For years, genomic medicine—medicine based on the growing understanding of the genetic contribution to many diseases and conditions—has been hailed as the future of medical treatment, but it has thus far had limited effect on day-to-day medical practice. The ultimate goal of genomic medicine has always been the ability not just to identify dangerous gene … Read more

Background: Since the National Institutes of Health (NIH) Revitalization Act of 1993, focus on the equitable inclusion of women in clinical research has been ongoing. NIH’s 2015 sex as a biological variable (SABV) policy aims to transform research design, analysis, and reporting in the preclinical sphere by including male and female organisms in vertebrate animal … Read more

Abstract This book review essay discusses Principles of Animal Research Ethics (2020), by Tom L. Beauchamp and David DeGrazia. Review Animal research has long been a focus of social controversy and ethical debate. As Tom Beauchamp and David DeGrazia summarize in Principles of Animal Research Ethics, use of animal subjects incapable of consent, in ways … Read more

This article appeals to virtue ethics to help guide laboratory animal research by considering the role of character and flourishing in these practices. Philosophical approaches to animal research ethics have typically focused on animal rights or on the promotion of welfare for all affected, while animal research itself has been guided in its practice by … Read more

Special Issue Celebrating the 40th Anniversary of the First Publication of The Principles of Biomedical Ethics by Tom L. Beauchamp and James F. Childress. This essay explores three issues in respect for autonomy that pose unfinished business for the concept. By this, I mean that the dialogue over them is ongoing and essentially unresolved. These … Read more

The increasing pace and international diffusion of developments in human genome editing research have prompted ongoing efforts to develop responsible governance for such research. One point of broad agreement across these efforts is that human genome editing research should prioritize medical applications over attempts to enhance human traits because of the moral concerns the latter … Read more

Recent developments in genome editing tools, along with limits in the translational potential of rodent models of human disease, have spurred renewed biomedical research interest in large mammals like nonhuman primates, pigs, and dogs. Such scientific developments raise ethical issues about the use of these animals in comparison with smaller mammals, such as mice and … Read more

In phase I clinical trials, healthy volunteers are dosed with investigational drugs and subjected to blood draws and other bodily monitoring procedures while they are confined to clinic spaces. In exchange, they are paid. These participants are, in a direct sense, selling access to their bodies for pharmaceutical companies and their associates to run drugs … Read more

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 … Read more

Nonhuman animal research and phase I healthy‐volunteer clinical trials are both critical components of testing the safety of investigational drugs as part of the development of new pharmaceuticals. In addition, these types of research share important structural features, as both take place in confinement and both use subjects that are dissimilar to the target population. … Read more