Rebecca Walker

Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules.

Background The ethical use both of human and non-human animals in research is predicated on the assumption that it is of a high quality and its projected benefits are more significant than the risks and harms imposed on subjects. Yet questions remain about whether and how IRBs and IACUCs should consider the scientific value of proposed research studies.Methods We draw upon 45 interviews with IRB and IACUC members and researchers with oversight experience about their perceptions of their own roles in reviewing the quality and value of scientific protocols. Interview transcripts were memoed to highlight specific findings, which were then used to identify key themes through an iterative process.Results IRB and IACUC members expressed broad trust in the need for and value of research, and they often assumed that protocols had social value or that prior review, especially when associated with funding, affirmed both the rigor and merit of those protocols. Some oversight members also took an explicit stance against scientific review by stating that such review is not within the regulatory mandates governing their parts in the oversight system. Yet other interviewees expressed uneasiness about the current paradigm for evaluating the quality and overall value of science, suggesting that IRB and IACUC members perceive gaps in the oversight systems.Conclusions These findings reveal many similarities in how IRB and IACUC members understand the roles and limitations of their respective oversight committees. We conclude with a discussion of how the lack of a clear mandate regarding scientific review within US federal regulations may undermine ethical engagement of whether human and animal research is scientifically justified, resulting in a “mission lapse” wherein no organizational body is clearly responsible for ensuring that the research being conducted has the potential to advance science and benefit society.

National and international agencies and organizations are currently considering which ethical principles should inform the governance and use of heritable and non-heritable human genome editing. In this paper, we consider the prevalence principle, according to which heritable and non-heritable genome editing in humans is permissible if and only if it involves the conversion of variants to ones expected to produce traits that are prevalent in the relevant population. This principle thus permits genome editing targeting variants responsible for disease and disability but prohibits genetic enhancement. We consider whether the prevalence principle is supported by considerations of egalitarian justice, as its proponents claim. We argue that it is not and that prominent theories of egalitarian justice instead offer different approaches to genome editing governance. We identify four egalitarian principles policymakers should consider when crafting anticipatory guidance for heritable and non-heritable genome editing.

The notion of autonomy commonly employed in medical ethics literature and practices is inadequate on three fronts: it fails to properly identify nonautonomous actions and choices, it gives a false account of which features of actions and choices makes them autonomous or nonautonomous, and it provides no grounds for the moral requirement to respect autonomy. In this paper I offer a more adequate framework for how to think about autonomy, but this framework does not lend itself to the kinds of practical application assumed in medical ethics. A general problem then arises: the notion of autonomy used in medical ethics is conceptually inadequate, but conceptually adequate notions of autonomy do not have the practical applications that are the central concern of medical ethics. Thus, a revision both of the view of autonomy and the practice of “respect for autonomy” are in order

Background: Nonhuman animals are regularly enhanced genomically with CRISPR and other gene editing tools as scientists aim at better models for biomedical research, more tractable agricultural animals, or animals that are otherwise well suited to a defined purpose. This study investigated how genome editors and policymakers perceived ethical or policy benefits and drawbacks for animal enhancement and how perceived benefits and drawbacks are alike, or differ from, those for human genome editing. Methods: We identified scientists through relevant literature searches as well as conference presentations. Policymakers were identified through rosters of genome editing oversight groups (e.g., International Commission on the Clinical Use of Human Germline Genome Editing, World Health Organization) or efforts aimed at influencing policy (e.g., deliberative democracy groups). Interviews covered participants’ views on ethical differences between interventions affecting somatic or germline cells and distinctions between using gene editing for disease treatment, prevention, and enhancement purposes. Results: Of the 92 participants interviewed, 81 were genome editing scientists, and 33 were policymakers, with 22 interviewees being both scientists and policymakers. Multiple areas were identified in which the ethical implications of genomic enhancements for nonhuman animals differ from those for human animals including with respect to experiential welfare; germline edits; environmental sustainability; and justice. Conclusions: Overall, respondents viewed that animal enhancement is unburdened by the ethical complexities of human enhancement. These views may be related to participant perceptions of animals’ lesser moral status and because germline editing in animals is common practice.

While somatic cell editing to treat disease is widely accepted, the use of human genome editing for “enhancement” remains contested. Scientists and policy-makers routinely cite the prospect of enhancement as a salient ethical challenge for human genome editing research. If preventive genome editing projects are perceived as pursuing human enhancement, they could face heightened barriers to scientific, public, and regulatory approval. This article outlines what we call “preventive strengthening research” (or “PSR”) to explore, through this example, how working to strengthen individuals’ resistance to disease beyond what biomedicine considers to be the human functional range may be interpreted as pursuing human enhancement. Those involved in developing guidance for PSR will need to navigate the interface between preventive goals and enhancement implications. This article identifies and critiques three of these ideas in the interest of anticipating the wider emergence of PSR and the need for a normative approach for its pursuit. All three “candidate criteria” merit attention, but each also faces challenges that will need to be addressed as further research policy is developed.

