CONSORTIUM OF
INDEPENDENT REVIEW BOARDS

S

 

et forth below are materials regarding independent review boards, the role of central institutional review boards and centralized IRB review.

CIRB members have spoken at industry meetings and are available for speaking engagements on a variety of issues related to IRBs and human subject protection. For more information, please contact us at info@consortiumofirb.org.

 


January 2013 – Use of Central IRBs for Multicenter Clinical Trials, Final Report, Clinical Trials Transformation Initiative: This CTTI project identified specific steps likely to facilitate adoption of central IRB review for multicenter clinical trials.


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


March 2009 – CIRB Press Release regarding Congressional Hearing on IRBs: Statement of CIRB in Connection with Congressional Hearing on Independent IRBs


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


November 2005 – The DHHS Office of Human Research Protection published a paper summarizing a variety of models for IRB review discussed at a workshop: 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 and 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 and 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:

~ January 2016 – Comments on the Common Rule NPRM: CIRB supports single IRB review for collaborative research

~ January 2015 – Comments on NIH Policy on use of Single IRB for Multi-Site Research: CIRB applauds NIH’s Draft Policy to require the use of a single IRB for NIH conducted or supported multi-site studies

~ January 2013 – Comments on FDA Draft Guidance for IRBs, Clinical Investigators and Sponsors – IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Statement of CIRB comment on FDA Draft Guidance for IRBs, Clinical Investigators and Sponsors

~ 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

~ April 2010 – Comments on FDA Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval

~ January 2010 – Comments on OHRP Draft Guidance Documents on IRB Continuing Review of Research and IRB Approval of Research with Conditions

~ June 2009 – Comments on ANPRM to Enable OHRP to Hold IRBs Directly Accountable for Certain HHS Regulatory Requirements

~ January 2008 – Comments on OHRP Request for Information on Research Involving Adults with Impaired Decision-Making Capacity

~ December 2007 – Comments on OHRP Proposed Amendments to the Categories of Research that may be Reviewed by an IRB Through Expedited Review

~ September 2006 – Competing Interests – Submission to PLoS Medicine

~ January 2006 – Comments on OHRP Draft Guidance on Reporting and Reviewing Adverse Events

~ May 2005 – Comments on FDA’s Draft Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials

~ April 2005 – Comments on FDA’s Request for General Information: Reporting of Adverse Events to IRBs

~ March 2005 – CIRB Statement at FDA Public Hearing on Reporting of Adverse Events to IRBs

~ October 2004 – Comments on FDA Proposed Rule: IRB Registration Requirements