This paper reports the results of an Australian qualitative study investigating the return of raw genomic data to research study participants. Increasing numbers of participants request access to their raw genomic data, although the legal position in relation to whether data should be returned lacks clarity, particularly in Australia. Interviews were conducted with stakeholders involved in two research studies where participants have undergone whole genome sequencing: ZERO Childhood Cancer, and the Australian Pancreatic Cancer Genome Initiative. Four major themes were identified: whether raw genomic data should be returned; reasons for seeking access; risks in returning data; and processes for return. Our findings indicate that health professionals, scientists, bioinformaticians, patients and patient advocates overwhelmingly support the return of raw data upon request, with ethical imperatives providing a strong basis for this support. Many stakeholders went on to stress the importance of adequate support for participants to ensure risks associated with the return of raw genomic data are minimized, including the provision of explanation and, where necessary, counselling and clinical advice. Our findings provide a basis for arguing that adequate resourcing must be built into research projects from the outset, given expected increases in participant demand for genomic data.
We advocate for a change in the way individuals with cognitive impairment are enrolled in minimal risk clinical research. We do so in the hope that such a change will lead to more cognitively impaired individuals being enrolled in research. Our proposal applies only to cases where would-be participants retain some interest in decision-making as well as the ability to express a decision. In these cases, we argue that the common practice whereby researchers either obtain consent from the individual or consent from a surrogate and assent from the individual, is ethically unnecessary. Instead, a process of facilitated decision-making based on SDM (supported decision-making) should be employed. Although it is possible that this process of facilitation will enable some individuals to make a capacitated choice who would not otherwise have done so, this should not be a requirement of getting to choose. In those cases where a would-be participant, despite support, fails to make a capacitated choice, the individual should still have the final say about participation. In this respect, our proposal deviates from standard practice. However, we argue that our proposal offers participants as much ethical protection as the more common procedures involving surrogates.
This article explores the potential of supported decision-making for helping individuals with intellectual or cognitive disabilities to make value-aligned or authentic decisions with respect to participation in clinical research. We argue that supported decision-making is valuable in this context not merely because it promotes self-determination, but also because it increases the likelihood that individuals' decisions align with what matters to them. To realize this potential, it is important to recognize and address situations in which individuals with intellectual or cognitive disabilities are at increased risk of making decisions that are contrary to their values. We focus on two such situations in particular: when the individual must integrate multiple, potentially competing values, and when the relevant values are insufficiently specified and require unpacking. These challenges can be met, we propose, by integrating dialectical support - a form of structured, dialogue-based assistance designed to help individuals explore and apply their values - into supported decision-making practices.
In recent years, some have argued that supported decision-making can be ethically superior to surrogate decision-making with respect to decisions involving adults with cognitive and intellectual impairments or disabilities. In this paper, we argue that supported decision-making could also be ethically superior to surrogate decision-making in the context of clinical research that involves greater than minimal net risks. In current practice, adults who lack decisional capacity are often excluded from research that involves greater than minimal net risks (call this the minimal risk requirement). While this approach is intended to protect them, it can be ethically problematic, in part because excluding adults who cannot consent blocks scientifically valuable research that needs to enroll them and undermines the generalizability of the research that excludes them. With this concern in mind, we argue that supported decision-making can provide an ethical means to enroll adults who cannot independently consent in greater than minimal net risk research. Supported decision-making thus offers a valuable modification to the surrogate enrollment requirement, and provides good reason to reject the minimal risk requirement as well.
Supported decision-making presents a promising avenue to address tensions between the benefits of clinical research for persons with intellectual disability (PWIDs) and the potential exploitation of PWIDs in research. However, while much has been written about supported decision-making with PWIDs in clinical practice, there has been little attention to its possible use in clinical research, especially for PWIDs whose capacity to benefit from support may be uncertain or disputed. In this article, we will interrogate three challenges that arise in this context: communication, influence, and speculation and displacement. Through examples adapted from ethics consultations and cases in the literature, we aim to provide guidance on how to address these challenges.
When a prospective participant in clinical research appears perhaps to lack decision-making capacity, many investigators do a capacity evaluation themselves, and if the person lacks capacity, reach out to the next of kin, presuming them to be the legally authorized representative (LAR) to consent (or not) on that person's behalf. However, that approach often does not actually comport with applicable law. This article begins with some history, explaining how, if there is no state law specifically governing clinical research, Institutional Review Boards have been instructed to base their policies concerning capacity determination and surrogacy selection on that jurisdiction's laws governing ordinary healthcare. A deep dive into many states' statutes reveals a remarkable, hitherto largely unrecognized diversity of provisions that, in turn, create unexpected legal and ethical hazards for investigators whose research participants may lack capacity. Several potential resolutions are suggested.
Honoring a patient's wishes for end-of-life care can be challenging if the patient loses decision-making capacity and the identified alternate decision-maker will not respect the patient's wishes. This article discusses how to proceed ethically and legally when the alternate decision-maker and care team disagree about respecting a patient's end-of-life preferences.
