretical concepts into the clinical environment, leading to patient safety risks and potential adverse outcomes. Furthermore, the new graduates experience a deficit that contributed to decreased job satisfaction, increased job turnover rates, and patient care mistakes. This paper aims to address the gap between nursing education and practice in the nursing profession. The nurse’s role has grown substantially in recent years due to the shift in patients’ medical needs. Nurses are no longer just the “bedside healers” who hand you your medication and make sure your bedpan is clean, and they are also critical components of your healthcare team. The shift in inpatient medical needs requires more than just bedside healers. Nurses want to work on the skills needed for clinicians. Nurses need to take any opportunity they can get to stand out more than ever (1). Over the past 30 years, nurses’ education has been shifted from hospitals to universities. The theory part has begun to gain greater popularity in nursing education. Literature shows a clear gap between classroom teaching and student nurses’ experiences in clinical areas (2). Nurses are essential to excellent health care at all levels and provide complex patient services in different facilities. These services are only provided if the nursing profession has excellent clinical knowledge of nursing and can meet the needs of many different public health services. In view of the needs of the general public, new graduate nurses must be educated and equipped to use the clinical skills needed after nursing school with confidence. However, clinical competence is only part of providing excellent health care, and new graduate nurses must make the best clinical judgment for patients (3). Nursing is a holistic approach involving caring for people with compassion, but it has changed because patients expect to be treated quickly and transferred to the next. In addition, nurses face challenges because they are challenged in clinical fields and do not have the necessary capacity to cope with daily situations (4). Therefore, this article aims to review the gap between theory and practice in the workplace nursing profession. It is important to think about the differences between theories and practices. As defined by dictionaries, a theory is a set of statements or principles devised to explain a group of facts or phenomena, especially one that has been repeatedly tested or is widely accepted and can be used to make predictions about natural phenomena. Practice is defined as the act or the process of doing something, performance, or action. In definition, these terms appear to be at odds with each other, but when considered in terms of professional setup, they have to enable the application of ‘applying the theory into practice’(5). New graduate nurses face challenges transitioning from school to clinical training, affecting their performance. These challenges include knowledge level, physical demands, social acceptance stress from colleagues, and adaptation to new working environment culture. Concern about nurses’ competence stems from the rise in-hospital mortality rates in the United States. New and experienced nurses are highly expected to provide effective and safe patient care. There is still no clear answer to whether the new graduate nurses lack the appropriate education or if there is excessive pressure on the schools to quickly graduate a larger number of nurses to fill the increasing need for nurses in the clinical environment. The transition from nursing student to nurse work has proven to be a difficult transition that many researchers have studied. Some studies show that new graduate nurses lack the necessary skills to play the role of nurses without clinical experience. New graduate nurses are faced with many different challenges and intense pressures to meet the expectations of their profession. The nursing education programme encourages professional nurses to integrate theory and practice to provide high-quality nursing care in practice. Practical learning allows nurses to provide nursing care based on their knowledge. Nursing is an important field where knowledge is applied after education to practical skills. The distinction between theory and practice is one of the many topics of nursing discussion issues, such as the unresolved threads of a long time (6). Though nurses have been required to do more than ever before, the way they prepare for and embark on this career path has remained unchanged. According to a survey, 83% of new graduate nurses did not receive any formal training in their profession before starting work. A survey has found that 80% of nurses believe that this is a problem in their workplace (7). 90% have expressed the intention to work one or more additional days as they describe as ‘clinical application’ days. A gap has been found between the educational experience and the level of competence required by the clinical setting. Nursing students need to be prepared for various clinical settings where they will be called on to use a wide range of skills and techniques (8). The nursing programs lack clinical skills, but the issue stems from what is being taught to the students. For example, nurses are not learning how to keep infections out of hospitals by washing their hands properly. Students have not gained the necessary knowledge because they are being taught about theory rather than clinical practice. Another issue is that teachers have difficulty keeping up with the fast-paced changes in nursing because they were trained before many of these changes occurred (9). The new generation of nurses lacks adequate on-the-job training due to the uncertainty of getting a job offer after finishing their course. Nurses are also not given enough time on-site with patients during their graduate studies for practical experience (10). This is because patients are generally only admitted for short periods during their stay at hospitals or nursing homes. There is a considerable gap between the skills required from a nursing student to provide clinical skills. A nursing student needs to know pre-hospital, hospital, home care, treatments, associated procedures, and first aid. This gap could be due to insufficient preparation for clinical scenarios or not nursing educators practicing these skills. The solution should provide sufficient clinical skills preparations for nursing students, engage teachers to practice these skills, and engage clinical professionals to participate in the education of the students (11). In this regard, organizations such as the International Laboure Organization (ILO) endorsed articulation arrangements allowing post-secondary students across countries to access top traditional higher education. However, though other academic institutions offer certificates or diplomas in nursing assistant studies, not all of them have been recognized by ILO. Others push to improve the training opportunities by increasing the hours of accommodation visits, block releases, and summer programs to see long-lasting changes. Nurses should start preparing for the workplace before they graduate. That way, they can be more prepared for these future challenges. Primarily focus on supporting collaboration between academics and clinicians, establishing a research culture in a clinical environment, and improving access to research. In order to do so, practitioners need access to current information, learning resources, and opportunities for continuous education. The theory-practice gap, it would seem, is a multifaceted problem. The most common reasons included that the theory was about building a knowledge base while practice was about learning nursing skills. Education is an essential element of the preparation of nurses for real situations. However, education must include theory and nursing practice, and the teaching of excellent teachers in these two areas is linked (12). New graduate nurses must be confident and prepared to take on a role that will life-changing environment. Nurses are stressed because nurses know that the health of patients is dependent on good care. Research in this field is essential to ensure the workforce is equipped with the best-qualified nurses. Thus, overall, it is quite evident that the gap exists and has areas that can be improved. Strategies for solving this problem include re-examining the curriculum and liaising between education and practice. In education and clinical environments, leaders and followers will create operational plans for this proposed model and link it to benefits to make nursing professionals beneficial at large.

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The aim of the article. The purposes of this article are to establish the place and role of the analysis of the payment card market in the substantiation of the marketing policy of banks, to analyze the state of the payment card market in Ukraine, to identify existing trends, problems and prospects for development, to suggest ways to solve problems in the field of management and marketing of card products. Analyses results. As a result of the articles: 1) establishment of the place and role of the analysis of the payment card market in the substantiation of the marketing policy of banks; 2) analysis of payment card market in Ukraine on the basis of statistical data on the issue of state and commercial banks, collecting by National Bank of Ukraine; 3) establishment of payment cards in Ukraine and the development of the trend of development; 4) searching the problems and prospects for the development of the market of payment cards in Ukraine; 5) ability to improve the use of the foreign examples for the management and marketing of card products. The economic and statistical analysis of market processes is an integral part of the algorithm for making managerial decisions in the field of marketing. Statistical analysis of the payment card market should serve as a reliable basis for the formation of the bank's marketing policy in general and, in particular, the marketing policy for the implementation of settlements and the use of card products. The dynamics of the payment card market and the level of its development today are indicators by which it is possible to track the degree of development of the banking sector of the economy. Analysis of the payment card market in Ukraine carried out on the basis of statistical data collected by the National Bank of Ukraine as a regulator of banking activity, gave us the next results. All the main indicators characterizing the development of the payment card market in Ukrvain have a steady upward trend in recent years. These are, in particular, the number and amount of non-cash payment transactions, the number of issued and active payment cards, indicators of payment infrastructure development. In order to ensure further development of the payment card market in Ukraine and increase the efficiency of its functioning, it is necessary to implement the following measures: the government of Ukraine and the National Bank of Ukraine should inform citizens about the effectiveness and expediency of using payment cards; carry out advertising and information campaigns to improve the financial literacy of the population; reduce commission costs to a level that allows banks and payment service providers to provide enterprises with tariffs lower than the cost of accepting and processing cash payments; expand bonus programs that will be interesting for different groups of the population and will be based on the daily needs of customers; additionally stimulate customers by accruing interest on their own funds on the card account; investigate governmental and national factors hindering the processes and implementation of new technologies for the implementation of payment card projects; others. To carry out interstate comparisons, it is proposed to apply relative indicators that allow leveling the influence of the size of territories and population. These indicators include relative indicators of assessing the scale of the market, market infrastructure and the development of card payments. There is no doubt that the current development of payment card infrastructure in Ukraine is not favorable enough for the necessary use of payment cards and reducing the volume of cash transactions. To compare the level of development of the infrastructure of banks' operations with payment cards in Ukraine and some EU countries, we consider data on the number of terminals per 1 million people, which proves that this figure is almost 3.5 times lower than the average European level. That is, there is a certain potential for the development of this segment. Conclusions and directions for further research. As soon as the market of payment cards in Ukraine is available, it is possible to say that banks can use their payment cards to work a regular basis. Cardholders will be able to transfer the right to transactions with the vicoristanie of payment cards. The number of payment infrastructures has been expanded, and the payment of the goods has been extended to the technical progress. The bank's payment card market in Ukraine will continue to grow. At a greater pace, there is a greater increase in the number of operations with card use, first of all, for the development of banking payment services. On the basis of the market of payment cards, we will be able to observe our parameters up to the markets of the European powers and the United States. Analyzing the foreign experience of banking technologies, we can say that the development and openness of developed payment systems is an impetus for the non-cash market of Ukraine and has a significant impact on the development of banks' operations with payment cards in Ukraine. After all, the gross share of new products of the last 10 years commercial banks of Ukraine borrowed on world payment markets (for example, electronic interbank mail, telemarketing, mobile applications, real-time payments, client-bank system, Internet banking and telebanking). That is, exploring the world experience of non-cash payments and their implementation in Ukraine, it can be noted that commercial banks in Ukraine are quite skillful in implementing the positive experience of their foreign colleagues, adjusting it to personal practice, which significantly increases the turnover of integration of the banking system of Ukraine into the world banking system.

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AbstractThis article analyzes the public comments submitted to the Commodity Futures Trading Commission (CFTC), 2010–2014, in response to proposed rules for implementing the Dodd‐Frank reforms. By addressing a fine‐grained typology of commenting organizations to a topic model of the combined comments, we illuminate a new pattern of public engagement in financial regulation. Contrary to the economic concept of regulatory capture, our data show no sharp divide between the suppliers of complex derivatives (the dealer banks) and their customers in other parts of the finance industry. In keeping with the general concept of financialization—but contrary to its strongest versions—our data show distinctly delimited evidence of a convergence between the banks and other sectors. Instead of either capture or all‐embracing financialization, the comments submitted to the CFTC display an overriding opposition in the justifications used by commenters to explain their preferences. Commenters from the financial services and allied sectors consistently adopt a language of technical legitimation. Commenters in agriculture, livestock, retail energy, and many nonmarket organizations adopt a language of moral justification. The clarity of the divide between these two idioms indicates that the underlying purposes of new financial instruments are now being questioned. Even in the realm of esoteric financial instruments such as derivatives, the moral economy of market competition is once again subject to debate among market participants as well as observers.

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AbstractArab immigrants constitute a sizable portion of the US population, and their adjustment and relocation challenges might escalate mental health issues. Nevertheless, mental health care accessibility among such populations is not recognized as policy issue. Hence, it is crucial to explore the political tools that might be employed to improve immigrants’ access to mental health treatment. The Public Arenas Model (Hilgartner and Bosk, American Journal of Sociology 94:53–78, 1988) provides better understanding of how access to mental health care is defined in the public sphere, why mental health inaccessibility among Arabs has not received attention, and how stakeholders worked to raise the public’s attention to such issue (Smith, Policy, Politics & Nursing Practice 10:134–142, 2009). Ultimately, several policy options are proposed to address Arab immigrants’ access to mental health care issue, including increasing mental health service providers’ language proficiency and cultural competency, integration of behavioral health and primary care services for immigrant populations, and considering novel modes of mental health delivery.

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PURPOSE: Since 2016, the American College of Surgeons' Commission on Cancer (CoC) has required routine distress screening (DS) of cancer survivors treated in their accredited facilities to facilitate early identification of survivors with psychosocial concerns. Lung and ovarian cancer survivors have relatively low 5-year survival rates and may experience high levels of distress. We examined the extent to which ovarian and lung cancer survivors received CoC-mandated DS and whether DS disparities exist on the basis of diagnosis, sociodemographic factors, or facility geography (urban/rural). METHODS: This study included a quantitative review of DS documentation and follow-up services provided using existing electronic health records (EHRs). We worked with 21 CoC-accredited facilities across the United States and examined EHRs of 2,258 survivors from these facilities (1,618 lung cancer survivors and 640 ovarian cancer survivors) diagnosed in 2016 or 2017. RESULTS: Documentation of DS was found in half (54.8%) of the EHRs reviewed. Disparities existed across race/ethnicity, cancer type and stage, and facility characteristics. Hispanic/Latino and Asian/Pacific Islander survivors were screened at lower percentages than other survivors. Patients with ovarian cancer, those diagnosed at earlier stages, and survivors in urban facilities had relatively low percentages of DS. Non-Hispanic Black survivors were more likely than non-Hispanic White survivors to decline further psychosocial services. CONCLUSION: Despite the mandate for routine DS in CoC-accredited oncology programs, gaps remain in how many and which survivors are screened for distress. Improvements in DS processes to enhance access to DS and appropriate psychosocial care could benefit cancer survivors. Collaboration with CoC during this study led to improvement of their processes for collecting DS data for measuring standard adherence.

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The document “Feasibility Study for the Implementation of Number Portability in Nicaragua” proposes the mechanisms to implement operator Number Portability, taking into account the ITU-T Series Q and E regulations. The existing information is analyzed, after the collection of information through interviews with operator officials, as well as surveys of users of telephone services. After reviewing the advantages and conditions of the different techniques to implement number portability, we recommend the All Call Query technique, a simple and effective method, as well as operator Number Portability, for which you need intelligent network capabilities to recognize the ported number, the status, the conditions and the operator must develop activities to adapt their networks to this model. The documents that legally and regulatory support the implementation of Number Portability are: Administrative Agreement No. 036-2003, the Numbering Resource Regulations and the National Numbering Plan, all of these issued by TELCOR Regulatory Entity, the Free Trade Agreement between the Dominican Republic - Central America and the United States (DR-CAFTA) and the Regional Technical Telecommunications Commission of Central America, COMTELCA The elaboration of regulatory documents such as the Number Portability Regulation is proposed and indications are given for the creation of the Centralized Database Administrator with its subordinates in the different nodes that make up the network and a proposal for a General Implementation Plan.

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Background: Public health emergencies leave little time to develop novel surveillance efforts. Understanding which preexisting clinical datasets are fit for surveillance use is high value. Covid-19 offers a natural applied informatics experiment to understand the fitness of clinical datasets for use in disease surveillance. Objectives: This study evaluates the agreement between legacy surveillance time series data and discovers their relative fitness for use in understanding the severity of the Covid-19 emergency in the United States. Here fitness for use means the statistical agreement between events across series. Methods: 13 weekly clinical event series from before and during the Covid-19 era for the United States were collected and integrated into a (multi) time series event data model. The Centers for Disease Control and Prevention (CDC) Covid-19 attributable mortality, CDC’s excess mortality model, national Emergency Medical System (EMS) calls and Medicare encounter level claims were the data sources considered in this study. Cases were indexed by week from January 2015 through June of 2021 and fit to distributed random forest models. Models returned the variable importance when predicting the series of interest from the remaining time series. Results: Model r2 statistics ranged from .78 to .99 for the share of the volumes predicted correctly. Prehospital EMS data was high value and cardiac arrest prior to EMS arrival was on average the best predictor (tied with study week). Covid-19 Medicare claims volumes can predict Covid-19 death certificates (agreement) while generic viral respiratory Medicare claim volumes cannot predict Medicare Covid-19 claims (disagreement). Conclusions: Prehospital EMS data should be considered when evaluating the severity of Covid-19 because prehospital cardiac arrest known to EMS was the strongest predictor on average across indices. Key Words Random Forest Covid-19 Public Health Statistical methods Syndromic Surveillance 1.Introduction Creating long term, multi-source, national surveillance data services for emerging disease response is a complex topic which Covid-19 has given new importance1–5. Public health emergencies seldom leave surplus time or resources to stand up novel methods and respond; further essentializing (specific) disease preparedness6–8. More often than not epidemic response is managed using preexisting data services, often legacy data series from yesteryear’s epidemics9–11. Epidemic preparedness in the United States is generally weak; and the Covid-19 response is largely drawn from preexisting pan-flu emergency plans12,13. During a public health emergency, the clinical knowledge needed to respond is developed by case surveillance drawn from preexisting data series. Covid-19 has presented an unusual opportunity to evaluate agreement across surveillance efforts within the United States. The ability to detect clinical findings from surveillance nets and epidemiology methods which were not necessarily designed to detect them in meaningful ways is high priority for the future management of emerging infectious diseases. Strikingly the difference in Covid-19 mortality for SARS impacted countries (China, South Korea, Australia) vs. the United States may come down to what emergency response plan was last implemented (SARS vs. Swine Flu) and the fitness of surveillance (case specific vs general population) rather than deeper cultural, economic, or racial differences, as have been proposed in popular media14–20. 2.Objectives In this study public health surveillance data is processed using a machine learning approach to discover the relative agreement of a surveillance event series when predicting surveillance event series. Towards objectives this study seeks to assess the agreement between event series and contrast the value of traditional surveillance methods (death certificates, influenza and respiratory infection claims volumes) with non-traditional sources such as national Emergency Medical Services (EMS) call volume data in the Covid-19 era in the United States. 3.Methods 3.1 Statistic of Interest Variable importance is the statistic of interest in this study. Variable importance means that when predicting the dependent variable, an independent variable which is of comparatively higher predictive value (association) than another is of higher (predictive) use value. When considering high variable importance with weekly event series data, series which help the machine learning models learn, predict or guess the correct dependent weekly event series could be co-occurring or mutually observed events. The high variable importance scores from different sources suggests that series are observing the same real world event across surveillance efforts as they support prediction better than noise and other candidate series (other independent variables). Of special interest are ‘high variable importance, independent variables’ from a different data source than the dependent variable. High same source variables are most likely high in value because they are similarly distributed across study weeks to their parent-sister series and in turn are not necessarily interesting. A series of events can be said to have ‘agreement value’ if it has high statistical agreement with other series from a different source. Low statistical agreement suggests ‘out of era’ events, or events which are not driven by the same causes as other series considered here. Towards noise and disagreement, influenza and respiratory infection claims volumes are considered below with Covid-19 claims volumes. Claims volumes are traditionally used in influenza surveillance. As a test of the efficacy of the models described here, Covid-19 volumes should be able to ‘out perform’ influenza volumes as the Covid-19 era is largely understood to be influenza sparse. In this way respiratory and influenza events could be understood as a control arm as well as a model output of independent interest.

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Background: The Joint Commission (JC) recently proposed criteria for certification of comprehensive stroke centers (CSCs), which have capabilities for stroke care in addition to those of primary stroke centers (PSCs). CSCs may be ideal facilities to care for patients ineligible for intravenous thrombolysis (IT). We sought to assess the availability of PSCs and CSCs and variability in their designation mechanisms in the United States (US). Methods: Numbers of designated stroke centers were determined from state Departments of Health (DOH) and JC listings and DOH surveys. These were integrated with 2010 US Census bureau data. Minimum hospital volumes for annual procedures and disease specific admissions required for CSCs (IT for 25 stroke patients, care of 20 subarachnoid hemorrhage patients, endovascular embolization of 15 cerebral aneurysms and surgical clipping of 10 aneurysms) were extracted per state from the 2009 Nationwide Inpatient Sample (NIS). Results: Projected number of CSCs are low (.28+/-0.54 per million capita). States with their own DOH based PSC designation had significantly higher numbers of all stroke centers per million capita (7+/-2 vs 3+/-2, p<0.001), primarily constituted by DOH designated PSCs. These states also had a non-significant trend towards higher numbers of CSCs per million capita, (0.81+/-0.72 vs 0.18+/-0.47). NIS data demonstrate only 1.6% (82 of 5128) of hospitals meet all 4 volume criteria, with the most deficient item being required aneurysm clippings (3.9%). Among hospitals lacking only 1 of the 4 criteria (n=131), IT volume was the major deficiency (51.8%). States with DOH based PSC designation had significantly higher numbers of hospitals achieving this goal for IT (10.8% vs 3.0%, p<0.001) even after controlling for bed size and teaching status (OR: 1.77; 95% CI: 1.49-2.11). Conclusion: Projected numbers of CSCs are low. Hospital deficiencies must be investigated in order to meet the public’s needs. States with DOH designation mechanisms have higher numbers of all stroke centers, which administer thrombolysis at higher rates. More widespread adoption of these successful state policies may increase stroke centers’ ability to care for acute ischemic stroke.

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SummaryExhaustive research is being done to establish the technologies and standards of the fifth generation (5G) of wireless communication systems. Some of the most challenging requirements of 5G systems are to increase the spectral efficiency and the capacity by a factor of 10 and 1,000, respectively. New technologies must offer an adequate framework for the 5G uses cases, which will enable higher capacities and the flexibility to adapt to dynamic scenarios. To cope with these challenging demands, a compelling approach is to exploit the current radio service bands by means of spectrum sharing and cooperation techniques, which alleviate the bandwidth requirements. In addition, advanced modulation schemes have a fundamental role in ensuring the best usage of the spectrum available in band‐limited systems. In this manuscript, we present the ultra‐wideband (UWB) technology as a prospective solution for 5G picocells and femtocells. Its main feature is its capability to operate simultaneously, without introducing interference, with current radio services on an unlicensed basis. We report experimental results reaching data rates up to 35 Gbit/s using the multiband approach of carrierless amplitude phase (MB‐CAP) modulation. To validate the versatility of the proposed system, our experimental tests were performed under the UWB regulations defined by the United States' Federal Communications Commission (FCC), the European Electronic Communications Committee (ECC), and the Russian State Committee for Radio Frequencies (SCRF). The regulations chosen provide diversity enough to demonstrate the capacity of MB‐CAP modulation to comply with worldwide regulations.

Abstract:

Background: The Uganda Government, together with development partners, has provided continuing support services (including protection, food, nutrition, healthcare, water and sanitation) to refugee-hosting Districts to successfully manage refugees from different neighbouring countries in established settlements. This service has increased the need for timely and accurate information to facilitate planning, resource allocation and decision-making. Complexity in providing effective public health interventions in refugee settings coupled with increased funding requirements has created demands for better data and improved accountability. Health data management in refugee settings is faced with several information gaps that require harmonisation of the Ugandan National Health Management Information System (UHMIS) and United Nations High Commission for Refugees (UNHCR) Refugee Health Information System (RHIS). This article discusses the rationale for harmonisation of the UNHCR RHIS, which currently captures refugee data, with the UHMIS. It also provides insights into how refugee health data management can be harmonised within a country’s national health management information system. Method: A consultative meeting with various stakeholders, including the Ugandan Ministry of Health, district health teams, representatives from UNHCR, the United Nations Children Education Fund (UNICEF), United States Government and civil society organisations, was held with an aim to review the UHMIS and UNHCR RHIS health data management systems and identify ways to harmonise the two to achieve an integrated system for monitoring health service delivery in Uganda. Results: Several challenges facing refugee-hosting district health teams with regard to health data management were identified, including data collection, analysis and reporting. There was unanimous agreement to prioritise an integrated data management system and harmonisation of national refugee stakeholder data requirements, guided by key recommendations developed at the meeting. Conclusion: This article outlines a proposed model that can be used to harmonise the UNHCR RHIS with the UHMIS. The national refugee stakeholder data requirements have been harmonised, and Uganda looks forward to achieving better health data quality through a more comprehensive national UHMIS to inform policy planning and evidence-based decision-making.

Abstract:

Background: In July 2023, the Center for Medicare and Medicaid Services (CMS) proposed broader coverage for carotid artery stenting (CAS) for patients with symptomatic (Sx) and asymptomatic carotid disease (Asx) in the United States (US) Objectives: This study provides a 15-year snapshot of current CAS and carotid endarterectomy (CEA) use in various age and sex groups of the US. Methods: We identified all Sx and Asx CAS and CEA admissions in adults (≥18 years) from the 2006-2020 National Inpatient Sample using International Classification of Diseases codes. We calculated the age and sex-specific proportions of revascularizations that were CAS and combined annual CAS/CEA counts with census data to determine annual utilization rate per 100,000 population. We used Joinpoint regression to estimate annualized percentage change (APC) in usage over time. Results: Of 1,591,651 weighted procedures over the study period, 30% were done in 60-69 year olds and 20% in ≥80 year olds. This age distribution was constant over time. 15.1% of all procedures were CAS but this proportion doubled over time such that in 2020, 29.6% of all procedures were CAS. CAS proportion increased in all age groups including those >70 years and in women, even after excluding patients with tandem occlusions (Figure 1). 22.5% of CAS and 11.7% of CEA were done in Sx patients but this proportion increased over time in both CAS and CEA (p-trend <0.001). Annual usage of CEA declined from 51.6 to 22.5 cases/100,000 population in both sexes combined (APC -5.4%, 95%CI -6.0 to -4.8), while CAS use declined from 2006-2016 but increased significantly over 2016-2020 in both men (APC 16.5%, 95%CI 10.0 to 23.3) and women (APC 15.2%, 95%CI 10.2 to 20.4) (Figure 1). Conclusion: Despite uncertain benefit in selected age and sex groups including those > 70years, CAS use has continued to increase in all age and sex groups and now accounts for one-third of carotid revascularizations . With the CMS change CAS use could increase further.

Abstract:

Abstract Background Accidental and assault gunshot wounds (GSWs) are the second leading cause of injury in the United States for youth ages 1- to 17-years-old, resulting in significant negative effects on pediatric patients’ mental health functioning. Despite the critical implications of GSWs, there has yet to be a systematic review synthesizing trends in mental health outcomes for pediatric patients; a gap the present review fills. Additionally, this review identifies evidence-based psychological interventions shown to be effective in the treatment of subclinical symptoms of psychological disorders in the general population. Methods A comprehensive search was conducted using five databases: American Psychological Association (APA) PsycInfo, APA PsycArticles, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Education Resource Information Center (ERIC), and Medical Literature Analysis and Retrieval Systems Online (MEDLINE). Twenty-two articles met inclusion criteria. Results Findings suggest pediatric GSW patients are at a significantly elevated risk for mental health disorders when compared to other- (e.g., motor vehicle collision) and non-injured youth. Disorders include post-traumatic stress, disruptive behavior, anxiety, depression, and substance use. Hospital-based violence intervention programs, cultivating supportive relationships with adults in one’s community, and trauma-focused outpatient services were identified as effective interventions for treating subclinical psychological symptoms. Conclusions Depicted in the proposed conceptual model, the present study delineates a direct association between pediatric GSWs and subsequent onset of mental health disorders. This relation is buffered by evidence-based psychological interventions targeting subclinical symptoms. Results suggest brief psychological interventions can help treat mental health challenges, minimizing risk for significant long-term concerns. Cultural adaptations to enhance the utility and accessibility of interventions for all patients are recommended.

Abstract:

