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Welcome to the Library 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.
October 2011 - Comments on ANPRM "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay and Ambiguity for Investigators"
Statement of CIRB comment on how to modernize human subject protection regulations to make them more effective  .
August 2011 - Comments on Proposed Rule: HIPAA Privacy Rule Accounting and Disclosures under the Health Information Technology for Economic and Clinical Health Act
Statement of CIRB comment on significant modifications to the Privacy Rule and its application to research disclosures .
June 2010 - CIRB collaborated with the American Society of Clinical Oncology (ASCO) to develop the IRB section of ASCO's Expanded Access Educational Initiative.
(The educational modules are open to the public and require the user to register with ASCO to log in to the program.)
Press release announcing the launch of the educational initiative.
CIRB Press Release on March 26, 2009 Congressional Hearing on IRBs
Statement of CIRB in Connection with Congressional Hearing on Independent IRBs
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
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 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
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 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
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:
Comments on FDA Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval (April 2010)
Comments on OHRP Draft Guidance Documents on IRB Continuing Review of Research and IRB Approval of Research with Conditions (January 2010)
Comments on ANPRM to Enable OHRP to Hold IRBs Directly Accountable for Certain HHS Regulatory Requirements (June 2009)
Comments on OHRP Request for Information on Research Involving Adults with Impaired Decision-Making Capacity (Jan. 2008)
Comments on OHRP Proposed Amendments to the Categories of Research that may be Reviewed by an IRB Through Expedited Review (Dec. 2007)
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)
(Please Note: The freely available Adobe Acrobat Reader is required to view & print PDF files.)
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