Balancing Uncertain Risks and Benefits in Human Subjects Research

Composed of a variety of scientific and technical experts plus a few lay members, thousands of Institutional Review Boards (IRBs) in the US must identify and assess the potential risks to human research subjects, and balance those risks against the potential benefits of the research. These assessments are laden with uncertainty, however. Most IRBs handle risk and its uncertainty by adopting a version of the precautionary principle, which is largely suggested by the Belmont Report and the Common Rule. To assess scientific merit, IRBs tacitly employ a “sanguinity principle,” which treats uncertainty as inevitable in scientific progress. In balancing the uncertainties of human subjects risks and scientific benefits, IRBs use uncertainty as a bridging device that allows the approaches of science and ethics to be reconciled. Nevertheless, the flexibility and lack of consistent oversight of how IRBs apply these principles leads to frustration by investigators who are unclear about the criteria by which their proposals are evaluated.

• Richard Barke

• School of Public Policy