Introduction The scientific validity of climate change claims, how to intervene (if at all) in environmental, economic, political and social consequences of climate change, and the adaptation and mitigation needed with any given climate change scenario, are contested areas of public, policy and academic discourses. For marginalised populations, the climate discourses around adaptation, mitigation, vulnerability and resilience are of particular importance. This paper considers the silence around disabled people in these discourses. Marci Roth of the Spinal Cord Injury Association testified before Congress in regards to the Katrina disaster: [On August 29] Susan Daniels called me to enlist my help because her sister in-law, a quadriplegic woman in New Orleans, had been unsuccessfully trying to evacuate to the Superdome for two days. […] It was clear that this woman, Benilda Caixetta, was not being evacuated. I stayed on the phone with Benilda, for the most part of the day. […] She kept telling me she’d been calling for a ride to the Superdome since Saturday; but, despite promises, no one came. The very same paratransit system that people can’t rely on in good weather is what was being relied on in the evacuation. […] I was on the phone with Benilda when she told me, with panic in her voice “the water is rushing in.” And then her phone went dead. We learned five days later that she had been found in her apartment dead, floating next to her wheelchair. […] Benilda did not have to drown. (National Council on Disability, emphasis added) According to the Intergovernmental Panel on Climate Change (IPCC), adaptation is the “Adjustment in natural or human systems in response to actual or expected climatic stimuli or their effects, which moderates harm or exploits beneficial opportunities” (IPCC, Climate Change 2007). Adaptations can be anticipatory or reactive, and depending on their degree of spontaneity they can be autonomous or planned (IPCC, Fourth Assessment Report). Adaptations can be private or public (IPCC, Fourth Assessment Report), technological, behavioural, managerial and structural (National Research Council of Canada). Adaptation, in the context of human dimensions of global change, usually refers to a process, action or outcome in a system (household, community, group, sector, region, country) in order for that system to better cope with, manage or adjust to some changing condition, stress, hazard, risk or opportunity (Smit and Wandel). Adaptation can encompass national or regional strategies as well as practical steps taken at the community level or by individuals. According to Smit et al, a framework for systematically defining adaptations is based on three questions: (i) adaptation to what; (ii) who or what adapts; and (iii) how does adaptation occur? These are essential questions that have to be looked at from many angles including cultural and anthropological lenses as well as lenses of marginalised and highly vulnerable populations. Mitigation (to reduce or prevent changes in the climate system), vulnerability (the degree to which a system is susceptible to, and unable to cope with, the adverse effects of climate change), and resilience (the amount of change a system can undergo without changing state), are other important concepts within the climate change discourse. Non-climate stresses can increase vulnerability to climate change by reducing resilience and can also reduce adaptive capacity because of resource deployment to competing needs. Extending this to the context of disabled people, ableism (sentiment to expect certain abilities within humans) (Wolbring, “Is there an end to out-able?”) and disablism (the unwillingness to accommodate different needs) (Miller, Parker and Gillinson) are two concepts that will thus play themselves out in climate discourses. The “Summary for Policymakers” of the IPCC 2007 report, Climate Change 2007: Impacts, Adaptation and Vulnerability, states: “Poor communities can be especially vulnerable, in particular those concentrated in high-risk areas. They tend to have more limited adaptive capacities, and are more dependent on climate-sensitive resources such as local water and food supplies.” From this quote one can conclude that disabled people are particularly impacted, as the majority of disabled people live in poverty (Elwan). For instance, CARE International, a humanitarian organisation fighting global poverty, the UN Office for the Coordination of Humanitarian Affairs, and Maplecroft, a company that specialises in the calculation, analysis and visualisation of global risks, conclude: “The degree of vulnerability is determined by underlying natural, human, social, physical and financial factors and is a major reason why poor people—especially those in marginalised social groups like women, children, the elderly and people with disabilities—are most affected by disasters” (CARE International). The purpose of this paper is to expose the reader to (a) how disabled people are situated in the culture of the climate, adaptation, mitigation and resilience discourse; (b) how one would answer the three questions, (i) adaptation to what, (ii) who or what adapts, and (iii) how does adaptation occur (Smit et al), using a disabled people lens; and (c) what that reality of the involvement of disabled people within the climate change discourse might herald for other groups in the future. The paper contends that there is a pressing need for the climate discourse to be more inclusive and to develop a new social contract to modify existing dynamics of ableism and disablism so as to avoid the uneven distribution of evident burdens already linked to climate change. A Culture of Neglect: The Situation of Disabled People As climates changes, environmental events that are classified as natural disasters are expected to be more frequent. In the face of recent disaster responses, how effective have these efforts been as they relate to the needs and challenges faced by disabled people? Almost immediately after Hurricane Katrina devastated the Gulf Coast, the National Council on Disability (NCD) in the United States estimated that 155,000 people with disabilities lived in the three cities hardest hit by the hurricane (about 25 per cent of the cities’ populations). The NCD urged emergency managers and government officials to recognise that the need for basic necessities by hurricane survivors with disabilities was “compounded by chronic health conditions and functional impairments … [which include] people who are blind, people who are deaf, people who use wheelchairs, canes, walkers, crutches, people with service animals, and people with mental health needs.” The NCD estimated that a disproportionate number of fatalities were people with disabilities. They cited one statistic from the American Association of Retired Persons (AARP): “73 per cent of Hurricane Katrina-related deaths in New Orleans area were among persons age 60 and over, although they comprised only 15 per cent of the population in New Orleans.” As the NCD stated, “most of those individuals had medical conditions and functional or sensory disabilities that made them more vulnerable. Many more people with disabilities under the age of 60 died or were otherwise impacted by the hurricanes.” As these numbers are very likely linked to the impaired status of the elderly, it seems reasonable to assume similar numbers for non-elderly disabled people. Hurricane Katrina is but one example of how disabled people are neglected in a disaster (Hemingway and Priestley; Fjord and Manderson). Disabled people were also disproportionately impacted in other disasters, such as the 1995 Great Hanshin Earthquake in Japan (Nakamura) or the 2003 heatwave in France, where 63 per cent of heat-related deaths occurred in institutions, with a quarter of these in nursing homes (Holstein et al.). A review of 18 US heatwave response plans revealed that although people with mental or chronic illnesses and the homeless constitute a significant proportion of the victims in recent heatwaves, only one plan emphasised outreach to disabled persons, and only two addressed the shelter and water needs of the homeless (Ebi and Meehl; Bernhard and McGeehin). Presence of Disabled People in Climate Discourse Although climate change will disproportionately impact disabled people, despite the less than stellar record of disaster adaptation and mitigation efforts towards disabled people, and despite the fact that other social groups (such as women, children, ‘the poor’, indigenous people, farmers and displaced people) are mentioned in climate-related reports such as the IPCC reports and the Human Development Report 2007/2008, the same reports do not mention disabled people. Even worse, the majority of the material generated by, and physically set up for, discourses on climate, is inaccessible for many disabled people (Australian Human Rights Commission). For instance, the IPCC report, Climate Change 2007: Impacts, Adaptation and Vulnerability, contains Box 8.2: Gender and natural disasters, makes the following points: (a) “men and women are affected differently in all phases of a disaster, from exposure to risk and risk perception; to preparedness behaviour, warning communication and response; physical, psychological, social and economic impacts; emergency response; and ultimately to recovery and reconstruction”; (b) “natural disasters have been shown to result in increased domestic violence against, and post-traumatic stress disorders in, women”; and (c) “women make an important contribution to disaster reduction, often informally through participating in disaster management and acting as agents of social change. Their resilience and their networks are critical in household and community recovery.” The content of Box 8.2 acknowledges the existence of different perspectives and contributions to the climate discourse, and that it is beneficial to explore these differences. It seems reasonable to assume that differences in perspectives, contributions and impact may well also exist between people with and without disabilities, and that it may be likewise beneficial to explore these differences. Disabled people are differently affected in all phases of a disaster, from exposure to risk and risk perception; to preparedness behaviour, warning communication and response; physical, psychological, social and economic impacts; emergency response; and ultimately to recovery and reconstruction. Disabled people could also make an important contribution to disaster reduction, often informally through participating in disaster management and acting as agents of social change. Their resilience and their networks are critical in household and community recovery, important as distributors of relief efforts and in reconstruction design. The Bonn Declaration from the 2007 international conference, Disasters are always Inclusive: Persons with Disabilities in Humanitarian Emergency Situations, highlighted many problems disabled people are facing and gives recommendations for inclusive disaster preparedness planning, for inclusive response in acute emergency situations and immediate rehabilitation measures, and for inclusive post-disaster reconstruction and development measures. Many workshops were initiated by disabled people groups, such as Rehabilitation International. However, the disabled people disaster adaptation and mitigation discourse is not mainstreamed. Advocacy by people with disability for accessible transport and universal or “life-cycle” housing (among other things) shows how they can contribute significantly to more effective social systems and public facilities. These benefit everyone and help to shift public expectations towards accessible and flexible amenities and services—for example, emergency response and evacuation procedures are much easier for all if such facilities are universally accessible. Most suggestions by disabled people for a more integrative, accessible physical environment and societal attitude benefit everyone, and gain special importance with the ever-increasing proportion of elderly people in society. The IPCC Fourth Assessment Report is intended to be a balanced assessment of current knowledge on climate change mitigation. However, none of the 2007 IPCC reports mention disabled people. Does that mean that disabled people are not impacted by, or impact, climate change? Does no knowledge of adaptation, mitigation and adaptation capacity from a disabled people lens exist, or does the knowledge not reach the IPCC, or does the IPCC judge this knowledge as irrelevant? This culture of neglect and unbalanced assessment of knowledge evident in the IPCC reports was recognised before for rise of a ‘global’ climate discourse. For instance, a 2001 Canadian government document asked that research agendas be developed with the involvement of, among others, disabled people (Health Canada). The 2009 Nairobi Declaration on Africa’s response to climate change (paragraph 36) also asks for the involvement of disabled people (African Ministerial Conference on the Environment). However, so far nothing has trickled up to the international bodies, like the IPCC, or leading conferences such as the United Nations Climate Change Conference Copenhagen 2009. Where Will It End? In his essay, “We do not need climate change apartheid in adaptation”, in the Human Development Report 2007/2008, Archbishop Desmond Tutu suggests that we are drifting into a situation of global adaptation apartheid—that adaptation becomes a euphemism for social injustice on a global scale (United Nations Development Programme). He uses the term “adaptation apartheid” to highlight the inequality of support for adaptation capacity between high and low income countries: “Inequality in capacity to adapt to climate change is emerging as a potential driver of wider disparities in wealth, security and opportunities for human development”. I submit that “adaptation apartheid” also exists in regard to disabled people, with the invisibility of disabled people in the climate discourse being just one facet. The unwillingness to accommodate, to help the “other,” is nothing new for disabled people. The ableism that favours species-typical bodily functioning (Wolbring, “Is there an end to out-able?”; Wolbring, “Why NBIC?”) and disablism (Miller, Parker, and Gillinson)—the lack of accommodation enthusiasm for the needs of people with ‘below’ species-typical body abilities and the unwillingness to adapt to the needs of “others”—is a form of “adaptation apartheid,” of accommodation apartheid, of adaptation disablism that has been battled by disabled people for a long time. In a 2009 online survey of 2000 British people, 38 per cent believed that most people in British society see disabled people as a “drain on resources” (Scope). A majority of human geneticist concluded in a survey in 1999 that disabled people will never be given the support they need (Nippert and Wolff). Adaptation disablism is visible in the literature and studies around other disasters. The 1988 British Medical Association discussion document, Selection of casualties for treatment after nuclear attack, stated “casualties whose injuries were likely to lead to a permanent disability would receive lower priority than those expected to fully recover” (Sunday Morning Herald). Famine is seen to lead to increased infanticide, increased competitiveness and decreased collaboration (Participants of the Nuclear Winter: The Anthropology of Human Survival Session). Ableism and disablism notions experienced by disabled people can now be extended to include those challenges expected to arise from the need to adapt to climate change. It is reasonable to expect that ableism will prevail, expecting people to cope with certain forms of climate change, and that disablism will be extended, with the ones less affected being unwilling to accommodate the ones more affected beyond a certain point. This ableism/disablism will not only play itself out between high and low income countries, as Desmond Tutu described, but also within high income countries, as not every need will be accommodated. The disaster experience of disabled people is just one example. And there might be climate change consequences that one can only mitigate through high tech bodily adaptations that will not be available to many of the ones who are so far accommodated in high income countries. Desmond Tutu submits that adaptation apartheid might work for the fortunate ones in the short term, but will be destructive for them in the long term (United Nations Development Programme). Disability studies scholar Erik Leipoldt proposed that the disability perspective of interdependence is a practical guide from the margins for making new choices that may lead to a just and sustainable world—a concept that reduces the distance between each other and our environment (Leipoldt). This perspective rejects ableism and disablism as it plays itself out today, including adaptation apartheid. Planned adaptation involves four basic steps: information development and awareness-raising; planning and design; implementation; and monitoring and evaluation (Smit et al). Disabled people have important knowledge to contribute to these four basic steps that goes far beyond their community. Their understanding and acceptance of, for example, the concept of interdependence, is just one major contribution. Including the concept of interdependence within the set of tools that inform the four basic steps of adaptation and other facets of climate discourse has the potential to lead to a decrease of adaptation apartheid, and to increase the utility of the climate discourse for the global community as a whole. References African Ministerial Conference on the Environment. Nairobi Declaration on the African Process for Combating Climate Change. 2009. 26 Aug. 2009 ‹ http://www.unep.org/roa/Amcen/Amcen_Events/3rd_ss/Docs/nairobi-Decration-2009.pdf ›. American Association of Retired Persons. We Can Do Better: Lessons Learned for Protecting Older Persons in Disasters. 2009. 26 Aug. 2009 ‹ http://assets.aarp.org/rgcenter/il/better.pdf ›. Australian Human Rights Commission. “Climate Change Secretariat Excludes People with Disabilities.” 2008. 26 Aug. 2009 ‹ http://www.hreoc.gov.au/about/media/media_releases/2008/95_08.html ›. Bernhard, S., and M. McGeehin. “Municipal Heatwave Response Plans.” American Journal of Public Health 94 (2004): 1520-21. CARE International, the UN Office for the Coordination of Humanitarian Affairs, and Maplecroft. Humanitarian Implications of Climate Change: Mapping Emerging Trends and Risk Hotspots for Humanitarian Actors. CARE International, 2008. 26 Aug. 2009 ‹ http://www.careclimatechange.org/files/reports/Human_Implications_PolicyBrief.pdf ›, ‹ http://www.careclimatechange.org/files/reports/CARE_Human_Implications.pdf ›. "Disasters Are Always Inclusive: Persons with Disabilities in Humanitarian Emergency Situations." Bonn Declaration from the International Conference: Disasters Are Always Inclusive: Persons with Disabilities in Humanitarian Emergency Situations. 2007. 26 Aug. 2009 ‹ http://www.disabilityfunders.org/webfm_send/6, http://www.disabilityfunders.org/emergency_preparedness ›, ‹ http://bezev.de/bezev/aktuelles/index.htm ›. Ebi, K., and G. Meehl. Heatwaves and Global Climate Change: The Heat Is On: Climate Change and Heatwaves in the Midwest. 2007. 26 Aug. 2009 ‹ www.pewclimate.org/docUploads/Regional-Impacts-Midwest.pdf ›. Elwan, A. Poverty and Disability: A Survey of the Literature. Worldbank, Social Protection Discussion Paper Series (1999): 9932. 26 Aug. 2009 ‹ http://siteresources.worldbank.org/DISABILITY/Resources/Poverty/Poverty_and_Disability_A_Survey_of_the_Literature.pdf ›. Fjord, L., and L. Manderson. “Anthropological Perspectives on Disasters and Disability: An Introduction.” Human Organisation 68.1 (2009): 64-72. Health Canada. First Annual National Health and Climate Change Science and Policy Research Consensus Conference: How Will Climate Change Affect Priorities for Your Health Science and Policy Research? Health Canada, 2001. 26 Aug. 2009 ‹ http://www.hc-sc.gc.ca/ewh-semt/pubs/climat/research-agenda-recherche/population-eng.php ›. Hemingway, L., and M. Priestley. “Natural Hazards, Human Vulnerability and Disabling Societies: A Disaster for Disabled People?” The Review of Disability Studies (2006). 26 Aug. 2009 ‹ http://www.rds.hawaii.edu/counter/count.php?id=13 ›. Holstein, J., et al. “Were Less Disabled Patients the Most Affected by the 2003 Heatwave in Nursing Homes in Paris, France?” Journal of Public Health Advance 27.4 (2005): 359-65. Intergovernmental Panel on Climate Change. Climate Change 2007: Impacts, Adaptation and Vulnerability. 2007. 26 Aug. 2009 ‹ http://www.ipcc.ch/publications_and_data/publications_ipcc_fourth_assessment_report_wg2_report_impacts_adaptation_and_vulnerability.htm ›. Intergovernmental Panel on Climate Change. “Summary for Policymakers.” Eds. O. F. Canziani, J. P. Palutikof, P. J. van der Linden, C. E. Hanson, and M.L.Parry. Cambridge, UK: Cambridge University Press, 2007. 7-22. 26 Aug. 2009 ‹ http://www.ipcc.ch/pdf/assessment-report/ar4/wg2/ar4-wg2-spm.pdf ›. Intergovernmental Panel on Climate Change. IPCC Fourth Assessment Report Working Group III Report: Mitigation of Climate Change Glossary. 2007. 26 Aug. 2009 ‹ http://www.ipcc.ch/ipccreports/ar4-wg3.htm, http://www.ipcc.ch/pdf/assessment-report/ar4/wg3/ar4-wg3-annex1.pdf ›. Leipoldt, E. “Disability Experience: A Contribution from the Margins. Towards a Sustainable Future.” Journal of Futures Studies 10 (2006): 3-15. Miller, P., S. Parker and S. Gillinson. “Disablism: How to Tackle the Last Prejudice.” Demos, 2004. 26 Aug. 2009 ‹ http://www.demos.co.uk/files/disablism.pdf ›. Nakamura, K. “Disability, Destitution, and Disaster: Surviving the 1995 Great Hanshin Earthquake in Japan.” Human Organisation 68.1 (2009): 82-88. National Council on Disability, National Council on Independent Living, National Organization on Disability, and National Spinal Cord Injury Association and the Paralyzed Veterans of America. Emergency Management and People with Disabilities: before, during and after Congressional Briefing, 10 November 2005. 26 Aug. 2009 ‹ http://www.ncd.gov/newsroom/publications/2005/transcript_emergencymgt.htm ›. National Council on Disability. National Council on Disability on Hurricane Katrina Affected Areas. 2005. 26 Aug. 2009 ‹ http://www.ncd.gov/newsroom/publications/2005/katrina2.htm ›. National Research Council of Canada. From Impacts to Adaptation: Canada in a Changing Climate 2007. 26 Aug. 2009 ‹ http://adaptation.nrcan.gc.ca/assess/2007/pdf/full-complet_e.pdf ›. Nippert, I. and G. Wolff. “Ethik und Genetik: Ergebnisse der Umfrage zu Problemaspekten angewandter Humangenetik 1994-1996, 37 Länder.” Medgen 11 (1999): 53-61. Participants of the Nuclear Winter: The Anthropology of Human Survival Session. Proceedings of the 84th American Anthropological Association's Annual Meeting. Washington, D.C., 6 Dec. 1985. 26 Aug. 2009 ‹ http://www.fas.org/sgp/othergov/doe/lanl/lib-www/la-pubs/00173165.pdf ›. Scope. “Most Britons Think Others View Disabled People ‘As Inferior’.” 2009. 26 Aug. 2009 ‹ http://www.scope.org.uk/cgi-bin/np/viewnews.cgi?id=1244379033, http://www.comres.co.uk/resources/7/Social%20Polls/Scope%20PublicPoll%20Results%20May09.pdf ›. Smit, B., et al. “The Science of Adaptation: A Framework for Assessment.” Mitigation and Adaptation Strategies for Global Change 4 (1999): 199-213. Smit, B., and J. Wandel. “Adaptation, Adaptive Capacity and Vulnerability.” Global Environmental Change 16 (2006): 282-92. Sunday Morning Herald. “Who Lives and Dies in Britain after the Bomb.” Sunday Morning Herald 1988. 26 Aug. 2009 ‹ http://news.google.com/newspapers?nid=1301&dat=19880511&id=wFYVAAAAIBAJ&sjid=kOQDAAAAIBAJ&pg=3909,113100 ›. United Nations Development Programme. Human Development Report 2007/2008: Fighting Climate Change – Human Solidarity in a Divided World. 2008. 26 Aug. 2009 ‹ http://hdr.undp.org/en/media/HDR_20072008_EN_Complete.pdf ›. Wolbring, Gregor. “Is There an End to Out-Able? Is There an End to the Rat Race for Abilities?” M/C Journal 11.3 (2008). 26 Aug. 2009 ‹ http://journal.media-culture.org.au/index.php/mcjournal/article/viewArticle/57 ›. Wolbring, Gregor. “Why NBIC? Why Human Performance Enhancement?” Innovation: The European Journal of Social Science Research 21.1 (2008): 25-40.

Abstract:

Introduction: Cesarean section is one of the most commonly performed surgical procedures. In 2020, there were over 3.6 million births in the United States, and of these, approximately 31.8% were delivered by cesarean section. In 2015, the World Health organization issued a statement in which a 10-15% population-based cesarean rate was recommended. It was noted that any increase in the cesarean section rate above this 10-15% baseline was not associated with any reduced neonatal/maternal mortality. Shortly after the WHO’s statement, a report was released noting that there was an observed improvement in maternal and neonatal mortality as cesarean section rates increased up to nearly 20%. The WHO subsequently acknowledged that there had been no standardized method for monitoring the rate of c-sections when they came to their proposed rate of 10-15%. Since their 2015 statement, the WHO has clarified their position and has explicitly stated that recommending a specific/targeted c-section rate for a hospital is inappropriate. In February of 2021, the Joint Commission began reporting hospitals’ primary cesarean section rates, giving then an “acceptable” rating if the facility’s PC-02 rate was 30% or lower, or a rating of unacceptable if their rate was higher than 30%. (The PC-02 rate consists solely of the number of deliveries for women with their first full-term, singleton pregnancy with baby in vertex presentation -head down). The Joint Commission recommends a primary c-section rate of under 30%, and as hospital accreditation and reimbursem*nt from Medicare and Medicaid is closely tied to Joint Commission accreditation, many hospitals are now working to influence their physicians in a manner that will bring about a decrease in the number of c-sections that occur at their facilities. It is important to note that at this time neither the American Medical Association, the American Academy of Family Physicians, nor the American College of Obstetricians and Gynecologists have offered recommendations regarding what they believe the optimal c-section rate to be. The American College of Obstetricians and Gynecologists has instead taken a more epidemiological approach, and in their statement to USA Today notes, “National target c-section rates should be based on clinical data that has been risk-adjusted specifically to the hospital’s patient population, and that target rates are meant to be calculated across all births, not across hospitals.” This report is the first to our knowledge to look at a sole provider’s PC-02 rate across multiple hospitals. Methods: Clinic data was reviewed from patients who saw a single practitioner, Jonathan Faro, MD, PhD, from October 1, 2021 through September 30, 2022. This provider had maintained clinical privileges at three hospitals in the Houston metropolitan area, and when counseling his patients at where they would prefer to deliver, he simply asked them their preference. The hospitals that Dr. Faro delivered at during this period were Memorial Hermann Hospital Memorial City, The Woman’s Hospital of Texas, and Memorial Hermann Hospital Texas Medical Center. As this was a retrospective chart review and no identifying patient data were obtained, no IRB approval was requested. Patients were excluded if they were not nulliparous, were not full term, did not have a singleton pregnancy or if the fetus was not in vertex presentation. Demographic data was abstracted as well from the patient’s clinic record and included the patient’s age, gravidity, parity, BMI at delivery, ethnicity, and presence of any co-morbidities including diabetes, hypertension, and tobacco use. Results: From October 1, 2021 through September 30, 2022, a total of 105 patients were delivered by the physician. (This excludes patients that the physician delivered for any other physicians while on call.) 57 of these were delivered at Hospital A, 46 were delivered at Hospital B, and only 2 were delivered at Hospital C. Of these 105 patients, 19 met the criteria to be considered under the PC-02 criteria. Review of the demographic data revealed that there were no statistically significant differences between age, ethnicity, or presence of medical co-morbidities in either group. In Hospital A, obesity did appear to be associated with greater risk of c-section. Of the 9 patients delivered at Hospital A by the Physician, 11% resulted in c-section. Of the 8 patients delivered at Hospital B by the physician, 50% resulted in c-section. Of the 2 patients who delivered at Hospital C, none underwent c-section. Discussion: The Centers for Disease Control and Prevention established a recommended c-section rate of 23.9% as one of its healthy people 2020 goals. Shortly after, multiple organizations endorsed this, including the national Quality Forum, the Joint Commission, the Leapfrog Group, and the Centers for Medicaid and Medicare Services. This paper illustrates three very different primary c-section rates for a single provider. With rates ranging from 0%, to 11%, to 50%, one can easily see that it may be anything but the provider who is the driving force determining the primary c-section rate. This paper indirectly suggests that there are likely multiple factors separate from the provider that contribute towards a patient undergoing a primary c-section. Focusing on applying disincentives or even punishments to providers is perhaps the greatest disservice and this approach should be abandoned.

Abstract:

Introduction: Cesarean section is one of the most commonly performed surgical procedures. In 2020, there were over 3.6 million births in the United States, and of these, approximately 31.8% were delivered by cesarean section. In 2015, the World Health organization issued a statement in which a 10-15% population-based cesarean rate was recommended. It was noted that any increase in the cesarean section rate above this 10-15% baseline was not associated with any reduced neonatal/maternal mortality. Shortly after the WHO’s statement, a report was released noting that there was an observed improvement in maternal and neonatal mortality as cesarean section rates increased up to nearly 20%. The WHO subsequently acknowledged that there had been no standardized method for monitoring the rate of c-sections when they came to their proposed rate of 10-15%. Since their 2015 statement, the WHO has clarified their position and has explicitly stated that recommending a specific/targeted c-section rate for a hospital is inappropriate. In February of 2021, the Joint Commission began reporting hospitals’ primary cesarean section rates, giving then an “acceptable” rating if the facility’s PC-02 rate was 30% or lower, or a rating of unacceptable if their rate was higher than 30%. (The PC-02 rate consists solely of the number of deliveries for women with their first full-term, singleton pregnancy with baby in vertex presentation -head down). The Joint Commission recommends a primary c-section rate of under 30%, and as hospital accreditation and reimbursem*nt from Medicare and Medicaid is closely tied to Joint Commission accreditation, many hospitals are now working to influence their physicians in a manner that will bring about a decrease in the number of c-sections that occur at their facilities. It is important to note that at this time neither the American Medical Association, the American Academy of Family Physicians, nor the American College of Obstetricians and Gynecologists have offered recommendations regarding what they believe the optimal c-section rate to be. The American College of Obstetricians and Gynecologists has instead taken a more epidemiological approach, and in their statement to USA Today notes, “National target c-section rates should be based on clinical data that has been risk-adjusted specifically to the hospital’s patient population, and that target rates are meant to be calculated across all births, not across hospitals.” This report is the first to our knowledge to look at a sole provider’s PC-02 rate across multiple hospitals. Methods: Clinic data was reviewed from patients who saw a single practitioner, Jonathan Faro, MD, PhD, from October 1, 2021 through September 30, 2022. This provider had maintained clinical privileges at three hospitals in the Houston metropolitan area, and when counseling his patients at where they would prefer to deliver, he simply asked them their preference. The hospitals that Dr. Faro delivered at during this period were Memorial Hermann Hospital Memorial City, The Woman’s Hospital of Texas, and Memorial Hermann Hospital Texas Medical Center. As this was a retrospective chart review and no identifying patient data were obtained, no IRB approval was requested. Patients were excluded if they were not nulliparous, were not full term, did not have a singleton pregnancy or if the fetus was not in vertex presentation. Demographic data was abstracted as well from the patient’s clinic record and included the patient’s age, gravidity, parity, BMI at delivery, ethnicity, and presence of any co-morbidities including diabetes, hypertension, and tobacco use. Results: From October 1, 2021 through September 30, 2022, a total of 105 patients were delivered by the physician. (This excludes patients that the physician delivered for any other physicians while on call.) 57 of these were delivered at Hospital A, 46 were delivered at Hospital B, and only 2 were delivered at Hospital C. Of these 105 patients, 19 met the criteria to be considered under the PC-02 criteria. Review of the demographic data revealed that there were no statistically significant differences between age, ethnicity, or presence of medical co-morbidities in either group. In Hospital A, obesity did appear to be associated with greater risk of c-section. Of the 9 patients delivered at Hospital A by the Physician, 11% resulted in c-section. Of the 8 patients delivered at Hospital B by the physician, 50% resulted in c-section. Of the 2 patients who delivered at Hospital C, none underwent c-section. Discussion: The Centers for Disease Control and Prevention established a recommended c-section rate of 23.9% as one of its healthy people 2020 goals. Shortly after, multiple organizations endorsed this, including the national Quality Forum, the Joint Commission, the Leapfrog Group, and the Centers for Medicaid and Medicare Services. This paper illustrates three very different primary c-section rates for a single provider. With rates ranging from 0%, to 11%, to 50%, one can easily see that it may be anything but the provider who is the driving force determining the primary c-section rate. This paper indirectly suggests that there are likely multiple factors separate from the provider that contribute towards a patient undergoing a primary c-section. Focusing on applying disincentives or even punishments to providers is perhaps the greatest disservice and this approach should be abandoned.

Abstract:

BOB Hydrographics, LLC conducted a marine archaeological assessment for portions of the Bluewater SPM Project proposed in Nueces and Aransas counties and adjoining federal waters. These archaeological investigations were sponsored by Lloyd Engineering, Inc. on behalf of Bluewater Texas Terminal, LLC. The marine portion of this project comprises two segments: Offshore and Inshore. The Inshore project corridor parallels the Aransas Ship Channel from the community of Aransas Pass to Harbor Island, crossing portions of State Mineral Lease Tracts 309, 310, 313, 314 in Corpus Christi Bay, and then crosses beneath the Lydia Ann Channel to San Jose Island, including a portion of Tract 306 in Aransas Bay. The Offshore project corridor crosses portions of State Mineral Lease Tracts 693, 694, 695 (same as MI-695), 721, 836, 837, 838, 839, 844, 845, 846, 847, 848, 849, 850, and 851 on the Gulf side of San Jose Island, and then crosses portions of Federal Lease Blocks MI-695, MI-696, MI-697, MI-698, and MI-699. The marine Area of Potential Effect (APE) is a 2,000-foot-wide corridor, offshore of San Jose Island, and a 1,000-foot-wide corridor, inshore of San Jose Island. Both Inshore and Offshore APEs are centered on the construction right-of-way and include the proposed lay barge anchorage. The APE totals 7,174 acres, including 3,079 acres in federal waters and 4,095 acres in state waters. The APE in state waters totals 288 acres Inshore and 3,807 acres Offshore in the Gulf of Mexico. Water depth ranges from 2-30 feet (ft) Inshore and from 0-92 ft Offshore. The Project proposes construction of a Deepwater Port (DWP) with two single point mooring (SPM) buoys and associated pipelines. The DWP would be located 17.3 miles offshore of San Jose Island in approximately 89.5 ft of water. The DWP would allow simultaneous loading of two Very Large Crude Carrier tankers with domestic crude oil via two 30-inch sub-marine pipelines. Pipes will be directionally drilled beneath all shorelines and Inshore waterways. Offshore pipes will be buried by a jetting sled to a depth of 6-7 ft below the seafloor with 36 inches of cover. The sled will discharge sediment back into the trench to facilitate backfilling. Subsea pipes will be separated by 10-15 ft, horizontally, within a proposed 75-ft-wide construction right-of-way. Offshore pipes will be installed from a conventional pipelay barge with an 8-point anchor system (using 4 at a time). Inshore pipes will be directionally drilled beneath all bay waters. The purpose of this study was to assess the potential for submerged archaeological sites in the APE; however, no artifacts were collected during the survey. Submerged archaeological sites, in this context, might be historic sites, such as sunken or abandoned watercraft; or drowned terrestrial prehistoric sites dating to the late Pleistocene or Early Holocene when the APE was last above sea level. A review of the cultural background determined that 11 marine archaeological investigations have been conducted within 3 miles of this project. At least, 95 wrecks have been reported within 3 miles of the APE. Geophysical survey was completed by Naismith Marine Services, Inc. from January 4 through April 19, 2019 under Texas Antiquities Permit 8672. A variety of equipment was used to conduct the marine survey, depending on water depths, including multi- and single-beam echo sounders, a sub-bottom profiler, sidescan sonar, and a magnetometer. Archaeologists monitored the acquisition of all data in state waters. Analysis of geophysical survey results from this investigation discovered three significant targets, including one in federal waters (Anomaly 1), and two in state waters (anomalies 2 and 3). All three targets are potentially eligible for the National Register of Historic Places and are recommended for avoidance. The two targets in state waters also may be eligible as State Antiquities Landmarks. Anomaly 2, is confirmed as a shipwreck by sonar imagery and is designated as an archaeological site, 41AS119. No potential historic sites were discovered by the Inshore survey. There is low potential for the presence of intact prehistoric sites in the Offshore APE. The top of the Beaumont Formation is exposed at the seafloor between the 31- ft and 46-ft isobaths and is buried by Holocene sediments to varying depths beneath the remainder of the survey corridor. This former land surface had little protection from wave energy during sea-level rise and is still actively eroding along portions of the APE where exposed. The Texas Historical Commission did not require sub-bottom data in the bay, so areas of high potential for submerged prehistoric sites were not mapped there. This study was completed in compliance with Section 106 of the National Historic Preservation Act (Public Law 89-665; 16 U.S.C. 470) and the Antiquities Code of Texas (Texas Natural Resource Code, Title 9, Chapter 191). The minimum reporting and survey requirements for marine archaeological studies conducted under a Texas Antiquities Permit are mandated by The Texas Administrative Code, Title 13, Part 2, Chapters 26 and 28, respectively. The petroleum industry is regulated in federal waters, beyond 9 nautical miles offshore, by the Bureau of Ocean Energy Management (BOEM), an agency of the United States Department of the Interior. This study also complies with archaeological requirements published by BOEM in their Notice to Lessees 2005-G07. Archaeological project records are curated at the Center for Archeological Study at Texas State University in San Marcos.

Abstract:

Energy Transfer Company (ETC) is proposing to construct the Orbit Pipeline Project (Project) located in Jefferson, Liberty, and Chambers counties, Texas. The Project consists of approximately 68.7 miles (mi) (110.6 kilometer [km]) of new 20.0-inch (in) (50.8-centimeter [cm]) diameter pipeline that will be used to transmit ethane and propane. The Project is located within the jurisdictional boundary of the United States Army Corps of Engineers (USACE) - Galveston District. At the request of ETC, Perennial Environmental Services, LLC (Perennial) conducted an intensive Phase I cultural resources investigation for the proposed Project to comply with anticipated USACE permitting requirements. Archaeological investigations for the Project were conducted in accordance with Section 106 of the National Historic Preservation Act (NHPA) and Texas State Historical Preservation Office (SHPO) standards. Additionally, the Project traverses several discontinuous publicly-owned tracts that fall under the jurisdiction of the Antiquities Code of Texas (Code). The results of survey investigations conducted under Texas Antiquities Permit (TAP) #8690 (issued December 17, 2018, and amended on August 30, 2019) across six discontinuous publicly -owned tracts are also presented herein. Consistent with USACE application requirements, and in accordance with Section 106 of the NHPA of 1966, as amended (36 CFR 800) and the Code, the proposed Project must make a reasonable and good faith effort to identify historic properties within the Project Area of Potential Effect (APE) and to take into account any potential effects, direct or indirect, the proposed undertaking could have on properties listed or considered eligible for listing in the National Register of Historic Places (NRHP) or for designation as a State Antiquities Landmark (SAL), as warranted. As the Project footprint was not finalized at the time of field investigations, survey efforts were concentrated within the vicinity of delineated wetland and waterbody features along the length of the route within a 300.0-foot- (ft-) (91.4-meter- [m-]) wide Environmental Survey Area (ESA). The anticipated depths of impact for the Project will range from 4.0 to 7.0 ft. (1.2 to 2.1 m) along the pipeline centerline, with limited deeper impacts at horizontal directional drill (HDD) and bore locations, including Cow Island Bayou, Hillebrandt Bayou, Lower Neches Valley River Authority canals, Nolte Canal, the Trinity River, Turtle Bayou, Whites Bayou, Willow Marsh Bayou, and public road crossings. The anticipated depths of impact for temporary workspace areas within the Project APE corridor would not exceed 0.6 to 1.0 ft. (0.1 to 0.3 m). The overall APE for direct effects for the Project measured 2307.19 acres (ac) (933.68 ha), while APE for Code-permitted tracts totaled 210.0 ac (85.06 ha). As presented herein, the Project ESA is coterminous with the Project APE, which is also referred to as the USACE permit areas. Only the areas adjacent to the USACE permit areas and the entirety of Code-permitted areas were surveyed for cultural resources. Jennifer Cochran served as the Principal Investigator, and field efforts were conducted by Sarah Boudreaux, Rafael Cortez, Wyatt Ellison, Rachel Kelley, William Kinkner, Colene Knaub, Jonathan Laird, Alejandro Martinez, and Thomas Ross across multiple field mobilizations between October 1, 2018, and November 12, 2019. Investigations included an archival background review and intensive pedestrian surveys augmented by shovel testing in the vicinity of delineated wetland and waterbody features. Archival research determined that there are no previously recorded sites within, or directly adjacent to the Project APE, and approximately 32.7% of the Project APE has been previously surveyed for cultural resources. However, many of these surveys are outdated and do not meet modern survey standards. Additionally, many of these previously surveys were conducted for USACE-permitted projects, and the entire Project was not surveyed for the presence of cultural resources. As such, all areas surrounding identified wetland and waterbody for this Project were surveyed. Perennial biologists delineated a total of 490 wetland areas. Of the 490 wetlands identified within the Project APE, 290 were characterized as palustrine emergent (PEM) wetlands, 106 were characterized as palustrine forested (PFO) wetlands, 4 were classified as PFO-Cypress wetlands, and 90 were characterized as palustrine scrub-shrub (PSS) wetlands. Perennial biologists also identified 270 waterbodies that ranged from perennial streams to ephemeral streams. Of the 270 waterbodies delineated, 36 were classified as having perennial flow, 66 were classified as having intermittent flow, and 148 were classified as ephemeral flow. Additionally, 20 open water features were delineated and classified as manmade ponds. Survey efforts were concentrated in the vicinity of these features where land access was voluntarily granted in accordance with a scope of work for the Project approved by the USACE on August 28, 2018, and the Texas Historical Commission (THC) on October 1, 2018. Following the approval of the scope of work, ETC extended the eastern terminus of the Project to the western bank of the Neches River, and other minor reroutes were also implemented. Perennial applied the approved survey methodology to all new Project components. For Code-permitted tracts, surveys were conducted across the entire length of the Project APE corridor in accordance with a stand-alone scope submitted to the THC on December 14, 2018, and amended August 30, 2019. Additionally, following the receipt of TAP#8690, the proposed Project was routed onto two additional publicly-owned tracts belonging to the Texas Department of Corrections (DOC) – Stiles Unit and Jefferson County. The TAP #8690 was revised and amended on August 30, 2019. Following this August 30, 2019 amendment, ETC added additional route options across the DOC – Stiles Unit tract. This additional mileage was surveyed using the same methods as stated in the previously presented revised TAP scope of work for this property. In all, the survey investigations included the excavation of a total of 1,250 shovel tests of which 1,171 shovel tests were excavated within the Project APE. The remaining 79 shovel tests were excavated outside of USACE permit areas but within the Project workspace. For the purposes of this report, only investigations within the Project APE will be discussed. Survey investigations within the Project APE resulted in entirely negative findings. No archeological sites were encountered within the survey areas reported herein. Additionally, no historic standing structures or landscape features such as historic-age canals were observed with any USACE permit areas. Overall, the surveys documented predominately inundated landscapes with a low probability for intact cultural resources. Numerous existing pipeline corridors and modern canal features are traversed by the Project. While some of the modern canals could be historic in nature or connected to a greater network of irrigation features used historically to supply agricultural crops with water, it is important to note that the majority of the waterways associated with these features will be bypassed via bore/HDD. As such, any impacts to these waterbodies as well as the associated canal structure will be entirely avoided. Additionally, all visual impacts from the proposed pipeline corridor will be temporary in nature. To date, field surveys have been completed for all accessible wetland and waterbody features along the pipeline route, as well as the total length of the Project survey corridor across all Codepermitted tracts. Prior to the beginning of November 2019, field surveys had not been conducted along the eastern banks and associated bottomlands of the Trinity River due to multiple flooding events that resulted in heavy inundation beginning in September 2018 which prevented access or survey investigations of any kind. Additionally, field surveys did not occur along portions of the Project containing denied landowner permissions. On November 6, 2019, a survey crew was able to access previously inaccessible areas associated with the Trinity River due to several months of normalized weather conditions throughout portions of Eastern Texas. Even under normal conditions, large portions of this area remain constantly inundated due to strong hydrological influences and the geomorphic position of the landscape. However, crews were able to traverse inundated areas by foot to access portions of the Project located immediately adjacent to the Trinity River. While the area located immediately adjacent to the Trinity River was not inundated at the time of survey, wetlands with strong hydrological indicators still dominate the landscape. Of the 760 delineated wetland and waterbody features, 74 features were originally not surveyed for cultural resources due to restricted land access including denied landowner permissions and significant inundation. Of these 74 features, 38 feature locations (27 streams and 42 wetlands) will be bypassed via horizontal directional drill (HDD) or bore trenchless construction methods resulting in no impacts to these features. The remaining five features (including multiple crossing locations of the same feature) are located along the eastern banks of the Trinity River. While these features were surveyed for cultural resources with negative findings, the presence of buried deposits exists within the vicinity of these features. However, access to these features with heavy machinery is not feasible due to the remote location and constant hydrological influences (e.g. inundation and saturation) associated with the floodplain setting of the Trinity River. As such, these five features are proposed to be monitored by a qualified Archeological Monitor during construction efforts. Appendix C provides each wetland and waterbody feature crossed by the Project with management recommendations and associated comments, while Appendix F provides a Cultural Monitoring Plan to evaluate the five features that will not be avoided during construction efforts. Appendix F also includes a table in response to a letter issued by the USACE Staff Archeologist, Mr. Jerry Androy, on May 17, 2019, indicating that the 74 aforementioned permit areas associated with the Project would require cultural resources investigations. The table lists each permit area, the reason surveys were not originally conducted, and justification for/against the need for monitoring. Based on the results of the survey effort reported here, no cultural resources will be affected by any construction activities within the Project APE. Aside from Cultural Monitoring at five features (including multiple crossing locations of the same feature) within the Trinity River floodplain, it is Perennial’s opinion that no further cultural resources investigations are warranted for the Project. Should archaeological remains be encountered during construction, work in the immediate area will cease, and a qualified archaeologist will be called upon to evaluate the remains and provide recommendations for how to manage the resources under the State’s Historic Preservation Plan.

