Protecting research participants while reducing regulatory burdens.

摘要

In this Commentary, 3 major issues in the Advance Notice of Proposed Rule-Making (ANPRM)ensuring risk-based protections, institutional review board (IRB) reviews of multisite studies, and informed consentare 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.