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Showing papers in "Journal of Law Medicine & Ethics in 2020"


Journal ArticleDOI
TL;DR: The government recognizes that social factors cause racial inequalities in access to resources and opportunities that result in racial health disparities, but this recognition fails to acknowledge the root cause of these racial inequalities: structural racism.
Abstract: The government recognizes that social factors cause racial inequalities in access to resources and opportunities that result in racial health disparities. However, this recognition fails to acknowledge the root cause of these racial inequalities: structural racism. As a result, racial health disparities persist.

147 citations


Journal ArticleDOI
TL;DR: Historical foundations rooted in reproductive oppression have implications for how racism has been integrated into the structures of society, including public policies, institutional practices, and cultural representations that reinforce racial inequality in maternal health.
Abstract: Historical foundations rooted in reproductive oppression have implications for how racism has been integrated into the structures of society, including public policies, institutional practices, and cultural representations that reinforce racial inequality in maternal health. This article examines these connections and sheds light on how they perpetuate both racial disparities in maternal health and high rates of maternal mortality and morbidity among Black women.

88 citations


Journal ArticleDOI
TL;DR: This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both health care and legal actors to address and manage those liability risks.
Abstract: Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both health care and legal actors to address and manage those liability risks.

39 citations


Journal ArticleDOI
TL;DR: It will be crucial to develop legal commitments to ensure vaccine access prior to a scientific breakthrough, analyzing the legal barriers that impede global access and the global health law reforms necessary to facilitate global solidarity.
Abstract: This column explores the global health law reforms necessary to progressively realize universal access to a future COVID-19 vaccine. We begin by explaining the importance of global health law in the distribution of essential vaccines as a determinant of public health. The column then turns to examine the human rights foundations of global health law, conceptualizing vaccination access as a universal human right. We find that it will be crucial to develop legal commitments to ensure vaccine access prior to a scientific breakthrough, analyzing the legal barriers that impede global access and the global health law reforms necessary to facilitate global solidarity.

31 citations


Journal ArticleDOI
TL;DR: A series of measures are recommended, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry.
Abstract: Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.

30 citations


Journal ArticleDOI
TL;DR: Global health law is essential in responding to the infectious disease threats of a globalizing world, where no single country, or border, can wall off disease.
Abstract: Global health law is essential in responding to the infectious disease threats of a globalizing world, where no single country, or border, can wall off disease

27 citations



Journal ArticleDOI
TL;DR: How the regulations in three jurisdictions distinguish between different levels of anonymization of health data is analyzed, and whether and how these levels align with technical advancements is assessed.
Abstract: Kerstin N. Vokinger, Daniel J. Stekhoven, and Michael Krauthammer In recent years, advances in technology have enabled research with health data derived from large volumes of electronic health records (EHR) and other health-related data sources to improve innovation and quality in medicine.1 This has also been accelerated through national and international efforts offering access to repositories containing an increasing amount of clinical knowledge and collaborative platforms harmonizing not only the algorithms used, but also ontologies enabling better interoperability.2 At the same time there is growing concern that the use of health data for publiclyfunded research may lead to exposure of patients’ personal information, which potentially increases, among other things, risks for discrimination.3 Legislators have addressed this issue by implementing regulations to protect patient privacy, often focusing on data anonymization, i.e., the removal or masking of identifiable information. In this study we analyze, how the regulations in three jurisdictions (United States, European Union, Switzerland) distinguish between different levels of anonymization of health data, and assess whether and how these levels align with technical advancements.

21 citations


Journal ArticleDOI
TL;DR: Risks may be particularly high during adolescence when cannabis use may disrupt critical periods of neurodevelopment, and more research is needed to identify which adolescents are most at risk and to develop effective interventions addressing contributing factors.
Abstract: Cannabis use in some individuals can meaningfully introduce de novo risk for the initiation of opioid use and development of opioid use disorder These risks may be particularly high during adolescence when cannabis use may disrupt critical periods of neurodevelopment Current research studying the combination of genetic and environmental factors involved in substance use disorders is poorly understood More research is needed, particularly to identify which adolescents are most at risk and to develop effective interventions addressing contributing factors such as trauma and psychiatric comorbidity

20 citations


Journal ArticleDOI
TL;DR: Dynamic consent (DC) as mentioned in this paper is both a model and a specific web-based tool that enables clear, granular communication and recording of participant consent choices over time, and it enables individual consent choices to be expressed and recorded over time.
Abstract: Dynamic Consent (DC) is both a model and a specific web-based tool that enables clear, granular communication and recording of participant consent choices over time. The DC model enables individual...