Through emerging interpretations of individual "medical freedoms," a panoply of state legislative bills seeks to undermine long-standing public health and health care requirements including recommendations to test, screen, treat, and vaccinate persons. To the extent these bills could upend decades of laws and policies protecting individual and communal health, especially among vulnerable individuals, they threaten the health - and freedoms - of all persons.
Recent US policy changes, including abortion bans and reductions to social safety nets, have intensified structural pressures on reproductive decision-making. Research has examined interpersonal and clinical forms of reproductive coercion, but legal and policy forces remain undertheorized. This commentary introduces and defines sociolegal reproductive coercion as occurring when individuals feel pressured or constrained in their reproductive choices due to legal and policy landscapes that are reinforced and reified by social and cultural forces. These pressures operate collectively to make certain options, such as long-acting reversible contraception, feel obligatory even when undesired, by amplifying risks associated with pregnancy, abortion, and parenting. Sociolegal coercion interacts with clinical practice, shaping provider counseling and narrowing perceived options, and disproportionately affects marginalized communities already subject to systemic inequities. We situate this construct within existing scholarship on constrained choice and social control, propose a conceptual framework, and outline implications for research, clinical care, and policy. Recognizing sociolegal reproductive coercion is critical for understanding how health policy and sociocultural dynamics jointly constrain autonomy and for informing reforms that advance reproductive justice in a post-Roe landscape.
The use of restraint in hospital settings is divisive, and internationally there are calls for its elimination. However, this is at odds with the experience of many hospital staff, who consider restraint, at times, a "necessary evil". In this paper, we explore the definition of restraint and potential ethical justifications for its use. We argue that the current ethical literature employs two definitions of restraint - outcome-oriented and intent-oriented - neither of which successfully captures all ethically relevant features of the practice. We propose a new conceptualization of restraint which centers on the number of individuals impacted by an act of patient restraint - a continuum between therapeutic restraint and public-safety restraint. Understood in this way, neither the principlist nor human rights frameworks that dominate the current literature are appropriate for assessing the ethical legitimacy of restraint. We suggest that, given the similarities between restraint and public health interventions, the use of public health ethics principles to consider the ethical justifiability of restraint in hospitals is a potentially productive way forward in this controversial area.
An involuntary commitment is a rights-restrictive procedure that is rarely afforded visibility through useful data. Pennsylvania is a nationally relevant case study on the promises, perils, and misconceptions surrounding involuntary commitment data. In this study, we survey the minimal available Pennsylvania data and then contextualize our results within state laws and norms by (1) framing involuntary commitment data within the state's gun control agenda, (2) implementing the language of undone science, agnotology, and visibility, and (3) discussing the rights and social obligations surrounding privacy, confidentiality, and dangerousness. We find that sensitive administrative data is collected at several points during the involuntary commitment process but is rarely available in a useful, de-identified form. Improved access to useful data about the commitment population would close a major gap in state and national healthcare delivery, policy, and accountability.
President Trump and his administration have repeatedly threatened to invoke insurrection powers and unleash US military and National Guard members in American cities in response to civil uprisings and alleged interferences with immigration officials' actions. In so doing, they raise a specter of significant constitutional clashes over the use of these antiquated emergency authorities. To the extent Congress is unwilling to constrain presidential discretion, the US Supreme Court may be called on to clarify the scope and limits of Insurrection Act powers.
The World Health Organization has declared 2021-2030 the "Decade of Healthy Ageing", aiming for the best quality of life through health as the population ages. Beyond healthy ageing, scientists are adopting artificial intelligence technologies for longevity science which can foreseeably enable humans to routinely live to 120 years and beyond. With such breakthroughs within reach, the challenges associated with longevity need to be considered, from the impact on the social system to the possibility of an international law right to longevity, along with associated considerations such as on sustainability. This article questions whether there already is, or should be, an international human right to facilitate considerably extended lifespans, along with other relevant legal frameworks.
The rise of health care AI raises concerns over whether patent disclosure supports reproducibility and legal validity. This study analyzes 865 granted medical AI patents (2015-2025) from the US, China, and the EU using a five-dimensional framework (algorithm transparency, training data accessibility, model reproducibility, result verifiability, and mathematical support) implemented through NLP-assisted expert scoring. Results suggest limited technical transparency; approximately 40% of patents score zero in at least two dimensions. Performance varies significantly: algorithm transparency is relatively strong (>60% score 2), while training data accessibility is less prevalent (4.6% score 2) and mathematical support is frequently omitted (39.4% score 0). Statistical testing indicates US patents significantly outperform Chinese patents (p < 0.001), while EU results remain exploratory (N = 31, mean 6.2). These patterns appear associated with institutional factors, strategic applicant behaviour, and technical complexity. Such limitations may pose risks to enforceability and market development, highlighting the need for targeted disclosure improvements. This study contributes a replicable framework for translating legal standards into measurable indicators, providing cross-jurisdictional evidence to guide examination, litigation, and policy refinement in medical AI governance.
