S. K. Shah, J. Kimmelman, A. D. Lyerly, H. F. Lynch, and others
Science 13 Apr 2018 : 158-159
Two critical, recurring questions can arise in many areas of research with human subjects but are poorly addressed in much existing research regulation and ethics oversight: How should research risks to “bystanders” be addressed? And how should research be evaluated when risks are substantial but not offset by direct benefit to participants, and the benefit to society (“social value”) is context-dependent? We encountered these issues while serving on a multidisciplinary, independent expert panel charged with addressing whether human challenge trials (HCTs) in which healthy volunteers would be deliberately infected with Zika virus could be ethically justified (1). Based on our experience on that panel, which concluded that there was insufficient value to justify a Zika HCT at the time of our report, we propose a new review mechanism to preemptively address issues of bystander risk and contingent social value.
Some may object that generalizing and institutionalizing this approach could slow valuable research by adding an additional layer for review. However, embedding this process within funding agencies could preempt ethical problems that might otherwise stymie research. Concerns that CERCs might suffer from “mission creep” could be countered by establishing clear charters and triggers for deploying CERCs. Unlike IRBs, their opinions should be publicly available to provide precedent for future research programs or for IRBs evaluating particular protocols at a later date.
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