Abstract:

The Australian Government has been actively evaluating how best to merge the functions of the Australian Communications Authority (ACA) and the Australian Broadcasting Authority (ABA) for around two years now. Broadly, the reason for this is an attempt to keep pace with the communications media transformations we reduce to the term “convergence.” Mounting pressure for restructuring is emerging as a site of turf contestation: the possibility of a regulatory “one-stop shop” for governments (and some industry players) is an end game of considerable force. But, from a public interest perspective, the case for a converged regulator needs to make sense to audiences using various media, as well as in terms of arguments about global, industrial, and technological change. This national debate about the institutional reshaping of media regulation is occurring within a wider global context of transformations in social, technological, and politico-economic frameworks of open capital and cultural markets, including the increasing prominence of international economic organisations, corporations, and Free Trade Agreements (FTAs). Although the recently concluded FTA with the US explicitly carves out a right for Australian Governments to make regulatory policy in relation to existing and new media, considerable uncertainty remains as to future regulatory arrangements. A key concern is how a right to intervene in cultural markets will be sustained in the face of cultural, politico-economic, and technological pressures that are reconfiguring creative industries on an international scale. While the right to intervene was retained for the audiovisual sector in the FTA, by contrast, it appears that comparable unilateral rights to intervene will not operate for telecommunications, e-commerce or intellectual property (DFAT). Blurring Boundaries A lack of certainty for audiences is a by-product of industry change, and further blurs regulatory boundaries: new digital media content and overlapping delivering technologies are already a reality for Australia’s media regulators. These hypothetical media usage scenarios indicate how confusion over the appropriate regulatory agency may arise: 1. playing electronic games that use racist language; 2. being subjected to deceptive or misleading pop-up advertising online 3. receiving messaged imagery on your mobile phone that offends, disturbs, or annoys; 4. watching a program like World Idol with SMS voting that subsequently raises charging or billing issues; or 5. watching a new “reality” TV program where products are being promoted with no explicit acknowledgement of the underlying commercial arrangements either during or at the end of the program. These are all instances where, theoretically, regulatory mechanisms are in place that allow individuals to complain and to seek some kind of redress as consumers and citizens. In the last scenario, in commercial television under the sector code, no clear-cut rules exist as to the precise form of the disclosure—as there is (from 2000) in commercial radio. It’s one of a number of issues the peak TV industry lobby Commercial TV Australia (CTVA) is considering in their review of the industry’s code of practice. CTVA have proposed an amendment to the code that will simply formalise the already existing practice . That is, commercial arrangements that assist in the making of a program should be acknowledged either during programs, or in their credits. In my view, this amendment doesn’t go far enough in post “cash for comment” mediascapes (Dwyer). Audiences have a right to expect that broadcasters, production companies and program celebrities are open and transparent with the Australian community about these kinds of arrangements. They need to be far more clearly signposted, and people better informed about their role. In the US, the “Commercial Alert” <http://www.commercialalert.org/> organisation has been lobbying the Federal Communications Commission and the Federal Trade Commission to achieve similar in-program “visual acknowledgements.” The ABA’s Commercial Radio Inquiry (“Cash-for-Comment”) found widespread systemic regulatory failure and introduced three new standards. On that basis, how could a “standstill” response by CTVA, constitute best practice for such a pervasive and influential medium as contemporary commercial television? The World Idol example may lead to confusion for some audiences, who are unsure whether the issues involved relate to broadcasting or telecommunications. In fact, it could be dealt with as a complaint to the Telecommunication Industry Ombudsman (TIO) under an ACA registered, but Australian Communications Industry Forum (ACIF) developed, code of practice. These kind of cross-platform issues may become more vexed in future years from an audience’s perspective, especially if reality formats using on-screen premium rate service numbers invite audiences to participate, by sending MMS (multimedia messaging services) images or short video grabs over wireless networks. The political and cultural implications of this kind of audience interaction, in terms of access, participation, and more generally the symbolic power of media, may perhaps even indicate a longer-term shift in relations with consumers and citizens. In the Internet example, the Australian Competition and Consumer Commission’s (ACCC) Internet advertising jurisdiction would apply—not the ABA’s “co-regulatory” Internet content regime as some may have thought. Although the ACCC deals with complaints relating to Internet advertising, there won’t be much traction for them in a more complex issue that also includes, say, racist or religious bigotry. The DVD example would probably fall between the remits of the Office of Film and Literature Classification’s (OFLC) new “convergent” Guidelines for the Classification of Film and Computer Games and race discrimination legislation administered by the Human Rights and Equal Opportunity Commission (HREOC). The OFLC’s National Classification Scheme is really geared to provide consumer advice on media products that contain sexual and violent imagery or coarse language, rather than issues of racist language. And it’s unlikely that a single person would have the locus standito even apply for a reclassification. It may fall within the jurisdiction of the HREOC depending on whether it was played in public or not. Even then it would probably be considered exempt on free speech grounds as an “artistic work.” Unsolicited, potentially illegal, content transmitted via mobile wireless devices, in particular 3G phones, provide another example of content that falls between the media regulation cracks. It illustrates a potential content policy “turf grab” too. Image-enabled mobile phones create a variety of novel issues for content producers, network operators, regulators, parents and viewers. There is no one government media authority or agency with a remit to deal with this issue. Although it has elements relating to the regulatory activities of the ACA, the ABA, the OFLC, the TIO, and TISSC, the combination of illegal or potentially prohibited content and its carriage over wireless networks positions it outside their current frameworks. The ACA may argue it should have responsibility for this kind of content since: it now enforces the recently enacted Commonwealth anti-Spam laws; has registered an industry code of practice for unsolicited content delivered over wireless networks; is seeking to include ‘adult’ content within premium rate service numbers, and, has been actively involved in consumer education for mobile telephony. It has also worked with TISSC and the ABA in relation to telephone sex information services over voice networks. On the other hand, the ABA would probably argue that it has the relevant expertise for regulating wirelessly transmitted image-content, arising from its experience of Internet and free and subscription TV industries, under co-regulatory codes of practice. The OFLC can also stake its claim for policy and compliance expertise, since the recently implemented Guidelines for Classification of Film and Computer Games were specifically developed to address issues of industry convergence. These Guidelines now underpin the regulation of content across the film, TV, video, subscription TV, computer games and Internet sectors. Reshaping Institutions Debates around the “merged regulator” concept have occurred on and off for at least a decade, with vested interests in agencies and the executive jockeying to stake claims over new turf. On several occasions the debate has been given renewed impetus in the context of ruling conservative parties’ mooted changes to the ownership and control regime. It’s tended to highlight demarcations of remit, informed as they are by historical and legal developments, and the gradual accretion of regulatory cultures. Now the key pressure points for regulatory change include the mere existence of already converged single regulatory structures in those countries with whom we tend to triangulate our policy comparisons—the US, the UK and Canada—increasingly in a context of debates concerning international trade agreements; and, overlaying this, new media formats and devices are complicating existing institutional arrangements and legal frameworks. The Department of Communications, Information Technology & the Arts’s (DCITA) review brief was initially framed as “options for reform in spectrum management,” but was then widened to include “new institutional arrangements” for a converged regulator, to deal with visual content in the latest generation of mobile telephony, and other image-enabled wireless devices (DCITA). No other regulatory agencies appear, at this point, to be actively on the Government’s radar screen (although they previously have been). Were the review to look more inclusively, the ACCC, the OFLC and the specialist telecommunications bodies, the TIO and the TISSC may also be drawn in. Current regulatory arrangements see the ACA delegate responsibility for broadcasting services bands of the radio frequency spectrum to the ABA. In fact, spectrum management is the turf least contested by the regulatory players themselves, although the “convergent regulator” issue provokes considerable angst among powerful incumbent media players. The consensus that exists at a regulatory level can be linked to the scientific convention that holds the radio frequency spectrum is a continuum of electromagnetic bands. In this view, it becomes artificial to sever broadcasting, as “broadcasting services bands” from the other remaining highly diverse communications uses, as occurred from 1992 when the Broadcasting Services Act was introduced. The prospect of new forms of spectrum charging is highly alarming for commercial broadcasters. In a joint submission to the DCITA review, the peak TV and radio industry lobby groups have indicated they will fight tooth and nail to resist new regulatory arrangements that would see a move away from the existing licence fee arrangements. These are paid as a sliding scale percentage of gross earnings that, it has been argued by Julian Thomas and Marion McCutcheon, “do not reflect the amount of spectrum used by a broadcaster, do not reflect the opportunity cost of using the spectrum, and do not provide an incentive for broadcasters to pursue more efficient ways of delivering their services” (6). An economic rationalist logic underpins pressure to modify the spectrum management (and charging) regime, and undoubtedly contributes to the commercial broadcasting industry’s general paranoia about reform. Total revenues collected by the ABA and the ACA between 1997 and 2002 were, respectively, $1423 million and $3644.7 million. Of these sums, using auction mechanisms, the ABA collected $391 million, while the ACA collected some $3 billion. The sale of spectrum that will be returned to the Commonwealth by television broadcasters when analog spectrum is eventually switched off, around the end of the decade, is a salivating prospect for Treasury officials. The large sums that have been successfully raised by the ACA boosts their position in planning discussions for the convergent media regulatory agency. The way in which media outlets and regulators respond to publics is an enduring question for a democratic polity, irrespective of how the product itself has been mediated and accessed. Media regulation and civic responsibility, including frameworks for negotiating consumer and citizen rights, are fundamental democratic rights (Keane; Tambini). The ABA’s Commercial Radio Inquiry (‘cash for comment’) has also reminded us that regulatory frameworks are important at the level of corporate conduct, as well as how they negotiate relations with specific media audiences (Johnson; Turner; Gordon-Smith). Building publicly meaningful regulatory frameworks will be demanding: relationships with audiences are often complex as people are constructed as both consumers and citizens, through marketised media regulation, institutions and more recently, through hybridising program formats (Murdock and Golding; Lumby and Probyn). In TV, we’ve seen the growth of infotainment formats blending entertainment and informational aspects of media consumption. At a deeper level, changes in the regulatory landscape are symptomatic of broader tectonic shifts in the discourses of governance in advanced information economies from the late 1980s onwards, where deregulatory agendas created an increasing reliance on free market, business-oriented solutions to regulation. “Co-regulation” and “self-regulation’ became the preferred mechanisms to more direct state control. Yet, curiously contradicting these market transformations, we continue to witness recurring instances of direct intervention on the basis of censorship rationales (Dwyer and Stockbridge). That digital media content is “converging” between different technologies and modes of delivery is the norm in “new media” regulatory rhetoric. Others critique “visions of techno-glory,” arguing instead for a view that sees fundamental continuities in media technologies (Winston). But the socio-cultural impacts of new media developments surround us: the introduction of multichannel digital and interactive TV (in free-to-air and subscription variants); broadband access in the office and home; wirelessly delivered content and mobility, and, as Jock Given notes, around the corner, there’s the possibility of “an Amazon.Com of movies-on-demand, with the local video and DVD store replaced by online access to a distant server” (90). Taking a longer view of media history, these changes can be seen to be embedded in the global (and local) “innovation frontier” of converging digital media content industries and its transforming modes of delivery and access technologies (QUT/CIRAC/Cutler & Co). The activities of regulatory agencies will continue to be a source of policy rivalry and turf contestation until such time as a convergent regulator is established to the satisfaction of key players. However, there are risks that the benefits of institutional reshaping will not be readily available for either audiences or industry. In the past, the idea that media power and responsibility ought to coexist has been recognised in both the regulation of the media by the state, and the field of communications media analysis (Curran and Seaton; Couldry). But for now, as media industries transform, whatever the eventual institutional configuration, the evolution of media power in neo-liberal market mediascapes will challenge the ongoing capacity for interventions by national governments and their agencies. Works Cited Australian Broadcasting Authority. Commercial Radio Inquiry: Final Report of the Australian Broadcasting Authority. Sydney: ABA, 2000. Australian Communications Information Forum. Industry Code: Short Message Service (SMS) Issues. Dec. 2002. 8 Mar. 2004 <http://www.acif.org.au/__data/page/3235/C580_Dec_2002_ACA.pdf >. Commercial Television Australia. Draft Commercial Television Industry Code of Practice. Aug. 2003. 8 Mar. 2004 <http://www.ctva.com.au/control.cfm?page=codereview&pageID=171&menucat=1.2.110.171&Level=3>. Couldry, Nick. The Place of Media Power: Pilgrims and Witnesses of the Media Age. London: Routledge, 2000. Curran, James, and Jean Seaton. Power without Responsibility: The Press, Broadcasting and New Media in Britain. 6th ed. London: Routledge, 2003. Dept. of Communication, Information Technology and the Arts. Options for Structural Reform in Spectrum Management. Canberra: DCITA, Aug. 2002. ---. Proposal for New Institutional Arrangements for the ACA and the ABA. Aug. 2003. 8 Mar. 2004 <http://www.dcita.gov.au/Article/0,,0_1-2_1-4_116552,00.php>. Dept. of Foreign Affairs and Trade. Australia-United States Free Trade Agreement. Feb. 2004. 8 Mar. 2004 <http://www.dfat.gov.au/trade/negotiations/us_fta/outcomes/11_audio_visual.php>. Dwyer, Tim. Submission to Commercial Television Australia’s Review of the Commercial Television Industry’s Code of Practice. Sept. 2003. Dwyer, Tim, and Sally Stockbridge. “Putting Violence to Work in New Media Policies: Trends in Australian Internet, Computer Game and Video Regulation.” New Media and Society 1.2 (1999): 227-49. Given, Jock. America’s Pie: Trade and Culture After 9/11. Sydney: U of NSW P, 2003. Gordon-Smith, Michael. “Media Ethics After Cash-for-Comment.” The Media and Communications in Australia. Ed. Stuart Cunningham and Graeme Turner. Sydney: Allen and Unwin, 2002. Johnson, Rob. Cash-for-Comment: The Seduction of Journo Culture. Sydney: Pluto, 2000. Keane, John. The Media and Democracy. Cambridge: Polity, 1991. Lumby, Cathy, and Elspeth Probyn, eds. Remote Control: New Media, New Ethics. Melbourne: Cambridge UP, 2003. Murdock, Graham, and Peter Golding. “Information Poverty and Political Inequality: Citizenship in the Age of Privatized Communications.” Journal of Communication 39.3 (1991): 180-95. QUT, CIRAC, and Cutler & Co. Research and Innovation Systems in the Production of Digital Content and Applications: Report for the National Office for the Information Economy. Canberra: Commonwealth of Australia, Sept. 2003. Tambini, Damian. Universal Access: A Realistic View. IPPR/Citizens Online Research Publication 1. London: IPPR, 2000. Thomas, Julian and Marion McCutcheon. “Is Broadcasting Special? Charging for Spectrum.” Conference paper. ABA conference, Canberra. May 2003. Turner, Graeme. “Talkback, Advertising and Journalism: A cautionary tale of self-regulated radio”. International Journal of Cultural Studies 3.2 (2000): 247-255. ---. “Reshaping Australian Institutions: Popular Culture, the Market and the Public Sphere.” Culture in Australia: Policies, Publics and Programs. Ed. Tony Bennett and David Carter. Melbourne: Cambridge UP, 2001. Winston, Brian. Media, Technology and Society: A History from the Telegraph to the Internet. London: Routledge, 1998. Web Links http://www.aba.gov.au http://www.aca.gov.au http://www.accc.gov.au http://www.acif.org.au http://www.adma.com.au http://www.ctva.com.au http://www.crtc.gc.ca http://www.dcita.com.au http://www.dfat.gov.au http://www.fcc.gov http://www.ippr.org.uk http://www.ofcom.org.uk http://www.oflc.gov.au Links http://www.commercialalert.org/ Citation reference for this article MLA Style Dwyer, Tim. "Transformations" M/C: A Journal of Media and Culture <http://www.media-culture.org.au/0403/06-transformations.php>. APA Style Dwyer, T. (2004, Mar17). Transformations. M/C: A Journal of Media and Culture, 7, <http://www.media-culture.org.au/0403/06-transformations.php>

Abstract:

Photo by niu niu on Unsplash ABSTRACT Shackling prisoners has been implemented as standard procedure when transporting prisoners in labor and during childbirth. This procedure ensures the protection of both the public and healthcare workers. However, the act of shackling pregnant prisoners violates the principles of ethics that physicians are supposed to uphold. This paper will explore how shackling pregnant prisoners violates the principle of justice and beneficence, making the practice unethical. INTRODUCTION Some states allow shackling of incarcerated pregnant women during transport and while in the hospital for labor and delivery. Currently, only 22 states have legislation prohibiting the shackling of pregnant women.[1] Although many states have anti-shackling laws prohibiting restraints, these laws also contain an “extraordinary circ*mstances” loophole.[2] Under this exception, officers shackle prisoners if they pose a flight risk, have any history of violence, and are a threat to themselves or others.[3] Determining as to whether a prisoner is shackled is left solely to the correctional officer.[4] Yet even state restrictions on shackling are often disregarded. In shackling pregnant prisoners during childbirth, officers and institutions are interfering with the ability of incarcerated women to have safe childbirth experiences and fair treatment. Moreover, physicians cannot exercise various ethical duties as the law constrains them. In this article, I will discuss the physical and mental harms that result from the use of restraints under the backdrop of slavery and discrimination against women of color particularly. I argue that stereotypes feed into the phenomenon of shackling pregnant women, especially pregnant women of color. I further assert that shackling makes it difficult for medical professionals to be beneficent and promote justice. BACKGROUND Female incarceration rates in the United States have been fast growing since the 1980s.[5] With a 498 percent increase in the female incarceration population between 1981 and 2021, the rates of pregnancy and childbirth by incarcerated people have also climbed.[6],[7] In 2021, over 1.2 million women were incarcerated in the United States.[8] An estimated 55,000 pregnant women are admitted to jails each year.[9],[10] Many remain incarcerated throughout pregnancy and are transported to a hospital for labor and delivery. Although the exact number of restrained pregnant inmates is unclear, a study found that 83 percent of hospital prenatal nurses reported that their incarcerated patients were shackled.[11] I. Harms Caused by Shackling Shackling has caused many instances of physical and psychological harm. In the period before childbirth, shackled pregnant women are at high risk for falling.[12] The restraints shift pregnant women’s center of gravity, and wrist restraints prevent them from breaking a fall, increasing the risk of falling on their stomach and harming the fetus.[13] Another aspect inhibited by using restraints is testing and treating pregnancy complications. Delays in identifying and treating conditions such as hypertension, pre-eclampsia, appendicitis, kidney infection, preterm labor, and especially vagin*l bleeding can threaten the lives of the mother and the fetus.[14] During labor and delivery, shackling prevents methods of alleviating severe labor pains and giving birth.[15] Usually, physicians recommend that women in labor walk or assume various positions to relieve labor pains and accelerate labor.[16] However, shackling prevents both solutions.[17] Shackling these women limits their mobility during labor, which may compromise the health of both the mother and the fetus.[18] Tracy Edwards, a former prisoner who filed a lawsuit for unlawful use of restraints during her pregnancy, was in labor for twelve hours. She was unable to move or adjust her position to lessen the pain and discomfort of labor.[19] The shackles also left the skin on her ankles red and bruised. Continued use of restraints also increases the risk of potentially life-threatening health issues associated with childbirth, such as blood clots.[20] It is imperative that pregnant women get treated rapidly, especially with the unpredictability of labor. Epidural administration can also become difficult, and in some cases, be denied due to the shackled woman’s inability to assume the proper position.[21] Time-sensitive medical care, including C-sections, could be delayed if permission from an officer is required, risking major health complications for both the fetus and the mother.[22] After childbirth, shackling impedes the recovery process. Shackling can result in post-delivery complications such as deep vein thrombosis.[23] Walking prevents such complications but is not an option for mothers shackled to their hospital beds.[24] Restraints also prevent bonding with the baby post-delivery and the safe handling of the baby while breast feeding.[25] The use of restraints can also result in psychological harm. Many prisoners feel as though care workers treat them like “animals,” with some women having multiple restraints at once— including ankles, wrists, and even waist restraints.[26] Benidalys Rivera describes the feeling of embarrassment as she was walking while handcuffed, with nurses and patients looking on, “Being in shackles, that make you be in stress…I about to have this baby, and I’m going to go back to jail. So it’s too much.”[27] Depression among pregnant prisoners is highly prevalent. The stress of imprisonment and the anticipation of being separated from their child is often overwhelming for these mothers.[28] The inhumane action has the potential to add more stress, anxiety, and sadness to the already emotionally demanding process of giving birth. Shackling pregnant prisoners displays indifference to the medical needs of the prisoner.[29] II. Safety as a Pretense While public safety is an argument for using shackles, several factors make escape or violence extremely unlikely and even impossible.[30] For example, administering epidural anesthesia causes numbness and eliminates flight risk.[31] Although cited as the main reason for using shackles, public safety is likely just an excuse and not the main motivator for shackling prisoners. I argue that underlying the shackling exemplifies the idea that these women should not have become pregnant. The shackling reflects a distinct discrimination: the lawmakers allowing it perhaps thought that people guilty of crimes would make bad mothers. Public safety is just a pretense. The language used to justify the use of restraint of Shawanna Nelson, the plaintiff in Nelson v. Correctional Medical Services, discussed below, included the word “aggressive.”[32] In her case, there was no evidence that she posed any danger or was objectively aggressive. Officer Turnesky, who supervised Nelson, testified that she never felt threatened by Nelson.[33] The lack of documented attempts of escape and violence from pregnant prisoners suggests that shackling for flight risk is a false pretense and perhaps merely based on stereotypes.[34] In 2011, an Amnesty International report noted that “Around the USA, it is common for restraints to be used on sick and pregnant incarcerated women when they are transported to and kept in hospital, regardless of whether they have a history of violence (which only a minority have) and regardless of whether they have ever absconded or attempted to escape (which few women have).”[35] In a 2020 survey of correctional officers in select midwestern prisons, 76 percent disagreed or strongly disagreed with restraining pregnant women during labor and delivery.[36] If a correctional officer shackles a pregnant prisoner, it is not because they pose a risk but because of a perception that they do. This mindset is attributed to select law enforcement, who have authority to use restraints.[37] In 2022, the Tennessee legislature passed a bill prohibiting the use of restraints on pregnant inmates. However, legislators amended the bill due to the Tennessee Sherriff Association’s belief that even pregnant inmates could pose a “threat.”[38] Subjecting all prisoners to the same “precautions” because a small percentage of individuals may pose such risks could reflect stereotyping or the assumption that all incarcerated people pose danger and flight risk. To quell the (unjustified) public safety concern, there are other options that do not cause physical or mental harm to pregnant women. For example, San Francisco General Hospital does not use shackles but has deputy sheriffs outside the pregnant women’s doors.[39] III. Historical Context and Race A. Slavery and Post-Civil War The treatment of female prisoners has striking similarities to that of enslaved women. Originally, shackling of female slaves was a mechanism of control and dehumanization.[40] This enabled physical and sexual abuses. During the process of intentionally dehumanizing slaves to facilitate subordination, slave owners stripped slave women of their feminine identity.[41] Slave women were unable to exhibit the Victorian model of “good mothering” and people thought they lacked maternal feelings for their children.[42] In turn, societal perception defeminized slave women, and barred them from utilizing the protections of womanhood and motherhood. During the post-Civil War era, black women were reversely depicted as sexually promiscuous and were arrested for prostitution more often than white women.[43] In turn, society excluded black women; they were seen as lacking what the “acceptable and good” women had.[44] Some argue that the historical act of labeling black women sexually deviant influences today’s perception of black women and may lead to labeling them bad mothers.[45] Over two-thirds of incarcerated women are women of color.[46] Many reports document sexual violence and misconduct against prisoners over the years.[47] Male guards have raped, sexually assaulted, and inappropriately touched female prisoners. Some attribute the physical abuse of black female prisoners to their being depicted or stereotyped as “aggressive, deviant, and domineering.”[48] Some expect black women to express stoicism and if they do not, people label them as dangerous, irresponsible, and aggressive.[49] The treatment of these prisoners mirrors the historical oppression endured by black women during and following the era of slavery. The act of shackling incarcerated pregnant women extends the inhumane treatment of these women from the prison setting into the hospital. One prisoner stated that during her thirty-hour labor, while being shackled, she “felt like a farm animal.”[50] Another pregnant prisoner describes her treatment by a guard stating: “a female guard grabbed me by the hair and was making me get up. She was screaming: ‘B***h, get up.’ Then she said, ‘That is what happens when you are a f***ing junkie. You shouldn’t be using drugs, or you wouldn’t be in here.”[51] Shackling goes beyond punishing by isolation from society – it is an additional punishment that is not justified. B. Reproductive Rights and “Bad Mothers” As with slaves not being seen as maternal, prisoners are not viewed as “real mothers.” A female prison guard said the following: “I’m a mother of two and I know what that impulse, that instinct, that mothering instinct feels like. It just takes over, you would never put your kids in harm’s way. . . . Women in here lack that. Something in their nature is not right, you know?”[52] This comment implies that incarcerated women lack maternal instinct. They are not in line with the standards of what society accepts as a “woman” and “mother” and are thought to have abandoned their roles as caretakers in pursuit of deviant behaviors. Without consideration of racial discrimination, poverty issues, trauma, and restricted access to the child right after delivery, these women are stereotyped as bad mothers simply because they are in prison. Reminiscent of the treatment of female black bodies post-civil war and the use of reproductive interventions (for example, Norplant and forced sterilization) in exchange for shorter sentences, I argue that shackles are a form of reproductive control. Justification for the use of shackles even includes their use as a “punitive instrument to remind the prisoner of their punishment.”[53] However, a prisoner’s pregnancy should have no relevance to their sentence.[54] Using shackles demonstrates to prisoners that society tolerates childbirth but does not support it.[55] The shackling is evidence that women are being punished “for bearing children, not for breaking the law.”[56] Physicians and healthcare workers, as a result, are responsible for providing care for the delivery and rectifying any physical problems associated with the restraints. The issues that arise from the use of restraints place physicians in a position more complex than they experience with regular healthy pregnancies. C. Discrimination In the case of Ferguson v. City of Charleston, a medical university subjected black woman to involuntary drug testing during pregnancy. In doing so, medical professionals collaborated with law enforcement to penalize black women for their use of drugs during pregnancy.[57] The Court held the drug tests were an unreasonable search and violated the Fourth Amendment. Ferguson v. City of Charleston further reveals an unjustified assumption: the medical and legal community seemed suspicious of black women and had perhaps predetermined them more likely to use drugs while pregnant. Their fitness to become mothers needed to be proven, while wealthy, white women were presumed fit.[58] The correctional community similarly denies pregnant prisoners’ medical attention. In the case of Staten v. Lackawanna County, an African American woman whose serious medical needs were treated indifferently by jail staff was forced to give birth in her cell.[59] This woman was punished for being pregnant in prison through the withholding of medical attention and empathy. IV. Failure to Follow Anti-Shackling Laws Despite 22 states having laws against shackling pregnant prisoners, officers do not always follow these laws. In 2015, the Correctional Association of New York reported that of the 27 women who gave birth under state custody, officers shackled 23 women in violation of the anti-shackling laws.[60] The lawyer of Tracy Edwards, an inmate who officers shackled unlawfully during her twelve-hour labor stated, “I don’t think we can assume that just because there’s a law passed, that’s automatically going to trickle down to the prison.”[61] Even with more restrictions on shackling, it may still occur, partly due to the stereotype that incarcerated women are aggressive and dangerous. V. Constitutionality The Eighth Amendment protects people from cruel and unusual punishment. In Brown vs. Plata, the court stated, “Prisoners retain the essence of human dignity inherent in all persons.”[62] In several cases, the legal community has held shackling to be unconstitutional as it violates the Eighth Amendment unless specifically justified. In the case of Nelson v. Correctional Medical Services, a pregnant woman was shackled for 12 hours of labor with a brief respite while she pushed, then re-shackled. The shackling caused her physical and emotional pain, including intense cramping that could not be relieved due to positioning and her inability to get up to use a toilet.[63] The court held that a clear security concern must justify shackling. The court cited a similar DC case and various precedents for using the Eighth Amendment to hold correctional facilities and hospitals accountable.[64] An Arkansas law similarly states that shackling must be justified by safety or risk of escape.[65] If the Thirteenth Amendment applied to those convicted of crimes, shackling pregnant incarcerated people would be unconstitutional under that amendment as well as the Eighth. In the Civil Rights Cases, Congress upheld the right “to enact all necessary and proper laws for the obliteration and prevention of slavery with all its badges and incidents.”[66] Section two of the Thirteenth Amendment condemns any trace or acts comparable to that of slavery. Shackling pregnant prisoners, stripping them of their dignity, and justification based on stereotypes all have origins in the treatment of black female slaves. Viewed through the lens of the Thirteenth Amendment, the act of shackling would be unconstitutional. Nonetheless, the Thirteenth Amendment explicitly excludes people convicted of a crime. VI. Justice As a result of the unconstitutional nature of shackling, physicians should have a legal obligation, in addition to their ethical duty, to protect their patients. The principle of justice requires physicians to take a stand against the discriminatory treatment of their patients, even under the eye of law enforcement.[67],[68] However, “badge and gun intimidation,” threats of noncompliance, and the fear of losing one’s license can impede a physician’s willingness to advocate for their patients. The American College of Obstetricians and Gynecologists (ACOG) finds the use of physical restraints interferes with the ability of clinicians to practice medicine safely.[69] ACOG, The American Medical Association, the National Commission on Correctional Health Care, and other organizations oppose using restraints on pregnant incarcerated people.[70] Yet, legislators can adopt shackling laws without consultation with physicians. The ACOG argues that “State legislators are taking it upon themselves to define complex medical concepts without reference to medical evidence. Some of the penalties [faced by OBGYNs] for violating these vague, unscientific laws include criminal sentences.”[71] Legislation that does not consider medical implications or discourages physicians’ input altogether is unjust. In nullifying the voice of a physician in matters pertaining to the patient’s treatment, physicians are prevented from fulfilling the principle of justice, making the act of shackling patients unethical. VII. Principle of Beneficence The principle of beneficence requires the prevention of harm, the removal of harm, and the promotion of good.[72] Beneficence demands the physician not only avoid harm but benefit patients and promote their welfare.[73] The American Board of Internal Medicine Foundation states that physicians must work with other professionals to increase patient safety and improve the quality of care.[74] In doing so, physicians can adequately treat patients with the goal of prevention and healing. It is difficult to do good when law enforcement imposes on doctors to work around shackles during labor and delivery. Law enforcement leaves physicians and healthcare workers responsible not only to provide care for the delivery, but also rectify any ailments associated with the restraints. The issues arising from using restraints place physicians in a position more complex than they experience with other pregnancies. Doctors cannot prevent the application of the shackles and can only request officers to take them off the patient.[75] Physicians who simply go along with shackling are arguably violating the principle of beneficence. However, for most, rather than violating the principle of beneficence overtly, physicians may simply have to compromise. Given the intricate nature of the situation, physicians are tasked with minimizing potential harm to the best of their abilities while adhering to legal obligations.[76] It is difficult to pin an ethics violation on the ones who do not like the shackles but are powerless to remove them. Some do argue that this inability causes physicians to violate the principle of beneficence.[77] However, promoting the well-being of their patients within the boundaries of the law limits their ability to exercise beneficence. For physicians to fulfill the principle of beneficence to the fullest capacity, they must have an influence on law. Protocols and assessments on flight risks made solely by the officers and law enforcement currently undermine the physician’s expertise. These decisions do not consider the health and well-being of the pregnant woman. As a result, law supersedes the influence of medicine and health care. CONCLUSION People expect physicians to uphold the four major principles of bioethics. However, their inability to override restraints compromises their ability to exercise beneficence. Although pledging to enforce these ethical principles, physicians have little opportunity to influence anti-shackling legislation. Instead of being included in conversations regarding medical complexities, legislation silences their voices. Policies must include the physician's voice as they affect their ability to treat patients. Officers should not dismiss a physician's request to remove shackles from a woman if they are causing health complications. A woman's labor should not harm her or her fetus because the officer will not remove her shackles.[78] A federal law could end shackling pregnant incarcerated people. Because other options are available to ensure the safety of the public and the prisoner, there is no ethical justification for shackling pregnant prisoners. An incarcerated person is a human being and must be treated with dignity and respect. To safeguard the well-being of incarcerated women and the public, it is essential for advocates of individual rights to join forces with medical professionals to establish an all-encompassing solution. - [1] Ferszt, G. G., Palmer, M., & McGrane, C. (2018). Where does your state stand on shackling of Pregnant Incarcerated Women? Nursing for Women’s Health, 22(1), 17–23. https://doi.org/10.1016/j.nwh.2017.12.005 [2] S983A, 2015-2016 Regular Sessions (N.Y. 2015). https://legislation.nysenate.gov/pdf/bills/2015/S983A [3] Chris DiNardo, Pregnancy in Confinement, Anti-Shackling Laws and the “Extraordinary Circ*mstances” Loophole, 25 Duke Journal of Gender Law & Policy 271-295 (2018) https://scholarship.law.duke.edu/djglp/vol25/iss2/5 [4] Chris DiNardo (2018) [5] U.S. Bureau of Justice Statistics. 1980. " Prisoners in 1980 – Statistical Tables”. Retrieved April 20, 2023 (https://bjs.ojp.gov/content/pub/pdf/p80.pdf). [6] U.S. Bureau of Justice Statistics. 2022. " Prisoners in 2021 – Statistical Tables”. Retrieved April 20, 2023 (https://bjs.ojp.gov/sites/g/files/xyckuh236/files/media/document/p21st.pdf). [7] U.S. Bureau of Justice Statistics (1980) [8] Sufrin C, Jones RK, Mosher WD, Beal L. Pregnancy Prevalence and Outcomes in U.S. Jails. Obstet Gynecol. 2020;135(5):1177-1183. doi:10.1097/AOG.0000000000003834 [9] Kramer, C., Thomas, K., Patil, A., Hayes, C. M., & Sufrin, C. B. (2022). Shackling and pregnancy care policies in US prisons and jails. Maternal and Child Health Journal, 27(1), 186–196. https://doi.org/10.1007/s10995-022-03526-y [10] House, K. T., Kelley, S., Sontag, D. N., & King, L. P. (2021). Ending restraint of incarcerated individuals giving birth. AMA Journal of Ethics, 23(4). https://doi.org/10.1001/amajethics.2021.364 [11] Goshin, L. S., Sissoko, D. R., Neumann, G., Sufrin, C., & Byrnes, L. (2019). Perinatal nurses’ experiences with and knowledge of the care of incarcerated women during pregnancy and the postpartum period. Journal of Obstetric, Gynecologic &amp; Neonatal Nursing, 48(1), 27–36. https://doi.org/10.1016/j.jogn.2018.11.002 [12] Shackling and separation: Motherhood in prison. (2013). 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Abstract:

