Regulatory Innovation in the Governance of Human Subjects Research: A Cautionary Tale and Some Modest Proposals

Abstract

Under U.S. regulations known as the Common Rule, federally-supported human-subject research must be reviewed by an Institutional Review Board (IRB). The Common Rule system looks from a distance like an innovative instantiation of prescriptions for constitutive regulation and soft law, but in practice has grown into a self-referential, unresponsive and legalistic bureaucracy. The paper reviews the criticism of the system and discusses why it fails to regulate in an efficient and effective way, pointing in particular to the poor fit between the IRB and its assigned tasks. Turning to reforms, the paper uses the heuristic of regulatory space to describe the range of actual and potential regulators with the capacity to set standard, monitor compliance and discipline violators in the realm of research. Three essential conceptual changes are set out to frame the technical regulatory reform discussion: facing up to the built-in limitations of the IRB as an oversight body; narrowing the range of risks the system is tasked to control; and disentangling the conflicting regulatory logics of behavioral standard-setting and virtue promotion. It concludes with a roster of possible changes that would make the IRB a more responsive regulator, enroll a wider range of actors in the promotion of ethical virtue, focus resources on more serious risks, and address the structural causes of researcher misconduct.

Keywords: censorship, ethics, responsive regulation, institutional review board