Holly Lynch

When new drugs are approved by the Food and Drug Administration, the default assumption is that they will be available by prescription only, safe for use exclusively under clinical supervision. The paternalism underlying this default must be interrogated in order to ensure appropriate respect for patient autonomy. Upon closer inspection, prescription requirements are justified when nonprescription status would risk harm to third parties and when a large segment of the population would struggle to exercise their autonomy in using a drug safely and effectively on their own. Although these justifications can support prescription status for many drugs, we propose that reversing the FDA's current default to instead begin with a presumption in favor of over‐the‐counter status is the best way to avoid interference with valid claims of patient autonomy. Under this approach, a range of drug products could be considered for an OTC switch, including oral contraceptives, statins, and HIV‐prevention drugs.

Background Meaningfully evaluating the quality of institutional review boards (IRBs) and human research protection programs (HRPPs) is a long-recognized challenge. To be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), organizations must demonstrate that they measure and improve HRPP “quality, effectiveness, and efficiency” (QEE). We sought to learn how AAHRPP-accredited organizations interpret and satisfy this standard, in order to assess strengths, weaknesses, and gaps in current approaches and to inform recommendations for improvement.Methods We conducted 3 small-group interviews with a total of 19 participant representatives of accredited organizations at the 2019 AAHRPP annual meeting. Participants were eligible if they had familiarity with their organization’s approach to satisfying the relevant QEE standard.Results Participants reported lacking clear definitions for HRPP quality or effectiveness but described various approaches to assessing QEE, typically focused on turnaround time, compliance, and researcher satisfaction. Evaluation of IRB members was described as relatively superficial and information regarding research subject experience was not reported as central to QEE assessment, although participants described several efforts to improve consideration of patient, subject, and community perspectives in IRB review. Participants also described efforts to educate and build relationships with key stakeholders as important features of a high-quality HRPP. While generally satisfied with their approaches, participants expressed concern about resource and time constraints that pushed them to be reactive and automatic about QEE, rather than proactive and critical.Conclusions The relevant AAHRPP accreditation standard may obscure critical gaps in defining and measuring QEE elements. We recommend that AAHRPP: (1) offer a definition of QEE or require accredited organizations to provide their own, to help clarify the rationale and goals behind assessment and improvement efforts, and (2) require accredited organizations to establish QEE objectives and measures focused on participant outcomes and deliberative quality during protocol review.

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, 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.

There is limited guidance on how to assess the ethical acceptability of research risks that extend beyond research participants to third parties (or “research bystanders”). Community or stakeholder engagement has been proposed as one way to address potential harms to community members, including bystanders. Despite widespread agreement on the importance of community engagement in biomedical research, this umbrella term includes many different goals and approaches, agreement on which is ethically required or recommended for a particular context. We analyse the case of a potential Zika virus human challenge trial to assess whether and how community engagement can help promote the ethical acceptability of research posing risks to bystanders. We conclude that, in addition to having intrinsic value, community engagement can improve the identification of bystander risks, effective approaches to minimizing them, and transparency about bystander risks for host communities.

Law and racism are intertwined, with legal tools bearing the potential to serve as instruments of oppression or equity. This Special Issue explores this dual nature of health law, with attention to policing in the context of mental health, schools, and substance use disorders; industry and the environment in the context of food advertising, tobacco regulation, worker safety, and environmental racism; health care and research in the context of infant mortality, bias in medical applications of AI, and diverse inclusion in research; and anti-racist teaching and practice in the context of building an interprofessional curriculum and medical-legal partnerships.

When research poses risks to non‐participant bystanders, it is not always practicable to obtain their consent. One approach to assessing how much research risk may be imposed on nonconsenting bystanders is to examine analogous circumstances, including risk thresholds deemed acceptable for nonconsenting research participants and for nonconsensual risks imposed outside the research setting. For nonconsenting participants, US research regulations typically limit risks to those deemed to be “minimal.” Outside the research context, US tort law tolerates a more flexible “reasonable” risk threshold. This article advances a preliminary case that nonconsenting participants and nonconsenting bystanders exposed to similar research risks may be entitled to the same level of protection, but that risks generated by research may not be special in kind. Thus, limiting research risks to those that are “reasonable,” rather than demanding that they be held to the “minimal” standard, may be the best approach for both nonconsenting participants and nonconsenting bystanders. Further work is needed to establish whether the descriptive standards used to support the analogies relied on here are normatively justifiable, as well as the extent to which the minimal risk standard and the reasonable risk standard would lead to meaningfully different outcomes in practice.