A same-but-different dichotomy has recently been encapsulated within the US Food and Drug Administration’s ill-defined concept of “substantial equivalence” (USFDA, FDA). By invoking this concept the genetically modified organism (GMO) industry has escaped the rigors of safety testing that might otherwise apply. The curious concept of “substantial equivalence” grants a presumption of safety to GMO food. This presumption has yet to be earned, and has been used to constrain labelling of both GMO and non-GMO food. It is an idea that well serves corporatism. It enables the claim of difference to secure patent protection, while upholding the contrary claim of sameness to avoid labelling and safety scrutiny. It offers the best of both worlds for corporate food entrepreneurs, and delivers the worst of both worlds to consumers. The term “substantial equivalence” has established its currency within the GMO discourse. As the opportunities for patenting food technologies expand, the GMO recruitment of this concept will likely be a dress rehearsal for the developing debates on the labelling and testing of other techno-foods – including nano-foods and clone-foods. “Substantial Equivalence” “Are the Seven Commandments the same as they used to be, Benjamin?” asks Clover in George Orwell’s “Animal Farm”. By way of response, Benjamin “read out to her what was written on the wall. There was nothing there now except a single Commandment. It ran: ALL ANIMALS ARE EQUAL BUT SOME ANIMALS ARE MORE EQUAL THAN OTHERS”. After this reductionist revelation, further novel and curious events at Manor Farm, “did not seem strange” (Orwell, ch. X). Equality is a concept at the very core of mathematics, but beyond the domain of logic, equality becomes a hotly contested notion – and the domain of food is no exception. A novel food has a regulatory advantage if it can claim to be the same as an established food – a food that has proven its worth over centuries, perhaps even millennia – and thus does not trigger new, perhaps costly and onerous, testing, compliance, and even new and burdensome regulations. On the other hand, such a novel food has an intellectual property (IP) advantage only in terms of its difference. And thus there is an entrenched dissonance for newly technologised foods, between claiming sameness, and claiming difference. The same/different dilemma is erased, so some would have it, by appeal to the curious new dualist doctrine of “substantial equivalence” whereby sameness and difference are claimed simultaneously, thereby creating a win/win for corporatism, and a loss/loss for consumerism. This ground has been pioneered, and to some extent conquered, by the GMO industry. The conquest has ramifications for other cryptic food technologies, that is technologies that are invisible to the consumer and that are not evident to the consumer other than via labelling. Cryptic technologies pertaining to food include GMOs, pesticides, hormone treatments, irradiation and, most recently, manufactured nano-particles introduced into the food production and delivery stream. Genetic modification of plants was reported as early as 1984 by Horsch et al. The case of Diamond v. Chakrabarty resulted in a US Supreme Court decision that upheld the prior decision of the US Court of Customs and Patent Appeal that “the fact that micro-organisms are alive is without legal significance for purposes of the patent law”, and ruled that the “respondent’s micro-organism plainly qualifies as patentable subject matter”. This was a majority decision of nine judges, with four judges dissenting (Burger). It was this Chakrabarty judgement that has seriously opened the Pandora’s box of GMOs because patenting rights makes GMOs an attractive corporate proposition by offering potentially unique monopoly rights over food. The rear guard action against GMOs has most often focussed on health repercussions (Smith, Genetic), food security issues, and also the potential for corporate malfeasance to hide behind a cloak of secrecy citing commercial confidentiality (Smith, Seeds). Others have tilted at the foundational plank on which the economics of the GMO industry sits: “I suggest that the main concern is that we do not want a single molecule of anything we eat to contribute to, or be patented and owned by, a reckless, ruthless chemical organisation” (Grist 22). The GMO industry exhibits bipolar behaviour, invoking the concept of “substantial difference” to claim patent rights by way of “novelty”, and then claiming “substantial equivalence” when dealing with other regulatory authorities including food, drug and pesticide agencies; a case of “having their cake and eating it too” (Engdahl 8). This is a clever slight-of-rhetoric, laying claim to the best of both worlds for corporations, and the worst of both worlds for consumers. Corporations achieve patent protection and no concomitant specific regulatory oversight; while consumers pay the cost of patent monopolization, and are not necessarily apprised, by way of labelling or otherwise, that they are purchasing and eating GMOs, and thereby financing the GMO industry. The lemma of “substantial equivalence” does not bear close scrutiny. It is a fuzzy concept that lacks a tight testable definition. It is exactly this fuzziness that allows lots of wriggle room to keep GMOs out of rigorous testing regimes. Millstone et al. argue that “substantial equivalence is a pseudo-scientific concept because it is a commercial and political judgement masquerading as if it is scientific. It is moreover, inherently anti-scientific because it was created primarily to provide an excuse for not requiring biochemical or toxicological tests. It therefore serves to discourage and inhibit informative scientific research” (526). “Substantial equivalence” grants GMOs the benefit of the doubt regarding safety, and thereby leaves unexamined the ramifications for human consumer health, for farm labourer and food-processor health, for the welfare of farm animals fed a diet of GMO grain, and for the well-being of the ecosystem, both in general and in its particularities. “Substantial equivalence” was introduced into the food discourse by an Organisation for Economic Co-operation and Development (OECD) report: “safety evaluation of foods derived by modern biotechnology: concepts and principles”. It is from this document that the ongoing mantra of assumed safety of GMOs derives: “modern biotechnology … does not inherently lead to foods that are less safe … . Therefore evaluation of foods and food components obtained from organisms developed by the application of the newer techniques does not necessitate a fundamental change in established principles, nor does it require a different standard of safety” (OECD, “Safety” 10). This was at the time, and remains, an act of faith, a pro-corporatist and a post-cautionary approach. The OECD motto reveals where their priorities lean: “for a better world economy” (OECD, “Better”). The term “substantial equivalence” was preceded by the 1992 USFDA concept of “substantial similarity” (Levidow, Murphy and Carr) and was adopted from a prior usage by the US Food and Drug Agency (USFDA) where it was used pertaining to medical devices (Miller). Even GMO proponents accept that “Substantial equivalence is not intended to be a scientific formulation; it is a conceptual tool for food producers and government regulators” (Miller 1043). And there’s the rub – there is no scientific definition of “substantial equivalence”, no scientific test of proof of concept, and nor is there likely to be, since this is a ‘spinmeister’ term. And yet this is the cornerstone on which rests the presumption of safety of GMOs. Absence of evidence is taken to be evidence of absence. History suggests that this is a fraught presumption. By way of contrast, the patenting of GMOs depends on the antithesis of assumed ‘sameness’. Patenting rests on proven, scrutinised, challengeable and robust tests of difference and novelty. Lightfoot et al. report that transgenic plants exhibit “unexpected changes [that] challenge the usual assumptions of GMO equivalence and suggest genomic, proteomic and metanomic characterization of transgenics is advisable” (1). GMO Milk and Contested Labelling Pesticide company Monsanto markets the genetically engineered hormone rBST (recombinant Bovine Somatotropin; also known as: rbST; rBGH, recombinant Bovine Growth Hormone; and the brand name Prosilac) to dairy farmers who inject it into their cows to increase milk production. This product is not approved for use in many jurisdictions, including Europe, Australia, New Zealand, Canada and Japan. Even Monsanto accepts that rBST leads to mastitis (inflammation and pus in the udder) and other “cow health problems”, however, it maintains that “these problems did not occur at rates that would prohibit the use of Prosilac” (Monsanto). A European Union study identified an extensive list of health concerns of rBST use (European Commission). The US Dairy Export Council however entertain no doubt. In their background document they ask “is milk from cows treated with rBST safe?” and answer “Absolutely” (USDEC). Meanwhile, Monsanto’s website raises and answers the question: “Is the milk from cows treated with rbST any different from milk from untreated cows? No” (Monsanto). Injecting cows with genetically modified hormones to boost their milk production remains a contested practice, banned in many countries. It is the claimed equivalence that has kept consumers of US dairy products in the dark, shielded rBST dairy farmers from having to declare that their milk production is GMO-enhanced, and has inhibited non-GMO producers from declaring their milk as non-GMO, non rBST, or not hormone enhanced. This is a battle that has simmered, and sometimes raged, for a decade in the US. Finally there is a modest victory for consumers: the Pennsylvania Department of Agriculture (PDA) requires all labels used on milk products to be approved in advance by the department. The standard issued in October 2007 (PDA, “Standards”) signalled to producers that any milk labels claiming rBST-free status would be rejected. This advice was rescinded in January 2008 with new, specific, department-approved textual constructions allowed, and ensuring that any “no rBST” style claim was paired with a PDA-prescribed disclaimer (PDA, “Revised Standards”). However, parsimonious labelling is prohibited: No labeling may contain references such as ‘No Hormones’, ‘Hormone Free’, ‘Free of Hormones’, ‘No BST’, ‘Free of BST’, ‘BST Free’,’No added BST’, or any statement which indicates, implies or could be construed to mean that no natural bovine somatotropin (BST) or synthetic bovine somatotropin (rBST) are contained in or added to the product. (PDA, “Revised Standards” 3) Difference claims are prohibited: In no instance shall any label state or imply that milk from cows not treated with recombinant bovine somatotropin (rBST, rbST, RBST or rbst) differs in composition from milk or products made with milk from treated cows, or that rBST is not contained in or added to the product. If a product is represented as, or intended to be represented to consumers as, containing or produced from milk from cows not treated with rBST any labeling information must convey only a difference in farming practices or dairy herd management methods. (PDA, “Revised Standards” 3) The PDA-approved labelling text for non-GMO dairy farmers is specified as follows: ‘From cows not treated with rBST. No significant difference has been shown between milk derived from rBST-treated and non-rBST-treated cows’ or a substantial equivalent. Hereinafter, the first sentence shall be referred to as the ‘Claim’, and the second sentence shall be referred to as the ‘Disclaimer’. (PDA, “Revised Standards” 4) It is onto the non-GMO dairy farmer alone, that the costs of compliance fall. These costs include label preparation and approval, proving non-usage of GMOs, and of creating and maintaining an audit trail. In nearby Ohio a similar consumer versus corporatist pantomime is playing out. This time with the Ohio Department of Agriculture (ODA) calling the shots, and again serving the GMO industry. The ODA prescribed text allowed to non-GMO dairy farmers is “from cows not supplemented with rbST” and this is to be conjoined with the mandatory disclaimer “no significant difference has been shown between milk derived from rbST-supplemented and non-rbST supplemented cows” (Curet). These are “emergency rules”: they apply for 90 days, and are proposed as permanent. Once again, the onus is on the non-GMO dairy farmers to document and prove their claims. GMO dairy farmers face no such governmental requirements, including no disclosure requirement, and thus an asymmetric regulatory impost is placed on the non-GMO farmer which opens up new opportunities for administrative demands and technocratic harassment. Levidow et al. argue, somewhat Eurocentrically, that from its 1990s adoption “as the basis for a harmonized science-based approach to risk assessment” (26) the concept of “substantial equivalence” has “been recast in at least three ways” (58). It is true that the GMO debate has evolved differently in the US and Europe, and with other jurisdictions usually adopting intermediate positions, yet the concept persists. Levidow et al. nominate their three recastings as: firstly an “implicit redefinition” by the appending of “extra phrases in official documents”; secondly, “it has been reinterpreted, as risk assessment processes have … required more evidence of safety than before, especially in Europe”; and thirdly, “it has been demoted in the European Union regulatory procedures so that it can no longer be used to justify the claim that a risk assessment is unnecessary” (58). Romeis et al. have proposed a decision tree approach to GMO risks based on cascading tiers of risk assessment. However what remains is that the defects of the concept of “substantial equivalence” persist. Schauzu identified that: such decisions are a matter of “opinion”; that there is “no clear definition of the term ‘substantial’”; that because genetic modification “is aimed at introducing new traits into organisms, the result will always be a different combination of genes and proteins”; and that “there is no general checklist that could be followed by those who are responsible for allowing a product to be placed on the market” (2). Benchmark for Further Food Novelties? The discourse, contestation, and debate about “substantial equivalence” have largely focussed on the introduction of GMOs into food production processes. GM can best be regarded as the test case, and proof of concept, for establishing “substantial equivalence” as a benchmark for evaluating new and forthcoming food technologies. This is of concern, because the concept of “substantial equivalence” is scientific hokum, and yet its persistence, even entrenchment, within regulatory agencies may be a harbinger of forthcoming same-but-different debates for nanotechnology and other future bioengineering. The appeal of “substantial equivalence” has been a brake on the creation of GMO-specific regulations and on rigorous GMO testing. The food nanotechnology industry can be expected to look to the precedent of the GMO debate to head off specific nano-regulations and nano-testing. As cloning becomes economically viable, then this may be another wave of food innovation that muddies the regulatory waters with the confused – and ultimately self-contradictory – concept of “substantial equivalence”. Nanotechnology engineers particles in the size range 1 to 100 nanometres – a nanometre is one billionth of a metre. This is interesting for manufacturers because at this size chemicals behave differently, or as the Australian Office of Nanotechnology expresses it, “new functionalities are obtained” (AON). Globally, government expenditure on nanotechnology research reached US$4.6 billion in 2006 (Roco 3.12). While there are now many patents (ETC Group; Roco), regulation specific to nanoparticles is lacking (Bowman and Hodge; Miller and Senjen). The USFDA advises that nano-manufacturers “must show a reasonable assurance of safety … or substantial equivalence” (FDA). A recent inventory of nano-products already on the market identified 580 products. Of these 11.4% were categorised as “Food and Beverage” (WWICS). This is at a time when public confidence in regulatory bodies is declining (HRA). In an Australian consumer survey on nanotechnology, 65% of respondents indicated they were concerned about “unknown and long term side effects”, and 71% agreed that it is important “to know if products are made with nanotechnology” (MARS 22). Cloned animals are currently more expensive to produce than traditional animal progeny. In the course of 678 pages, the USFDA Animal Cloning: A Draft Risk Assessment has not a single mention of “substantial equivalence”. However the Federation of Animal Science Societies (FASS) in its single page “Statement in Support of USFDA’s Risk Assessment Conclusion That Food from Cloned Animals Is Safe for Human Consumption” states that “FASS endorses the use of this comparative evaluation process as the foundation of establishing substantial equivalence of any food being evaluated. It must be emphasized that it is the food product itself that should be the focus of the evaluation rather than the technology used to generate cloned animals” (FASS 1). Contrary to the FASS derogation of the importance of process in food production, for consumers both the process and provenance of production is an important and integral aspect of a food product’s value and identity. Some consumers will legitimately insist that their Kalamata olives are from Greece, or their balsamic vinegar is from Modena. It was the British public’s growing awareness that their sugar was being produced by slave labour that enabled the boycotting of the product, and ultimately the outlawing of slavery (Hochschild). When consumers boycott Nestle, because of past or present marketing practices, or boycott produce of USA because of, for example, US foreign policy or animal welfare concerns, they are distinguishing the food based on the narrative of the food, the production process and/or production context which are a part of the identity of the food. Consumers attribute value to food based on production process and provenance information (Paull). Products produced by slave labour, by child labour, by political prisoners, by means of torture, theft, immoral, unethical or unsustainable practices are different from their alternatives. The process of production is a part of the identity of a product and consumers are increasingly interested in food narrative. It requires vigilance to ensure that these narratives are delivered with the product to the consumer, and are neither lost nor suppressed. Throughout the GM debate, the organic sector has successfully skirted the “substantial equivalence” debate by excluding GMOs from the certified organic food production process. This GMO-exclusion from the organic food stream is the one reprieve available to consumers worldwide who are keen to avoid GMOs in their diet. The organic industry carries the expectation of providing food produced without artificial pesticides and fertilizers, and by extension, without GMOs. Most recently, the Soil Association, the leading organic certifier in the UK, claims to be the first organisation in the world to exclude manufactured nonoparticles from their products (Soil Association). There has been the call that engineered nanoparticles be excluded from organic standards worldwide, given that there is no mandatory safety testing and no compulsory labelling in place (Paull and Lyons). The twisted rhetoric of oxymorons does not make the ideal foundation for policy. Setting food policy on the shifting sands of “substantial equivalence” seems foolhardy when we consider the potentially profound ramifications of globally mass marketing a dysfunctional food. 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Boca Raton, FL: CRC Press, 2007.Romeis, Jorg, Detlef Bartsch, Franz Bigler, Marco Candolfi, Marco Gielkins, et al. “Assessment of Risk of Insect-Resistant Transgenic Crops to Nontarget Arthropods.” Nature Biotechnology 26.2 (Feb. 2008): 203-208.Schauzu, Marianna. “The Concept of Substantial Equivalence in Safety Assessment of Food Derived from Genetically Modified Organisms.” AgBiotechNet 2 (Apr. 2000): 1-4.Soil Association. “Soil Association First Organisation in the World to Ban Nanoparticles – Potentially Toxic Beauty Products That Get Right under Your Skin.” London: Soil Association, 17 Jan. 2008. 24 Apr. 2008 < http://www.soilassociation.org/web/sa/saweb.nsf/848d689047 cb466780256a6b00298980/42308d944a3088a6802573d100351790!OpenDocument >.Smith, Jeffrey. Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods. Fairfield, Iowa: Yes! Books, 2007.———. Seeds of Deception. Melbourne: Scribe, 2004.U.S. Dairy Export Council (USDEC). Bovine Somatotropin (BST) Backgrounder. Arlington, VA: U.S. Dairy Export Council, 2006.U.S. Food and Drug Administration (USFDA). Animal Cloning: A Draft Risk Assessment. Rockville, MD: Center for Veterinary Medicine, U.S. Food and Drug Administration, 28 Dec. 2006.———. FDA and Nanotechnology Products. U.S. Department of Health and Human Services, U.S. Food and Drug Administration, 2008. 24 Apr. 2008 < http://www.fda.gov/nanotechnology/faqs.html >.Woodrow Wilson International Center for Scholars (WWICS). “A Nanotechnology Consumer Products Inventory.” Data set as at Sep. 2007. Woodrow Wilson International Center for Scholars, Project on Emerging Technologies, Sep. 2007. 24 Apr. 2008 < http://www.nanotechproject.org/inventories/consumer >.

Abstract:

Introduction 1. In an era of globalization, international trade is inevitable. When we walk into a supermarket and find South American bananas, Malaysian rubber products, Brazilian coffee, we simply experience the impact of global trade. Global trade allows all countries around the world to publicise their markets and to supply goods and services that otherwise would not have been open to the domestic economy. As all goods and services are available at relatively cheaper prices in the international market, therefore domestic market becomes more competitive. People have got choices for competitive products. Therefore, the difference in the prices of goods of the foreign economy and domestic economy results in international trade. 2. Why nations trade with each other ? Not a single nation alone can generate all the goods and services for its households in today’s world of limitless desires. There is an unequal distribution of factors of production over the countries of the world. Countries of the world differ from each other in terms of natural resources, technology, entrepreneurial and managerial skills which determine the ability of the country concerned, at the lowest cost of production, to manufacture goods and services. For example, South Korea can manufacture cars or microelectronic products effectively in comparison with any other nation in the world, similarly Malaysia could produce rubber and palm oil more efficiently. The ability to manufacture these products, such as electronics or rubber, is much greater than their ability to consume these goods within the country so that they can sell these goods at comparatively cheaper prices to other countries around the world. Similarly, India and Brazil can import certain products from South Korea and Malaysia at lower prices and can in exchange, import Brazilian coffee or Indian textiles at a lower price. Therefore, generally trade benefits all the countries of the world provided it is free trade. If one country has a belief in free trade and the other beliefs in the opposite, only the previous one will end practicing free trade and suffering in the end. Economists say that trade conflicts safeguard economic interests and are advantageous to the local market, but critics claim that they ultimately hurt local companies, consumers, and the economy in long run. Protectionist policies always harm the concept of globalization. According to the World Commission on the social dimension of globalization (2004). “Globalisation should benefit all the countries and should raise the welfare of all people throughout the world”. Advocates of protectionist view put arguments in favour of restrictions of the trade like the expansion of the home market, keeping money at home, counteracting foreign low wages, defence or national security arguments, protection of infant industry, anti-dumping arguments, and balance of payment arguments. Trade restrictions are of two types; tariff barriers and non-tariff barriers. The tariff barrier is the most common barrier to trade. It is the tax or duties that one country imposes on exported or imported goods. There are various types of tariff barriers in international trade. If the tariff is imposed based on the physical weight of some goods, imported or exported, called a specific tariff. • If a tariff is imposed on the value of some goods, imported or exported is called “Ad Valorem tariff”. • If different rates of the tariff are imposed on different countries called discriminatory tariffs. • If the same rates of a tariff are imposed on different countries, called non-discriminatory tariff’. • If the main purpose of imposing a tariff is to produce revenue, called a revenue tariff. • And the most commonly used tariff is the Protective tariff. if the tariff is imposed mainly to protect domestic industries from foreign competitions are called the protective tariff 4. Followers of the protectionist policy argue that tariff imposition has two impacts; revenue increases after the imposition of tariff and home production increases which is called protective effect but if other countries retaliate in the same manner, the trade war is inevitable. A situation of trade war erupts when one nation or economy strike back against another economy by imposing trade barriers. The application of trade restrictions is not a new concept in international trade. If we study the background of the global trade war, we find that countries frequently used trade restrictions in global trade. The situation was aggravated after the second world war. Most of the countries were intentionally devaluing their currency to increase their export and minimise imports. This was also the reason for the currency war between countries. 5. We can divide the world trade in the pre-Bretton Woods and post Bretton Woods period. An efficient international monetary system is very essential for the smooth functioning and expansion of international trade. From the early 19th century until the first world war, the era was regarded as a period of internationalism. Most of the major industrialised nations of the world started participating in world trade. After the second world war and the hectic slump and currency war that followed it all the countries of the world wished to return to normalcy. Two causes were responsible for this wish: - • Reconstruction of the economies ravaged by the war. • To end the currency war. As far as the second cause is concerned many countries or the trading partners of the world started devaluating its currency to improve the conditions of their BOP. This resulted in a trade war between nations. Therefore, in Bretton Woods, New Hampshire, USA, members of 44 countries met to discuss these problems and to find realistic solutions for them. This conference proposed the establishment of: - • The International Monetary Fund (IMF), to help member countries to meet their BOP deficit problem. • IBRD, to reconstruct and develop economies of member countries. • An International Trade Organisation (ITO), to solve the problem of international trade and proper liberalisation of it. 6. However, the proposal for the International Trade Organisation did not materialise and the General Agreement on Tariff and Trade (GATT) was formed. The GATT was established in 1948 with a big and important objective of “free trade” and “no trade war”. Its main purpose was to remove trade restrictions which sooner or later converts into a trade war. The first seven rounds of GATT were focussed on the removal of trade barriers only. Despite these discussions in several rounds of GATT, it couldn’t provide a useful forum for discussion on international trade issues. 7. The 8th round of GATT is called Uruguay Round which started in 1986. Member countries negotiated in the areas of Tariffs, Non-Tariff Measures, Tropical Production, Natural resource-based products, Agriculture, GATT articles, Safeguards, Multilateral trade negotiation agreement, Subsidies, Disputes Settlement, Trade-Related Intellectual Property Rights (TRIPPS), Trade-Related Investments measures (TRIMS), Functioning of GATT system (FOGS). Despite serious discussion on these issues’ agreement could not be reached and member countries kept on using trade and non-trade barriers on each other. 8. COVID-19 pandemic, which started in March 2020, has adversely affected global trade. As per WTO statistics, a 3% fall in the volume of merchandise (export and import) trade is seen in the first quarter of 2020. Lockdown in many economies of the world aggravated the problem and declines are historically large. Strict social distancing and majors and restrictions on travel and transport adversely affected the service sector of the world economy which is the main contributor to gross domestic product (GDP) of many countries. Therefore, the economic recovery from the COVID situation is highly uncertain. This situation might give a boost to the global trade war which will be the endeavour during the research to be found out and a description of the same has been covered in Chapter 3. The research has tried to reveal how the pandemic has crippled the world economy and aggravating the pre-existing problem of the trade war. The recent trade war between China and the USA is an apt example. Recent Examples of Trade War​​ 9. Since the year 2018 world has been witnessing trade conflict which was earlier currency conflict between the USA and its economic partners mainly the EU and China. But in this conflict US’s all-weather friend Canada and Mexico were also hit. However, retaliation by other countries has been very limited. In March 2018, the United States announced the imposition of additional tariffs under Section 232 on imports of steel (25%) and aluminium (10%) from China to the United States. This might harm the Chinese economy as China is the major contributor of crude and finished steel in the world. 10. In the same month, the US President announced his strategy to endorse restrictions against China over its Intellectual Property Rights (IPR) policies which were severely affecting its stakeholders. In this sanction, the US raised tariffs by 24 to 25% on selected Chinese products which were valued to the tune of approximately $50 billion. By adopting the policy of quid pro quo China on 01 April responded with 25% tariffs on $50 billion in US exports on various American products, like agriculture, pork, and cars. On 3rd April 2018, the US administration released a list of 1,333 goods equivalent to $50 billion in trade, which it said would enforce a 25% tariff. 11. These Chinese products mainly belong to the category of important sectors like robotics, rail and shipping, information technology, health care, and medicine, and high-technology. China retaliated and published a list of 106 products on which 25% tariffs were imposed and its value was worth $50 billion in trade. Thus, quid pro quo tactics kept ongoing between China and the US. The US plans to tax $50 billion worth of Chinese imports was replied with threats by China to impose tariffs on American products worth $50 billion. China announced to hit back with additional taxes on American chemicals, automobiles, and other products. Interestingly all these 106 American products are produced in those regions of the US where President Trump enjoys great support of his people. Earlier this year both countries signed the first phase of the trade agreement to reduce trade pressures between them, which last year weakened global growth and scaled-down business investment around the world. But due to the blame game over the pandemic, progress has been derailed. 12. Apart from the above, the subsidy has been one of the major causes of dispute amongst countries of the world. According to the WTO agreement on agriculture, developed economies had to reduce their subsidies by 21% in six years and developing countries by 12% in 10 years. Recently restriction on Indian agriculture produce by US, EU, Canada, Brazil, and Japan has been imposed in August 2020. They have questioned that India is not following the WTO peace clause for surpassing the limit on support or, subsidy it can render to its peasants. In the platform of WTO, the ceiling for subsidy is 10% of the value of the produce. India provided the WTO with details that the value of its rice production in 2018 was $43.6 billion and subsidies were worth just $5 billion. Subsidies have therefore remained a major bone of contention between the various countries of the world, but there is one peace arrangement in the WTO that protects the WTO members’ food procurement program for developing countries from taking action in the event of a violation of the subsidy cap. It will also be a litmus test to observe if in circ*mstances like the ongoing pandemic, WTO members grant food security pre-eminence to emerging economies or whether developed nations are pursuing market entree. Globalisation has reached a few obstructions in recent times, following decades of surges in world trade, worldwide tourism, and global cooperation, as some of the development achieved in the past has been undone by the re-emergence of patriotism and protectionism. The COVID-19 pandemic is predicted to trigger an unprecedented deterioration in global trade after trade growth decelerated dramatically in 2019, owing in huge part to trade conflict between the United States and China. As per the forecasts of the WTO, merchandise business is going to plunge between 12.98% and 31.88% this year, depending on how easily the coronavirus is controlled and trade will return to pre-crisis levels. According to the WTO Director-General, Roberto Azevêdo, the swift and robust rebound is only possible through the focus on free trade. Global markets have to be kept open and predictable, in addition to promoting a more desirable business climate. 13. Though before the onset of the pandemic, the Indian economy was not affected much by the ongoing trade conflict between the USA and China because of the combined effect of the pandemic and trade war India’s GDP shrunk by 23.9% in the first quarter of FY 2020-21. In the first quarter, the worst-hit industry was construction, which contracted by 50 percent. The hotel industry contracted by 47%, production by 39.3%, and mining by 23.3%. Agriculture, which posted a 3.4 percent rise, was the only industry that managed to survive the recession. The economy is believed to have suffered the most during the June quarter as a result of the nationwide lockdown. 14. In January 2019, as the trade war was raging, India also placed anti-dumping duties on more than 99 Chinese goods to protect its domestic markets, such as anti-dumping duties on chemicals, petrochemicals, fabrics, yarn, pharmaceutical equipment, rubber, and steel products. As a follower of protectionist policy Indian government also imposes anti-dumping duty on imports of steel products, an alloy of aluminium. The total value of duty imposed was $13.07 per ton to $ 173.1 per ton, which is a big amount. China, Vietnam, South Korea for five years in June 2020. India needs to take some major steps and reforms to bounce back its economy back on track. 15. Review of Literature… To complete the research number of books, literatures in the forms of articles, journals, independent views of various economists have been reviewed and referred. Books…. ​Various books reviewed and which have contributed in the course of the research include the following: - (a) ​Trade War Are Class War: How Rising Inequality Distorts the Global Economy and Threatens International Peace by Mathew C. Klein and Michael Pettis published by Yale University Press, May 19, 2020. ​The roots of today’s trade wars are traced by Klein and Pettis to decisions taken over the past thirty years by policymakers and business leaders in China, Europe, and the United States. The authors include a coherent narrative in this book that demonstrates how the growing injustice of class wars is a challenge to the global economy and international peace, and what the ways ahead are. (b)​ Has China Won by Kishore Mahbubani published by PublicAffairs, March 2020. ​​The author of this book aims to provide an insight into the trade war between the USA and China. He also claims that China is not as is claimed, an expansionist country. By extending its trade, diplomacy and military might in the region, it secures its national interest. But his view appears to be skewed toward the Chinese target. (c)​ Superpower Showdown: How the Battle between Trump and Xi Threaten a New Cold War by Bob Davis and Lingling Wei published by HarperCollins, June 9, 2020. ​As told by two Wall Street Journal reporters, one based in Washington, D.C., the other in Beijing, who had more access to the decision-makers in the White House and China’s Zhongnanhai leadership compound than anyone else, this is the inside story of the US-China trade war, how ties between these superpowers unravelled, darkening prospects for global peace and prosperity. Over the seven years, they have collaborated on writing for the Wall Street Journal, Davis and Wei have conducted hundreds of interviews with government and business officials in both nations. They explain how we have reached this turning point and look at where we might be going, evaluating U.S.-China ties. (d) ​COVID-19 Challenges for the Indian Economy: Trade and Foreign Policy Effects by EEPCINDIA and AIC, 2020. ​​A study entitled ‘COVID-19: Challenges for the Indian Economy – Trade and Foreign Policy Consequences’ was developed by the ASEAN-India Centre(AIC) Research and Information System for Developing Countries(RIS) in collaboration with the Engineering Export Promotion Council (EEPC), it presents freshly written 40 primary comments on India’s trade and foreign policy challenges raised by this crisis and the way forward by Indian professors, economists, and practitioners. (e ) ​Global Economic Effects of COVID-19 by Congressional Research Service August 2020 by James K. Jackson, Martin A. Weiss, and Rebecca M. Nelson.​ It’s a Congressional Research paper published to analyse the effects of the pandemic on the world economy particularly, the USA. It’s a crystal gazing done by two seasoned economists and gives an excellent perspective of ongoing trade and its likely directions post COVID-19. Research is full of authentic data, facts and Pictures gathered from governmental and non-governmental sources. (f) ​Trade is Not a Four-Letter Word: How Six Everyday Products make the case for Trade, January 2014 by Fred Hochberg published by Simon and Schuster. ​Fred P. Hochberg breaks down colourful and convincing real-world examples through the prism of six traditional American items to reject the common myths and misunderstandings surrounding trade. Mr. Hochberg illustrates the story of America’s most unexpected business partnerships by using six commonly consumed American products; the taco salad, the minivan, the banana, the iPhone, the college degree, and the HBO series Game of Thrones – thus sharing the fundamentals of trade that everybody should know. (g) ​Indian Economy by Dutta and Sundhram published by S. Chand, New Delhi, 66th Revised Edition.​This book analyses structure of the Indian Economy, national income, study of human and natural resources in the context of economic development, pattern of foreign trade of India, broad cross-section of the Indian economy. Chapter 6 of this book deals with foreign trade in India and its balance of payment position which is significant for my study. (h) ​International Economics by Francis Cherunilam published by Tata McGraw Hill Publishing Company Limited, New Delhi, Third Edition. The author is a professor at the School of Management Studies at Cochin University of Science and Technology. This book deals with the conflicting national interest, international economic relations, and solutions of conflicting interests. Chapter 3 of this book shows the picture of international trade. Chapter 9th and 10th clear the picture of free trade versus protection and different types of trade barriers. (i) ​International Economics by H.G. Mannur published by Vikas Publishing House Private Limited, Second Revised Edition. ​The author of this book, H.G. Mannur paid his gratitude to the school of social sciences of the university of science in Penang Malaysia, which provided him a great opportunity to learn about the International economics of Malaysia related to the world. This book is dealing with the International economy of Malaysia which is the highest foreign trade-dependent economy. Chapter 1 explains why do nations trade with each other. Chapter 7 of this book deals with obstacles to trade and trade restrictions. (j) ​International Economics by Dominick Salvatore by Wiley, January 1, 2014. ​​Dominick Salvatore, the author of international economics is an American economist. This book presents theories of international economics and its relevance through real-world examples and applications. Articles. ​ Several articles on the subject relating to the global trade, trade conflict and its effects on world have been written by many noted columnists and authors. Apart from that in last 10 months number of organisations and research bodies also carried out the analysis and likely effects of the COVID-19 pandemic on the world trade and ongoing trade conflict. Articles from publications such as ‘The Economics Times’, ‘Business Today’, ‘The Hindu’, ‘National Council of Applied Economic Research’, ‘BBC Economic Research’, ‘Economic Research and Statistics Division (ERSD)’, ‘Investopedia’ and ‘Business Insider’ form a part of the literature review for the research. In addition to the articles and journals by various writers certain data were also taken from the governmental and non-governmental reports like United Nations Conference on Trade and Development(UNCTAD), WTO Press releases and Economic Survey of India. The existing literature provides great insight into the reasons of trade between the countries, trade conflict and its catalyst and how an unforeseen event like the pandemic brings the entire world to a standstill where even largest and strongest have no solution. There are number of literature and research available which brings out many scenarios where the current trade conflict can go. Besides, a large number of research papers have also been written about the likely recovery of the world trade in various different scenarios. Study of some of has definitely given an insightful perspective on the subject. There is, however a void in the research writings on the subject from Indian government’s concerned ministry like Ministry of Finance, Ministry of Trade and Commerce and Ministry of Agriculture. The Economic Survey of India was the only document where authentic data could have been found but that too was almost six to eight months old. The updated analytical facts and data from the ministry’s sites will go a long way in helping a researcher for his work. A critical study of books and articles mentioned above has assisted in the research to address the issues identified. ​16. Statement of Problem.​ The research seeks to investigate: - (a) ​How the current global trade war (GTW) has impacted the nations having a considerable share in world trade? (b) ​How has the Global Trade War (GTW) impacted the Indian economy? (c)​What are the effects of the COVID-19 pandemic on the Global Trade War? (d) ​What are the likely effects of the COVID -19 pandemic on the Indian economy? 17. Statement of Problem.​ The research seeks to investigate: - (a) ​How the current global trade war (GTW) has impacted the nations having a considerable share in world trade? (b) ​How has the Global Trade War (GTW) impacted the Indian economy? (c)​What are the effects of the COVID-19 pandemic on the Global Trade War? (d) ​What are the likely effects of the COVID -19 pandemic on the Indian economy? 18. Objectives of the Study. The specific objectives of the study are as under: - (a) ​To study the reasons and effects of the global trade war on nations having a major share in world trade. (b) ​To study the effects of COVID-19 pandemic and GTW on international trade with specific emphasis on the Indian economy. 19. Hypothesis The research is intended to deliberate and validate the following hypothesis: - (a) ​Global Trade War has severely impacted nations from having a major share in world trade. (b) ​India has not been affected much by the Global Trade War. (c)​COVID-19 pandemic is going to aggravate the Global Trade War. (d) ​Indian economy will be adversely affected by the ongoing pandemic. 20. The relevance of the Study… This study will contribute to academia with an in-depth insight into the existent trend of international trade and trade war. The present study will evaluate the effect of COVID-19 on international trade and its role in aggravating trade war. Besides, this study will also endeavour to furnish both analysis and suggestions towards: - (a) ​Trend of global trade and reasons behind trade war. (b) ​Likely direction of international trade post-COVID-19. (c)​Its impact on the Indian economy and recommendations for future economic policies. 21. Research Methodology Owing to the current and contemporary nature of the topic, research was based on the primary and secondary method of data collection wherein the number of books, open-source articles, internet blogs, periodicals, and research papers were referred and perused. Apart from the same reports and analysis of both governmental and non-governmental agencies, which were available in the open domain, were also accessed during the research. To support the arguments, an online public opinion, based on close-ended questionnaire, was be taken through Google forms. The survey questionnaire was analysed based on responses using Likert Scale. Non-random convenient sampling was used for selection of participants. A total of 114 respondents took part in the survey. 22. Organisation of the Research Research has been completed under five chapters. Headings of the chapters and their broad contents have been covered in succeeding paragraphs. (a) ​Chapter 1: Introduction and Research Methodology. In this chapter background of global trade, particularly after World War II, the role of WTO for free and fair trade amongst member nations along with research methodology have been covered in detail. (b) ​Chapter 2: Background of Global Trade War and Situation up to the onset of the COVID-19 pandemics. In this chapter issues like background of trade war, currency war and current state of global trade amidst ongoing trade conflict between the USA and China has been covered in detail. Apart from the same it has also been brought out in this chapter that which are the countries and which all products and services have been severely affected. All the affected nations are adopting their own policies to deal with the current situation of COVID-19 and ripples of trade dispute. Same have also been brought forward in this chapter. (c)​Chapter 3: Likely Directions of Global Trade War post-COVID-19 pandemics. COVID-19 pandemic has added a new dimension to the way nations were doing trade with each other, particularly in the light of disruption in production, supply chain, unpredicted market, and labour issues. Apart from that, it has severely affected the ongoing global trade war. The revival of the economy is incumbent on medical success in finding the vaccine for the disease. In this chapter likely direction of the trade war has been discussed in details. Apart from the foregoing, long and short term effects of the pandemic on global trade have also been covered in this chapter. (d) ​Chapter 4: Impact of Global Trade War and COVID-19 pandemics on the Indian Economy. The Indian economy was not affected much by the global trade war but since the onset of a pandemic, the combined effect of COVID-19 and trade war has started affecting the Indian economy. Apart from the same in this chapter impact on export and import capability of India during pandemic times have also been covered in detail. Recent development at Galwan valley in Eastern Ladakh which includes the steps taken by India and its likely implications on the trade between India and China has also been covered in this chapter. In the end an analysis of the Online survey with the help of Google form has been covered to check the hypothesis. (e)​ Chapter 5: Way Ahead for the Indian Economy, Recommendations and Conclusion. ​In continuation of the previous chapter, this chapter contains nthe state of global trade in the current times along with certain recommendations which can be followed to have a fair world trade. During COVID-19 pandemic the Indian government has taken large number of fiscal measures to control to the damage and bring the economy back on track and same have been covered in great details in this chapter. Apart from that actions which Indian government should take to minimise the impact of trade dispute between other nations have also been recommended. In last way ahead for the Indian economy has been recommended.

