An Expanded Role for IRBs in the Oversight of Research Biopsies.

Autor: Levit LA; Director of research analysis and publications in the Center for Research and Analytics at the American Society of Clinical Oncology., Kaneshiro J; Deputy director of the Office for Human Research Protections at the U.S. Department of Health and Human Services., Peppercorn J; Associate professor at Massachusetts General Hospital., Ratain MJ; Professor of medicine at the University of Chicago.
Jazyk: angličtina
Zdroj: Ethics & human research [Ethics Hum Res] 2022 Sep; Vol. 44 (5), pp. 32-41.
DOI: 10.1002/eahr.500141
Abstrakt: Research biopsies included in cancer clinical trials have the goal of advancing scientific understanding of the biological bases 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, especially when they are mandatory for study participation but do not support primary study objectives and thus are "nonintegral" to the study. 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. It concludes with guidance to IRBs on how to weigh the risks, benefits, and acceptability of such biopsies in different contexts that is based on a framework the American Society of Clinical Oncology developed for the inclusion of research biopsies in oncology clinical trials.
(© 2022 by The Hastings Center. All rights reserved.)
Databáze: MEDLINE
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