A Survey of IRB Process in 68 U.S. Hospitals

• Published in: Journal of nursing scholarship Vol. 36; no. 3; pp. 260 - 264
• Main Authors: Larson, Elaine, Bratts, Tiffany, Zwanziger, Jack, Stone, Patricia
• Format: Journal Article
• Language: English
• Published: 350 Main Street , Malden , MA 02148 , USA , and 9600 Garsington Road , Oxford OX4 2DQ , UK Blackwell Science Inc 01.01.2004; Blackwell Publishing Ltd
• Subjects: Analysis of Variance; clinical research; Conflict of Interest; Documentation - methods; Documentation - standards; Ethics Committees, Research - organization & administration; Guideline Adherence - standards; Guidelines as Topic; Hospital Bed Capacity - statistics & numerical data; Human Experimentation; human subjects; Humans; Organizational Affiliation; Outcome and Process Assessment (Health Care) - organization & administration; Patient Advocacy; Professional Competence - standards; research ethics; Surveys and Questionnaires; Time Factors; United States; United States; United States > US; Empirical Approach; Biomedical and Behavioral Research
• ISSN: 1527-6546; 1547-5069
• DOI: 10.1111/j.1547-5069.2004.04047.x

Purpose : To compare IRB processes in 68 U.S. hospitals for the same multicenter study. Design : Survey of IRB processes in 68 U.S. hospitals during 2001‐2002. Methods : Requirements of IRB submission including type and duration of review and qualifications of principal investigator were compared by hospital bed size, region, and academic affiliation. Findings : The majority of hospitals (63.2%) were on the East coast, and mean bed size was 465 (range: 77‐2,112). About one‐third (33.8%) required that the principal investigator listed on the application be from within the institution, 26.5% required evidence of human subjects research training, 10.3% required a conflict of interest statement. Mean number of pages for the application was 5.24 (1‐31) and up to eight copies were requested. Time from submission of the IRB application to approval averaged 45.4 days (range, 1‐303 days), and the majority of reviews were “expedited” (61.8%). Expedited reviews required more time (mean, 54.8 days) than did either exempt (mean, 10.8 days) or full (mean, 47.1 days) reviews. Conclusions : Current IRB review processes are cumbersome and nonstandardized, and review time varies widely. The absence of efficient and streamlined review might unnecessarily impede national clinical research projects without improving participant safety.