Human genetic data are simultaneously deeply personal, familial, and strategically valuable, raising regulatory challenges that individual-centered privacy frameworks only partially address. This is highlighted by the recent high-profile bankruptcy filing by 23andMe, which triggered widespread public concerns extending beyond consumer privacy interests to potential national security risks. To address this, this paper proposes a three-layer diagnostic model for more comprehensive analysis of genetic data governance: (1) individual privacy as sensitive personal data; (2) relational and group (privacy) interests reflecting genetic data’s shared nature; and (3) the state or strategic layer treating genetic information as a national asset relevant to public health and security. Drawing on comparative examination of select jurisdictions and critical review of scholarship, this integrated framework offers researchers, policymakers, and private actors a practicable pathway to navigate the complex governance challenges posed by genetic data.

There is little consensus on how to regulate information giving in reproductive donation – using donated gametes (eggs, sperm) to have children. Should gamete donors be anonymous or should donor-conceived individuals have access to their donor’s identity, and at what age? What information should be available about donor siblings and other donor relations? And, crucially, how should this information giving be appropriately managed and regulated? Before we can answer these questions, we need to first understand what reproductive donation is. This paper sets out options for how reproductive donation can be conceptualized and develops a typology of different approaches, by categorizing reproductive donation into two main models: the biomedical and the psychosocial. These models provide a conceptual framework, a useful heuristic, for both understanding reproductive donation and critiquing regulation and oversight. The purpose of this paper is not to take a stand on which model is optimal; this is a matter for further debate. Rather, it provides clarification of what is at stake, and this can form the basis for coherent and justifiable approaches to the oversight and regulation of reproductive donation, instead of the patchwork of provisions that currently exist in many jurisdictions.

This memorial essay introduces the Journal of Law, Medicine, and Ethics special issue on supported decision-making in research by honoring David T. Wasserman (1953–2025), a major organizer of the NIH workshop from which the issue emerged and a coauthor of two papers in the volume. It situates supported decision-making in research as an emerging approach that aims to make participation by people with cognitive disabilities possible without displacing their agency through default reliance on legally authorized representatives. The essay highlights Wasserman’s distinctive contribution to this developing area. He sought a position that is respectful while remaining clear eyed about exploitation risks and about well-intentioned practices that can undermine a participant’s interests, especially in hard cases where meaningful authorization is fragile. Drawing on the two coauthored papers in the issue and on colleagues’ recollections, the essay emphasizes Wasserman’s commitment to conceptual clarity, workable institutional design, and mentorship through collaboration. It closes by reflecting on his intellectual virtues, humor, and lasting influence on disability bioethics and research ethics.

Scientific discoveries and precision medicine research, especially efforts to identify individually tailored approaches to healthcare considering individual variability in genetics, environmental, and lifestyle factors, have the potential to transform health. This goal is especially critical for those who experience social injustices and substantial health disparities. Yet the inclusion of adults with intellectual disability in precision medicine research, a growing field in clinical and translational genomic research, raises ethical, social, and legal concerns about their ability to make informed decisions to participate, and subsequently whether this population should be excluded altogether or enrolled only via proxy consent. Both practices demand scrutiny and are sometimes without legal or ethical justification. Supported decision-making, a reasonable accommodation and relatively recent legal and ethical construct, can facilitate first-person consent and maintain the prospective participant’s position as the decision-maker. As such, supported decision-making is a promising development with critical implications for consent to precision medicine research. Using findings from our national survey with adults with intellectual disability and a legal analysis, our academic-community research partnership developed recommendations and a tool for using supported decision-making for enrollment in precision medicine research. We conclude with persistent challenges that need resolving to ensure the responsible inclusion of adults with intellectual disability in precision medicine research, and clinical research more generally.

International access to and sharing of biospecimens is critical to answer important questions about complex diseases, and to ensure the diversity in biospecimen collection necessary to advance science and develop therapies that benefit all. However, many challenges exist. These include the lack of harmonized ethical, legal, and policy frameworks regarding secondary uses of biospecimens and associated data; regulatory and policy hurdles; and differences in cultural perspectives and practices across regional and national jurisdictions.

In this manuscript, a set of ethical principles is presented with the intent to address some of these challenges by ensuring better alignment in ethical practices related to biobanking and the global use of human biospecimens. In addition, these principles could serve as a basis for promoting more consistency among national regulations and policies. The ultimate goal is to develop an international framework for global biospecimen and data sharing.

People with intellectual and other cognitive disabilities often face barriers to participating in clinical research, particularly related to the informed consent process. Recent federal policy and legal efforts have advanced strategies to address these challenges, including using supported decision-making. This article discusses this recent progress and the risks and potential opportunities to continuing it in a shifting federal landscape.