16 citations


Journal ArticleDOI
TL;DR: This research presents a meta-analyses of the determinants of death and disease in eight countries over a 25-year period and concludes with a call for action to promote informed consent in the selection of healthcare providers and the use of informed consent.
Abstract: Holly Fernandez Lynch, J.D., M.B.E., is the John Russell Dickson, M.D. Presidential Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine, University of Pennsylvania, where she is also a senior fellow at the Leonard Davis Institute of Health Economics. Alison Bateman-House, Ph.D., M.P.H., is an Assistant Professor in the Department of Population Health at NYU Grossman School of Medicine. Health Policy Portal

Journal ArticleDOI
TL;DR: How a calamitous rise in addiction and overdose involving opioids has both led to a clinical recalibration by healthcare providers, and to strong incentives favoring forcible opioid reduction by policy making agencies is described.
Abstract: This manuscript describes the institutional and clinical considerations that apply to the question of whether to mandate opioid dose reduction in patients who have received opioids long-term. It describes how a calamitous rise in addiction and overdose involving opioids has both led to a clinical recalibration by healthcare providers, and to strong incentives favoring forcible opioid reduction by policy making agencies. Neither the 2016 Guideline issued by the Centers for Disease Control and Prevention nor clinical evidence can justify or promote such policies as safe or effective.

Journal ArticleDOI
TL;DR: This paper suggests how to resolve conflicts while protecting the rights and interests of individuals sequenced through a more translational approach to law.
Abstract: Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.

Journal ArticleDOI
TL;DR: Using mobile health (mHealth) research as an extended example, this article provides an overview of when the Common Rule “applies” to a variety of activities.
Abstract: Using mobile health (mHealth) research as an extended example, this article provides an overview of when the Common Rule “applies” to a variety of activities, what might be meant when one says that...

Journal ArticleDOI
TL;DR: Four legal fixtures of the health care system have prevented the achievement of social solidarity: federalism, fiscal pluralism, privatization, and individualism; future reforms must confront these fixtures to realize social solidarity in health care, American-style.
Abstract: The ACA shifted U.S. health policy from centering on principles of actuarial fairness toward social solidarity. Yet four legal fixtures of the health care system have prevented the achievement of social solidarity: federalism, fiscal pluralism, privatization, and individualism. Future reforms must confront these fixtures to realize social solidarity in health care, American-style.

Journal ArticleDOI
TL;DR: Although opioid litigation is not a comprehensive solution to the opioid crisis, it can complement other strategies and infuse much needed money, behavior changes, and public accountability for prescription opioid and related harms.
Abstract: Opioid litigation continues a growing public health litigation trend in which governments seek to hold companies responsible for population harms related to their products The litigation can serve to address gaps in regulatory and legislative policymaking and in market self-regulation pervasive in the prescription opioid domain Moreover, prior opioid settlements have satisfied civil tort litigation objectives of obtaining compensation for injured parties, deterring harmful behavior, and holding certain opioid manufacturers, distributors and pharmacies accountable for their actions In this way, opioid litigation represents progress over prior public health litigation campaigns involving tobacco, lead paint, and asbestos, which had more limited tort litigation effects Although opioid litigation is not a comprehensive solution to the opioid crisis, it can complement other strategies and infuse much needed money, behavior changes, and public accountability for prescription opioid and related harms

Journal ArticleDOI
TL;DR: The article explores the limits of regulation mandating eIC for mobile application research, and addresses some of the broader social context around eIC.
Abstract: The article covers electronic informed consent (eIC) from different dimensions so that practitioners might understand the history, regulation, and current status of eIC. It covers the transition of informed consent to electronic screens and the implications of that transition in terms of design, costs, and data analysis. The article explores the limits of regulation mandating eIC for mobile application research, and addresses some of the broader social context around eIC.