Abstract:

Photo by 14825144 © Alita Xander | Dreamstime.com ABSTRACT The US government's approach to the War on Drugs has created laws to deter people from using illicit drugs through negative punishment. These laws have not controlled illicit drug use, nor has it stopped the opioid pandemic from growing. Instead, these laws have created a negative bias surrounding addiction and have negatively affected particularly vulnerable patient populations, including pregnant women with substance use disorder and newborns with neonatal abstinence syndrome. This article highlights some misconceptions and underscores the challenges they face as they navigate the justice and healthcare systems while also providing possible solutions to address their underlying addiction. INTRODUCTION Pregnant women with substance use disorder require treatment that is arguably for the benefit of both the mother and the fetus. Some suggest that addiction is a choice; therefore, those who misuse substances should not receive treatment. Proponents of this argument emphasize social and environmental factors that lead to addiction but fail to appreciate how chronic substance use alters the brain’s chemistry and changes how it responds to stress, reward, self-control, and pain. The medical community has long recognized that substance use disorder is not simply a character flaw or social deviance, but a complex condition that requires adequate medical attention. Unfortunately, the lasting consequences of the War on Drugs have created a stigma around addiction medicine, leading to significant treatment barriers. There is still a pervasive societal bias toward punitive rather than rehabilitative approaches to addiction. For example, many women with substance use disorder lose custody of their baby or face criminal penalties, including fines and jail time.[1] These punitive measures may cause patients to lose trust in their physicians, ultimately leading to high-risk pregnancies without prenatal care, untreated substance misuse, and potential lifelong disabilities for their newborns.[2] As a medical student, I have observed the importance of a rehabilitative approach to addiction medicine. Incentivizing pregnant women with substance use disorder to safely address their chronic health issues is essential for minimizing negative short-term and long-term outcomes for women and their newborns. This approach requires an open mind and supportive perspective, recognizing that substance use disorder is truly a medical condition that requires just as much attention as any other medical diagnosis.[3] BACKGROUND The War on Drugs was a government-led initiative launched in 1970 by President Richard M. Nixon with the aim of curtailing illegal drug use, distribution, and trade by imposing harsher prison sentences and punishments.[4] However, it is worth noting that one can trace the roots of this initiative back further. In 1914, Congress enacted the Harrison Narcotics Tax Act to target the recreational use of drugs such as morphine and opium.[5] Despite being in effect for over four decades, the War on Drugs failed to achieve its intended goals. In 2011, the Global Commission on Drug Policy released a report that concluded that the initiative had been futile, as “arresting and incarcerating tens of millions of these people in recent decades has filled prisons and destroyed lives and families without reducing the availability of illicit drugs or the power of criminal organizations.”[6] One study published in the International Journal of Drug Policy in the same year found that funding drug law enforcement paradoxically contributed to increasing gun violence and homicide rates.[7] The Commission recommended that drug policies focus on reducing harm caused by drug use rather than solely on reducing drug markets. Recognizing that many drug policies were of political opinion, it called for drug policies that were grounded in scientific evidence, health, security, and human rights.[8] Unfortunately, policy makers did not heed these recommendations. In 2014, Tennessee’s legislature passed a “Fetal Assault Law,” which made it possible to prosecute pregnant women for drug use during pregnancy. If found guilty, pregnant women could face up to 15 years in prison and lose custody of their child. Instead of deterring drug use, the law discouraged pregnant women with substance use disorder from seeking prenatal care. This law required medical professionals to report drug use to authorities, thereby compromising the confidentiality of the patient-physician relationship. Some avoided arrest by delivering their babies in other states or at home, while others opted for abortions or attempted to go through an unsafe withdrawal prior to receiving medical care, sacrificing the mother's and fetus's wellbeing. The law had a sunset provision and expired in 2016. During the two years this law was in effect, officials arrested 124 women.[9] The fear that this law instilled in pregnant women with substance use disorder can still be seen across the US today. Many pregnant women with substance use disorders stated that they feared testing positive for drugs. Due to mandatory reporting, they were not confident that physicians would protect them from the law.[10] And if a woman tried to stop using drugs before seeking care to avoid detection, she often ended up delaying or avoiding care.[11] The American College of Obstetricians and Gynecologists (ACOG) recognizes the fear those with substance use disorders face when seeking appropriate medical care and emphasizes that “obstetric–gynecologic care should not expose a woman to criminal or civil penalties, such as incarceration, involuntary commitment, loss of custody of her children, or loss of housing.”[12] Mandatory reporting strains the patient-physician relationship, driving a wedge between the doctor and patient. Thus, laws intended to deter people from using substances through various punishments and incarceration may be doing more harm than good. County hospitals that mainly serve lower socioeconomic patients encounter more patients without consistent health care access and those with substance use disorders.[13] These hospitals are facing the consequences of the worsening opioid pandemic. At one county hospital where I recently worked, there has been a dramatic increase in newborns with neonatal abstinence syndrome born to mothers with untreated substance use disorders during pregnancy. Infants exposed to drugs prenatally have an increased risk of complications, stillbirth, and life-altering developmental disabilities. At the hospital, I witnessed Child Protective Services removing two newborns with neonatal abstinence syndrome from their mother’s custody. Four similar cases had occurred in the preceding month. In the days leading up to their placement with a foster family, I saw both newborns go through an uncomfortable drug withdrawal. No baby should be welcomed into this world by suffering like that. Yet I felt for the new mothers and realized that heart-wrenching custody loss is not the best approach. During this period, I saw a teenager brought to the pediatric floor due to worsening psychiatric symptoms. He was born with neonatal abstinence syndrome that neither the residential program nor his foster family could manage. His past psychiatric disorders included attention deficit disorder, conduct disorder, major depressive disorder, anxiety disorder, disruptive mood dysregulation disorder, intellectual developmental disorder, and more. During his hospitalization, he was so violent towards healthcare providers that security had to intervene. And his attitude toward his foster parents was so volatile that we were never sure if having them visit was comforting or agitating. Throughout his hospital course, it was difficult for me to converse with him, and I left every interview with him feeling lost in terms of providing an adequate short- and long-term assessment of his psychological and medical requirements. What was clear, however, was that his intellectual and emotional levels did not match his age and that he was born into a society that was ill-equipped to accommodate his needs. Just a few feet away from his room, behind the nurses’ station, were the two newborns feeling the same withdrawal symptoms that this teenager likely experienced in the first few hours of his life. I wondered how similar their paths would be and if they would exhibit similar developmental delays in a few years or if their circ*mstance may follow the cases hyped about in the media of the 1980s and 1990s regarding “crack babies.” Many of these infants who experienced withdrawal symptoms eventually led normal lives.[14] Nonetheless, many studies have demonstrated that drug use during pregnancy can adversely impact fetal development. Excessive alcohol consumption can result in fetal alcohol syndrome, characterized by growth deficiency, facial structure abnormalities, and a wide range of neurological deficiencies.[15] Smoking can impede the development of the lungs and brain and lead to preterm deliveries or sudden infant death syndrome.[16] Stimulants like methamphetamine can also cause preterm delivery, delayed motor development, attention impairments, and a wide range of cognitive and behavioral issues.[17] Opioid use, such as oxycodone, morphine, fentanyl, and heroin, may result in neonatal opioid withdrawal syndrome, in which a newborn may exhibit tremors, irritability, sleeping problems, poor feeding, loose stools, and increased sweating within 72 hours of life.[18] In 2014, the American Association of Pediatrics (AAP) reported that one newborn was diagnosed with neonatal abstinence syndrome every 15 minutes, equating to approximately 32,000 newborns annually, a five-fold increase from 2004.[19] The AAP found that the cost of neonatal abstinence syndrome covered by Medicaid increased from $65.4 million to $462 million from 2004 to 2014.[20] In 2020, the CDC published a paper that showed an increase in hospital costs from $316 million in 2012 to $572.7 million in 2016.[21] Currently, the impact of the COVID-19 pandemic on the prevalence of newborns with neonatal abstinence syndrome is unknown. I predict that the increase in opioid and polysubstance use during the pandemic will increase the number of newborns with neonatal abstinence syndrome, thereby significantly increasing the public burden and cost.[22] In the 1990s, concerns arose about the potentially irreparable damage caused by intrauterine exposure to cocaine on the development of infants, which led to the popularization of the term “crack babies.”[23] Although no strong longitudinal studies supported this claim at the time, it was not without merit. The Maternal Lifestyle Study (NCT00059540) was a prospective longitudinal observational study that compared the outcomes of newborns exposed to cocaine in-utero to those without.[24] One of its studies revealed one month old newborns with cocaine exposure had “lower arousal, poorer quality of movements and self-regulation, higher excitability, more hypertonia, and more nonoptimal reflexes.”[25] Another study showed that at one month old, heavy cocaine exposure affected neural transmission from the ear to the brain.[26] Long-term follow up from the study showed that at seven years old, children with high intrauterine cocaine exposure were more likely to have externalizing behavior problems such as aggressive behavior, temper tantrums, and destructive acts.[27] While I have witnessed this behavior in the teenage patient during my pediatrics rotation, not all newborns with intrauterine drug exposure are inevitably bound to have psychiatric and behavioral issues later in life. NPR recorded a podcast in 2010 highlighting a mother who used substances during pregnancy and, with early intervention, had positive outcomes. After being arrested 50 times within five years, she went through STEP: Self-Taught Empowerment and Pride, a public program that allowed her to complete her GED and provided guidance and encouragement for a more meaningful life during her time in jail. Her daughter, who was exposed to cocaine before birth, had a normal childhood and ended up going to college.[28] From a public health standpoint, more needs to be done to prevent the complications of substance misuse during pregnancy. Some states consider substance misuse (and even prescribed use) during pregnancy child abuse. Officials have prosecuted countless women across 45 states for exposing their unborn children to drugs.[29] With opioid and polysubstance use on the rise, the efficacy of laws that result in punitive measures seems questionable.[30] So far, laws are not associated with a decrease in the misuse of drugs during pregnancy. Millions of dollars are being poured into managing neonatal abstinence syndrome, including prosecuting women and taking their children away. Rather than policing and criminalizing substance use, pregnant women should get the appropriate care they need and deserve. I. Misconception One: Mothers with Substance Use Disorder Can Get an Abortion If an unplanned pregnancy occurs, one course of action could be to terminate the pregnancy. On the surface, this solution seems like a quick fix. However, the reality is that obtaining an abortion can be challenging due to two significant barriers: accessibility and mandated reporting. Abortion laws vary by state, and in Tennessee, for instance, abortions are banned after six weeks of gestation, typically when fetal heart rhythms are detected. An exception to this is in cases where the mother's life is at risk.[31] Unfortunately, many women with substance use disorders are from lower socioeconomic backgrounds and cannot access pregnancy tests, which could indicate they are pregnant before the six-week cutoff. If a Tennessee woman with substance use disorder decides to seek an abortion after six weeks, she may need to travel to a neighboring state. However, this is not always a feasible option, as the surrounding states (WV, MO, AR, MI, AL, and GA) also have restrictive laws that either prohibit abortions entirely or ban them after six weeks. Moreover, she may be hesitant to visit an obstetrician for an abortion, as some states require physicians by law to report their patients' substance use during pregnancy. For example, Virginia considers substance use during pregnancy child abuse and mandates that healthcare providers report it. This would ultimately limit her to North Carolina if she wants to remain in a nearby state, but she must go before 20 weeks gestation.[32] For someone who may or may not have access to reliable transportation, traveling to another state might be impossible. Without resources or means, these restrictive laws have made it incredibly difficult to obtain the medical care they need. II. Misconception Two: Mothers with SUD are Not Fit to Care for Children If a woman cannot take care of herself, one might wonder how she can take care of another human being. Mothers with substance use disorders often face many adversities, including lack of economic opportunity, trauma from abuse, history of poverty, and mental illness.[33] Fortunately, studies suggest keeping mother and baby together has many benefits. Breastfeeding, for example, helps the baby develop a strong immune system while reducing the mother’s risk of cancer and high blood pressure.[34] Additionally, newborns with neonatal abstinence syndrome who are breastfed by mothers receiving methadone or buprenorphine require less pharmacological treatment, have lower withdrawal scores, and experience shorter hospital stays.[35] Opioid concentration in breastmilk is minimal and does not pose a risk to newborns.[36] Moreover, oxytocin, the hormone responsible for mother-baby bonding, is increased in breastfeeding mothers, reducing withdrawal symptoms and stress-induced reactivity and cravings while also increasing protective maternal instincts.[37] Removing an infant from their mother’s care immediately after birth would result in the loss of all these positive benefits for both the mother and her newborn. The newborns I observed during my pediatrics rotation probably could have benefited from breastfeeding rather than bottle feeding and being passed around from one nurse to the next. They probably would have cried less and suffered fewer withdrawal symptoms had they been given the opportunity to breastfeed. And even if the mothers were lethargic and unresponsive while going through withdrawal, it would still have been possible to breastfeed with proper support. Unfortunately, many believe mothers with substance use disorder cannot adequately care for their children. This pervasive societal bias sets them up for failure from the beginning and greatly inhibits their willingness to change and mend their relationship with their providers. It is a healthcare provider’s duty to provide non-judgmental care that prioritizes the patient’s well-being. They must treat these mothers with the same empathy and respect as any other patient, even if they are experiencing withdrawal. III. Safe Harbor and Medication-Assisted Treatment Addiction is like any other disease and society should regard treatment without stigma. There is no simple fix to this problem, given that it involves the political, legal, and healthcare systems. Punitive policies push pregnant women away from receiving healthcare and prevent them from receiving beneficial interventions. States need to enact laws that protect these women from being reported to authorities. Montana, for example, passed a law in 2019 that provides women with substance use disorders safe harbor from prosecution if they seek treatment for their condition.[38] Medication-assisted treatment with methadone or buprenorphine is the first line treatment option and should be available to all pregnant women regardless of their ability to pay for medical care.[39] To promote continuity of care, health officials could include financial incentives to motivate new mothers to go to follow-up appointments. For example, vouchers for groceries or enrollment in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) may offset financial burdens and allow a mother to focus on taking care of her child and her recovery. IV. Mandated Substance Abuse Programs Although the number of people sentenced to state prisons for drug related crimes has been declining, it is still alarming that there were 171,300 sentencings in 2019.[40] Only 11 percent of the 65 percent of our nation’s inmates with substance use disorder receive treatment, implying that the other 89 percent were left without much-needed support to overcome their addiction.[41] It is erroneous to assume that their substance use disorder would disappear after a period without substance use while behind bars. After withdrawal, those struggling with substance use disorder may still have cravings and the likelihood of relapsing remains high without proper medical intervention. Even if they are abstinent for some time during incarceration, the underlying problem persists, and the cycle inevitably continues upon release from custody. In line with the recommendations by Global Commission on Drug Policy and the lessons learned from the failed War on Drugs, one proposed change in our criminal justice system would be to require enrollment and participation in assisted alcohol cessation programs before legal punishment. Policy makers must place emphasis on the safety of the patient and baby rather than the cessation of substance use. This would incentivize people to actively seek medical care, restore the patient-physician relationship, and ensure that they take rehabilitation programs seriously. If the patient or baby is unsafe, a caregiver could intervene while the patient re-enrolls in the program. Those currently serving sentences in prisons and jails can treat their substance use disorder through medication assisted treatment, cognitive behavioral therapy, and programs like Self Taught Empowerment and Pride (STEP). Medication assisted treatment under the supervision of medical professionals can help inmates achieve and maintain sobriety in a healthy and safe way. Furthermore, cognitive behavioral therapy can help to identify triggers and teach healthier coping mechanisms to prepare for stressors outside of jail. Finally, multimodal empowerment programs can connect people to jobs, education, and support upon release. People often leave prisons and jail without a sense of purpose, which can lead to relapse and reincarceration. Structured programs have been shown to decrease drug use and criminal behavior by helping reintegrate productive individuals into society.[42] V. Medical Education: Narcotic Treatment Programs and Suboxone Clinics Another proactive approach could be to have medical residency programs register with the Drug Enforcement Administration (DEA) as Narcotic Treatment Programs and incorporate suboxone clinics into their education and rotations. Rather than family medicine, OB/GYN, or emergency medicine healthcare workers having to refer their patients to an addiction specialist, they could treat patients with methadone for maintenance or detoxification where they would deliver their baby. Not only would this educate and prepare the future generation of physicians to handle the opioid crisis, but it would allow pregnant women to develop strong patient-physician relationships. CONCLUSION Society needs to change from the mindset of tackling a problem after it occurs to taking a proactive approach by addressing upstream factors, thereby preventing those problems from occurring in the first place. Emphasizing public health measures and adequate medical care can prevent complications and developmental issues in newborns and pregnant women with substance use disorders. Decriminalizing drug use and encouraging good health habits during pregnancy is essential, as is access to prenatal care, especially for lower socioeconomic patients. Many of the current laws and regulations that policy makers initially created due to naïve political opinion and unfounded bias to serve the War on Drugs need to be changed to provide these opportunities. To progress as a society, physicians and interprofessional teams must work together to truly understand the needs of patients with substance use disorders and provide support from prenatal to postnatal care. There should be advocation for legislative change, not by providing an opinion but by highlighting the facts and conclusions of scientific studies grounded in scientific evidence, health, security, and human rights. There can be no significant change if society continues to view those with substance use disorders as underserving of care. Only when the perspective shifts to compassion can these mothers and children receive adequate care that rehabilitates and supports their future and empowers them to raise their children. - [1] NIDA. 2023, February 15. Pregnant People with Substance Use Disorders Need Treatment, Not Criminalization. https://nida.nih.gov/about-nida/noras-blog/2023/02/pregnant-people-substance-use-disorders-need-treatment-not-criminalization [2] Substance Use Disorder Hurts Moms and Babies. National Partnership for Women and Families. June 2021 [3] All stories have been fictionalized and anonymized. [4] A History of the Drug War. Drug Policy Alliance. https://drugpolicy.org/issues/brief-history-drug-war [5] The Harrison Narcotic Act (1914) https://www.druglibrary.org/Schaffer/library/studies/cu/cu8.html [6] The War on Drugs. The Global Commission on Drug Policy. Published June 2011. https://www.globalcommissionondrugs.org/reports/the-war-on-drugs [7] Werb D, Rowell G, Guyatt G, Kerr T, Montaner J, Wood E. Effect of drug law enforcement on drug market violence: A systematic review. Int J Drug Policy. 2011;22(2):87-94. doi:10.1016/j.drugpo.2011.02.002 [8] Global Commission on Drug Policy, 2011 [9] Women NA for P. Tennessee’s Fetal Assault Law: Understanding its impact on marginalized women - New York. Pregnancy Justice. Published December 14, 2020. https://www.pregnancyjusticeus.org/tennessees-fetal-assault-law-understanding-its-impact-on-marginalized-women/ [10] Roberts SCM, Nuru-Jeter A. Women’s perspectives on screening for alcohol and drug use in prenatal care. Womens Health Issues Off Publ Jacobs Inst Womens Health. 2010;20(3):193-200. doi:10.1016/j.whi.2010.02.003 [11] Klaman SL, Isaacs K, Leopold A, et al. Treating Women Who Are Pregnant and Parenting for Opioid Use Disorder and the Concurrent Care of Their Infants and Children: Literature Review to Support National Guidance. J Addict Med. 2017;11(3):178-190. doi:10.1097/ADM.0000000000000308 [12] Substance Abuse Reporting and Pregnancy: The Role of the Obstetrician–Gynecologist. https://www.acog.org/en/clinical/clinical-guidance/committee-opinion/articles/2011/01/substance-abuse-reporting-and-pregnancy-the-role-of-the-obstetrician-gynecologist [13] R. Ghertner, G Lincoln The Opioid Crisis and Economic Opportunity: Geographic and Economic Trends. ASPE. Office of Assistant Secretary for Planning and Evaluation. DHHS Revised September 11, 2018 https://aspe.hhs.gov/reports/economic-opportunity-opioid-crisis-geographic-economic-trends [14] Midon, M. Z., Gerzon, L. R., & de Almeida, C. S. (2021). Crack and motor development of babies living in an assistance shelter. ABCS Health Sciences, 46, e021215-e021215. And for example, see Crack Babies: Twenty Years Later : NPR https://www.npr.org/templates/story/story.php?storyId=126478643 [15] Williams JF, Smith VC, the Committee on Substance Abuse. Fetal Alcohol Spectrum Disorders. Pediatrics. 2015;136(5):e20153113. doi:10.1542/peds.2015-3113 [16] CDC Tobacco Free. Smoking During Pregnancy. Centers for Disease Control and Prevention. Published April 11, 2022. https://www.cdc.gov/tobacco/basic_information/health_effects/pregnancy/index.htm [17] Abuse NI on D. What are the risks of methamphetamine misuse during pregnancy? National Institute on Drug Abuse. https://nida.nih.gov/publications/research-reports/methamphetamine/what-are-risks-methamphetamine-misuse-during-pregnancy [18] CDC. Basics About Opioid Use During Pregnancy | CDC. Centers for Disease Control and Prevention. Published July 21, 2021. https://www.cdc.gov/pregnancy/opioids/basics.html [19] Honein MA, Boyle C, Redfield RR. Public Health Surveillance of Prenatal Opioid Exposure in Mothers and Infants. Pediatrics. 2019;143(3):e20183801. doi:10.1542/peds.2018-3801 [20] Winkelman TNA, Villapiano N, Kozhimannil KB, Davis MM, Patrick SW. Incidence and Costs of Neonatal Abstinence Syndrome Among Infants with Medicaid: 2004–2014. Pediatrics. 2018;141(4):e20173520. doi:10.1542/peds.2017-3520 [21] Strahan AE, Guy GP Jr, Bohm M, Frey M, Ko JY. Neonatal Abstinence Syndrome Incidence and Health Care Costs in the United States, 2016. JAMA Pediatr. 2020;174(2):200-202. doi:10.1001/jamapediatrics.2019.4791 [22] Ghose R, Forati AM, Mantsch JR. Impact of the COVID-19 Pandemic on Opioid Overdose Deaths: a Spatiotemporal Analysis. J Urban Health Bull N Y Acad Med. 2022;99(2):316-327. doi:10.1007/s11524-022-00610-0 [23] Mayes LC, Granger RH, Bornstein MH, Zuckerman B. The Problem of Prenatal Cocaine Exposure: A Rush to Judgment. JAMA. 1992;267(3):406-408. doi:10.1001/jama.1992.03480030084043 [24] NICHD Neonatal Research Network. The Maternal Lifestyle Study. clinicaltrials.gov; 2016. https://clinicaltrials.gov/ct2/show/study/NCT00059540 [25] Lester BM, Tronick EZ, LaGasse L, et al. The maternal lifestyle study: effects of substance exposure during pregnancy on neurodevelopmental outcome in 1-month-old infants. Pediatrics. 2002;110(6):1182-1192. doi:10.1542/peds.110.6.1182 [26] Lester BM, Lagasse L, Seifer R, et al. The Maternal Lifestyle Study (MLS): effects of prenatal cocaine and/or opiate exposure on auditory brain response at one month. J Pediatr. 2003;142(3):279-285. doi:10.1067/mpd.2003.112 [27] Bada HS, Bann CM, Bauer CR, et al. Preadolescent behavior problems after prenatal cocaine exposure: Relationship between teacher and caretaker ratings (Maternal Lifestyle Study). Neurotoxicol Teratol. 2011;33(1):78-87. doi:10.1016/j.ntt.2010.06.005 [28] N, P, R. Crack Babies: Twenty Years Later. NPR. Published May 3, 2010. https://www.npr.org/templates/story/story.php?storyId=126478643 [29] Miranda L, Dixon V, September CRP on, 30, 2015. How States Handle Drug Use During Pregnancy http://projects.propublica.org/graphics/maternity-drug-policies-by-state [30] NCDAS: Substance Abuse and Addiction Statistics [2023]. NCDAS. https://drugabusestatistics.org/ [31] (Tenn. Code Ann. § 39-15-216). [32] Institute G. Interactive Map: US Abortion Policies and Access After Roe. https://states.guttmacher.org/policies/ [33] Whitesell M, Bachand A, Peel J, Brown M. Familial, Social, and Individual Factors Contributing to Risk for Adolescent Substance Use. J Addict. 2013;2013:579310. doi:10.1155/2013/579310 [34] CDC. Five Great Benefits of Breastfeeding. Centers for Disease Control and Prevention. Published July 27, 2021. https://www.cdc.gov/nccdphp/dnpao/features/breastfeeding-benefits/index.html [35] Welle-Strand GK, Skurtveit S, Jansson LM, Bakstad B, Bjarkø L, Ravndal E. Breastfeeding reduces the need for withdrawal treatment in opioid-exposed infants. Acta Paediatr. 2013;102(11):1060-1066. doi:10.1111/apa.12378 [36] Ilett KF, Hackett LP, Gower S, Doherty DA, Hamilton D, Bartu AE. Estimated dose exposure of the neonate to buprenorphine and its metabolite norbuprenorphine via breastmilk during maternal buprenorphine substitution treatment. Breastfeed Med Off J Acad Breastfeed Med. 2012;7:269-274. doi:10.1089/bfm.2011.0096 [37] Pedersen CA, Smedley KL, Leserman J, et al. Intranasal Oxytocin Blocks Alcohol Withdrawal in Human Subjects. Alcohol Clin Exp Res. 2013;37(3):484-489. doi:10.1111/j.1530-0277.2012.01958.x [38] Montana SB0289. https://leg.mt.gov/bills/2019/billhtml/SB0289.htm [39] Mullins N, Galvin SL, Ramage M, Gannon M, Lorenz K, Sager B, Coulson CC. Buprenorphine and Naloxone Versus Buprenorphine for Opioid Use Disorder in Pregnancy: A Cohort Study. J Addict Med. 2020 May/Jun;14(3):185-192. doi: 10.1097/ADM.0000000000000562. PMID: 31567599. [40] Drug Related Crime Statistics [2023]: Offenses Involving Drug Use. NCDAS. https://drugabusestatistics.org/drug-related-crime-statistics/ [41] Association APH. Online only: Report finds most U.S. inmates suffer from substance abuse or addiction. Nations Health. 2010;40(3):E11-E11. [42] Principles of Drug Addiction Treatment: A Research-Based Guide (Third Edition) | NIDA Archives. Published January 17, 2018. http://archives.nida.nih.gov/publications/principles-drug-addiction-treatment-research-based-guide-third-edition

Abstract:

