Rationalizing Risk Assessment in Human Subject Research

Abstract:     
Our system of protecting human subjects in medical research faces an unprecedented crisis. In addition to a few highly publicized scandals in which previously healthy individuals died during the course of clinical trials, a series of government investigations has documented significant deficiencies in the system's capacity to ensure compliance with federal regulations governing human subject protection. There is widespread consensus that any effective reform program must do something to improve the existing system of institutional review boards (IRBs), the committees within research institutions that decide which protocols can go forward and under what conditions. However, most of the current discussion about IRB reform has focused on questions about the basic structure of the IRB system, ignoring important process-oriented questions about how IRBs actually decide which protocols to accept, reject, or revise. To fill this gap, Professor Coleman takes a critical look at the process IRBs use to review research protocols, focusing specifically on risk assessment, one of the most important, and least understood, elements of protocol review. He argues that IRBs' current approach to risk assessment closely mirrors the deliberative process used by common-law juries, and that in both juries and IRBs this process suffers from considerable flaws. After examining the limitations of a jury approach to risk assessment determinations, Professor Coleman explains why our willingness to tolerate these limitations in the context of jury deliberations does not mean they also should be accepted in IRB review. He argues that, in place of the ill-fitting model of the common-law jury, IRBs should incorporate decision-making mechanisms used by judges and administrative agencies, including reasoning by analogy, written opinions, appellate review and precedent, and notice-and-comment rulemaking. He shows how adopting these strategies could improve the quality of IRB risk assessments, and examines the practical considerations such changes are likely to raise.

Keywords: Human subject research, risk assessment, institutional review boards, juries, analogical reasoning

Accepted Paper Series