Protecting Research Participants While Reducing Regulatory Burdens

Abstract

THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) has proposed sweeping revisions to the federal regulations for the protection of human research participants. The goal is to “enhance protection while simultaneously eliminating unreasonable burdens.” Although the goal is admirable, some changes intended to remove unnecessary regulatory burdens may allow serious risks (ie, the probability of harm is significant, not merely possible or conceivable), particularly to highly vulnerable participants (ie, participants’ ability to give free and informed consent is seriously compromised). In this Commentary, 3 major issues in the Advance Notice of Proposed Rule-Making (ANPRM)—ensuring riskbased protections, institutional review board (IRB) reviews of multisite studies, and informed consent—are discussed. New policies to reduce regulatory burdens should be coupled with procedures to protect participants if research poses serious risks, involve highly stigmatizing conditions, or include significantly vulnerable participants.