Imprisonment may sometimes be a justified form of punishment. Yet the U.S. carceral system suffers from appalling problems of justice—in who is put into prisons, in how imprisoned people are treated, and in downstream personal and community health impacts. Medical personnel working in prisons and jails take on risky work for highly vulnerable and underserved patients. They are to be lauded for their professional commitments. Yet at the same time, prison care undercuts the ability of medical personnel to uphold their own professional standards and sometimes fails in even basic health protection. Doctors in prisons are stuck between their commitment to vulnerable patients and complicity in a system that requires their participation to uphold its constitutionality. Medical ethics is frayed in prisons, and the problem deserves our attention.

The need for informed analyses of health policy is now greater than ever. The twelve essays in this volume show that public debates routinely bypass complex ethical, sociocultural, historical, and political questions about how we should address ideals of justice and equality in health care. Integrating perspectives from the humanities, social sciences, medicine, and public health, this volume illuminates the relationships between justice and health inequalities to enrich debates. Understanding Health Inequalities and Justice explores three questions: How do scholars approach relations between health inequalities and ideals of justice? When do justice considerations inform solutions to health inequalities, and how do specific health inequalities affect perceptions of injustice? And how can diverse scholarly approaches contribute to better health policy? From addressing patient agency in an inequitable health care environment to examining how scholars of social justice and health care amass evidence, this volume promotes a richer understanding of health and justice and how to achieve both. The contributors are Judith C. Barker, Paula Braveman, Paul Brodwin, Jami Suki Chang, Debra DeBruin, Leslie A. Dubbin, Sarah Horton, Carla C. Keirns, J. Paul Kelleher, Nicholas B. King, Eva Feder Kittay, Joan Liaschenko, Anne Drapkin Lyerly, Mary Faith Marshall, Carolyn Moxley Rouse, Jennifer Prah Ruger, and Janet K. Shim.

A person of good character treats other sentient beings with care and compassion. Yet virtue ethics apparently has trouble accounting for the moral status of nonhuman animals because of its focus on excellent character traits, rather than the moral “patient,” and because of its non-codifiability, at least in some forms. The task of this article is to answer the question: How can virtue ethics account for the moral value of nonhuman animals in the context of biomedical research? I argue that it can do so through attention to animal good lives, human-animal bonds, and the virtues themselves. The virtue ethics resources I draw on to support nonhuman animal value are not the same as those typically brought to bear in moral status discussions, but I suggest that moral status as usually conceived has its own problems as a tool for use in practical contexts like animal research.

The standard notion of autonomy in medical ethics does not require that autonomous choices not be irrational. The paper gives three examples of seemingly irrational patient choices and discusses how a rational autonomy analysis differs from the standard view. It then considers whether a switch to the rational autonomy view would lead to overriding more patient decisions but concludes that this should not be the case. Rather, a determination of whether individual patient decisions are autonomous is much less relevant than usually considered in determining whether health care providers must abide by these decisions. Furthermore, respect for rational autonomy entails strong positive requirements of respect for the autonomy of the person as a rational decision maker. The rationality view of autonomy is conceptually stronger than the standard view, allows for a more nuanced understanding of the practical moral calculus involved in respecting patient autonomy, and promotes positive respect for patient autonomy.

In phase I clinical trials, healthy volunteers are dosed with investigational drugs and subjected to blood draws and other bodily monitoring procedures. In exchange, they are paid. Healthy volunteers are, in a very direct sense, selling access to their bodies for pharmaceutical companies and their associates to run drugs through. In his ethnographic study of socalled professional guinea pigs, Roberto Abadie writes, "Paid volunteers are well aware of the demand for an idealized, perfectly healthy volunteer. They also realize that their body is a valued commodity in clinical trials research". It is perhaps surprising, then, that commodification is little discussed in the bioethics literature on phase I...

Research uses of human bodies maintained by mechanical ventilation after being declared dead by neurological criteria, were first published in the early 1980s with a renewed interest in research on the newly or nearly dead occurring in about last decade. While this type of research may take many different forms, recent technologic advances in genomic sequencing along with high hopes for genomic medicine, have inspired interest in genomic research with the newly dead. For example, the Genotype-Tissue Expression program through the National Institutes of Health aims to collect large numbers of diverse human tissues with the eventual goal of elucidating the genetic bases of common diseases through a better understanding of the relationship between genetic variation and gene expression.

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials.