Ethics of controlled human infection to study COVID-19

Shah, S.K, Miller, F.G., and others
Science  07 May 2020
DOI: 10.1126/science.abc1076

Abstract

Development of an effective vaccine is the clearest path to controlling the coronavirus disease 2019 (COVID-19) pandemic. To accelerate vaccine development, some researchers are pursuing, and thousands of people have expressed interest in participating in, controlled human infection studies (CHIs) with severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2) (1, 2). In CHIs, a small number of participants are deliberately exposed to a pathogen to study infection and gather preliminary efficacy data on experimental vaccines or treatments. We have been developing a comprehensive, state-of-the-art ethical framework for CHIs that emphasizes their social value as fundamental to justifying these studies. The ethics of CHIs in general are underexplored (3, 4), and ethical examinations of SARS-CoV-2 CHIs have largely focused on whether the risks are acceptable and participants could give valid informed consent (1). The high social value of such CHIs has generally been assumed. Based on our framework, we agree on the ethical conditions for conducting SARS-CoV-2 CHIs (see the table). We differ on whether the social value of such CHIs is sufficient to justify the risks at present, given uncertainty about both in a rapidly evolving situation; yet we see none of our disagreements as insurmountable. We provide ethical guidance for research sponsors, communities, participants, and the essential independent reviewers considering SARS-CoV-2 CHIs.

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Bystander risk, social value, and ethics of human research

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.

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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.

The information is here.