Fda Perspective on Irbs and Overview of Fda Inspection of Irbs

Abstract

Clinical studies of investigational drugs must comply with the Food and Drug Administration (FDA) requirements for patient consent and Institutional Review Board (IRB) review. Foreign clinical research, not done under an investigational new drug application (IND), may be accepted by the FDA if conducted in accordance with the Declaration of Helsinki or the standards of the country in which the research was conducted, whichever offers greater protection to the study subjects.

Under FDA's Bioresearch Monitoring Program, the Institutional Review Branch of the Division of Scientific Investigations conducts inspections of approximately 250 IRBs annually. Inspectional findings are summarized and the impact of the program on the development of and adherence to measures designed to provide protection to human subjects of research is described and discussed.