Edward Fuchs

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When a serious adverse event in research occurs, how do other volunteers react?

Caitlin E Kennedy; Nancy Kass; Rachel K Myers; Edward J Fuchs; Charles Flexner (Profiled Authors: Charles Flexner; Caitlin Kennedy; Edward Fuchs; Nancy Kass)

Johns Hopkins University, Bloomberg School of Public Health, Department of International Health, Baltimore, MD 21205, USA. ckennedy@jhsph.edu
Journal of empirical research on human research ethics : JERHRE 2011;6(2):47-56.

Serious adverse events in research involving healthy volunteers are rare, but their impact on other volunteers is unknown. We conducted semi-structured interviews with 60 healthy volunteers at an institution where a healthy research volunteer died. Most volunteers (85%) had heard of the event, but few said it changed their thoughts about joining research (17%), approach to studies or questions asked (25%), or future participation (4%). Despite knowing few facts, respondents created narratives about the case that served to distance them from the event and justify their continued participation in research. Downward social comparison theory, optimistic bias, and feelings of responsibility and control may help explain these narratives. Findings underscore the importance of communication and understanding of research risks and protections.

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