IRB Procedures

Abstract

The steady evolution of federal regulations from the 1966 Surgeon General’s Requirement of Peer Review for Human Subjects Research to the National Research Act of 1974, which created the present day institutional review boards (IRBs), has led to regulations that now specify how the IRB is to function, how long records must be kept, what must appear in required minutes, what constitutes a quorum, which committee members make up a quorum, and what prospective subjects must be told about their participation in research. Regulations now also indicate when an IRB and/or the institution can be disqualified from conducting human subject research and when an institution can be disqualified from recovering federal funds for serious violations of the principles governing human research. All this has led to some disquiet on the part of those involved with IRBs while the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have made it clear that their program of reviewing IRBs for compliance with regulations is neither directed to assessing the quality of IRB review, nor to “second-guess” difficult IRB decisions, but rather to review the procedural aspects of the review process.