Ethical Criteria for Improved Human Subject Protections in Phase I Healthy Volunteer Trials
Rebecca L. Walker, Douglas MacKay, Margaret Waltz, Anne D. Lyerly, Jill A. Fisher
Phase I healthy volunteer trials test the safety and tolerability of investigational pharmaceuticals. Participants are exposed to study-drug risks without the possibility of direct medical benefit and typically must spend days or weeks in a residential research facility. Monetary payments are used to incentivize enrollment and compensate participants for their time. Together, these features of phase I healthy volunteer trials create a research context that differs markedly from most other clinical research, including by enrolling disproportionate numbers of economically disadvantaged people of color as participants. Traditional biomedical research oversight offers inadequate ethical and policy guidance for phase I healthy volunteer research. This article details five ethical criteria crafted to be responsive to the particularities of this type of research: translational science value, fair opportunity and burden sharing, fair compensation for service, experiential welfare, and enhanced voice and recourse.
An Expanded Role for IRBs in the Oversight of Research Biopsies
Laura A. Levit, Julie Kaneshiro, Jeffrey Peppercorn, Mark J. Ratain
Research biopsies included in cancer clinical trials aim to advance scientific understanding of cancer and its treatments but may offer no prospect of direct benefit to participants and often pose more than minimal risk. The research community is examining the ethics of research biopsies increasingly often. Ethical concerns center on the limited scientific justification supporting some biopsies, risks to research participants, and the potential for coercion and therapeutic misconception during the informed consent process. There is also a lack of comprehensive oversight of research biopsies by regulatory agencies and institutions. This paper reviews these ethical concerns, discusses the scope of federal oversight, and suggests that institutional review boards (IRBs) should assume a larger role in ensuring the ethical conduct of research biopsies.
Table of contents of the September-October 2022 Ethics & Human Research:
https://onlinelibrary.wiley.com/toc/25782363/2022/44/5