Journal ArticleDOI
TL;DR: There are good reasons for supporting citizen scientists in sharing data and publishing findings, and it is problematic to treat data sharing and publication as ethical requirements for citizen scientists, especially where there is the potential for burden and harm without compensating benefit.
Abstract: As citizen science expands, questions arise regarding the applicability of norms and policies created in the context of conventional science. This article focuses on data sharing in the conduct of health-related citizen science, asking whether citizen scientists have obligations to share data and publish findings on par with the obligations of professional scientists. We conclude that there are good reasons for supporting citizen scientists in sharing data and publishing findings, and we applaud recent efforts to facilitate data sharing. At the same time, we believe it is problematic to treat data sharing and publication as ethical requirements for citizen scientists, especially where there is the potential for burden and harm without compensating benefit.

Journal ArticleDOI
TL;DR: The extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met is investigated.
Abstract: Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles - the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA - effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

Journal ArticleDOI
TL;DR: It is demonstrated that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is engaged, which helps clarify the risks of engaged consent.
Abstract: The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing (n=44) to elicit diverse research stakeholders' views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is engaged. In engaged consent, a participant's ongoing relationship with a repository serves as a substitute or adjunct to information exchange at enrollment. We detail research stakeholders' views of the risks of engaged consent and suggest questions for further study about engagement and consent procedures in initiatives that aim to store data for future unspecified research purposes.

Journal ArticleDOI
TL;DR: These tools are a game changer in behavioral health research and, not surprisingly, introduce new ethical, regulatory/legal and social implications described in this article.
Abstract: Behavioral scientists are developing new methods and frameworks that leverage mobile health technologies to optimize individual level behavior change. Pervasive sensors and mobile apps allow researchers to passively observe human behaviors "in the wild" 24/7 which supports delivery of personalized interventions in the real-world environment. This is all possible because these technologies contain an incredible array of sensors that allow applications to constantly record user location and can contextualize current environmental conditions through barometers, thermometers, and ambient light sensors and can also capture audio and video of the user and their surroundings through multiple integrated high-definition cameras and microphones. These tools are a game changer in behavioral health research and, not surprisingly, introduce new ethical, regulatory/legal and social implications described in this article.

Journal ArticleDOI
TL;DR: It is argued that to respect the autonomy of individuals, it is essential to establish their agency, and how these conditions may diminish agency is reviewed.
Abstract: Agency is the human capacity to freely choose one's thoughts, motivations and actions without undue internal or external influences; it is distinguished from decisional capacity. Four well-known conditions that can deeply affect agency are depression, demoralization, existential distress, and family dysfunction. The study reviews how they may diminish agency in persons whose circumstances may lead them to consider or request euthanasia or assisted suicide. Since agency has been a relatively neglected dimension of autonomous choice at the end of life, it is argued that to respect the autonomy of individuals, it is essential to establish their agency.

Journal ArticleDOI
TL;DR: It is concluded that litigation is not the best solution to the opioid crisis and state and local government lawsuits against prescription opioid producers and sellers should stop.
Abstract: This paper examines the lawsuits brought by state and local government entities against prescription opioid producers and sellers. It examines their potential liability as well as some of the defenses they might raise. The paper also discusses multidistrict litigation and government lawsuits in state court. It concludes that litigation is not the best solution to the opioid crisis.