Photo ID 158378414 © Eduard Muzhevskyi | Dreamstime.com ABSTRACT There is a debate about the ethical implications of using human embryos in stem cell research, which can be influenced by cultural, moral, and social values. This paper argues for an adaptable framework to accommodate diverse cultural and religious perspectives. By using an adaptive ethics model, research protections can reflect various populations and foster growth in stem cell research possibilities. INTRODUCTION Stem cell research combines biology, medicine, and technology, promising to alter health care and the understanding of human development. Yet, ethical contention exists because of individuals’ perceptions of using human embryos based on their various cultural, moral, and social values. While these disagreements concerning policy, use, and general acceptance have prompted the development of an international ethics policy, such a uniform approach can overlook the nuanced ethical landscapes between cultures. With diverse viewpoints in public health, a single global policy, especially one reflecting Western ethics or the ethics prevalent in high-income countries, is impractical. This paper argues for a culturally sensitive, adaptable framework for the use of embryonic stem cells. Stem cell policy should accommodate varying ethical viewpoints and promote an effective global dialogue. With an extension of an ethics model that can adapt to various cultures, we recommend localized guidelines that reflect the moral views of the people those guidelines serve. BACKGROUND Stem cells, characterized by their unique ability to differentiate into various cell types, enable the repair or replacement of damaged tissues. Two primary types of stem cells are somatic stem cells (adult stem cells) and embryonic stem cells. Adult stem cells exist in developed tissues and maintain the body’s repair processes.[1] Embryonic stem cells (ESC) are remarkably pluripotent or versatile, making them valuable in research.[2] However, the use of ESCs has sparked ethics debates. Considering the potential of embryonic stem cells, research guidelines are essential. The International Society for Stem Cell Research (ISSCR) provides international stem cell research guidelines. They call for “public conversations touching on the scientific significance as well as the societal and ethical issues raised by ESC research.”[3] The ISSCR also publishes updates about culturing human embryos 14 days post fertilization, suggesting local policies and regulations should continue to evolve as ESC research develops.[4] Like the ISSCR, which calls for local law and policy to adapt to developing stem cell research given cultural acceptance, this paper highlights the importance of local social factors such as religion and culture. I. Global Cultural Perspective of Embryonic Stem Cells Views on ESCs vary throughout the world. Some countries readily embrace stem cell research and therapies, while others have stricter regulations due to ethical concerns surrounding embryonic stem cells and when an embryo becomes entitled to moral consideration. The philosophical issue of when the “someone” begins to be a human after fertilization, in the morally relevant sense,[5] impacts when an embryo becomes not just worthy of protection but morally entitled to it. The process of creating embryonic stem cell lines involves the destruction of the embryos for research.[6] Consequently, global engagement in ESC research depends on social-cultural acceptability. a. US and Rights-Based Cultures In the United States, attitudes toward stem cell therapies are diverse. The ethics and social approaches, which value individualism,[7] trigger debates regarding the destruction of human embryos, creating a complex regulatory environment. For example, the 1996 Dickey-Wicker Amendment prohibited federal funding for the creation of embryos for research and the destruction of embryos for “more than allowed for research on fetuses in utero.”[8] Following suit, in 2001, the Bush Administration heavily restricted stem cell lines for research. However, the Stem Cell Research Enhancement Act of 2005 was proposed to help develop ESC research but was ultimately vetoed.[9] Under the Obama administration, in 2009, an executive order lifted restrictions allowing for more development in this field.[10] The flux of research capacity and funding parallels the different cultural perceptions of human dignity of the embryo and how it is socially presented within the country’s research culture.[11] b. Ubuntu and Collective Cultures African bioethics differs from Western individualism because of the different traditions and values. African traditions, as described by individuals from South Africa and supported by some studies in other African countries, including Ghana and Kenya, follow the African moral philosophies of Ubuntu or Botho and Ukama, which “advocates for a form of wholeness that comes through one’s relationship and connectedness with other people in the society,”[12] making autonomy a socially collective concept. In this context, for the community to act autonomously, individuals would come together to decide what is best for the collective. Thus, stem cell research would require examining the value of the research to society as a whole and the use of the embryos as a collective societal resource. If society views the source as part of the collective whole, and opposes using stem cells, compromising the cultural values to pursue research may cause social detachment and stunt research growth.[13] Based on local culture and moral philosophy, the permissibility of stem cell research depends on how embryo, stem cell, and cell line therapies relate to the community as a whole. Ubuntu is the expression of humanness, with the person’s identity drawn from the “’I am because we are’” value.[14] The decision in a collectivistic culture becomes one born of cultural context, and individual decisions give deference to others in the society. Consent differs in cultures where thought and moral philosophy are based on a collective paradigm. So, applying Western bioethical concepts is unrealistic. For one, Africa is a diverse continent with many countries with different belief systems, access to health care, and reliance on traditional or Western medicines. Where traditional medicine is the primary treatment, the “’restrictive focus on biomedically-related bioethics’” [is] problematic in African contexts because it neglects bioethical issues raised by traditional systems.”[15] No single approach applies in all areas or contexts. Rather than evaluating the permissibility of ESC research according to Western concepts such as the four principles approach, different ethics approaches should prevail. Another consideration is the socio-economic standing of countries. In parts of South Africa, researchers have not focused heavily on contributing to the stem cell discourse, either because it is not considered health care or a health science priority or because resources are unavailable.[16] Each country’s priorities differ given different social, political, and economic factors. In South Africa, for instance, areas such as maternal mortality, non-communicable diseases, telemedicine, and the strength of health systems need improvement and require more focus[17] Stem cell research could benefit the population, but it also could divert resources from basic medical care. Researchers in South Africa adhere to the National Health Act and Medicines Control Act in South Africa and international guidelines; however, the Act is not strictly enforced, and there is no clear legislation for research conduct or ethical guidelines.[18] Some parts of Africa condemn stem cell research. For example, 98.2 percent of the Tunisian population is Muslim.[19] Tunisia does not permit stem cell research because of moral conflict with a Fatwa. Religion heavily saturates the regulation and direction of research.[20] Stem cell use became permissible for reproductive purposes only recently, with tight restrictions preventing cells from being used in any research other than procedures concerning ART/IVF. Their use is conditioned on consent, and available only to married couples.[21] The community's receptiveness to stem cell research depends on including communitarian African ethics. c. Asia Some Asian countries also have a collective model of ethics and decision making.[22] In China, the ethics model promotes a sincere respect for life or human dignity,[23] based on protective medicine. This model, influenced by Traditional Chinese Medicine (TCM), [24] recognizes Qi as the vital energy delivered via the meridians of the body; it connects illness to body systems, the body’s entire constitution, and the universe for a holistic bond of nature, health, and quality of life.[25] Following a protective ethics model, and traditional customs of wholeness, investment in stem cell research is heavily desired for its applications in regenerative therapies, disease modeling, and protective medicines. In a survey of medical students and healthcare practitioners, 30.8 percent considered stem cell research morally unacceptable while 63.5 percent accepted medical research using human embryonic stem cells. Of these individuals, 89.9 percent supported increased funding for stem cell research.[26] The scientific community might not reflect the overall population. From 1997 to 2019, China spent a total of $576 million (USD) on stem cell research at 8,050 stem cell programs, increased published presence from 0.6 percent to 14.01 percent of total global stem cell publications as of 2014, and made significant strides in cell-based therapies for various medical conditions.[27] However, while China has made substantial investments in stem cell research and achieved notable progress in clinical applications, concerns linger regarding ethical oversight and transparency.[28] For example, the China Biosecurity Law, promoted by the National Health Commission and China Hospital Association, attempted to mitigate risks by introducing an institutional review board (IRB) in the regulatory bodies. 5800 IRBs registered with the Chinese Clinical Trial Registry since 2021.[29] However, issues still need to be addressed in implementing effective IRB review and approval procedures. The substantial government funding and focus on scientific advancement have sometimes overshadowed considerations of regional cultures, ethnic minorities, and individual perspectives, particularly evident during the one-child policy era. As government policy adapts to promote public stability, such as the change from the one-child to the two-child policy,[30] research ethics should also adapt to ensure respect for the values of its represented peoples. Japan is also relatively supportive of stem cell research and therapies. Japan has a more transparent regulatory framework, allowing for faster approval of regenerative medicine products, which has led to several advanced clinical trials and therapies.[31] South Korea is also actively engaged in stem cell research and has a history of breakthroughs in cloning and embryonic stem cells.[32] However, the field is controversial, and there are issues of scientific integrity. For example, the Korean FDA fast-tracked products for approval,[33] and in another instance, the oocyte source was unclear and possibly violated ethical standards.[34] Trust is important in research, as it builds collaborative foundations between colleagues, trial participant comfort, open-mindedness for complicated and sensitive discussions, and supports regulatory procedures for stakeholders. There is a need to respect the culture’s interest, engagement, and for research and clinical trials to be transparent and have ethical oversight to promote global research discourse and trust. d. Middle East Countries in the Middle East have varying degrees of acceptance of or restrictions to policies related to using embryonic stem cells due to cultural and religious influences. Saudi Arabia has made significant contributions to stem cell research, and conducts research based on international guidelines for ethical conduct and under strict adherence to guidelines in accordance with Islamic principles. Specifically, the Saudi government and people require ESC research to adhere to Sharia law. In addition to umbilical and placental stem cells,[35] Saudi Arabia permits the use of embryonic stem cells as long as they come from miscarriages, therapeutic abortions permissible by Sharia law, or are left over from in vitro fertilization and donated to research.[36] Laws and ethical guidelines for stem cell research allow the development of research institutions such as the King Abdullah International Medical Research Center, which has a cord blood bank and a stem cell registry with nearly 10,000 donors.[37] Such volume and acceptance are due to the ethical ‘permissibility’ of the donor sources, which do not conflict with religious pillars. However, some researchers err on the side of caution, choosing not to use embryos or fetal tissue as they feel it is unethical to do so.[38] Jordan has a positive research ethics culture.[39] However, there is a significant issue of lack of trust in researchers, with 45.23 percent (38.66 percent agreeing and 6.57 percent strongly agreeing) of Jordanians holding a low level of trust in researchers, compared to 81.34 percent of Jordanians agreeing that they feel safe to participate in a research trial.[40] Safety testifies to the feeling of confidence that adequate measures are in place to protect participants from harm, whereas trust in researchers could represent the confidence in researchers to act in the participants’ best interests, adhere to ethical guidelines, provide accurate information, and respect participants’ rights and dignity. One method to improve trust would be to address communication issues relevant to ESC. Legislation surrounding stem cell research has adopted specific language, especially concerning clarification “between ‘stem cells’ and ‘embryonic stem cells’” in translation.[41] Furthermore, legislation “mandates the creation of a national committee… laying out specific regulations for stem-cell banking in accordance with international standards.”[42] This broad regulation opens the door for future global engagement and maintains transparency. However, these regulations may also constrain the influence of research direction, pace, and accessibility of research outcomes. e. Europe In the European Union (EU), ethics is also principle-based, but the principles of autonomy, dignity, integrity, and vulnerability are interconnected.[43] As such, the opportunity for cohesion and concessions between individuals’ thoughts and ideals allows for a more adaptable ethics model due to the flexible principles that relate to the human experience The EU has put forth a framework in its Convention for the Protection of Human Rights and Dignity of the Human Being allowing member states to take different approaches. Each European state applies these principles to its specific conventions, leading to or reflecting different acceptance levels of stem cell research. [44] For example, in Germany, Lebenzusammenhang, or the coherence of life, references integrity in the unity of human culture. Namely, the personal sphere “should not be subject to external intervention.”[45] Stem cell interventions could affect this concept of bodily completeness, leading to heavy restrictions. Under the Grundgesetz, human dignity and the right to life with physical integrity are paramount.[46] The Embryo Protection Act of 1991 made producing cell lines illegal. Cell lines can be imported if approved by the Central Ethics Commission for Stem Cell Research only if they were derived before May 2007.[47] Stem cell research respects the integrity of life for the embryo with heavy specifications and intense oversight. This is vastly different in Finland, where the regulatory bodies find research more permissible in IVF excess, but only up to 14 days after fertilization.[48] Spain’s approach differs still, with a comprehensive regulatory framework.[49] Thus, research regulation can be culture-specific due to variations in applied principles. Diverse cultures call for various approaches to ethical permissibility.[50] Only an adaptive-deliberative model can address the cultural constructions of self and achieve positive, culturally sensitive stem cell research practices.[51] II. Religious Perspectives on ESC Embryonic stem cell sources are the main consideration within religious contexts. While individuals may not regard their own religious texts as authoritative or factual, religion can shape their foundations or perspectives. The Qur'an states: “And indeed We created man from a quintessence of clay. Then We placed within him a small quantity of nutfa (sperm to fertilize) in a safe place. Then We have fashioned the nutfa into an ‘alaqa (clinging clot or cell cluster), then We developed the ‘alaqa into mudgha (a lump of flesh), and We made mudgha into bones, and clothed the bones with flesh, then We brought it into being as a new creation. So Blessed is Allah, the Best of Creators.”[52] Many scholars of Islam estimate the time of soul installment, marked by the angel breathing in the soul to bring the individual into creation, as 120 days from conception.[53] Personhood begins at this point, and the value of life would prohibit research or experimentation that could harm the individual. If the fetus is more than 120 days old, the time ensoulment is interpreted to occur according to Islamic law, abortion is no longer permissible.[54] There are a few opposing opinions about early embryos in Islamic traditions. According to some Islamic theologians, there is no ensoulment of the early embryo, which is the source of stem cells for ESC research.[55] In Buddhism, the stance on stem cell research is not settled. The main tenets, the prohibition against harming or destroying others (ahimsa) and the pursuit of knowledge (prajña) and compassion (karuna), leave Buddhist scholars and communities divided.[56] Some scholars argue stem cell research is in accordance with the Buddhist tenet of seeking knowledge and ending human suffering. Others feel it violates the principle of not harming others. Finding the balance between these two points relies on the karmic burden of Buddhist morality. In trying to prevent ahimsa towards the embryo, Buddhist scholars suggest that to comply with Buddhist tenets, research cannot be done as the embryo has personhood at the moment of conception and would reincarnate immediately, harming the individual's ability to build their karmic burden.[57] On the other hand, the Bodhisattvas, those considered to be on the path to enlightenment or Nirvana, have given organs and flesh to others to help alleviate grieving and to benefit all.[58] Acceptance varies on applied beliefs and interpretations. Catholicism does not support embryonic stem cell research, as it entails creation or destruction of human embryos. This destruction conflicts with the belief in the sanctity of life. For example, in the Old Testament, Genesis describes humanity as being created in God’s image and multiplying on the Earth, referencing the sacred rights to human conception and the purpose of development and life. In the Ten Commandments, the tenet that one should not kill has numerous interpretations where killing could mean murder or shedding of the sanctity of life, demonstrating the high value of human personhood. In other books, the theological conception of when life begins is interpreted as in utero,[59] highlighting the inviolability of life and its formation in vivo to make a religious point for accepting such research as relatively limited, if at all.[60] The Vatican has released ethical directives to help apply a theological basis to modern-day conflicts. The Magisterium of the Church states that “unless there is a moral certainty of not causing harm,” experimentation on fetuses, fertilized cells, stem cells, or embryos constitutes a crime.[61] Such procedures would not respect the human person who exists at these stages, according to Catholicism. Damages to the embryo are considered gravely immoral and illicit.[62] Although the Catholic Church officially opposes abortion, surveys demonstrate that many Catholic people hold pro-choice views, whether due to the context of conception, stage of pregnancy, threat to the mother’s life, or for other reasons, demonstrating that practicing members can also accept some but not all tenets.[63] Some major Jewish denominations, such as the Reform, Conservative, and Reconstructionist movements, are open to supporting ESC use or research as long as it is for saving a life.[64] Within Judaism, the Talmud, or study, gives personhood to the child at birth and emphasizes that life does not begin at conception:[65] “If she is found pregnant, until the fortieth day it is mere fluid,”[66] Whereas most religions prioritize the status of human embryos, the Halakah (Jewish religious law) states that to save one life, most other religious laws can be ignored because it is in pursuit of preservation.[67] Stem cell research is accepted due to application of these religious laws. We recognize that all religions contain subsets and sects. The variety of environmental and cultural differences within religious groups requires further analysis to respect the flexibility of religious thoughts and practices. We make no presumptions that all cultures require notions of autonomy or morality as under the common morality theory, which asserts a set of universal moral norms that all individuals share provides moral reasoning and guides ethical decisions.[68] We only wish to show that the interaction with morality varies between cultures and countries. III. A Flexible Ethical Approach The plurality of different moral approaches described above demonstrates that there can be no universally acceptable uniform law for ESC on a global scale. Instead of developing one standard, flexible ethical applications must be continued. We recommend local guidelines that incorporate important cultural and ethical priorities. While the Declaration of Helsinki is more relevant to people in clinical trials receiving ESC products, in keeping with the tradition of protections for research subjects, consent of the donor is an ethical requirement for ESC donation in many jurisdictions including the US, Canada, and Europe.[69] The Declaration of Helsinki provides a reference point for regulatory standards and could potentially be used as a universal baseline for obtaining consent prior to gamete or embryo donation. For instance, in Columbia University’s egg donor program for stem cell research, donors followed standard screening protocols and “underwent counseling sessions that included information as to the purpose of oocyte donation for research, what the oocytes would be used for, the risks and benefits of donation, and process of oocyte stimulation” to ensure transparency for consent.[70] The program helped advance stem cell research and provided clear and safe research methods with paid participants. Though paid participation or covering costs of incidental expenses may not be socially acceptable in every culture or context,[71] and creating embryos for ESC research is illegal in many jurisdictions, Columbia’s program was effective because of the clear and honest communications with donors, IRBs, and related stakeholders. This example demonstrates that cultural acceptance of scientific research and of the idea that an egg or embryo does not have personhood is likely behind societal acceptance of donating eggs for ESC research. As noted, many countries do not permit the creation of embryos for research. Proper communication and education regarding the process and purpose of stem cell research may bolster comprehension and garner more acceptance. “Given the sensitive subject material, a complete consent process can support voluntary participation through trust, understanding, and ethical norms from the cultures and morals participants value. This can be hard for researchers entering countries of different socioeconomic stability, with different languages and different societal values.[72] An adequate moral foundation in medical ethics is derived from the cultural and religious basis that informs knowledge and actions.[73] Understanding local cultural and religious values and their impact on research could help researchers develop humility and promote inclusion. IV. Concerns Some may argue that if researchers all adhere to one ethics standard, protection will be satisfied across all borders, and the global public will trust researchers. However, defining what needs to be protected and how to define such research standards is very specific to the people to which standards are applied. We suggest that applying one uniform guide cannot accurately protect each individual because we all possess our own perceptions and interpretations of social values.[74] Therefore, the issue of not adjusting to the moral pluralism between peoples in applying one standard of ethics can be resolved by building out ethics models that can be adapted to different cultures and religions. Other concerns include medical tourism, which may promote health inequities.[75] Some countries may develop and approve products derived from ESC research before others, compromising research ethics or drug approval processes. There are also concerns about the sale of unauthorized stem cell treatments, for example, those without FDA approval in the United States. Countries with robust research infrastructures may be tempted to attract medical tourists, and some customers will have false hopes based on aggressive publicity of unproven treatments.[76] For example, in China, stem cell clinics can market to foreign clients who are not protected under the regulatory regimes. Companies employ a marketing strategy of “ethically friendly” therapies. Specifically, in the case of Beike, China’s leading stem cell tourism company and sprouting network, ethical oversight of administrators or health bureaus at one site has “the unintended consequence of shifting questionable activities to another node in Beike's diffuse network.”[77] In contrast, Jordan is aware of stem cell research’s potential abuse and its own status as a “health-care hub.” Jordan’s expanded regulations include preserving the interests of individuals in clinical trials and banning private companies from ESC research to preserve transparency and the integrity of research practices.[78] The social priorities of the community are also a concern. The ISSCR explicitly states that guidelines “should be periodically revised to accommodate scientific advances, new challenges, and evolving social priorities.”[79] The adaptable ethics model extends this consideration further by addressing whether research is warranted given the varying degrees of socioeconomic conditions, political stability, and healthcare accessibilities and limitations. An ethical approach would require discussion about resource allocation and appropriate distribution of funds.[80] CONCLUSION While some religions emphasize the sanctity of life from conception, which may lead to public opposition to ESC research, others encourage ESC research due to its potential for healing and alleviating human pain. Many countries have special regulations that balance local views on embryonic personhood, the benefits of research as individual or societal goods, and the protection of human research subjects. To foster understanding and constructive dialogue, global policy frameworks should prioritize the protection of universal human rights, transparency, and informed consent. In addition to these foundational global policies, we recommend tailoring local guidelines to reflect the diverse cultural and religious perspectives of the populations they govern. Ethics models should be adapted to local populations to effectively establish research protections, growth, and possibilities of stem cell research. For example, in countries with strong beliefs in the moral sanctity of embryos or heavy religious restrictions, an adaptive model can allow for discussion instead of immediate rejection. In countries with limited individual rights and voice in science policy, an adaptive model ensures cultural, moral, and religious views are taken into consideration, thereby building social inclusion. While this ethical consideration by the government may not give a complete voice to every individual, it will help balance policies and maintain the diverse perspectives of those it affects. Embracing an adaptive ethics model of ESC research promotes open-minded dialogue and respect for the importance of human belief and tradition. By actively engaging with cultural and religious values, researchers can better handle disagreements and promote ethical research practices that benefit each society. This brief exploration of the religious and cultural differences that impact ESC research reveals the nuances of relative ethics and highlights a need for local policymakers to apply a more intense adaptive model. - [1] Poliwoda, S., Noor, N., Downs, E., Schaaf, A., Cantwell, A., Ganti, L., Kaye, A. D., Mosel, L. I., Carroll, C. B., Viswanath, O., & Urits, I. (2022). Stem cells: a comprehensive review of origins and emerging clinical roles in medical practice. 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[14] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics, 22(2), 112–122. https://doi.org/10.1111/dewb.12324 [15] Jecker, N. S., & Atuire, C. (2021). Bioethics in Africa: A contextually enlightened analysis of three cases. Developing World Bioethics, 22(2), 112–122. https://doi.org/10.1111/dewb.12324 [16] Jackson, C.S., Pepper, M.S. Opportunities and barriers to establishing a cell therapy programme in South Africa. Stem Cell Res Ther 4, 54 (2013). https://doi.org/10.1186/scrt204; Pew Research Center. (2014, May 1). Public health a major priority in African nations. Pew Research Center’s Global Attitudes Project. https://www.pewresearch.org/global/2014/05/01/public-health-a-major-priority-in-african-nations/ [17] Department of Health Republic of South Africa. (2021). Health Research Priorities (revised) for South Africa 2021-2024. 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Middle East Fertil Soc J 24, 8 (2020). https://doi.org/10.1186/s43043-019-0011-0; Gaobotse, G. (2018) Stem Cell Research in Africa: Legislation and Challenges. J Regen Med 7:1. doi: 10.4172/2325-9620.1000142 [22] Pang M. C. (1999). Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions. Journal of medical ethics, 25(3), 247–253. https://doi.org/10.1136/jme.25.3.247 [23] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. Journal of law and the biosciences, 8(1). https://doi.org/10.1093/jlb/lsab019 https://academic.oup.com/jlb/article/8/1/lsab019/6299199 [24] Wang, Y., Xue, Y., & Guo, H. D. (2022). Intervention effects of traditional Chinese medicine on stem cell therapy of myocardial infarction. Frontiers in pharmacology, 13, 1013740. https://doi.org/10.3389/fphar.2022.1013740 [25] Li, X.-T., & Zhao, J. (2012). Chapter 4: An Approach to the Nature of Qi in TCM- Qi and Bioenergy. In Recent Advances in Theories and Practice of Chinese Medicine (p. 79). InTech. [26] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students. Stem cells international, 2021, 6667743. https://doi.org/10.1155/2021/6667743 [27] Luo, D., Xu, Z., Wang, Z., & Ran, W. (2021). China's Stem Cell Research and Knowledge Levels of Medical Practitioners and Students. Stem cells international, 2021, 6667743. https://doi.org/10.1155/2021/6667743 [28] Zhang, J. Y. (2017). Lost in translation? accountability and governance of Clinical Stem Cell Research in China. Regenerative Medicine, 12(6), 647–656. https://doi.org/10.2217/rme-2017-0035 [29] Wang, L., Wang, F., & Zhang, W. (2021). Bioethics in China’s biosecurity law: Forms, effects, and unsettled issues. 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Accountability in research, 13(1), 101–109. https://doi.org/10.1080/08989620600634193. [35] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6 [36]Association for the Advancement of Blood and Biotherapies. https://www.aabb.org/regulatory-and-advocacy/regulatory-affairs/regulatory-for-cellular-therapies/international-competent-authorities/saudi-arabia [37] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6 [38] Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: Interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6 Culturally, autonomy practices follow a relational autonomy approach based on a paternalistic deontological health care model. The adherence to strict international research policies and religious pillars within the regulatory environment is a great foundation for research ethics. However, there is a need to develop locally targeted ethics approaches for research (as called for in Alahmad, G., Aljohani, S., & Najjar, M. F. (2020). Ethical challenges regarding the use of stem cells: interviews with researchers from Saudi Arabia. BMC medical ethics, 21(1), 35. https://doi.org/10.1186/s12910-020-00482-6), this decision-making approach may help advise a research decision model. For more on the clinical cultural autonomy approaches, see: Alabdullah, Y. Y., Alzaid, E., Alsaad, S., Alamri, T., Alolayan, S. W., Bah, S., & Aljoudi, A. S. (2022). Autonomy and paternalism in Shared decision‐making in a Saudi Arabian tertiary hospital: A cross‐sectional study. Developing World Bioethics, 23(3), 260–268. https://doi.org/10.1111/dewb.12355; Bukhari, A. A. (2017). Universal Principles of Bioethics and Patient Rights in Saudi Arabia (Doctoral dissertation, Duquesne University). https://dsc.duq.edu/etd/124; Ladha, S., Nakshawani, S. A., Alzaidy, A., & Tarab, B. (2023, October 26). Islam and Bioethics: What We All Need to Know. Columbia University School of Professional Studies. https://sps.columbia.edu/events/islam-and-bioethics-what-we-all-need-know [39] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics. Research Ethics, 17(2), 228-241. https://doi.org/10.1177/1747016120966779 [40] Ababneh, M. A., Al-Azzam, S. I., Alzoubi, K., Rababa’h, A., & Al Demour, S. (2021). Understanding and attitudes of the Jordanian public about clinical research ethics. Research Ethics, 17(2), 228-241. https://doi.org/10.1177/1747016120966779 [41] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East. Nature 510, 189. https://doi.org/10.1038/510189a [42] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East. Nature 510, 189. https://doi.org/10.1038/510189a [43] The EU’s definition of autonomy relates to the capacity for creating ideas, moral insight, decisions, and actions without constraint, personal responsibility, and informed consent. However, the EU views autonomy as not completely able to protect individuals and depends on other principles, such as dignity, which “expresses the intrinsic worth and fundamental equality of all human beings.” Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3 [44] Council of Europe. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164) https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164 (forbidding the creation of embryos for research purposes only, and suggests embryos in vitro have protections.); Also see Drabiak-Syed B. K. (2013). New President, New Human Embryonic Stem Cell Research Policy: Comparative International Perspectives and Embryonic Stem Cell Research Laws in France. Biotechnology Law Report, 32(6), 349–356. https://doi.org/10.1089/blr.2013.9865 [45] Rendtorff, J.D., Kemp, P. (2019). Four Ethical Principles in European Bioethics and Biolaw: Autonomy, Dignity, Integrity and Vulnerability. In: Valdés, E., Lecaros, J. (eds) Biolaw and Policy in the Twenty-First Century. International Library of Ethics, Law, and the New Medicine, vol 78. Springer, Cham. https://doi.org/10.1007/978-3-030-05903-3_3 [46] Tomuschat, C., Currie, D. P., Kommers, D. P., & Kerr, R. (Trans.). (1949, May 23). Basic law for the Federal Republic of Germany. https://www.btg-bestellservice.de/pdf/80201000.pdf [47] Regulation of Stem Cell Research in Germany. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-germany [48] Regulation of Stem Cell Research in Finland. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-finland [49] Regulation of Stem Cell Research in Spain. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-spain [50] Some sources to consider regarding ethics models or regulatory oversights of other cultures not covered: Kara MA. Applicability of the principle of respect for autonomy: the perspective of Turkey. J Med Ethics. 2007 Nov;33(11):627-30. doi: 10.1136/jme.2006.017400. PMID: 17971462; PMCID: PMC2598110. Ugarte, O. N., & Acioly, M. A. (2014). The principle of autonomy in Brazil: one needs to discuss it ... Revista do Colegio Brasileiro de Cirurgioes, 41(5), 374–377. https://doi.org/10.1590/0100-69912014005013 Bharadwaj, A., & Glasner, P. E. (2012). Local cells, global science: The rise of embryonic stem cell research in India. Routledge. For further research on specific European countries regarding ethical and regulatory framework, we recommend this database: Regulation of Stem Cell Research in Europe. Eurostemcell. (2017, April 26). https://www.eurostemcell.org/regulation-stem-cell-research-europe [51] Klitzman, R. (2006). Complications of culture in obtaining informed consent. The American Journal of Bioethics, 6(1), 20–21. https://doi.org/10.1080/15265160500394671 see also: Ekmekci, P. E., & Arda, B. (2017). Interculturalism and Informed Consent: Respecting Cultural Differences without Breaching Human Rights. Cultura (Iasi, Romania), 14(2), 159–172.; For why trust is important in research, see also: Gray, B., Hilder, J., Macdonald, L., Tester, R., Dowell, A., & Stubbe, M. (2017). Are research ethics guidelines culturally competent? Research Ethics, 13(1), 23-41. https://doi.org/10.1177/1747016116650235 [52] The Qur'an (M. Khattab, Trans.). (1965). Al-Mu’minun, 23: 12-14. https://quran.com/23 [53] Lenfest, Y. (2017, December 8). Islam and the beginning of human life. Bill of Health. https://blog.petrieflom.law.harvard.edu/2017/12/08/islam-and-the-beginning-of-human-life/ [54] Aksoy, S. (2005). Making regulations and drawing up legislation in Islamic countries under conditions of uncertainty, with special reference to embryonic stem cell research. Journal of Medical Ethics, 31:399-403.; see also: Mahmoud, Azza. "Islamic Bioethics: National Regulations and Guidelines of Human Stem Cell Research in the Muslim World." Master's thesis, Chapman University, 2022. https://doi.org/10.36837/ chapman.000386 [55] Rashid, R. (2022). When does Ensoulment occur in the Human Foetus. Journal of the British Islamic Medical Association, 12(4). ISSN 2634 8071. https://www.jbima.com/wp-content/uploads/2023/01/2-Ethics-3_-Ensoulment_Rafaqat.pdf. [56] Sivaraman, M. & Noor, S. (2017). Ethics of embryonic stem cell research according to Buddhist, Hindu, Catholic, and Islamic religions: perspective from Malaysia. Asian Biomedicine,8(1) 43-52. https://doi.org/10.5372/1905-7415.0801.260 [57] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.), Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues (pp. 79-94). Berkeley: University of California Press. https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005 [58] Lecso, P. A. (1991). The Bodhisattva Ideal and Organ Transplantation. Journal of Religion and Health, 30(1), 35–41. http://www.jstor.org/stable/27510629; Bodhisattva, S. (n.d.). The Key of Becoming a Bodhisattva. A Guide to the Bodhisattva Way of Life. http://www.buddhism.org/Sutras/2/BodhisattvaWay.htm [59] There is no explicit religious reference to when life begins or how to conduct research that interacts with the concept of life. However, these are relevant verses pertaining to how the fetus is viewed. ((King James Bible. (1999). Oxford University Press. (original work published 1769)) Jerimiah 1: 5 “Before I formed thee in the belly I knew thee; and before thou camest forth out of the womb I sanctified thee…” In prophet Jerimiah’s insight, God set him apart as a person known before childbirth, a theme carried within the Psalm of David. Psalm 139: 13-14 “…Thou hast covered me in my mother's womb. I will praise thee; for I am fearfully and wonderfully made…” These verses demonstrate David’s respect for God as an entity that would know of all man’s thoughts and doings even before birth. [60] It should be noted that abortion is not supported as well. [61] The Vatican. (1987, February 22). Instruction on Respect for Human Life in Its Origin and on the Dignity of Procreation Replies to Certain Questions of the Day. Congregation For the Doctrine of the Faith. https://www.vatican.va/roman_curia/congregations/cfaith/documents/rc_con_cfaith_doc_19870222_respect-for-human-life_en.html [62] The Vatican. (2000, August 25). Declaration On the Production and the Scientific and Therapeutic Use of Human Embryonic Stem Cells. Pontifical Academy for Life. https://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html; Ohara, N. (2003). Ethical Consideration of Experimentation Using Living Human Embryos: The Catholic Church’s Position on Human Embryonic Stem Cell Research and Human Cloning. Department of Obstetrics and Gynecology. Retrieved from https://article.imrpress.com/journal/CEOG/30/2-3/pii/2003018/77-81.pdf. [63] Smith, G. A. (2022, May 23). Like Americans overall, Catholics vary in their abortion views, with regular mass attenders most opposed. Pew Research Center. https://www.pewresearch.org/short-reads/2022/05/23/like-americans-overall-catholics-vary-in-their-abortion-views-with-regular-mass-attenders-most-opposed/ [64] Rosner, F., & Reichman, E. (2002). Embryonic stem cell research in Jewish law. Journal of halacha and contemporary society, (43), 49–68.; Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.), Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues (pp. 79-94). Berkeley: University of California Press. https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005 [65] Schenker J. G. (2008). The beginning of human life: status of embryo. Perspectives in Halakha (Jewish Religious Law). Journal of assisted reproduction and genetics, 25(6), 271–276. https://doi.org/10.1007/s10815-008-9221-6 [66] Ruttenberg, D. (2020, May 5). The Torah of Abortion Justice (annotated source sheet). Sefaria. https://www.sefaria.org/sheets/234926.7?lang=bi&with=all&lang2=en [67] Jafari, M., Elahi, F., Ozyurt, S. & Wrigley, T. (2007). 4. Religious Perspectives on Embryonic Stem Cell Research. In K. Monroe, R. Miller & J. Tobis (Ed.), Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues (pp. 79-94). Berkeley: University of California Press. https://escholarship.org/content/qt9rj0k7s3/qt9rj0k7s3_noSplash_f9aca2e02c3777c7fb76ea768ba458f0.pdf https://doi.org/10.1525/9780520940994-005 [68] Gert, B. (2007). Common morality: Deciding what to do. Oxford Univ. Press. [69] World Medical Association (2013). World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA, 310(20), 2191–2194. https://doi.org/10.1001/jama.2013.281053 Declaration of Helsinki – WMA – The World Medical Association.; see also: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html [70] Zakarin Safier, L., Gumer, A., Kline, M., Egli, D., & Sauer, M. V. (2018). Compensating human subjects providing oocytes for stem cell research: 9-year experience and outcomes. Journal of assisted reproduction and genetics, 35(7), 1219–1225. https://doi.org/10.1007/s10815-018-1171-z https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6063839/ see also: Riordan, N. H., & Paz Rodríguez, J. (2021). Addressing concerns regarding associated costs, transparency, and integrity of research in recent stem cell trial. Stem Cells Translational Medicine, 10(12), 1715–1716. https://doi.org/10.1002/sctm.21-0234 [71] Klitzman, R., & Sauer, M. V. (2009). Payment of egg donors in stem cell research in the USA. Reproductive biomedicine online, 18(5), 603–608. https://doi.org/10.1016/s1472-6483(10)60002-8 [72] Krosin, M. T., Klitzman, R., Levin, B., Cheng, J., & Ranney, M. L. (2006). Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa. Clinical trials (London, England), 3(3), 306–313. https://doi.org/10.1191/1740774506cn150oa [73] Veatch, Robert M. Hippocratic, Religious, and Secular Medical Ethics: The Points of Conflict. Georgetown University Press, 2012. [74] Msoroka, M. S., & Amundsen, D. (2018). One size fits not quite all: Universal research ethics with diversity. Research Ethics, 14(3), 1-17. https://doi.org/10.1177/1747016117739939 [75] Pirzada, N. (2022). The Expansion of Turkey’s Medical Tourism Industry. Voices in Bioethics, 8. https://doi.org/10.52214/vib.v8i.9894 [76] Stem Cell Tourism: False Hope for Real Money. Harvard Stem Cell Institute (HSCI). (2023). https://hsci.harvard.edu/stem-cell-tourism, See also: Bissassar, M. (2017). Transnational Stem Cell Tourism: An ethical analysis. Voices in Bioethics, 3. https://doi.org/10.7916/vib.v3i.6027 [77]Song, P. (2011) The proliferation of stem cell therapies in post-Mao China: problematizing ethical regulation, New Genetics and Society, 30:2, 141-153, DOI: 10.1080/14636778.2011.574375 [78] Dajani, R. (2014). Jordan’s stem-cell law can guide the Middle East. Nature 510, 189. https://doi.org/10.1038/510189a [79] International Society for Stem Cell Research. (2024). Standards in stem cell research. International Society for Stem Cell Research. https://www.isscr.org/guidelines/5-standards-in-stem-cell-research [80] Benjamin, R. (2013). People’s science bodies and rights on the Stem Cell Frontier. Stanford University Press.

