STRUCTURE AND PRACTICE OF INSTITUTIONAL REVIEW BOARDS IN THE UNITED-STATES

Objective: The institutional review board (IRE) is a critical element in the protection of patients' and subjects' rights with regard to the ir participation in research protocols. The purpose of this study was to describe the structure and current practices of IRBs in the United States. Methods: A self-administered questionnaire was mailed to the I RB chair of each U.S. hospital with a capacity of at least 400 beds (n = 907). The survey contained 21 questions outlining committee size an d structure, review of research proposals, and policies concerning sci entific misconduct. Chairs also were asked what advice they would offe r a young investigator preparing a proposal for submission. Results: A total of 488 surveys (54%) were returned; 447 of the responding insti tutions had an IRE committee. Committees had an average of 14 members, representing 27 medical specialties. Orthopedics had the least IRE re presentation (10% of committees), followed by emergency medicine (12%) and ophthalmology (15%). The majority of research proposals go throug h 5 specific steps once submitted for review. Common reasons for propo sal rejection were improperly designed consent form (54%), poor study design (44%), unacceptable risk to subjects (34%), ethical or legal re asons (24%), and scientific merit (14%). When a research proposal is r ejected, 86% of the responding IRBs assist the investigator in making appropriate revisions. Although a number of IRBs (17%) have dealt with scientific misconduct allegations, only 58% have a written policy reg arding research integrity. Conclusion: Despite variations in committee structure and representation, IRBs have similar procedures for govern ing research. Investigators should be familiar with these procedures a nd are encouraged to discuss their proposal with an IRE representative prior to formal review.