This article proposes a novel strategy, one that draws on insights from antidiscrimination law, for addressing a persistent challenge in medical ethics and the philosophy of disability: whether health systems can consider quality of life without unjustly discriminating against individuals with disabilities. It argues that rather than uniformly considering or ignoring quality of life, health systems should take a more nuanced approach. Under the article's proposal, health systems should treat cases where (1) quality of life suffers because of disability-focused exclusion or injustice differently from cases where (2) lower quality of life results from laws of nature, resource scarcity, or appropriate tradeoffs. Decisionmakers should ignore quality-of-life losses that result from injustice or exclusion when ignoring them would improve the prospects of individuals with disabilities; in contrast, they should consider quality-of-life losses that are unavoidable or stem from resource scarcity or permissible tradeoffs. On this proposal, while health systems should not amplify existing injustice against individuals with disabilities, they are not required to altogether ignore the potential effects of disability on quality of life.

The federal system for allocating donated livers in the United States is often criticized for allowing geographic disparities in access to livers. Critics argue that such disparities are unfair on the grounds that where one lives is morally arbitrary and so should not influence one's access to donated livers. They argue instead that livers should be allocated in accordance with the equal opportunity principle, according to which US residents who are equally sick should have the same opportunity to receive a liver, regardless of where they live. In this paper, we examine a central premise of the argument for the equal opportunity principle, namely, that geographic location is a morally arbitrary basis for allocating livers. We raise some serious doubts regarding the truth of this premise, arguing that under certain conditions, factors closely associated with geographic location are relevant to the allocation of livers, and so that candidates' geographic location is sometimes a morally non-arbitrary basis for allocating livers. Geographic location is morally non-arbitrary, we suggest, since by taking it into account, the UNOS may better fulfill its central goals of facilitating the effective and efficient placement of organs for transplantation and increasing organ donation.

One fundamental barrier to eliminating health disparities, particularly with regard to the determinants of health, is the persistence of discrimination. Civil rights law is the primary legal mechanism used to address discrimination. Federal civil rights laws have been the subject of wider analyses as a determinant of health as well as a tool to address health disparities. The research on state civil rights laws, while more limited, is growing. This article will highlight a few examples of how some states are using civil rights laws to combat discrimination, particularly in more expansive ways and in the interest of new populations, presenting tools that can target determinants and address the goal of reducing health disparities.

Laws and policies are vital tools in preventing outbreaks and limiting the further spread of disease, but they can vary in content and implementation. This manuscript provides insight into challenges in responding to recent vaccine-preventable disease outbreaks by examining legislative changes in California, policy changes on certain university campuses, and the laws implicated in a measles outbreak in Minnesota.

Quality improvement (QI) is an important function of learning health systems, and public policy should promote QI activities. Use of systematic methodologies in QI has prompted substantial confusion regarding when QI is human subjects research under the Common Rule, and this confusion persists with the revised Rule. Difficulty distinguishing research from QI imposes costs on the quality improvement process. I offer guidance to IRBs to mitigate these costs and suggest a new regulatory exclusion for minimal risk quality improvement activities.

States have implemented a variety of legal and policy approaches to address the overdose epidemic. Some approaches, like increasing access to naloxone and connecting overdose survivors with evidence-based treatment, have a strong public health foundation and a compelling evidence base. Others, like increasing reliance on punitive criminal justice approaches, have neither. This article examines law and policy changes that are likely to be effective in reducing overdose-related harm as well as those that are likely to increase it.

The United States wastes approximately 40% of its food supply. This article will examine the implications of this waste for food insecurity and climate change. It will also explore how the law and social entrepreneurship can be used to confront this public health challenge.

Knowledge of the law and its impact on health outcomes is increasingly important in public health practice. The CDC's Public Health Law Academy helps satisfy this need by providing online trainings, facilitator toolkits, and legal epidemiology tools to aid practitioners in learning about the law's role in promoting public health.

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections (SACHRP), and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation.

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of the adverse events (AEs) they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity.

This article discusses (1) the ways in which law functions as a determinant of health, (2) historical collaborations between the health and legal professions, (3) the benefits of creating medical-public health-legal collaborations, and (4) how viewing law through a collaborative, population health lens can lead to health equity.

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime.

Following the confirmation of U.S. Supreme Court Justice Brett Kavanaugh in one of the most sensational jurisprudence events of the modern era, we examine potential repercussions across multiple themes in public health, law, and policy stemming from his ideology and the confirmation process.