Document Detail


Variation in institutional review board responses to a standard protocol for a multicenter randomized, controlled surgical trial.
MedLine Citation:
PMID:  19375101     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: The primary responsibility of institutional review boards is to protect human research subjects and, therefore, ensure that studies are performed in accordance with a standard set of ethical principles. A number of groups have compared the responses of institutional review boards in multicenter clinical trials involving medical therapies. To our knowledge no such studies have been performed to date of trials investigating surgical intervention. We investigated the consistency of the recommendations issued by various institutional review boards in the Minimally Invasive Surgical Therapies study for benign prostatic hyperplasia, a multicenter trial with a uniform consent and study protocol. MATERIALS AND METHODS: We obtained the institutional review board response from 6 of the 7 participating institutions after initial submission of the Minimally Invasive Surgical Therapies study protocol and classified the responses. We then redistributed the approved protocols to an institutional review board at another participating institution and analyzed that review of these protocols. RESULTS: We found that the number and type of responses required for institutional review board approval of an identical study protocol varied significantly among participating institutions. We also found that institutional review board responses were inconsistent in the second review, although all protocols were ultimately approved. CONCLUSIONS: The current system of local institutional review board review in the context of a multicenter surgical trial is inefficient in the review process and may not provide expertise for overseeing surgical trials. Based on these results a central surgical institutional review board may be needed to improve the ethical review process in multicenter trials.
Authors:
Brian T Helfand; Anne K Mongiu; Claus G Roehrborn; Robert F Donnell; Reginald Bruskewitz; Steven A Kaplan; John W Kusek; Laura Coombs; Kevin T McVary;
Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2009-04-16
Journal Detail:
Title:  The Journal of urology     Volume:  181     ISSN:  1527-3792     ISO Abbreviation:  J. Urol.     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-05-11     Completed Date:  2009-06-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0376374     Medline TA:  J Urol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2674-9     Citation Subset:  AIM; IM    
Affiliation:
Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois 60611, USA.
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MeSH Terms
Descriptor/Qualifier:
Clinical Protocols / standards*
Ethics Committees, Research / standards*
Humans
Male
Multicenter Studies as Topic / standards*
Prostatic Hyperplasia / surgery*
Randomized Controlled Trials as Topic / standards*
Surgical Procedures, Minimally Invasive / standards*
Investigator
Investigator/Affiliation:
R Bruskewitz / ; K Slawin / ; S V Pavlik / ; S Kaplan / ; R Valenzuela / ; M Lieber / ; C Van Oort / ; R Donnell / ; M Pigsley / ; K McVary / ; M Velez / ; D Crawford / ; A DeVore / ; C Roehrborn / ; A Beaver / ; K Hirst / ; L Coombs / ; L Meyer / ; J Kusek / ; L Nyberg /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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