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A New Governance Overnance Approach to Regulating Human Genome Editing

December 10, 2020
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...

Evaluating the National Institutes of Health’s Sex as a Biological Variable Policy: Conflicting Accounts from the Front Lines of Animal Research

December 1, 2020
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...

Can We Do without Respect and Justice in Animal Research Ethics?

October 23, 2020
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...

Virtue Ethics and Laboratory Animal Research

October 1, 2020
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...

The Unfinished Business of Respect for Autonomy: Persons, Relationships, and Nonhuman Animals

July 6, 2020
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...

Incidental Enhancements: A Neglected Governance Challenge for Human Genome Editing Research

June 25, 2020
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...

From Mice to Monkeys? Beyond Orthodox Approaches to the Ethics of Animal Model Choice

January 23, 2020
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...

“My Body is One of the Best Commodities”: Exploring the Ethics of Commodification in Phase I Healthy Volunteer Clinical Trials

January 23, 2020
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...

Picking and Choosing Among Phase I Trials: A Qualitative Examination of How Healthy Volunteers Understand Study Risks.

January 23, 2020
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...

Advancing Ethics and Policy for Healthy‐Volunteer Research through a Model‐Organism Framework

February 18, 2019
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...