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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 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~ January 2013 – Comments on FDA Draft Guidance for IRBs, Clinical Investigators and Sponsors – IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Statement of CIRB comment on FDA Draft Guidance for IRBs, Clinical Investigators and Sponsors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~ April 2010 – Comments on FDA Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval
~ January 2010 – Comments on OHRP Draft Guidance Documents on IRB Continuing Review of Research and IRB Approval of Research with Conditions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~ January 2006 – Comments on OHRP Draft Guidance on Reporting and Reviewing Adverse Events
~ May 2005 – Comments on FDA’s Draft Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trials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