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Research Biopsies in Phase I Studies: Views and Perspectives of Participants and Investigators

In many research studies, tumor biopsies are an unavoidable requirement for achieving key scientific aims. Yet some commentators view mandatory research biopsies as coercive and suggest they should be optional, or at least optional until further data are obtained regarding their scientific usefulness. Further complicating the ethical picture is the fact that some research biopsies offer a potential for clinical benefit to trial participants. We interviewed and surveyed a convenience sample of participants in phase I clinical trials at a single institution. Our primary aim was to describe phase I participants’ understanding of whether a research biopsy offered them the prospect of medical benefit. We also endeavored to describe participants’ views about biopsies—specifically, the benefits of biopsies, if any, and whether biopsies were acceptable, risky, or discouraged trial participation. Finally, we collected data on demographics and attitudes to see if any strong correlations with misunderstanding, acceptability, or riskiness existed. Overall, the respondents tended to view research biopsies as acceptable, though they did not succeed in identifying the lack of benefit of a research biopsy. These findings call for renewed efforts in consent conversations and documents to carefully describe the benefits, or lack thereof, of research biopsies.

Key words/concepts: research ethics, research biopsies, phase I studies, human subjects protection, informed consent, coercion

Rebecca D. Pentz, R. Donald Harvey, Margaret White, Zachary Luke Farmer, Olga Dashevskaya, Zhengjia Chen, Colleen Lewis, Taofeek K. Owonikoko, and Fadlo R. Khuri, “Research Biopsies in Phase I Studies: Views and Perspectives of Participants and Investigators,” IRB: Ethics & Human Research 34, no. 2 (2012): 1-8.

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