While supported decision-making for persons with dynamic cognitive impairment has been considered in the context of medical treatment, there has been little attention to its application in the context of enrolling cognitively impaired subjects in clinical research. The Common Rule allows enrollment permission from a Legally Authorized Representative, one empowered under institutional policy to provide consent for subjects lacking decision-making capacity, but many Legally Authorized Representatives lack knowledge of the person’s values and preferences adequate to an ethically valid judgement about research enrollment. Supported decision-making and surrogate decision-making can be complementary as subjects transition between impairment stages, providing an opportunity to address ethical problems with the current practice of reliance on uninformed surrogates. Through designation of a supporter who is willing to serve through the progression of impairment, dementia patients choose their supporter and ultimate surrogate, engage with them on the issues that later give rise to requests to enroll the subject in research, and ensure that the surrogate will have knowledge of the values and preferences of the subject necessary to an ethically defensible substituted judgement. Legal frameworks can be adapted to provide recognition of research enrollment as an area of valid decision by supporters on behalf of beneficiaries.

This exploratory study aimed to empower people with serious mental illness to create and implement supported decision-making plans and study the impact on their decision-making process. We found that study participants were able to: (1) use supported decision-making once empowered to do so; (2) decide when and how to use supported decision-making; and (3) develop individualized decision-making strategies based upon their unique characteristics and situations. The adoption of supported decision-making in clinical practice, research, and policy is essential to ensure the rights and well-being of adults with decisional incapacity. In particular, integrating supported decision-making into clinical research protocols can enhance informed consent processes and promote meaningful participation of individuals with serious mental illness, balancing respect for their autonomy with appropriate protections.

There is a widespread perception among academics, doctors and patients that the common law can effectively drive the development and incorporation of patients’ autonomy-based rights into medical practice. However, there is reason to doubt that this is correct.

We present a critical analysis of this view, prompted by themes that emerged from interviews with n=31 lawyers and n=24 doctors as part of a larger interdisciplinary study. We focus on the limitations of case law in driving autonomy-respecting clinical practice. Part I examines how the development and impact of decided cases is dominated by practical and economic considerations. It also considers the lack of understanding of case law among clinicians and the extent to which this limits its ability to drive change. Part II sets out our reasons for treating these limitations as a cause for concern. In Part III, we conclude by considering different levers for supporting case law in creating or confirming autonomy-respecting norms in medical practice, suggesting ways in which these might be developed further.

We argue that clinical negligence litigation is important as a guide to clinical practice and a means of enforcing autonomy-based patient rights but that it cannot be relied upon to drive changes in practice. Both professional guidance and legislation can augment case law but, for them to be effective, proper communication between doctors and legislators, courts, lawyers and insurance organizations is essential.

In recent decades, theorists of disability rights have made the moral and legal case for supported decision-making. Whereas surrogate decision-making, the long upheld legal standard, looks to a third party to make a decision for a person deemed to lack the capacity to make that decision for themselves, support in decision-making empowers that person to make their own decisions. In this article, we argue for a significant shift in the norms governing enrollment in clinical trials. Rather than assume that support is only appropriate for individuals who cannot independently make sufficiently informed enrollment decisions, we propose “support in decision-making for all” when research protocols are beyond a certain risk threshold. Drawing inspiration from the universal design movement and feminist insights about autonomy, we argue that making support in decision-making the presumption has substantial expressive and practical benefits, and better empowers all potential research participants to make more informed, autonomous decisions.

Federal disability anti-discrimination laws expect clinical trials to render study processes and sites accessible to potential participants, including through the provision of reasonable accommodations. Nonetheless, people with disabilities, and particularly people with mental illness, are often excluded from clinical trials. Supported decision-making, a strategy that allows people to select trusted others to help them understand and communicate decisions, is an important accommodation to further inclusion. However, because mental illness can be dynamic and vary widely in nature (e.g., diagnosis, symptom severity, functional impairment) and duration (e.g., short-term, intermittent, progressive, permanent), supported decision-making is neither a one-size-fits-all strategy nor one that can serve as a reasonable accommodation in every situation. While prior work on supported decision-making has focused predominantly on adults with intellectual and developmental disabilities or dementias, people with mental illness may also benefit from supported decision-making, although the variability in decision-making capacity in mental illness presents nuanced challenges. Here, we explore supported decision-making in the case of people with intermittent or episodic mental illness that may impact decision-making capacity to varying degrees at different times.

This paper argues that research ethics for individuals with intellectual and developmental disabilities must attend to the value of non-domination. First, we highlight the role of domination in the history of abusive research practices against individuals with intellectual and developmental disabilities, practices which directly led to existing protections for this vulnerable population. Second, we argue that existing protections do not adequately safeguard potential participants from domination in decision-making about whether to participate. This is a distinct concern from the well-established criticisms that existing protections may wrongfully exclude potential participants. Finally, we outline and defend an account of supported decision-making grounded in the value of non-domination in order to safeguard potential participants from domination. Our account nonetheless preserves supported decision-making’s possibilities for greater inclusion of individuals with intellectual and developmental disabilities in research participation.

