A survey of IRB process in 68 U.S. hospitals

A survey of IRB process in 68 U.S. hospitals

Larson E; Bratts T; Zwanziger J; Stone P

Journal Of Nursing Scholarship

2004

Humans; United States; Questionnaires; Guidelines as Topic; Time Factors; Patient Advocacy; Analysis of Variance; Empirical Approach; Ethics Committees; Biomedical and Behavioral Research; Multi-site Ethics; Guideline Adherence/standards; Professional Competence/standards; Research/organization & administration; Human Experimentation; Conflict of Interest; Documentation/methods/standards; Hospital Bed Capacity/statistics & numerical data; Organizational Affiliation; Outcome and Process Assessment (Health Care)/organization & administration

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.

2004

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