Background Diversity in Institutional Review Board (IRB) membership is important for both intrinsic and instrumental reasons, including fairness, promoting trust, improving decision quality, and responding to systemic racism. Yet U.S. IRBs remain racially and ethnically homogeneous, even as gender diversity has improved. Little is known about IRB chairpersons’ perspectives on membership diversity and barriers to increasing it, as well as current institutional efforts to promote diversity, equity, and inclusion (DEI) within IRB membership.Methods We surveyed IRB chairpersons leading U.S. boards registered with the Office for Human Research Protections. Here, we focus exclusively on responses from a subset of 388 chairpersons of IRBs at universities and academic medical centers (AMCs).Results Board chairs were predominantly white and evenly split between men and women. Only about half reported that their boards had at least one member who is Black or African American (51%), Asian (56%), or Hispanic (48%), with 85% of university/AMC boards comprised entirely (15%) or mostly (70%) of white members. Most IRB chairpersons (64%) reported satisfaction with the current diversity of their membership. Participants largely agreed that considering diversity in the selection of IRB members is important (91%), including to improve the quality of IRB deliberation (80%), with an emphasis on racial/ethnic (85%) and gender diversity (74%). Most participants (80%) reported some type of active DEI effort regarding board membership at their university/AMC and just over half (57%) expressed satisfaction with these efforts.Conclusions Our national survey found that although university/AMC IRB chairpersons report valuing diversity in board membership, it may be lacking in key areas. Going forward, it will be important to specify clear reasons for diversity in the IRB context, as well to establish targets for acceptable levels of board diversity and to match DEI efforts to those targets.

The right to withdraw from research without penalty is well established around the world. However, it has been challenged in some corners of bioethics based on concerns about various harms—to participants, to scientific integrity, and to research bystanders—that may stem from withdrawal. These concerns have become particularly salient in emerging debates about the ethics of controlled human infection (CHI) studies in which participants are intentionally infected with pathogens, often in inpatient settings with extensive follow‐up. In this article, I provide support for preserving the right to withdraw from research without penalty and demonstrate that it is also typically justified in the specific context of CHI studies. The right is well aligned with individual freedoms outside the research setting, where autonomous individuals are permitted to engage in behaviors that will foreseeably cause them harm; where they cannot be compelled to satisfy contracts for their services, nor penalized for failure to do so; and where their behavior is not constrained by public health authorities except in extreme circumstances. These freedoms are supported by U.S. law, as well as by ethical analysis that is more globally relevant. The problems associated with the right to withdraw, however, remain. The best approach to addressing them is not to restrict the right but rather to avoid initiating research when withdrawal would be especially problematic. If research proceeds, steps can still be taken to minimize participant withdrawal without infringing the right. Investigators can avoid participant surprise through informed consent focused on a study’s most burdensome aspects and promote study completion through financial incentives. Should participants nonetheless seek to withdraw, investigators may attempt to persuade them not to do so by encouraging consideration of the range of potential harms that may result. Researchers conducting CHI studies and other research from which withdrawal might be especially problematic should prepare for the possibility of participant withdrawal, respect participant requests to withdraw without penalty, and incorporate various measures to avoid such requests.

Pushing back on policies favored by dying patients is a challenging endeavor, requiring tact, engagement, openness to bidirectional learning, and willingness to offer alternative solutions. It's easy to make missteps, especially in the age of social media. Holly Fernandez Lynch shares her experience learning with and from the amyotrophic lateral sclerosis (ALS) community, first as a caricature of an ivory tower bioethicist and more recently as a trusted advisor, at least for some. Patient‐engaged bioethics doesn't mean taking the view that patients are always right, but even when disagreement continues, progress is possible if academics and patients recognize the unique expertise each has to offer.