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Text
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<a href="http://doi.org/10.1111/j.1547-5069.2004.04047.x" target="_blank" rel="noreferrer">http://doi.org/10.1111/j.1547-5069.2004.04047.x</a>
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Title
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A survey of IRB process in 68 U.S. hospitals
Publisher
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Journal Of Nursing Scholarship
Date
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2004
Subject
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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
Creator
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Larson E; Bratts T; Zwanziger J; Stone P
Description
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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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<a href="http://doi.org/10.1111/j.1547-5069.2004.04047.x" target="_blank" rel="noreferrer">10.1111/j.1547-5069.2004.04047.x</a>
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Article information provided for research and reference use only. PedPalASCNET does not hold any rights over the resource listed here. All rights are retained by the journal listed under publisher and/or the creator(s).
Type
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Journal Article
2004
Analysis of Variance
Backlog
Biomedical and Behavioral Research
Bratts T
Conflict of Interest
Documentation/methods/standards
Empirical Approach
Ethics Committees
Guideline Adherence/standards
Guidelines As Topic
Hospital Bed Capacity/statistics & numerical data
Human Experimentation
Humans
Journal Article
Journal Of Nursing Scholarship
Larson E
Multi-site Ethics
Organizational Affiliation
Outcome and Process Assessment (Health Care)/organization & administration
Patient Advocacy
Professional Competence/standards
Questionnaires
Research/organization & administration
Stone P
Time Factors
United States
Zwanziger J