A survey of IRB process in 68 U.S. hospitals.
OBJECTIVE
To compare IRB processes in 68 U.S. hospitals for the same multicenter study.


METHODS
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.


RESULTS
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.
Larson
Elaine
E
Columbia University School of Nursing, Mailman School of Public Health, 630 W. 168th St., New York, NY 10032, USA. Ell23@columbia.edu
Bratts
Tiffany
T
Zwanziger
Jack
J
Stone
Patricia
P
D000704:Analysis of Variance; D016265:Conflict of Interest; D004282:Documentation / Q000379:methods / Q000592:standards*; D028744:Ethics Committees, Research / Q000458:organization & administration*; D019983:Guideline Adherence / Q000592:standards; D017408:Guidelines as Topic; D006742:Hospital Bed Capacity / Q000706:statistics & numerical data; D006805:Human Experimentation; D006801:Humans; D009935:Organizational Affiliation; D010043:Outcome and Process Assessment, Health Care / Q000458:organization & administration; D010344:Patient Advocacy; D011361:Professional Competence / Q000592:standards; D011795:Surveys and Questionnaires; D013997:Time Factors; D014481:United States