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Welcome to the Resources Page of the CIRB website.
Set forth below are materials regarding independent review boards, the role of central institutional review boards and centralized IRB review.
In 1998, the Office of the Inspector General of the Department of Health and Human Services published a series of reports regarding institutional review boards, including independent review boards. Two reports from the series are set forth below:
IRBs - A Time For Reform 
The Emergence of Independent Boards
In 2000, OIG issued two reports regarding the recruitment of research participants.
Recruiting Human Subjects - Pressures in Industry-Sponsored Clinical Research
Recruiting Human Subjects - Sample Guidelines for Practices
In 2000, the following white paper on "The History, Function, and Future of Independent Institutional Review Boards" was submitted to the National Bioethics Advisory Committee.
History - Independent IRBs
The DHHS Office of Human Research Protection published a paper summarizing a variety of models for IRB review discussed at a November 2005 workshop. The report is set forth below:
Alt Models of IRB Review
In March 2006, the Food and Drug Administration published guidance describing the parameters for appropriate use of centralized IRB review.
Centralized IRB Review Process in Multicenter Clinical Trials
CIRB has submitted public comments on a variety of proposed regulatory measures, including adverse event reporting and the use of a centralized IRB process. These comments are posted below:
Competing Interests - Submission to PLoS Medicine (Sept. 2006)
Comments on OHRP Draft Guidance on Reporting and Reviewing Adverse Events (January 2006)
Comments on FDA's Draft Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials (May 2005)
Comments on FDA's Request for General Information: Reporting of Adverse Events to IRBs (April 2005)
CIRB Statement at FDA Public Hearing on Reporting of Adverse Events to IRBs (March 2005)
Comments on FDA Proposed Rule: IRB Registration Requirements (October 2004)
Comments on OHRP Proposed Amendments to the Categories of Research that may be Reviewed by an IRB Through Expedited Review (Dec. 2007)
Comments on OHRP Request for Information on Research Involving Adults with Impaired Decision-Making Capacity (Jan. 2008)
(Please Note: The freely available Adobe Acrobat Reader is required to view & print PDF files.)
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