Central Institutional Review Board–Facilitated Review Metrics Omit Critical Components

2010 ◽  
Vol 28 (6) ◽  
pp. e105-e105 ◽  
Author(s):  
Michael S. Katz ◽  
Mary L. Smith
Keyword(s):  
Institutional Review Board ◽  
Institutional Review ◽  
Critical Components ◽  
Central Institutional Review Board

scholarly journals Costs and Benefits of the National Cancer Institute Central Institutional Review Board

2010 ◽  
Vol 28 (4) ◽  
pp. 662-666 ◽  
Author(s):  
Todd H. Wagner ◽  
Christine Murray ◽  
Jacquelyn Goldberg ◽  
Jeanne M. Adler ◽  
Jeffrey Abrams
Keyword(s):  
Societal Perspective ◽  
National Cancer Institute ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Phase Iii ◽  
Research Staff ◽  
Oncology Research ◽  
Institutional Review ◽  
Definition Of ◽  
Central Institutional Review Board

Purpose In 2001, the National Cancer Institute (NCI) formed the Central Institutional Review Board (CIRB) to conduct a single human subjects review for its multisite phase III oncology trials. The goal of this study was to assess whether NCI's CIRB was associated with lower effort, time, and cost in processing adult phase III oncology trials. Methods We conducted an observational study and compared sites affiliated with the NCI CIRB to unaffiliated sites that used their local IRB for review. Oncology research staff and IRB staff were surveyed to understand effort and timing. Response rates were 60% and 42%, respectively. Analysis of these survey data yielded information on effort, timing, and costs. We combined these data with CIRB operational data to determine the net savings of the CIRB using a societal perspective. Results CIRB affiliation was associated with faster reviews (33.9 calendar days faster on average), and 6.1 fewer hours of research staff effort. CIRB affiliation was associated with a savings of $717 per initial review. The estimated cost of running the CIRB was $161,000 per month. The CIRB yielded a net cost of approximately $55,000 per month from a societal perspective. Whether the CIRB results in higher or lower quality reviews was not assessed because there is no standard definition of review quality. Conclusion The CIRB was associated with decreases in investigator and IRB staff effort and faster protocol reviews, although savings would be higher if institutions used the CIRB as intended.

scholarly journals Meeting the Challenge: The National Cancer Institute’s Central Institutional Review Board for Multi-Site Research

2018 ◽  
Vol 36 (8) ◽  
pp. 819-824 ◽  
Author(s):  
Holly A. Massett ◽  
Sharon L. Hampp ◽  
Jacquelyn L. Goldberg ◽  
Margaret Mooney ◽  
Linda K. Parreco ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
The United States ◽  
National Institutes Of Health ◽  
Institutional Review Board ◽  
Cancer Clinical Trials ◽  
Limited Data ◽  
Human Patient ◽  
Institutional Review ◽  
Central Institutional Review Board

The National Institutes of Health (NIH) issued a new policy that requires a single institutional review board (IRB) of record be used for all protocols funded by the NIH that are carried out at more than one site in the United States, effective January 2018. This policy affects several hundred clinical trials opened annually across the NIH. Limited data exist to compare the use of a single IRB to that of multiple local IRBs, so some institutions are resistant to or distrustful of single IRBs. Since 2001, the National Cancer Institute (NCI) has funded a central IRB (CIRB) that provides human patient reviews for its extensive national cancer clinical trials program. This paper presents data to show the adoption, efficiencies gained, and satisfaction of the CIRB among NCI trial networks and reviews key lessons gleaned from 16 years of experience that may be informative for others charged with implementation of the new NIH single-IRB policy.

Central IRB Review Is an Essential Requirement for Cancer Clinical Trials

2017 ◽  
Vol 45 (3) ◽  
pp. 341-347 ◽  
Author(s):  
Lowell E. Schnipper
Keyword(s):  
Clinical Trials ◽  
Institutional Review Board ◽  
Cancer Clinical Trials ◽  
Essential Requirement ◽  
Institutional Review ◽  
Legal Arguments ◽  
Central Institutional Review Board

There are compelling medical, ethical, and legal arguments that support mandating use of a central institutional review board (CIRB) for the review of clinical trials performed at multiple institutional sites. Progress against serious diseases depends on this.

A Central Institutional Review Board for Multi-Institutional Trials

2002 ◽  
Vol 346 (18) ◽  
pp. 1405-1408 ◽  
Author(s):  
Michaele C. Christian ◽  
Jacquelyn L. Goldberg ◽  
Jack Killen ◽  
Jeffrey S. Abrams ◽  
Mary S. McCabe ◽  
...  
Keyword(s):  
Institutional Review Board ◽  
Institutional Review ◽  
Central Institutional Review Board
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