Journal ArticleDOI
TL;DR: Involuntary civil commitment to treatment for opioid use disorder (OUD) prevents imminent overdose, but also restricts autonomy and raises other ethical concerns as discussed by the authors, including stigmatizing and punitive experiences, heightened family conflict and social isolation; eroded patient self-determination; limited or no provision of OUD medications; and long-term overdose risk.
Abstract: Involuntary civil commitment (ICC) to treatment for opioid use disorder (OUD) prevents imminent overdose, but also restricts autonomy and raises other ethical concerns. Using the Kass Public Health Ethics Framework, we identified ICC benefits and harms. Benefits include: protection of vulnerable, underserved patients; reduced legal consequences; resources for families; and "on-demand" treatment access. Harms include: stigmatizing and punitive experiences; heightened family conflict and social isolation; eroded patient self-determination; limited or no provision of OUD medications; and long-term overdose risk. To use ICC ethically, it should be recognized as comprising vulnerable patients worthy of added protections; be a last resort option; utilize consensual, humanizing processes; provide medications and other evidence-based-treatment; integrate with existing healthcare systems; and demonstrate effective outcomes before diffusion. ICC to OUD treatment carries significant potential harms that, if unaddressed, may outweigh its benefits. Findings can inform innovations for ensuring that ICC is used in an ethically responsible way.

Journal ArticleDOI
TL;DR: Recommendations are presented on when researchers and Institutional Review Boards should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation.
Abstract: Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis (PrEP) should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is "too immature" and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and/or limit adolescent participation, jeopardizing study findings' validity. This paper presents recommendations on when researchers and Institutional Review Boards (IRB) should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible.

Journal ArticleDOI
TL;DR: The United States is known for valuing personal independence and individualism, but would the American people respond to the coronavirus pandemic by complying with quarantines, social distancing, and other measures in which group interests are placed ahead of individual ones?
Abstract: The United States is known for valuing personal independence and individualism. With such societal values, would the American people respond to the coronavirus pandemic by complying with quarantines, social distancing, and other measures in which group interests are placed ahead of individual ones? With a relatively small number of exceptions, the American people, including health care providers, have demonstrated an extraordinary degree of community-oriented behavior. Unfortunately, a lack of public health preparedness and a series of blunders by elected officials have increased the peril for all Americans.

Journal ArticleDOI
TL;DR: Governmental efforts to re-open businesses, religious entities, schools, and other enterprises following months of social distancing in response to COVID-19 raise significant legal and policy issues on both sides of the “tug-of-war” between protecting the public’s health and rebooting the economy.
Abstract: Governmental efforts to re-open businesses, religious entities, schools, and other enterprises following months of social distancing in response to COVID-19 raise significant legal and policy issues on both sides of the “tug-of-war” between protecting the public’s health and rebooting the economy.

Journal ArticleDOI
TL;DR: This article surveys a new generation of general-purpose privacy laws and considers implications of these laws on collection, storage, and disclosure of genetic data.
Abstract: At one time, specialized health privacy laws represented the bulk of the rules regulating genetic privacy, Today, however, as both the field of genomics and the content of privacy law change rapidly, a new generation of general-purpose privacy laws may impose new restrictions on collection, storage, and disclosure of genetic data. This article surveys these laws and considers implications.

Journal ArticleDOI
TL;DR: To maximize the participation of currently disenfranchised groups, those involved in unregulated mHealth research must become aware of potential risks, adopt targeted education policies, audit algorithms for hidden biases, and engage citizen scientists and other community members to identify and forestall possible harms.
Abstract: mHealth devices and applications, with their wide accessibility and ease of use, have the potential to address persistent inequities in biomedical research participation. Yet, while mHealth technologies may facilitate more inclusive research participation, negative features of some unregulated use in research - misleading enrollment practices, the promotion of secondary mHealth applications, discriminatory profiling, and poorer quality feedback due to dependencies on biased data and algorithms - may threaten the trust and engagement of underrepresented individuals and communities. To maximize the participation of currently disenfranchised groups, those involved in unregulated mHealth research must become aware of potential risks, adopt targeted education policies, audit algorithms for hidden biases, and engage citizen scientists and other community members to identify and forestall possible harms.

Journal ArticleDOI
TL;DR: In 2014, the United States health care industry produced an estimated 480 million metric tons of carbon dioxide (CO2), nearly 8% of the country's total emissions as mentioned in this paper, and the importance of sustainability in health care has been highlighted.
Abstract: In 2014, the United States health care industry produced an estimated 480 million metric tons of carbon dioxide (CO2); nearly 8% of the country's total emissions. The importance of sustainability i...