Public policies contribute to structural racism and health inequities. To dismantle structural racism and advance health equity, methods aligning scientific evidence, community priorities, and political will are needed to implement equity-focused interventions. This study combined community-based participatory research and legal epidemiology methods to inform local policy in East Point, Georgia. The community informed a comprehensive policy approach to address social determinants of health (SDOH) and advance health equity and identified East Point’s Comprehensive Plan Update as an opportunity to advance health equity through policy. Key findings informed a legal epidemiology study to assess variation in including equity and health equity in comprehensive plans across 32 jurisdictions. Limited adoption of equity and health equity provisions were found, revealing opportunities to inform the East Point policymaking process. Research findings were summarized and disseminated to the community and policymakers. In 2023, East Point adopted equity, health, and health equity into its comprehensive plan for the first time. This case study demonstrates that collaborative, multi-sector, community-centered approaches can support policy interventions that address historical race-based, health-harming policies, and thereby dismantle structural racism. Inclusion of health equity in East Point’s comprehensive plan provides a foundation for future implementation of policies that address SDOH and health inequities.

Supported decision-making is rapidly gaining attention as an alternative to guardianship and other forms of surrogate decision-making for people with cognitive disabilities. This article provides an overview of the legal status of supported decision-making in the United States, with particular attention to how states are recognizing supported decision-making in different legal contexts. It then explores how the law of supported decision-making applies to clinical research. It explains that although federal research regulations and guidance do not explicitly address formal supported decision-making, individuals may use supported decision-making to make decisions about participating in clinical research and researchers may be required to allow such use under federal laws that protect against disability discrimination. It then concludes by considering legal barriers to greater use of supported decision-making and how these barriers might be overcome.

Public input can provide state agencies with critical information as they adopt health-shaping rules. However, generating meaningful public input is challenging. State administrative procedure acts set out how state agencies must make rules and establish notice and comment processes to seek input into rulemaking. Notice and comment, though, is not conducive to meaningful public input. To enhance public input into state rules, government entities should not limit their engagement to notice and comment and should deploy, and maybe even amend, rulemaking processes to facilitate public input. Meanwhile, advocates and community members should prioritize state rulemaking, in all its phases, as part of their advocacy efforts.

Medical-legal partnership (MLP) is an intervention embedding legal professionals within a clinical setting to address patients’ health harming legal needs (HHLN). While much of the literature focuses on the role of the lawyer in the partnership, less is understood about the role of the clinician. Data were collected about MLP medical champions from workshop attendees at an MLP conference held by the Solomon Center at Yale Law School, a leader in health law. From the 107 concepts collected at the workshop, 40 mechanisms by which the medical champion can best serve an MLP were identified and ranked by expert MLP champions, using a Delphi method. Medical champions’ relations with the legal team and with direct patient care were of high priority, in contrast with their role in larger scale advocacy. The findings from this study provide evidence that medical champions are a cornerstone of MLPs as they understand clinical workflows, are aware of patient population needs, and can support the multi-disciplinary MLP team to address HHLN. By gaining a deeper understanding of the potential responsibilities and actionable steps that a medical champion can undertake, it is possible to mitigate the challenges faced by MLPs and enhance their implementation and longevity.

We conducted an exploratory cross-sectional analysis of ethical principles and practices in forty-one published research papers with empirical data on HIV prevalence, incidence, or risk factors in humanitarian settings. We identified ten key concepts pertinent to ethical principles and applications, and presented recommendations to inform future HIV prevention research.

Tort law has traditionally prioritized physical over emotional injury claims, due in part to insufficient methods of quantifying the latter. But advances in neuroimaging now make it possible to measure the distinct (and often chronic) neurological damage caused by PTSD, suggesting that it should be treated as both a physical and emotional harm. I argue that this recategorization may help PTSD victims win just restitution, especially for those from marginalized groups whose suffering has traditionally been overlooked and underappreciated by the legal system. Lingering probative and prejudicial flaws will likely limit current judicial applications of PTSD neuroimaging to citations of aggregate research. Until the technology improves in accuracy and sensitivity, individual PTSD neuroimaging on tort plaintiffs will fail to meet most state and federal evidentiary standards. When it does achieve sufficient reliability, neuroimaging precedent for traumatic brain injury may offer guidance on how to incorporate the technology without creating a “CSI effect” that harms plaintiffs unable to access or afford brain scans. PTSD neuroimaging may ultimately foster a greater appreciation for the physical toll of psychological illnesses, catalyzing the movement to dismantle the mind-body divide in tort jurisprudence.

By centering the experiences of minoritized community members, this study explores how Good Samaritan laws (GSLs) impact health behaviors related to opioid overdose response. Most states have GSLs that address overdose response. However, their scope can perpetuate structural racism by extending inequitable protection through rigid requirements and exclusions. In this paper, we look at Indiana’s GSL, Aaron’s Law, and consider how its limitations impact Black Indianapolis residents. We analyzed 50 semi-structured one-on-one interviews with Black residents of four urban Indianapolis zip code areas. We engaged the Health Belief Model using directed qualitative content analysis to consider participants’ evaluation of perceived benefits and barriers as they relate to calling 911 following an opioid overdose. We explore participants’ feelings about calling 911 and interacting with law enforcement, and their understanding of Aaron’s Law and its practical application in their neighborhoods. We demonstrate structural racism’s presence in the impressions and applications of policies and highlight how addressing them can improve health outcomes in minoritized communities. Finally, we make recommendations for GSLs nationwide that address the impact of structural racism on overdose fatalities and strengthen their protections, making laypeople more likely to call 911 after an overdose.