Request for Information and Comments on IRB Accountability.

March 5, 2009

Background:

The Office for Human Research Protections (OHRP), has issued a Federal Register notice requesting information and comments from the public about whether the office should pursue a notice of proposed rulemaking to enable OHRP to hold IRBs and the institutions or organizations operating the IRBs directly accountable for meeting certain regulatory requirements of 45 CFR part 46. OHRP is contemplating this regulatory change to encourage institutions to rely on IRBs that are operated by another institution or organization, when appropriate. OHRP believes that such a regulatory change in its enforcement authority may address one of the main disincentives institutions have cited as inhibiting them from exercising the regulatory flexibility that currently permits institutions to implement a variety of cooperative review arrangements and to rely on the review of an IRB operated by another institution or organization. If institutions become more willing to rely on cooperative review arrangements and on review of IRBs operated by other institutions or organizations, OHRP believes that this will reduce administrative burdens associated with implementing 45 CFR part 46 without diminishing human subject protections.

This request for information and comments stems from interest in this issue from the Secretary's Advisory Committee on Human Research Protections and others, as well as two meetings on alternative IRB models that OHRP co-sponsored in November 2005 and November 2006 along with the National Institutes of Health, the Association of American Medical Colleges, and the American Society of Clinical Oncology.

Submit written or electronic information and comments by June 3, 2009. Written comments may be sent to IRB ACCOUNTABILITY, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to IRBaccountability@hhs.gov", or via facsimile at 301-402-2071.

Comments received within the comment period, including any personal information provided, will be made available to the public upon request. The notice can be accessed at: http://edocket.access.gpo.gov/2009/E9-4628.htm or http://edocket.access.gpo.gov/2009/pdf/E9-4628.pdf.

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