Health Policy and Systems A Survey of IRB Process in 68 U.S. Hospitals Elaine Larson, Tiffany Bratts, Jack Zwanziger, Patricia Stone 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 qualifi- cations 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. JOURNAL OF NURSING SCHOLARSHIP , 2004; 36:3, 260-264. C 2004 SIGMA THETA TAU INTERNATIONAL. [Key words: human subjects, clinical research, research ethics] * * * I nstitutional review boards (IRBs) exist to protect the welfare and safety of research participants and to evaluate the balance of risks and benefits of a study within the context of a protocol while retaining the scien- tific rigor and feasibility of the study. Achieving a balance between protection of research participants and maximum efficiency poses challenges to researchers. If IRBs are not functioning efficiently they slow the research process and waste resources. We describe our experiences in conducting a multicen- ter study of the relationship between working conditions in hospital intensive care units (ICUs) and patient and nurse health outcomes. The purpose of this paper is to compare IRB processes across U.S. institutions and to consider the public policy issues indicated in our experience. The ques- tion addressed was: “How does the IRB process vary across U.S. hospitals?” Methods Sample and Setting This project was a secondary analysis of data obtained as part of a multicenter study funded by the Agency for Healthcare Research and Quality (“Outcomes of ICU Work- ing Conditions”) to investigate the effect of nurses’ working conditions in ICUs on patient and health care worker safety. The parent study included collection of three types of data: (a) prospective collection of survey data from ICU nursing staff, (b) retrospective data obtained from Centers for Medi- care and Medicaid Services (CMS) on patients discharged from the same ICU, and (c) routinely collected hospital ad- ministrative data such as nurse-patient staffing ratios. The main outcome of the parent study was health care- associated infections. Therefore, hospitals invited to par- ticipate had to have (a) infection control departments to collect infection surveillance data using criteria defined by Elaine Larson, RN, PhD, FAAN, CIC, Alpha Zeta, Associate Dean for Research and Professor of Therapeutic and Pharmaceutical Research, Columbia University School of Nursing, and Professor of Epidemiology, Mailman School of Public Health, New York, NY; Tiffany Bratts, MPH, Project Coordinator, Columbia University School of Nursing, New York, NY; Jack Zwanziger, PhD, Professor and Director, Health Policy and Adminis- tration, University of Illinois at Chicago, School of Public Health, Chicago, IL, Patricia Stone, RN, PhD, Alpha Zeta, Assistant Professor, Columbia University School of Nursing, New York, NY. The study was funded by a grant from the Agency for Healthcare Research and Quality, RO1 HS13114, P. Stone, principal investigator. Correspondence to Dr. Larson, Columbia University School of Nursing, Mailman School of Public Health, 630 W. 168th St., New York, NY 10032. E-mail: Ell23@columbia.edu Accepted for publication April 15, 2004. 260 Third Quarter 2004 Journal of Nursing Scholarship