Abstract:

Photo 190773207 / Transplant Medicine © Victor Moussa | Dreamstime.com ABSTRACT Xenotransplant research offers hope to individuals waiting for vital organ transplants. Nascent first-in-human xenotransplantation research trials present unique ethical challenges which may translate into obligations for researchers and special considerations for institutional review boards (IRBs). Contextual vulnerability is an important consideration in reviewing proposed subject selection methods. Some recipients are uniquely prone to receiving an unfair offer to enroll in an experimental clinical trial when excluded from allograft waitlists due to psychosocial or compliance evaluations. These exclusions represent an allocational injustice. Enrolling research subjects subjectively excluded from allotransplantation into xenotransplant research is not a mechanism of fair access but rather an exploitation of an unjustly option-constrained vulnerable group by the clinical transplant system. Carefully considering contextual vulnerability can help researchers and IRBs clarify eligibility criteria for xenograft clinical trials. A requirement for simultaneous allograft co-listing can safeguard the interests of vulnerable potential subjects. INTRODUCTION In the United States, the supply of allogeneic, or human-derived, organs and tissues from living donors and cadavers available for transplant into critically ill individuals is inadequate.[i] Physicians refer only half of potentially eligible patients for transplant evaluation, and the clinical transplant team ultimately waitlists less than 30 percent.[ii] Waitlists are lengthy for those who make it through the evaluation process, and many individuals die while waiting for a transplant.[iii] In contrast to allogeneic transplants, xenotransplantation, from the prefix, xeno- meaning foreign, is the process of taking live organs or tissues from an animal for surgical placement into a human recipient. Xenografts are typically sourced from porcine animals (domestic pigs) or non-human primates (baboons) and range from simple tissues like corneas to complex vital organs like hearts, lungs, or kidneys. Scientists have explored xenotransplantation methods for decades, but research with vital organ xenotransplants has been in largely haphazard and non-controlled studies, which demonstrated only short-duration survival for recipients.[iv] Recent advances using gene modification and improved immunosuppression in single-patient attempts to transplant porcine organs into brain-dead human recipients have presented more realistic human-environment models; however, these modified xenografts have still functioned only for very short durations.[v] The limited bioethics discourse on xenotransplantation centers primarily on the ethical use of high-order animals and the risks of zoonotic infectious disease spread.[vi] Bioethics pays insufficient attention to the potential for exploitation of vulnerable individuals in need of a transplant amid growing interest in phase I clinical trials in living human subjects. Clinician-investigators in contemporary literature repeatedly recommend that these trials enroll subjects who are medically eligible for, but effectively excluded or outright denied access to, an allograft.[vii] The Food & Drug Administration (FDA) recommends xenotransplants be limited to subjects with serious or life-threatening diseases for whom adequately safe and effective alternative therapies are not available.[viii] The ethically salient difference between the investigator and the regulatory recommendations is why alternatives are not available to potential subjects: because transplant centers have subjectively denied access or because there is a clinical contraindication that proves prohibitively risky. In a notable single-patient emergency use authorization, physician-investigators offered a genetically modified porcine heart to a living male recipient after denying him access to the waitlist for a human-donor heart, citing a history of non-compliance.[ix] This case suggests that a person denied access to a transplant waitlist due to subjective compliance criteria is an appropriate research subject. The physician-investigators failed to acknowledge how offering a xenotransplant to a contextually vulnerable subject is potentially unfair. Contextual vulnerability is a specific feature of a research environment that increases a subject’s risk of harm. Bioethics discourse must address this vulnerability within the transplant research environment. This paper describes the current transplant system’s use of subjective evaluation criteria, particularly psychosocial support and compliance. Subjective evaluation criteria perpetuate discriminatory medical biases rather than advance the transplant system’s goal of additional life-years gained. Researchers designing controlled human subject trials and institutional review boards (IRBs) reviewing and approving proposed protocols must consider how disparate waitlisting practices unjustly preclude some patients from a fair opportunity to access an allograft and impacts their participation in research. It is unethical for physician-investigators to intentionally take advantage of this vulnerability, creating an exploitative and unethical transaction.[x] Protocol inclusion criteria requiring proof of simultaneous allograft listing is a feasible procedural safeguard to protect research subjects’ interests. I. Injustices in Organ Allocation Solid organ allocation systems are varied but aim for equity and efficiency in granting individuals with similar claims a fair opportunity to access the scarce resource. Allocation decisions attempt to maximize the common good of additional life-years gained.[xi] The federal oversight of allograft allocation in the US uses objective clinical metrics like blood type, immune compatibility, body size, and geographic distance to match organs to recipients to increase both graft and patient survival.[xii] Transplant centers additionally use their own evaluations to waitlist patients. Although variation exists between transplant center criteria across more objective measurements, such as lab values and concurrent diseases, significant inconsistencies arise in how they incorporate subjective factors like compliance with medical recommendations, psychosocial support, and intellectual disability into the review process.[xiii] Only 7 percent of renal transplant programs use formal criteria for subjective psychosocial assessments, while no pediatric solid organ transplant programs use formal, explicit, or uniform review to assess developmental delays and psychosocial support.[xiv] Failing to establish uniform definitions and inconsistently applying evaluation criteria in the review of potential transplant candidates introduce bias into listing practices.[xv] The center they present to and the variable evaluative criteria the center uses may discount an individual’s claim to a fair opportunity to access a scarce resource. Labeling a patient non-compliant can preclude both a referral to and placement on a waitlist for potentially suitable recipients. Compliance considerations presuppose that graft longevity will be jeopardized by an individual’s failure to adhere to pre- and post-transplant regimens. It is necessary to distinguish individuals who are intentionally non-adherent to treatment regimens and demonstrate willful disregard for medical recommendations from those who are involuntarily non-adherent due to barriers that limit full participation in care plans. The former would not be offered a spot on the waitlist for an allograft, nor would investigators offer them a spot in a xenotransplantation research study. Significant and repeated refusals to participate in treatment plans would confound the ability of researchers to collect necessary data and perform the safety monitoring required by early-phase clinical trials. Enrolling subjects who are medically eligible for a traditional transplant but denied access requires a population that is suitably compliant to participate in a clinical trial reliably and safely yet judged not worthy of receipt of a standard allograft during the evaluation process. The latter population is most disadvantaged by compliance judgments and unsubstantiated outcome predictions. Multi-center research studies have found that moderate non-adherence to immunosuppression regimens is not directly associated with poor kidney transplant outcomes.[xvi] Nor are intellectual and developmental disabilities, conditions for which transplant centers may categorically refuse evaluation, clear indicators of an individual’s ability to comply with treatment regimens.[xvii] Large cohort studies of both pediatric kidney and liver transplant recipients found no correlation between intellectual disability and graft or patient survival.[xviii] Rather, it is the perpetuation of medical biases and quality-of-life judgments that presumptively label specific populations poor transplant candidates or label their support systems insufficient, notwithstanding data demonstrating their ability to achieve successful transplant outcomes.[xix] Variability in compliance assessments and psychosocial support criteria allows medical biases to persist and disproportionately impedes waitlist access to patients from underserved populations.[xx] Low-income Medicaid patients are 2.6 times more likely to be labelled non-compliant as privately insured patients.[xxi] Additionally, the medical records of Black patients are 2.5 times more likely to contain negative descriptors like non-compliant, non-adherent, aggressive, unpleasant, and hysterical than those of white patients.[xxii] The higher prevalence of stigmatizing, compliance-based language in the medical records of minority, economically disadvantaged, and disabled persons decreases the likelihood that they will be recommended for a transplant, referred for an evaluation, placed on a waiting list, or ultimately receive a transplant.[xxiii] These populations are at heightened risk of being used in ethically inappropriate ways by xenograft research that capitalizes on this precluded access. II. Defining Vulnerability Subjective evaluation criteria in allograft waitlisting disproportionately impact some populations. This precluded access to waitlists increases their vulnerability to experience harm in experimental xenotransplant research. Fair subject selection requires the development of specific and appropriate inclusion and exclusion criteria designed to address and minimize known subject vulnerabilities.[xxiv] This process begins with physician-investigators designing research trials and IRB review of proposed trials in which some or all potential subjects are vulnerable.[xxv] The literature has no consensus on defining vulnerability in the clinical or research setting.[xxvi] Prominent guidelines such as the Common Rule and the Declaration of Helsinki focus on a categorical, consent-based approach to assessing vulnerability. The capacity to provide freely given consent is a necessary prerequisite for ethical human subject research. Still, consent alone is insufficient to establish ethical permissibility or assure that a research transaction is fair.[xxvii] Harm can occur even with informed consent if it results from coercion, undue influence, or exploitation.[xxviii] Subjects have limited ability to avoid exploitation and act as an autonomous moral agents under such circ*mstances. Categorical assessments label groups whose members share salient features, such as prisoners or children, as vulnerable. This shared characteristic may compromise their capacity for free consent and autonomous ability to protect their interests. Although widely used, broad categorizations create monolithic views of populations but lack clarity as to why a particular feature makes one vulnerable or what a given characteristic decidedly renders one vulnerable to.[xxix] Individuals broadly vulnerable in society, such as the severely economically disadvantaged or incarcerated, are not necessarily vulnerable as research subjects in a given proposed trial.[xxx] Categorical vulnerability is insufficient to recognize that research-related harm is specific to a particular subject potentially participating in a given protocol at a definite time and place. III. Assessing for Contextual Vulnerability Ensuring ethical consent, therefore, requires more than an accounting of capacity, competency, and freedom from coercion. This requires looking beyond voluntariness to ask whether the research offer is fair. Contextual vulnerability recognizes and addresses how some subjects are at a heightened risk of being used in ethically inappropriate ways due to research-specific situations and environments.[xxxi] Contextual vulnerability derives from a specific feature of the research environment that increases a subject’s risk of harm rather than an intrinsic categorical condition of that subject. Accounting for contextual vulnerabilities is necessary because it is ethically unsound for a competent subject to give voluntary consent to an offer that is nonetheless unfair or exploitative.[xxxii] Potential subjects excluded from accessing an allograft are contextually vulnerable in a research environment that may view their diminished range of choice as an opportunity for experimental research enrollment. Proposals to exploit or take advantage of this vulnerability places these individuals at a heightened risk of research-related harm. IV. Exploitative Transactions in Xenotransplant Research In the landmark single-patient case in Maryland, a genetically modified porcine heart was offered to the subject only because he was denied access to the allograft waitlist due to a history of noncompliance with a recommended medical regimen.[xxxiii] Physician-investigators did not define how they evaluated compliance, nor did they elaborate on how this claim demonstrated the subject’s clear and convincing contraindication to receive a conventional cardiac allograft. The subject was presented with a so-called Hobson’s choice, in which there is the illusion of free choice but ultimately there is no real choice as only one outcome, the acceptance of the experimental xenograft, is permitted; access to other choices, such as pursuing standard of care waitlisting, have been removed.[xxxiv] This case set a precedent for researchers and IRBs to view individuals denied access to conventional allografts as an appropriate subject population without acknowledgment of how this transaction is consensually exploitative. Consensual exploitation occurs when researchers intentionally and wrongfully take advantage of a subject’s vulnerability.[xxxv] In the cardiac xenotransplant case, the application of subjective evaluation criteria created a unique contextual vulnerability specific to transplant waitlist practices. Investigators took advantage of the subject’s diminished ability to access the heart transplant waitlist to obtain consent for the xenotransplant procedure. Researchers have no obligation to repair unjust conditions that they bear no responsibility for causing.[xxxvi] The wrongfulness in this case is how subjective compliance-based waitlisting criteria precluded the subject from accessing the heart transplant waitlist and denied him fair consideration in accessing the standard clinical option. Then, the transplantation team exploited this disadvantage they were morally responsible for creating. The subject agreed to the terms for an experimental and high-risk xenograft from a place of vulnerability due to the diminished range of choice specifically constructed by the policy and actions of the transplant center. The options offered by the physician-investigators to the patient were manipulated to promote the research system’s interests through the production of new scientific knowledge, not necessarily the subject’s conception of his own good.[xxxvii] V. Recommendation for Simultaneous Allograft Listing Ethical research design calls for assessments of which vulnerabilities and in which contexts researchers and IRBs ought to offer additional safeguards. Subjects should be clinically suitable to produce robust, reliable, and generalizable scientific knowledge and be presented with a fair research offer. Researchers and IRBs can achieve this through an inclusion criterion requiring that a subject has previously been placed on and maintains a spot on a waitlist for a conventional allograft. Investigators and IRBs must ensure that subjects are selected based on scientific rationale, not because they are easy to recruit due to a compromised or vulnerable position.[xxxviii] Evidence of simultaneous allograft listing would provide verification that a researcher expects a potential subject to survive the burdens of an experimental xenotransplant procedure. Individuals of advanced age or with severe life-limiting comorbidities separate from their end-stage organ failure are less likely to survive after receiving an allograft or a research xenograft. These subjects would not produce valuable data in service to the study’s endpoints or knowledge generalizable to broader patient populations. Requiring evidence of simultaneous allograft listing fulfills the ethical requirement that subjects who withdraw consent are not worse off than if they had not pursued research enrollment.[xxxix] If a subject withdraws consent before receiving a xenograft, their continued place on a waitlist ensures that their fair opportunity claim to an allograft has been maintained. Simultaneous allograft waitlisting excludes contextually vulnerable subjects clinically suitable to receive a graft but denied access to a waitlist. This inclusion criteria provides an additional safeguard against unfairly capitalizing on a subject’s marginalized status. Requiring simultaneous allograft listing will narrow the potential subject population to those clinically suitable and well situated to receive a fair opportunity to enroll in research: individuals listed for an allograft but significantly unlikely to receive or to benefit from that allograft. This potential subject population includes individuals with broadly reactive antibodies who are unlikely to match to a donor organ and individuals with anatomical contraindications who face prohibitive risks with standard allografts or bridging therapies.[xl] This subject population aligns with the FDA recommendation to enroll subjects for whom safe and effective alternatives are not available.[xli] These individuals have not had their claim to a fair opportunity transgressed by a subjective evaluation process, nor has their interest in accessing a scarce resource been unjustly discounted.[xlii] Neither the individual nor the transplant clinicians are responsible for creating a clinical or statistical disadvantage to receiving a standard allograft. An offer of research enrollment extended to this population has not been manipulated to favor one party over the other, but rather appropriately considers the interests of both parties.[xliii] Researchers have an interest in identifying subjects capable of producing scientifically valuable knowledge. Potential subjects have an interest in exploring alternatives to the high morbidity of a traditional allograft. This subject population retains the autonomous choice to pursue a standard-of-care allograft or to enroll in xenograft research. Having few treatment options available does not inexorably undermine the voluntariness of research consent or increase vulnerability.[xliv] The consent transaction is not exploitative or unfair because the transplant system is not responsible for creating this diminished range of choice. Simultaneous allograft listing represents an eligibility criterion that responds to and limits the products of subjective decisions from unjustly impacting trial enrollment. VI. Counterargument: Is Something Better Than Nothing? Some may argue that for medically exigent individuals in need of a transplant, any option to participate in research is better than no option. Autonomy and dignity, however, are not advanced when an inability to access the standard of care compels a subject’s decision to pursue experimental research. An offer of research enrollment that is unfair or exploitative remains unethical regardless of whether the subject stands to benefit. Nor should benefit be expected in early-phase research. The goals of phase I research are primarily to collect short-term safety, toxicity, dosing, and pharmacologic data, not to provide efficacious treatment.[xlv] Expanding access to experimental research trials cannot be conflated with fair access to equitable health care.[xlvi] Broadened access alone does not produce a more ethical research environment. Excluding contextually vulnerable subjects from research should not be the end goal, but rather a necessary interim to call attention to the need to redress biases and existing injustices in transplant access. Research that targets a population’s vulnerability serves to enable the continuation of unjust systems. CONCLUSION In summary, the urgent and significant clinical need for transplantable organs cannot undermine the requirements of ethical research design and conduct. Fair subject selection is a requirement of ethical clinical research.[xlvii] Potential subjects enrolled in upcoming xenograft research must be selected for their ability to answer the scientific objectives of a proposed study and must have the capacity to provide freely given informed consent within a fair research environment. Denying access to allotransplants for subjective psychosocial or compliance-based claims creates contextual vulnerability specific to transplant research that perpetuates the unfairness of the organ allocation system. Ethical research that produces valuable scientific knowledge cannot exploit the rights or interests of subjects in the process. A look beyond categorical vulnerability to contextual vulnerability highlights this currently overlooked area of exploitation. - [i] “Organ Donation Statistics,” Health Resources and Services Administration, accessed April 18, 2022, https://www.organdonor.gov/learn/organ-donation-statistics. [ii] Schold, J.D. et al., “Barriers to Evaluation and Wait Listing for Kidney Transplantation,” Clinical Journal of the American Society of Nephrology 6, no. 7 (2011): 1760-67. [iii] Abouna, G.M. “Ethical Issues in Organ Transplantation,” Medical Principles and Practice 12, no. 1 (2003): 54-69. [iv] Anderson, M. “Xenotransplantation: A Bioethical Evaluation,” Journal of Medical Ethics 32, no. 4 (2006): 205-8. [v] Lambert, J. “What Does the First Successful Test of a Pig-to-Human Kidney Transplant Mean?,” ScienceNews, October 22, 2021, https://www.sciencenews.org/article/xenotransplantation-pig-human-kidney-transplant.; Koplon, S. “Xenotransplantation: What It Is, Why It Matters and Where It Is Going,” UAB News, February 17, 2022, https://www.uabmedicine.org/-/xenotransplantation-what-it-is-why-it-matters-and-where-it-is-going. [vi] Anderson, supra; Daar, A.S. “Ethics of Xenotransplantation: Animal Issues, Consent, and Likely Transformation of Transplant Ethics,” World Journal of Surgery 21, no. 9 (1997): 975-82.; Kim, M.K., et al., “The International Xenotransplantation Association Consensus Statement on Conditions for Undertaking Clinical Trials of Xenocorneal Transplantation,” Xenotransplantation 21, no. 5 (2014): 420-30. [vii] Abouna, supra; Pierson, R.N., et al., “Pig-to-Human Heart Transplantation: Who Goes First?,” American Journal of Transplantation 20, no. 10 (2020): 2669-74. [viii] Food and Drug Administration, Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans (Silver Spring, MD, 2016), 43, https://www.fda.gov/media/102126/download. [ix] Wang, W., et al., “First Pig-to-Human Heart Transplantation,” Innovation (Camb) 3, no. 2 (2022): 100223. [x] Carse, A.L. and Little, M.O. “Exploitation and the Enterprise of Medical Research,” in Exploitation and Developing Countries, ed. J. S. Hawkins and E. J. Emanuel (Princeton, NJ: Princeton University Press, 2008), 206-45. [xi] Halpern, S.D. and Goldberg, D.“Allocating Organs to Cognitively Impaired Patients,” New England Journal of Medicine 376, no. 4 (2017): 299-301. [xii] “How We Match Organs,” United Network for Organ Sharing, accessed April 18, 2022, https://unos.org/transplant/how-we-match-organs/. [xiii] UW Medicine Harborview Medical Center – UW Medical Center University of Washington Physicians, Selection Criteria: Kidney Transplant Recipient (Seattle, WA, 2019), 1-3, https://www.uwmedicine.org/sites/stevie/files/2020-11/UW-Medicine-Kidney-Selection-Criteria-UH2701.pdf; Penn Medicine, Kidney Transplant Selection Criteria (Philadelphia, PA: Hospital of the University of Pennsylvania), 1-2. https://www.pennmedicine.org/media/documents/instructions/transplant/kidney_transplant_selection_criteria.ashx. [xiv] Dudzinski, D.M. “Shifting to Other Justice Issues: Examining Listing Practices,” American Journal of Bioethics 4, no. 4 (2004): 35-37.; Richards, C.T., et al., “Use of Neurodevelopmental Delay in Pediatric Solid Organ Transplant Listing Decisions: Inconsistencies in Standards Across Major Pediatric Transplant Centers,” Pediatric Transplant 13, no. 7 (2009): 843-50. [xv] Dudzinski, supra. [xvi] Israni, A.K., et al., “Electronically Measured Adherence to Immunosuppressive Medications and Kidney Function after Deceased Donor Kidney Transplantation,” Clinical Transplantation 25, no. 2 (2011): 124-31. [xvii] National Council on Disability, Organ Transplant Discrimination against People with Disabilities (Washington, DC, 2019), 25-35, https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf.; Halpern and Goldberg, supra. [xviii] Wightman, A., et al., “Prevalence and Outcomes of Renal Transplantation in Children with Intellectual Disability,” Pediatric Transplantation 18, no. 7 (2014): 714-19.; Wightman, A., et al., “Prevalence and Outcomes of Liver Transplantation in Children with Intellectual Disability,” Journal of Pediatric Gastroenterology and Nutrition 62, no. 6 (2016): 808-12. [xix] Richards et al., supra; Godown, J., et al., “Heart Transplantation in Children with Down Syndrome,” Journal of the American Heart Association 11, no. 10 (2022): e024883. [xx] Silverman, H. and Odonkor, P.N. “Reevaluating the Ethical Issues in Porcine-to-Human Heart Xenotransplantation,” Hastings Center Report 52, no. 5 (2022): 32-42. [xxi] Sun, M., et al., “Negative Patient Descriptors: Documenting Racial Bias in the Electronic Health Record,” Health Affairs 41, no. 2 (2022): 203-11. [xxii] Ibid. [xxiii] Dudzinski, supra; Garg, P.P., et al., “Reducing Racial Disparities in Transplant Activation: Whom Should We Target?,” American Journal of Kidney Diseases 37, no. 5 (2001): 921-31. [xxiv] Emanuel, E.J., et al., “What Makes Clinical Research Ethical?,” JAMA 283, no. 20 (2000): 2701-11. [xxv] 45 C.F.R. 46.111(b). [xxvi] Hurst, S.A. “Vulnerability in Research and Health Care; Describing the Elephant in the Room?,” Bioethics 22, no. 4 (2008): 191-202. [xxvii] The Nuremberg Code, Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law 2, no. 10: 181-2 (Washington, DC: U.S. Government Printing Office, 1949); Kipnis, K. “Vulnerability in Research Subjects: A Bioethical Taxonomy. Ethical and Policy Issues in Research Involving Human Participants.,” in Ethical and Policy Issues in Research Involving Human Participants, (Bethesda, MD: National Bioethics Advisory Commission, August 2001), G1-G13. [xxviii] Dickert, N. and Grady, C. “Incentives for Research Participants,” in The Oxford Textbook of Clinical Research Ethics, ed. E. J. Emanuel et al. (Oxford University Press, 2008), 386-96. [xxix] Gordon, B.G. “Vulnerability in Research: Basic Ethical Concepts and General Approach to Review,” Ochsner Journal 20, no. 1 (2020): 34-38. [xxx] Kipnis, supra. [xxxi] Hurst, supra. [xxxii] Lamkin, M. and Elliott, C. “Avoiding Exploitation in Phase I Clinical Trials: More Than (Un)Just Compensation,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 52-63.; Jansen, L.A. “A Closer Look at the Bad Deal Trial: Beyond Clinical Equipoise,” Hastings Center Report 35, no. 5 (2005): 29-36. [xxxiii] Wang et al., supra; Silverman and Odonkor, supra. [xxxiv] Silverman and Odonkor, supra. [xxxv] Carse and Little, supra. [xxxvi] Wertheimer, A. “Exploitation in Clinical Research,” in The Oxford Textbook of Clinical Research Ethics, ed. E. J. Emanuel et al. (Oxford University Press, 2008), 201-210. [xxxvii] Brock, D.W. “Philosophical Justifications of Informed Consent in Research,” in The Oxford Textbook of Clinical Research Ethics, ed. E. J. Emanuel et al. (Oxford University Press, 2008), 606-612. [xxxviii] Council for International Organizations of Medical Sciences, International Ethical Guidelines for Health-Related Research Involving Humans (Geneva: World Health Organization, 2016), https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf. [xxxix] Ibid. [xl] Pierson et al., supra. [xli] Food and Drug Administration, supra. [xlii] Hurst, supra. [xliii] Kipnis, supra. [xliv] Hawkins, J.S. and Emanuel, E.J. “Introduction: Why Exploitation?,” in Exploitation and Developing Countries, ed. J. S. Hawkins and E. J. Emanuel (Princeton, NJ: Princeton Universiy Pres, 2008), 1-20. [xlv] Muglia, J.J. and DiGiovanna, J.J. “Phase 1 Clinical Trials,” Journal of Cutaneous Medicine and Surgery 2, no. 4 (1998): 236-41. [xlvi] Dresser, R. “The Role of Patient Advocates and Public Representatives in Research,” in The Oxford Textbook of Clinical Research Ethics, ed. E. J. Emanuel et al. (Oxford University Press, 2008), 231-41. [xlvii] MacKay, D. and Saylor, K.W. “Four Faces of Fair Subject Selection,” The American Journal of Bioethics 20, no. 2 (2020): 5-19.

Abstract:

Photo by Adhy Savala on Unsplash ABSTRACT During a crisis, when healthcare capacity becomes overwhelmed and cannot meet regular standards of patient care, crisis standards of care are invoked to distribute scarce hospital space, staff, and supplies. When transitioning between conventional standards of care and crisis standards, hospitals may have to manage resources under scarcity constraints in an intermediate phase defined as the contingency phase. While much attention has been paid to the ethics of crisis standard of care protocols, contingency measures were more widely implemented, though little exists within the literature on the ethics of contingency measures or a clearly explicated contingency standard of care. This paper addresses three ethical issues with the current contingency response to COVID-19: the lack of formalization, the risks of using short-term solutions for prolonged contingency shortages, and the danger of exacerbating health disparities through hospital-level resource allocation. To mitigate these ethical issues, I offer recommendations for reimagining resource allocation during contingency standards of care. INTRODUCTION When transitioning between conventional standards of care and crisis standards, or in situations where shortages do not immediately threaten care delivery, hospitals may have to manage scarce resources in an intermediate phase, known as the “contingency” phase.[1] While much attention has been paid to the ethics of crisis standards, less literature covers the ethics of contingency measures or a clearly explicated contingency standard of care. Many states and hospital systems do not have contingency standards of care to dictate allocation absent an event triggering crisis standards. Crisis standards of care, used when healthcare capacity becomes overwhelmed and cannot meet regular standards of patient care, reflect ethical priorities relevant in times of shortage or other emergencies. These priorities include saving the most lives, the stewardship of scarce resources, and justice relating to equitable resource distribution.[2] Crisis standards of care delineate specialized allocation protocols and triage decision-making bodies at the institutional or state levels. Crisis standards of care require formal activation at the state level, and in the absence of clear triggers or governmental willingness to use them, hospitals may adopt informal strategies to manage allocation in the form of contingency measures. The contingency phase is defined by two simultaneous goals: prevent or stall crisis-level scarcity by managing limited resources and providing patient care that is functionally equivalent to usual care.[3] In other words, allocate scarce resources with no significant health consequences to patients. However, this is an unrealistic expectation: meeting a patient’s medical needs and allocating resources on the basis of scarcity instead of medical indications can be at odds, creating ethical tension. This paper addresses three ethical issues with the current contingency response stemming from this tension: the lack of formalization, the risk of using short-term solutions for prolonged contingency shortages, and the danger of exacerbating health disparities through hospital-level resource allocation. To mitigate these ethical issues, I offer recommendations for reimagining resource allocation during contingency standards of care. l. Lack of Formalization One shortcoming of current contingency measures is that they fail to meet the same level of procedural detail and clarity as crisis standards. The early COVID-19 surges in Italy and France demonstrated the pitfalls of bedside allocation in the absence of procedural guidance. The acute scarcity of critical care resources forced doctors in these countries to make allocation decisions at the bedside, which often resulted in de facto age-based allocation as well as experiences of moral distress and shame among providers.[4] In France, medical allocation guidelines and statistics were never released to the public, raising concerns over the role of transparency in implementing crisis standards and triage guidelines and causing the public to question the trustworthiness of provider triage.[5] Though many states in the US have crisis standards of care that can be implemented in the case of a large-scale triage event, these measures vary widely. A 2020 review of 31 crisis standards of care in the US found that only 18 contained strong “ethical grounding,” 28 used “evidence-based clinical processes and operations,” 21 included “ongoing community and provider engagement, education, and communication,” and 16 had “clear indicators, triggers, and lines of responsibility.”[6] The need for standardization, public transparency, and guidelines for crisis standards of care to prevent bedside allocation has been widely recognized. However, these issues remain unresolved by public policy or legislative efforts during the contingency period before (or after) crisis standards apply. A recent public health study that observed triage team members in a high-fidelity triage simulation highlighted the challenges of making equitable frontline allocation decisions.[7] In the simulation, participants nudged patient priority status up or down depending on what they subjectively identified as morally relevant factors. Through the simulation, participants reported difficulty separating implicit biases about patient characteristics from their clinical judgment. In the absence of formal institutional or regional guidelines for allocation during contingency-level shortages, there are few to no procedural safeguards against biased, ad hoc, and non-transparent rationing. Without formalized or standardized contingency allocation guidance, providers are left to make bedside allocation decisions that are susceptible to individual biases and patterns of unintended discrimination. An example of this susceptibility is seen when hospitals allow patients who no longer benefit from ICU resources to continue occupying ICU beds. This is based on a first-come-first-served (FCFS) approach to bed allocation. FCFS is often a default for patient intake, which led to disparities in care access during the early COVID-19 pandemic. Media reports of hospitals with “plenty of space” being unwilling to accept patients from overwhelmed, lower-income hospitals illustrate that the FCFS default advantages those who could show up first to a particular hospital: often privileged, well-funded healthcare systems that were inaccessible to low-income communities.[8] FCFS is blind to several morally relevant factors, including the likelihood of survival to discharge, reciprocity (i.e. prioritizing healthcare workers), and varying degrees of access to healthcare. Therefore, it inappropriately privileges those in proximity to healthcare systems or with social connections enabling greater initial access to care.[9] During crisis standards of care, excessive mortality that would result from FCFS is mitigated through formalized system-wide triage protocols based on current patient health status and potential benefit from resources. Crisis and contingency standards may provide liability coverage for providers who reallocate critical care beds away from those who no longer benefit during periods of scarcity. This liability coverage shifts bed allocation away from an FCFS model, but only if the policy is well-defined, clearly established, and known to providers. Without a formal system to guide the process or transition from the usual method of allocation to the contingency period, contingency decisions about who gets a scarce resource may continue to operate on an implicit FCFS basis, even when approaching crisis levels of scarcity. Additionally, these decisions will fall unsustainably on individual providers or transfer center workers, leading to moral distress on the frontlines when hospitals are already strained. Lessons from the crisis and contingency responses during COVID-19 can improve future contingency responses. There are multiple ways of achieving equity during contingency allocation, ranging from hospital-level to state-level policy changes. State-wide policies and interventions to facilitate resource-sharing can relieve some of the scarcity burdens that hospitals may face during the contingency period. For example, moving ICU patients to lower levels of care once they have sufficiently recovered is a challenge for doctors, who often call other hospitals to find open beds. In these situations, providers who do not move patients who no longer benefit from ICU beds unknowingly reinforce the FCFS system in which those who arrive first keep the scarce beds, while those who arrive later or wait for one are disadvantaged by having limited access to them. State-wide patient transfer centers, often facilitated by state public health departments, present an alternative by balancing patient needs and bed distribution more equitably and efficiently than individual physicians do, as demonstrated following COVID-19 surges in hospitalization.[10] These centers aid not only in allocating open tertiary care beds, but also in identifying open beds at lower levels of care and assisting physicians with transferring out patients who can be safely downgraded and no longer benefit from tertiary care resources. However, the simplest solution is to encourage the creation of ethics guidance or protocols for contingency allocation at the hospital level. In hospitals, institutional ethics guidance can help providers navigate difficult decisions and conversations with patients. When providers face time-sensitive allocation decisions, like the allocation of open ICU beds, the guidance would be a useful tool for making transparent, principled, and ethically justified allocation decisions in real-time to mitigate the risk of ad hoc or implicit rationing. ll. Unsuited for Prolonged Resource Shortages Secondly, neither contingency nor crisis standards are currently designed to respond to prolonged strains on the healthcare system. Since the start of the pandemic, a prolonged period of staffing shortages began and is projected to persist.[11] However, both crisis and contingency standards assume that the system will eventually return to conventional standards of care. For example, as a contingency or crisis standard, many hospitals deferred elective surgeries to preserve limited resources for emergency and life-saving procedures. Massachusetts, for instance, issued a public health emergency order that required hospitals to defer 50 percent of all non-essential and non-urgent (elective) surgeries. This order demonstrates the use of this contingency measure in response to prolonged staffing and bed shortages.[12] However, the deferral of elective procedures can result in adverse long-term community health consequences. Medical conditions typically addressed through elective surgery, such as joint replacement surgeries for osteoarthritis patients, may worsen if delayed. This can result in greater numbers of acute emergencies, the need for more complex surgical procedures later, increased reliance on pain medications, and longer recovery times.[13] Without a greater understanding of long-term complications in community health, existing contingency strategies, such as the deferral of elective surgeries, may be unsuitable for prolonged shortages. This becomes a greater threat to patient safety when contingency measures inappropriately take the place of crisis standards, risking the long-term implementation of emergency measures designed for temporary use. Although some state emergency planning documents identify indicators and triggers for activating contingency and crisis operations,[14] this transition is not always clear in action. For example, New York did not implement crisis standards of care during the early COVID-19 pandemic despite being one of the hardest-hit cities in the US.[15] Other states, including California, Texas, and Florida, did not activate crisis standards of care, leaving hospitals to implement informal contingency measures that ultimately required allocation strategies very similar or identical to many crisis standards of care protocols.[16] Due to the hesitance to activate crisis standards, ad hoc contingency measures and bedside decision-making prevailed over formal triage protocols. If contingency measures are not set forth in objective documents and are inappropriately used in the place of crisis standards, these short-term measures may result in an unfair or non-transparent distribution of scarce resources. When shortages in space, staff, or supplies jeopardize the ability to provide necessary care for critically ill patients under a conventional standard of care, failures to activate crisis standards risk the inappropriate use of ad hoc contingency measures in their place. With clear contingency standards of care, the duration of an ad hoc approach could be limited. Crisis standards are defined and activated at the regional or state-wide level, but outside of hospital-specific resource limitations, there are generally no standardized indications or triggers for transitioning into and out of contingency measures. Leaving contingency needs to individual hospitals may seem beneficial but defining the contingency period at the hospital level and the crisis period at the state or regional level blurs the line about when it is appropriate for decision makers to activate crisis standards, risking delayed activation or failure to activate them at all. Therefore, it is important that state policies implement automatic triggers for activation that clearly delineate between contingency and crisis responses.[17] Automatic triggers based on validated metrics like remaining available resources can inform the appropriate decision makers about when they must activate crisis standards. These triggers should be transparent to the public, validated, and updated over time with evolving data. These automatic triggers would prevent confusion, inconsistent guidelines, and inequitable contingency allocation at the hands of distressed providers when crisis standards are needed. Defining when to begin crisis standards could help limit the length of the contingency period. This would protect against the inappropriate application of contingency measures to crisis-level scarcity and prolonged shortages that they could not sustainably ameliorate. lll. Potential to Exacerbate Health Disparities Inconsistencies in contingency allocation open the door to disparities in care and unequal distribution of scarcity burdens among different communities based on their location or health needs. This is a concern because it is unclear whether contingency measures can meet their goal of achieving functionally equivalent patient outcomes when resource allocation must be balanced with patient-centered care.[18] The care under contingency standards is meant to be functionally equivalent to regular care. The definition assumes (or may wrongly suggest) that any contingency strategy in place to avoid critical scarcity has no significant impact on patient outcomes. While functional equivalence is attainable, there is currently little research into which contingency measures achieve functionally equivalent outcomes and which patient groups may be disproportionately affected by harmful resource allocation strategies. Although the transition from contingency standards to crisis standards is defined by the inability to provide functionally equivalent care, the difference in practice may merely be a distinction between visible, immediate sacrifices to patient well-being during crises and less-obvious, long-term decrements in community health due to protracted contingency care alterations. Two common contingency measures are cause for concern over disparate patient outcomes and the attainability of functional equivalence. First, restricting emergency room visits by the patient’s degree of need has worrying consequences. In late 2021 and early 2022, hospitals in Massachusetts faced widespread staffing shortages, leading to an emergency order that restricted emergency visits to emergency needs.[19] While this order is a reasonable method of allocating limited staff in the emergency department during severe shortages, it is doubtful that the outcomes of this restriction were equivalent to usual care. Health issues that are soon-to-be emergencies are filtered out until they worsen, resulting in patients overflowing to urgent care clinics or presenting to ERs with more severe forms of sicknesses later on. Given the empirical evidence demonstrating ER treatment and admission disparities that disadvantage Black and Hispanic patients, such a measure would only exacerbate these disparities by further limiting access to needed care.[20] Second, altered staffing ratios, which stretch a limited number of providers to meet patient needs during a staffing shortage, are another concerning yet common contingency measure. Staffing allocation is often viewed similarly to the allocation of space and medical equipment, such that contingency alterations to staffing operations may not seem like they significantly jeopardize patient care quality and outwardly appear functionally equivalent.[21] However, lower ratios of qualified nurses are associated with poor outcomes such as higher inpatient mortality[22] and lower survival rates of in-hospital cardiac arrest for Black patients.[23] These examples highlight the strong potential for contingency measures to amplify social health disparities, particularly when adopted over a prolonged time frame. Lowered standards of care in crisis allocation disproportionately impact racial and ethnic minorities.[24] For example, crisis standards of care used clinical scoring systems that were not developed or validated for crisis triage to prioritize access to life-saving treatments during the COVID-19 pandemic. This practice actively gives rise to racial health disparities and discrimination against disabled patients.[25] Not only were the standards inequitable in practice, but they varied widely from state to state and sometimes even from hospital to hospital, creating disparities across and within geographic regions.[26] If contingency measures are similarly implemented across hospitals or hospital departments without standardization or advance planning to ensure equitable outcomes, it is likely that the burden of a lower standard of care will fall primarily on disadvantaged patient groups and racial minorities. However, standardization alone may be insufficient. Other factors like varying levels of details on patients’ charts between hospitals could produce unfair outcomes if used to determine patient admission or transfer priority, even if the criteria for admissions and transfers are consistent. Thus, ongoing monitoring for unintended patterns of disparity must accompany standardization to ensure that blind spots in the allocation process are identified and corrected. Bioethics has long been preoccupied with the micro-allocation of limited resources within hospitals instead of confronting the structural inequities that underlie broader scarcity and patient needs. The traditional dilemma of allocating limited hospital resources among a certain number of patients overlooks questions about how other resources have already been allocated, which patients were present at the hospital in the first place, where hospitals have (and have not) been built, and whether previous allocation strategies created bias in the broader distribution of resources. Therefore, to achieve fairness, bioethicists must pay attention to aspects of the broader distribution of resources, such as social determinants of health and the allocation of preventative resources at the public health level. One strategy for measuring and addressing these disparities is the Area Deprivation Index (ADI). The ADI quantifies the effects of race, class, and socioeconomic background by geographic region for use in public health research and the prioritization of resources.[27] It has shown promise in identifying geographic regions in need of targeted community health efforts for diabetes management based on electronic patient health records.[28] The ADI and similar tools would be useful in proactively deciding how to allocate public health resources when hospitals are strained. Moreover, through using population health and resource data, public health organizations may forecast contingency shortages allowing for the adoption of early measures to mitigate health disparities that might otherwise be amplified from hospital-level contingency allocation decisions. CONCLUSION Meeting community health needs during periods of contingency scarcity, both before and after crisis standards of care apply, will require contingency standards of care rather than a bedside ad hoc distribution of scarce resources. While it is not inherently ethically unjustifiable for hospitals to adopt measures that may lower the standard of care during contingency standards, the necessity of these measures requires that bioethicists consider how equity, transparency, and the overall aim of functional equivalence can best be achieved under conditions of scarcity. The long-term health consequences of existing contingency measures, the potential for ad hoc and inconsistent allocation of scarce resources, and the need for consensus about when it becomes appropriate to make the formal transition to crisis standards of care demand further consideration. Because contingency measures will likely amplify existing disparities as crisis standards have, hospital-level management of scarcity is inadequate. Public health measures should be adopted in parallel to anticipate and manage health needs at the community or state level when resources are strained. - [1] Altevogt, B. M., Stroud, C., Hanson, S. L., Hanfling, D., & Gostin, L. O. (2009). Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations: A Letter Report. The National Academies Press. https://doi.org/10.17226/12749 [2] Emanuel, E. J., Persad, G., Upshur, R., Thome, B., Parker, M., Glickman, A., Zhang, C., Boyle, C., Smith, M., & Phillips, J. P. (2020). Fair Allocation of Scarce Medical Resources in the Time of Covid-19. New England Journal of Medicine, 382(21), 2049–2055. https://doi.org/10.1056/NEJMsb2005114 [3] Alfandre, D., Sharpe, V. A., Geppert, C., Foglia, M. B., Berkowitz, K., Chanko, B., & Schonfeld, T. (2021). Between Usual and Crisis Phases of a Public Health Emergency: The Mediating Role of Contingency Measures. The American Journal of Bioethics, 21(8), 4–16. https://doi.org/10.1080/15265161.2021.1925778 [4] Rosenbaum, L. (2020). Facing Covid-19 in Italy—Ethics, Logistics, and Therapeutics on the Epidemic’s Front Line. New England Journal of Medicine, 382(20), 1873–1875. https://doi.org/10.1056/NEJMp2005492 [5] Orfali, K. (2020). What Triage Issues Reveal: Ethics in the COVID-19 Pandemic in Italy and France. Journal of Bioethical Inquiry, 17(4), 675–679. https://doi.org/10.1007/s11673-020-10059-y [6] Romney, D., Fox, H., Carlson, S., Bachmann, D., O’Mathuna, D., & Kman, N. (2020). Allocation of Scarce Resources in a Pandemic: A Systematic Review of US State Crisis Standards of Care Documents. Disaster Medicine and Public Health Preparedness, 14(5), 677–683. https://doi.org/10.1017/dmp.2020.101 [7] Butler, C. R., Webster, L. B., Diekema, D. S., Gray, M. M., Sakata, V. L., Tonelli, M. R., & Vranas, K. C. (2022). Perspectives of Triage Team Members Participating in Statewide Triage Simulations for Scarce Resource Allocation During the COVID-19 Pandemic in Washington State. JAMA Network Open, 5(4), e227639. https://doi.org/10.1001/jamanetworkopen.2022.7639 [8] Dwyer, J. (2020, May 14). One Hospital Was Besieged by the Virus. Nearby Was ‘Plenty of Space.’—The New York Times. The New York Times. https://www.nytimes.com/2020/05/14/nyregion/coronavirus-ny-hospitals.html [9] Persad, G., Wertheimer, A., & Emanuel, E. J. (2009). Principles for allocation of scarce medical interventions. Lancet (London, England), 373(9661), 423–431. https://doi.org/10.1016/S0140-6736(09)60137-9 [10] Mitchell, S. H., Rigler, J., & Baum, K. (2022). Regional Transfer Coordination and Hospital Load Balancing During COVID-19 Surges. JAMA Health Forum, 3(2), e215048. https://doi.org/10.1001/jamahealthforum.2021.5048 [11] ASPE. (2022, May 3). Impact of the COVID-19 Pandemic on the Hospital and Outpatient Clinician Workforce: Challenges and Policy Responses. ASPE. https://aspe.hhs.gov/reports/covid-19-health-care-workforce [12] Executive Office of Health and Human Services. (2021). Baker-Polito Administration Provides COVID-19 Update on Mask Advisory, Hospital Support | Mass.gov. https://www.mass.gov/news/baker-polito-administration-provides-covid-19-update-on-mask-advisory-hospital-support [13] The Lancet Rheumatology. (2021). Too long to wait: The impact of COVID-19 on elective surgery. The Lancet Rheumatology, 3(2), e83. https://doi.org/10.1016/S2665-9913(21)00001-1 [14] For an example of transition planning between crisis and contingency standards, see Minnesota Department of Health. (2021). Ethical Framework for Transitions Between Conventional, Contingency, and Crisis Conditions in Pervasive or Catastrophic Public Health Events with Medical Surge Implications (Minnesota Crisis Standards of Care). https://www.health.state.mn.us/communities/ep/surge/crisis/framework_transitions.pdf [15] Powell, T., & Chuang, E. (2020). COVID in NYC: What We Could Do Better. The American Journal of Bioethics, 20(7), 62–66. https://doi.org/10.1080/15265161.2020.1764146 [16] Persoff, J., & Wynia, M. K. (2021). Ethically Navigating the Murky Waters of “Contingency Standards of Care.” The American Journal of Bioethics, 21(8), 20–21. https://doi.org/10.1080/15265161.2021.1939810 [17] Board on Health Sciences Policy & Institute of Medicine. (2013). Indicators and Triggers. In Crisis Standards of Care: A Toolkit for Indicators and Triggers. National Academies Press (US). http://www.ncbi.nlm.nih.gov/books/NBK202381/ [18] Frith, L., Draper, H., Fovargue, S., Baines, P., Redhead, C., & Chiumento, A. (2021). Neither ‘Crisis Light’ nor ‘Business as Usual’: Considering the Distinctive Ethical Issues Raised by the Contingency and Reset Phases of a Pandemic. The American Journal of Bioethics, 21(8), 34–37. https://doi.org/10.1080/15265161.2021.1940363 [19] Rosseau, M. (2022, January 14). New emergency orders issued to help understaffed Mass. Hospitals. Boston.Com. https://www.boston.com/news/coronavirus/2022/01/14/new-emergency-orders-issued-to-help-understaffed-mass-hospitals/ [20] Zhang, X., Carabello, M., Hill, T., Bell, S. A., Stephenson, R., & Mahajan, P. (2020). Trends of Racial/Ethnic Differences in Emergency Department Care Outcomes Among Adults in the United States From 2005 to 2016. Frontiers in Medicine, 7. https://www.frontiersin.org/articles/10.3389/fmed.2020.00300 [21] Hick, J. L., Hanfling, D., & Wynia, M. (2022). Hospital Planning for Contingency and Crisis Conditions: Crisis Standards of Care Lessons from COVID-19. The Joint Commission Journal on Quality and Patient Safety. https://doi.org/10.1016/j.jcjq.2022.02.003 [22] Musy, S. N., Endrich, O., Leichtle, A. B., Griffiths, P., Nakas, C. T., & Simon, M. (2021). The association between nurse staffing and inpatient mortality: A shift-level retrospective longitudinal study. International Journal of Nursing Studies, 120, 103950. https://doi.org/10.1016/j.ijnurstu.2021.103950 [23] Brooks Carthon, M., Brom, H., McHugh, M., Sloane, D. M., Berg, R., Merchant, R., Girotra, S., & Aiken, L. H. (2021). Better Nurse Staffing Is Associated With Survival for Black Patients and Diminishes Racial Disparities in Survival After In-Hospital Cardiac Arrests. Medical Care, 59(2), 169–176. https://doi.org/10.1097/MLR.0000000000001464 [24] Annas, G. J., & Crosby, S. S. (2021). Standard Racism: Trying to Use “Crisis Standards of Care” in the COVID-19 Pandemic. The American Journal of Bioethics, 21(8), 1–3. https://doi.org/10.1080/15265161.2021.1941424 [25] Wynia, M. K., & Sottile, P. D. (2020). Ethical Triage Demands a Better Triage Survivability Score. The American Journal of Bioethics, 20(7), 75–77. https://doi.org/10.1080/15265161.2020.1779412 [26] Fink, S. (2020). Ethical Dilemmas in Covid-19 Medical Care: Is a Problematic Triage Protocol Better or Worse than No Protocol at All? The American Journal of Bioethics, 20(7), 1–5. https://doi.org/10.1080/15265161.2020.1788663 [27] Knighton, A. J., Savitz, L., Belnap, T., Stephenson, B., & VanDerslice, J. (2016). Introduction of an Area Deprivation Index Measuring Patient Socioeconomic Status in an Integrated Health System: Implications for Population Health. EGEMS (Washington, DC), 4(3), 1238. https://doi.org/10.13063/2327-9214.1238 [28] Kurani, S. S., Lampman, M. A., Funni, S. A., Giblon, R. E., Inselman, J. W., Shah, N. D., Allen, S., Rushlow, D., & McCoy, R. G. (2021). Association Between Area-Level Socioeconomic Deprivation and Diabetes Care Quality in US Primary Care Practices. JAMA Network Open, 4(12), e2138438. https://doi.org/10.1001/jamanetworkopen.2021.38438

Abstract:

Alfred Hermida recently posited ‘ambient journalism’ as a new framework for para- and professional journalists, who use social networks like Twitter for story sources, and as a news delivery platform. Beginning with this framework, this article explores the following questions: How does Hermida define ‘ambient journalism’ and what is its significance? Are there alternative definitions? What lessons do current platforms provide for the design of future, real-time platforms that ‘ambient journalists’ might use? What lessons does the work of Brian Eno provide–the musician and producer who coined the term ‘ambient music’ over three decades ago? My aim here is to formulate an alternative definition of ambient journalism that emphasises craft, skills acquisition, and the mental models of professional journalists, which are the foundations more generally for journalism practices. Rather than Hermida’s participatory media context I emphasise ‘institutional adaptiveness’: how journalists and newsrooms in media institutions rely on craft and skills, and how emerging platforms can augment these foundations, rather than replace them. Hermida’s Ambient Journalism and the Role of Journalists Hermida describes ambient journalism as: “broad, asynchronous, lightweight and always-on communication systems [that] are creating new kinds of interactions around the news, and are enabling citizens to maintain a mental model of news and events around them” (Hermida 2). His ideas appear to have two related aspects. He conceives ambient journalism as an “awareness system” between individuals that functions as a collective intelligence or kind of ‘distributed cognition’ at a group level (Hermida 2, 4-6). Facebook, Twitter and other online social networks are examples. Hermida also suggests that such networks enable non-professionals to engage in ‘communication’ and ‘conversation’ about news and media events (Hermida 2, 7). In a helpful clarification, Hermida observes that ‘para-journalists’ are like the paralegals or non-lawyers who provide administrative support in the legal profession and, in academic debates about journalism, are more commonly known as ‘citizen journalists’. Thus, Hermida’s ambient journalism appears to be: (1) an information systems model of new platforms and networks, and (2) a normative argument that these tools empower ‘para-journalists’ to engage in journalism and real-time commentary. Hermida’s thesis is intriguing and worthy of further discussion and debate. As currently formulated however it risks sharing the blind-spots and contradictions of the academic literature that Hermida cites, which suffers from poor theory-building (Burns). A major reason is that the participatory media context on which Hermida often builds his work has different mental models and normative theories than the journalists or media institutions that are the target of critique. Ambient journalism would be a stronger and more convincing framework if these incorrect assumptions were jettisoned. Others may also potentially misunderstand what Hermida proposes, because the academic debate is often polarised between para-journalists and professional journalists, due to different views about institutions, the politics of knowledge, decision heuristics, journalist training, and normative theoretical traditions (Christians et al. 126; Cole and Harcup 166-176). In the academic debate, para-journalists or ‘citizen journalists’ may be said to have a communitarian ethic and desire more autonomous solutions to journalists who are framed as uncritical and reliant on official sources, and to media institutions who are portrayed as surveillance-like ‘monitors’ of society (Christians et al. 124-127). This is however only one of a range of possible relationships. Sole reliance on para-journalists could be a premature solution to a more complex media ecology. Journalism craft, which does not rely just on official sources, also has a range of practices that already provides the “more complex ways of understanding and reporting on the subtleties of public communication” sought (Hermida 2). Citizen- and para-journalist accounts may overlook micro-studies in how newsrooms adopt technological innovations and integrate them into newsgathering routines (Hemmingway 196). Thus, an examination of the realities of professional journalism will help to cast a better light on how ambient journalism can shape the mental models of para-journalists, and provide more rigorous analysis of news and similar events. Professional journalism has several core dimensions that para-journalists may overlook. Journalism’s foundation as an experiential craft includes guidance and norms that orient the journalist to information, and that includes practitioner ethics. This craft is experiential; the basis for journalism’s claim to “social expertise” as a discipline; and more like the original Linux and Open Source movements which evolved through creative conflict (Sennett 9, 25-27, 125-127, 249-251). There are learnable, transmissible skills to contextually evaluate, filter, select and distil the essential insights. This craft-based foundation and skills informs and structures the journalist’s cognitive witnessing of an event, either directly or via reconstructed, cultivated sources. The journalist publishes through a recognised media institution or online platform, which provides communal validation and verification. There is far more here than the academic portrayal of journalists as ‘gate-watchers’ for a ‘corporatist’ media elite. Craft and skills distinguish the professional journalist from Hermida’s para-journalist. Increasingly, media institutions hire journalists who are trained in other craft-based research methods (Burns and Saunders). Bethany McLean who ‘broke’ the Enron scandal was an investment banker; documentary filmmaker Errol Morris first interviewed serial killers for an early project; and Neil Chenoweth used ‘forensic accounting’ techniques to investigate Rupert Murdoch and Kerry Packer. Such expertise allows the journalist to filter information, and to mediate any influences in the external environment, in order to develop an individualised, ‘embodied’ perspective (Hofstadter 234; Thompson; Garfinkel and Rawls). Para-journalists and social network platforms cannot replace this expertise, which is often unique to individual journalists and their research teams. Ambient Journalism and Twitter Current academic debates about how citizen- and para-journalists may augment or even replace professional journalists can often turn into legitimation battles whether the ‘de facto’ solution is a social media network rather than a media institution. For example, Hermida discusses Twitter, a micro-blogging platform that allows users to post 140-character messages that are small, discrete information chunks, for short-term and episodic memory. Twitter enables users to monitor other users, to group other messages, and to search for terms specified by a hashtag. Twitter thus illustrates how social media platforms can make data more transparent and explicit to non-specialists like para-journalists. In fact, Twitter is suitable for five different categories of real-time information: news, pre-news, rumours, the formation of social media and subject-based networks, and “molecular search” using granular data-mining tools (Leinweber 204-205). In this model, the para-journalist acts as a navigator and “way-finder” to new information (Morville, Findability). Jaron Lanier, an early designer of ‘virtual reality’ systems, is perhaps the most vocal critic of relying on groups of non-experts and tools like Twitter, instead of individuals who have professional expertise. For Lanier, what underlies debates about citizen- and para-journalists is a philosophy of “cybernetic totalism” and “digital Maoism” which exalts the Internet collective at the expense of truly individual views. He is deeply critical of Hermida’s chosen platform, Twitter: “A design that shares Twitter’s feature of providing ambient continuous contact between people could perhaps drop Twitter’s adoration of fragments. We don’t really know, because it is an unexplored design space” [emphasis added] (Lanier 24). In part, Lanier’s objection is traceable back to an unresolved debate on human factors and design in information science. Influenced by the post-war research into cybernetics, J.C.R. Licklider proposed a cyborg-like model of “man-machine symbiosis” between computers and humans (Licklider). In turn, Licklider’s framework influenced Douglas Engelbart, who shaped the growth of human-computer interaction, and the design of computer interfaces, the mouse, and other tools (Engelbart). In taking a system-level view of platforms Hermida builds on the strength of Licklider and Engelbart’s work. Yet because he focuses on para-journalists, and does not appear to include the craft and skills-based expertise of professional journalists, it is unclear how he would answer Lanier’s fears about how reliance on groups for news and other information is superior to individual expertise and judgment. Hermida’s two case studies point to this unresolved problem. Both cases appear to show how Twitter provides quicker and better forms of news and information, thereby increasing the effectiveness of para-journalists to engage in journalism and real-time commentary. However, alternative explanations may exist that raise questions about Twitter as a new platform, and thus these cases might actually reveal circ*mstances in which ambient journalism may fail. Hermida alludes to how para-journalists now fulfil the earlier role of ‘first responders’ and stringers, in providing the “immediate dissemination” of non-official information about disasters and emergencies (Hermida 1-2; Haddow and Haddow 117-118). Whilst important, this is really a specific role. In fact, disaster and emergency reporting occurs within well-established practices, professional ethics, and institutional routines that may involve journalists, government officials, and professional communication experts (Moeller). Officials and emergency management planners are concerned that citizen- or para-journalism is equated with the craft and skills of professional journalism. The experience of these officials and planners in 2005’s Hurricane Katrina in the United States, and in 2009’s Black Saturday bushfires in Australia, suggests that whilst para-journalists might be ‘first responders’ in a decentralised, complex crisis, they are perceived to spread rumours and potential social unrest when people need reliable information (Haddow and Haddow 39). These terms of engagement between officials, planners and para-journalists are still to be resolved. Hermida readily acknowledges that Twitter and other social network platforms are vulnerable to rumours (Hermida 3-4; Sunstein). However, his other case study, Iran’s 2009 election crisis, further complicates the vision of ambient journalism, and always-on communication systems in particular. Hermida discusses several events during the crisis: the US State Department request to halt a server upgrade, how the Basij’s shooting of bystander Neda Soltan was captured on a mobile phone camera, the spread across social network platforms, and the high-velocity number of ‘tweets’ or messages during the first two weeks of Iran’s electoral uncertainty (Hermida 1). The US State Department was interested in how Twitter could be used for non-official sources, and to inform people who were monitoring the election events. Twitter’s perceived ‘success’ during Iran’s 2009 election now looks rather different when other factors are considered such as: the dynamics and patterns of Tehran street protests; Iran’s clerics who used Soltan’s death as propaganda; claims that Iran’s intelligence services used Twitter to track down and to kill protestors; the ‘black box’ case of what the US State Department and others actually did during the crisis; the history of neo-conservative interest in a Twitter-like platform for strategic information operations; and the Iranian diaspora’s incitement of Tehran student protests via satellite broadcasts. Iran’s 2009 election crisis has important lessons for ambient journalism: always-on communication systems may create noise and spread rumours; ‘mirror-imaging’ of mental models may occur, when other participants have very different worldviews and ‘contexts of use’ for social network platforms; and the new kinds of interaction may not lead to effective intervention in crisis events. Hermida’s combination of news and non-news fragments is the perfect environment for psychological operations and strategic information warfare (Burns and Eltham). Lessons of Current Platforms for Ambient Journalism We have discussed some unresolved problems for ambient journalism as a framework for journalists, and as mental models for news and similar events. Hermida’s goal of an “awareness system” faces a further challenge: the phenomenological limitations of human consciousness to deal with information complexity and ambiguous situations, whether by becoming ‘entangled’ in abstract information or by developing new, unexpected uses for emergent technologies (Thackara; Thompson; Hofstadter 101-102, 186; Morville, Findability, 55, 57, 158). The recursive and reflective capacities of human consciousness imposes its own epistemological frames. It’s still unclear how Licklider’s human-computer interaction will shape consciousness, but Douglas Hofstadter’s experiments with art and video-based group experiments may be suggestive. Hofstadter observes: “the interpenetration of our worlds becomes so great that our worldviews start to fuse” (266). Current research into user experience and information design provides some validation of Hofstadter’s experience, such as how Google is now the ‘default’ search engine, and how its interface design shapes the user’s subjective experience of online search (Morville, Findability; Morville, Search Patterns). Several models of Hermida’s awareness system already exist that build on Hofstadter’s insight. Within the information systems field, on-going research into artificial intelligence–‘expert systems’ that can model expertise as algorithms and decision rules, genetic algorithms, and evolutionary computation–has attempted to achieve Hermida’s goal. What these systems share are mental models of cognition, learning and adaptiveness to new information, often with forecasting and prediction capabilities. Such systems work in journalism areas such as finance and sports that involve analytics, data-mining and statistics, and in related fields such as health informatics where there are clear, explicit guidelines on information and international standards. After a mid-1980s investment bubble (Leinweber 183-184) these systems now underpin the technology platforms of global finance and news intermediaries. Bloomberg LP’s ubiquitous dual-screen computers, proprietary network and data analytics (www.bloomberg.com), and its competitors such as Thomson Reuters (www.thomsonreuters.com and www.reuters.com), illustrate how financial analysts and traders rely on an “awareness system” to navigate global stock-markets (Clifford and Creswell). For example, a Bloomberg subscriber can access real-time analytics from exchanges, markets, and from data vendors such as Dow Jones, NYSE Euronext and Thomson Reuters. They can use portfolio management tools to evaluate market information, to make allocation and trading decisions, to monitor ‘breaking’ news, and to integrate this information. Twitter is perhaps the para-journalist equivalent to how professional journalists and finance analysts rely on Bloomberg’s platform for real-time market and business information. Already, hedge funds like PhaseCapital are data-mining Twitter’s ‘tweets’ or messages for rumours, shifts in stock-market sentiment, and to analyse potential trading patterns (Pritchett and Palmer). The US-based Securities and Exchange Commission, and researchers like David Gelernter and Paul Tetlock, have also shown the benefits of applied data-mining for regulatory market supervision, in particular to uncover analysts who provide ‘whisper numbers’ to online message boards, and who have access to material, non-public information (Leinweber 60, 136, 144-145, 208, 219, 241-246). Hermida’s framework might be developed further for such regulatory supervision. Hermida’s awareness system may also benefit from the algorithms found in high-frequency trading (HFT) systems that Citadel Group, Goldman Sachs, Renaissance Technologies, and other quantitative financial institutions use. Rather than human traders, HFT uses co-located servers and complex algorithms, to make high-volume trades on stock-markets that take advantage of microsecond changes in prices (Duhigg). HFT capabilities are shrouded in secrecy, and became the focus of regulatory attention after several high-profile investigations of traders alleged to have stolen the software code (Bray and Bunge). One public example is Streambase (www.streambase.com), a ‘complex event processing’ (CEP) platform that can be used in HFT, and commercialised from the Project Aurora research collaboration between Brandeis University, Brown University, and Massachusetts Institute of Technology. CEP and HFT may be the ‘killer apps’ of Hermida’s awareness system. Alternatively, they may confirm Jaron Lanier’s worst fears: your data-stream and user-generated content can be harvested by others–for their gain, and your loss! Conclusion: Brian Eno and Redefining ‘Ambient Journalism’ On the basis of the above discussion, I suggest a modified definition of Hermida’s thesis: ‘Ambient journalism’ is an emerging analytical framework for journalists, informed by cognitive, cybernetic, and information systems research. It ‘sensitises’ the individual journalist, whether professional or ‘para-professional’, to observe and to evaluate their immediate context. In doing so, ‘ambient journalism’, like journalism generally, emphasises ‘novel’ information. It can also inform the design of real-time platforms for journalistic sources and news delivery. Individual ‘ambient journalists’ can learn much from the career of musician and producer Brian Eno. His personal definition of ‘ambient’ is “an atmosphere, or a surrounding influence: a tint,” that relies on the co-evolution of the musician, creative horizons, and studio technology as a tool, just as para-journalists use Twitter as a platform (Sheppard 278; Eno 293-297). Like para-journalists, Eno claims to be a “self-educated but largely untrained” musician and yet also a craft-based producer (McFadzean; Tamm 177; 44-50). Perhaps Eno would frame the distinction between para-journalist and professional journalist as “axis thinking” (Eno 298, 302) which is needlessly polarised due to different normative theories, stances, and practices. Furthermore, I would argue that Eno’s worldview was shaped by similar influences to Licklider and Engelbart, who appear to have informed Hermida’s assumptions. These influences include the mathematician and game theorist John von Neumann and biologist Richard Dawkins (Eno 162); musicians Eric Satie, John Cage and his book Silence (Eno 19-22, 162; Sheppard 22, 36, 378-379); and the field of self-organising systems, in particular cyberneticist Stafford Beer (Eno 245; Tamm 86; Sheppard 224). Eno summed up the central lesson of this theoretical corpus during his collaborations with New York’s ‘No Wave’ scene in 1978, of “people experimenting with their lives” (Eno 253; Reynolds 146-147; Sheppard 290-295). Importantly, he developed a personal view of normative theories through practice-based research, on a range of projects, and with different creative and collaborative teams. Rather than a technological solution, Eno settled on a way to encode his craft and skills into a quasi-experimental, transmittable method—an aim of practitioner development in professional journalism. Even if only a “founding myth,” the story of Eno’s 1975 street accident with a taxi, and how he conceived ‘ambient music’ during his hospital stay, illustrates how ambient journalists might perceive something new in specific circ*mstances (Tamm 131; Sheppard 186-188). More tellingly, this background informed his collaboration with the late painter Peter Schmidt, to co-create the Oblique Strategies deck of aphorisms: aleatory, oracular messages that appeared dependent on chance, luck, and randomness, but that in fact were based on Eno and Schmidt’s creative philosophy and work guidelines (Tamm 77-78; Sheppard 178-179; Reynolds 170). In short, Eno was engaging with the kind of reflective practices that underpin exemplary professional journalism. He was able to encode this craft and skills into a quasi-experimental method, rather than a technological solution. Journalists and practitioners who adopt Hermida’s framework could learn much from the published accounts of Eno’s practice-based research, in the context of creative projects and collaborative teams. In particular, these detail the contexts and choices of Eno’s early ambient music recordings (Sheppard 199-200); Eno’s duels with David Bowie during ‘Sense of Doubt’ for the Heroes album (Tamm 158; Sheppard 254-255); troubled collaborations with Talking Heads and David Byrne (Reynolds 165-170; Sheppard; 338-347, 353); a curatorial, mentor role on U2’s The Unforgettable Fire (Sheppard 368-369); the ‘grand, stadium scale’ experiments of U2’s 1991-93 ZooTV tour (Sheppard 404); the Zorn-like games of Bowie’s Outside album (Eno 382-389); and the ‘generative’ artwork 77 Million Paintings (Eno 330-332; Tamm 133-135; Sheppard 278-279; Eno 435). Eno is clearly a highly flexible maker and producer. 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