Patients living with nociplastic pain are at particular risk of being unfairly judged because their symptoms are subjective and occur without measurable abnormalities. Nociplastic pain, now recognized as a third category of pain alongside nociceptive and neuropathic pain, arises in the absence of tissue damage sufficient to explain the clinical presentation. This "unseen" pain affects at least ten percent of the population, commonly involves the musculoskeletal or visceral systems, and leads to substantial suffering and functional impairment. Validation of these chronic symptoms is often contentious because no objective biomarker or physical sign can reliably confirm their presence or severity. The concept of illness without measurable parameters challenges clinicians and conflicts with legal systems that rely heavily on objective evidence in adjudicating health-related questions. Most clinicians have limited training in medicolegal principles, standards of impartiality, or the ethical distinctions between patient advocacy and objective reporting. These challenges are amplified in cases involving chronic nociplastic pain, where the lack of observable findings complicates clinical interpretation and may conflict with traditional expectations for legal evidence. Bias, whether conscious or unconscious, may occur at multiple stages of the medicolegal process. Inaccurate, incomplete, or biased information from patients, treating clinicians, independent medical experts, insurers, or legal representatives can influence fairness, credibility, and decisional outcomes. This review summarizes key considerations in the adjudication of chronic nociplastic pain and examines how various sources of bias may shape medicolegal decision-making. Improving awareness of these risks and implementing strategies to reduce bias may promote a more reliable and equitable interface between clinical assessment and legal adjudication.
The role of pharmaceutical companies in promoting overuse of opioids by influencing medical discourse is underexamined. Marketing messages have been seeded in journal articles, continuing medical education (CME), prescribing guidelines, educational activities, and professional society recommendations. Terms generated or redefined by industry created a framework for promoting opioids. This paper focuses on the terms "opiophobia," "pseudoaddiction," "breakthrough pain" and "pain is the 5th vital sign." The reframing of incipient opioid use disorder as "tolerance" and "dependence" is also discussed. The proliferation of these industry-supported terms within medical discourse created a false evidence base that opioids were safe and effective for chronic pain and that withholding opioids deprived patients of the best care.
This article reports new legal data on state syringe services program (SSP) and drug paraphernalia laws in the United States. Scientific legal mapping methods were used to develop a longitudinal legal dataset capturing state-level SSP and drug paraphernalia laws in effect from January 1, 2010, through June 1, 2024. During that period, the number of states with a legal mechanism allowing for syringe distribution from SSPs nearly doubled. However, legal barriers to SSP operations remain in many states.
Amid growing interest in the integration of health and social care to improve outcomes, communities across the United States have explored development of Community Information Exchanges (CIEs). A CIE is a community governed infrastructure that enables critical health and social information to be responsibly shared among partner organizations in support of holistic coordination of care. The development and use of a CIE give rise to a host of legal and policy challenges. Use and disclosure of data through a CIE are governed by a patchwork of different legal requirements, at times distinct and at times overlapping. Development of a legal framework for a CIE requires attention to clearly articulated data flows, detailed use cases, strong legal agreements and policy considerations. CIEs typically rely on an individual's express consent to share their information, requiring careful evaluation of applicable laws and regulations and promotion of community trust and equity. And because many participants in a CIE are HIPAA covered entities, functions of the CIE must fit within HIPAA's regulatory framework. This article examines in depth two components of a sound legal framework-consent models and HIPAA compliance-identifying considerations and lessons learned to support lawful and ethical information sharing through a CIE.
Every US state requires drivers to pass a knowledge and skills examination before obtaining their driver's license. Surprisingly little is known about the progression of people through the examination process. To date, no research has been conducted on the proportion of individuals who pass from one stage of the driver examination process to the next compared to those who fail and are required to be reexamined. The purpose of this study was to follow the progression of a cohort of new drivers in Washington State as they advanced through the driver examination process. We reviewed driving records for 2,604 teens who started a driver education course in 2024. Of those who attempted the knowledge test at least once, 96 percent passed their knowledge test and 85 percent passed their skills exam. There were significant differences in pass and fail rates by sex, race, and household income. The overwhelming majority of new drivers passed both the knowledge and skills exams after two attempts. The fact that teenagers have a high risk of crashing in the first year of licensure suggests that the full safety potential of the knowledge and skills exams are not being realized.
Tribal nations possess the inherent sovereign authority to protect the health and welfare of their people. Without equitable access to public health data, Tribal nations cannot fulfill this essential governmental duty. Federal, state, and local public health agencies must implement Tribal data sovereignty principles to support the exchange and protection of Tribal public health data. The adoption of Tribal data-sharing agreements can provide a framework for strengthening Tribal data sovereignty and recognizing a Tribe's inherent right to collect and manage their data.
