Antimicrobials form the backbone of modern medicine and represent a foundational pillar of economic productivity. Overuse and misuse have led to a rising trend of antimicrobial resistance (AMR), depleting the efficacy of existing antimicrobials, necessitating conservation through stewardship and renewal through innovation. Poor global access exacerbates these challenges. We introduce the concept of antimicrobial effectiveness (AME) as a system in which antimicrobials are clinically and microbiologically efficacious against infectious pathogens and accessible for appropriate use. We frame AME as a global economic infrastructure, demonstrating its role as a key input to health, social, and economic outcomes and driver of positive spillovers. We investigate the balance between capacity constraints imposed by AMR and the benefits of maximizing non-discriminatory sharing of AME, exploring how a sustainable management approach comprised of infection prevention, universal access, stewardship, surveillance, and innovation can conserve AME. We explore economic mechanisms such as internalized healthcare overheads and hypothecated taxes to align contributions with benefits, ensuring that patients, hospitals, and businesses who rely on AME help to conserve it. Through identifying social value, patterns of payoffs, and downstream beneficiaries of AME, infrastructure framing provides a coherent axis to structure action, align incentives, and mobilize investment across sectors and scales.
Legal epidemiology - the study of how laws influence health outcomes - is an emerging field with potential to inform policy and improve public health. Shortages of specialists who can commit the extensive time required for these analyses has hindered progress in this area. Features of laws make them ideal candidates for artificial intelligence and natural language processing (AI/NLP) to address these constraints: standardized format, defined terms, and common terminology. However, there are concerns regarding valid AI/NLP application, especially given current underreporting of legal research in published policy evaluation studies. Drawing on lessons learned from case deployments and recent literature, we review opportunities and challenges for methods using AI/NLP in scientific legal research: assessing the scope of legal documents and data, identifying and collecting primary legal data, developing and applying coding schemes, and implementing quality controls to ensure the validity of produced legal datasets. We highlight methodologic research areas and innovation in the application of AI/NLP for scientific studies regarding effects of law on health and indicate methodologic reporting elements that will be essential for the field's innovation. This review provides a method-focused research agenda for AI/NLP in scientific legal epidemiology studies that might accelerate the field's growth and effects on evidence-based policy.
In an increasingly contemptuous political environment as the nation prepared to celebrate its semisquicentennial on July 4, 2026, the US Supreme Court capped its 2025-2026 term, which included profound decisions on a series of cases raising significant controversies in health law and policy. As per and analyses below, major topics addressed by the Court this term include: (1) the scope and limits of presidential emergency authorities; (2) state debates over LGBTQ+ rights and discrimination in parental and sports-related settings; (3) First Amendment interests juxtaposed against states' rights to regulate medical professionals or require vaccinations; (4) expansion of Second Amendment rights to possess firearms; and (5) state-based product liability and other claims foreclosed via Congress.
In their article Objective Standards of Medical Judgment: A Myth of Abortion Law, Graber et al. explore the different legal standards for evaluating if a physician properly offered abortion care under a medical exception to states' abortion restrictions. While this piece focuses tightly on the use of legal standards to limit access to abortion care, it should be understood in the broader context of a legal and political environment that is increasingly shifting the locus of medical decision-making power from the medical profession to state actors. We agree with Graber et al. that physicians should use their voices to speak out and educate the community on the medical decision-making process. But we are concerned that some state and legal actors are intentionally looking to improperly encroach upon the practice of medicine.
In response to the article So You Think You Know Who's the "Legally Authorized Representative": Clinical Research Hits a Snag, this invited commentary draws attention to the practical realities that are overlooked in the paper's examination of enrolling research participants without decisional capacity to provide their own consent. In such scenarios, the participant's Legally Authorized Representative (LAR) is co-enrolled to consent on the participant's behalf. Implementation of a research-based LAR is a two-part process that involves identifying the LAR according to legal hierarchy and performing a capacity assessment to determine whether the prospective participant requires an LAR. The paper makes several comparisons between standard care and research approaches to these decisions, most of which the author deems inadequate for clinical research contexts, and suggests that navigating this process may pose "unexpected legal and ethical hazards" for researchers. By offering a practitioner's perspective in this commentary, I hope to bring clarity to this argument by explaining from direct experience how LAR implementation includes much greater collaboration and thought partnership between researchers and IRBs than the author gives credit for.
The European Union's Artificial Intelligence Act introduces a novel regulatory category of "unacceptable risk," prohibiting specific AI practices that are deemed fundamentally incompatible with human rights and ethical principles. While much attention has focused on the regulation of high-risk AI systems, particularly in medical contexts, the AI Act's outright bans under Article 5 have received far less scrutiny. This paper addresses that gap by examining how these prohibitions apply to healthcare and public health, which are domains defined by rapid technological uptake, structural vulnerability, and ethically sensitive decision-making. Drawing on the European Commission's 2025 interpretative Guidelines, the paper argues that several health-related AI applications, such as emotion recognition tools, biometric categorisation systems, and technologies that influence or target vulnerable populations, may fall within the scope of the bans. It also shows that the Act's medical and safety exceptions risk weakening the vulnerability protections that the prohibitions aim to secure. By integrating legal analysis with real-world health examples, the paper offers a framework for interpreting these prohibitions and assesses how they should guide the ethical boundaries of AI in healthcare, within and beyond the European context.
This article reviews the history and current evidence of systematic pharmaceutical industry corruption. It draws on studies by the OECD on international corruption; reports of the Securities and Exchange Commission; studies of the Public Citizen health Research Group of settlement agreements between federal and state authorities and pharmaceutical firm; the history of the Medicare and Medicaid Anti-Kickback Act; professional and industry codes of ethics; the literature on institutional corruption; and studies of conflicts of interest. These sources support findings of systemic corruption since the mid-20th century. The paper also explores the relationship between classic corruption, institutional corruption and conflicts of interest in medicine and pharmaceutical policy.
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.
