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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 healthy volunteers enrolled in various … Read more

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 dissimilar to the target population. … Read more

Beyond Our Beginnings: 50 Years of Bioethics

February 12, 2019

“Beyond Our Beginnings:  50 Years of Bioethics“. We are hosting it at the Mews location at the  Graylyn International Conference Center In recognition of the Hastings Center’s 50th anniversary, this conference surveys the past, present, and future of bioethics scholarship, practice, and policy. The program addresses a broad range of issues and topics, including medical … Read more

Companion Animal Studies: Slipping Through a Research Oversight Gap

December 12, 2018

In human subject research ethics, we appeal to principles of respect for persons, beneficence, and justice. In laboratory animal studies, the three Rs (reduce, refine, replace) are key touchstones, along with an overarching principle of promoting animal welfare—when consistent with the needs of science and within the constraints introduced by the institutional setting. Underlying these … Read more

Is Enhancement the Price of Prevention in Human Gene Editing?

November 26, 2018

New gene-editing tools challenge conventional policy proscriptions of research aimed at either human germline gene editing or human enhancement by potentially lowering technical barriers to both kinds of intervention. Some recent gene-editing reports have begun to take up the prospect of germline editing, but most experts are in broad agreement that research should prioritize medical … Read more

Healthy volunteers’ perceptions of risk in US Phase I clinical trials: A mixed-methods study

November 26, 2018

There is limited research on healthy volunteers’ perceptions of the risks of Phase I clinical trials. In order to contribute empirically to long-standing ethical concerns about healthy volunteers’ involvement in drug development, it is crucial to assess how these participants understand trial risks. The objectives of this study were to investigate (1) participants’ views of … Read more

Healthy Volunteers’ Perceptions of the Benefits of Their Participation in Phase I Clinical Trials

October 11, 2018

Other than the financial motivations for enrolling in Phase I trials, research on how healthy volunteers perceive the benefits of their trial participation is scant. Using qualitative interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we investigated how participants described the benefits of their study involvement, including, but not limited to, … Read more

Virtue, Vice, and “Voracious” Science: How should we approach the ethics of primate research?

May 31, 2018

Philosophical approaches to animal research have typically asked whether nonhuman animals have rights that would prohibit such research or whether the benefit of such research on the whole balances out the harms to animals. The professional ethics approach instead promotes compliance with regulatory norms that aim to support science progress. In Voracious Science and Vulnerable … Read more

Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research

January 12, 2018

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 … Read more

The Ethics of General Population Preventive Genomic Sequencing

January 12, 2018

Advances in DNA sequencing technology open new possibilities for public health genomics, especially in the form of general population preventive genomic sequencing (PGS). Such screening programs would sit at the intersection of public health and preventive health care, and thereby at once invite and resist the use of clinical ethics and public health ethics frameworks. … Read more