Draft Guidance on IRB Approval of Research with Conditions

November 6, 2009 Note: Final guidance on this topic was issued November 10, 2010

Links to the Draft Guidance and Federal Register Notice of Availability:

The draft guidance can be accessed at:
http://www.hhs.gov/ohrp/sites/default/files/ohrp/documents/200911guidance_appr.pdf

A copy of the Federal Register notice announcing the availability of the draft guidance for comment can be accessed at:
http://edocket.access.gpo.gov/2009/E9-26830.htm or http://edocket.access.gpo.gov/2009/pdf/E9-26830.pdf

Background:

OHRP is seeking comment on a draft guidance document entitled “Guidance on IRB Approval of Research with Conditions.” The draft guidance document, when finalized, would provide OHRP’s first formal guidance on this topic. The draft document is intended primarily for institutional review boards (IRBs), investigators, Department of Health and Human Services (HHS) funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. The guidance document would apply to non-exempt human subjects research conducted or supported by HHS. It provides guidance on the authority of IRBs to approve research with conditions. OHRP will consider comments received before issuing the final guidance document.

In a March 14, 2007 letter, SACHRP transmitted to the Secretary of Health and Human Services recommendations regarding IRB continuing review and expedited review of research. Two of these recommendations are addressed by the draft guidance document. TheFederal RegisterNotice of Availability referenced above describes OHRP’s response to these SACHRP recommendations and identifies the section(s) of the draft guidance document that address each recommendation.

When and How to Submit Comments:

Submit comments by January 5, 2010.

You may submit comments, identified by docket ID number HHS-OPHS-2009-0017, by one of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov. Enter the above docket ID number in the “Enter Keyword or ID” field and click on “Search.” On the next web page, click on the “Submit a Comment” action and follow the instructions.

• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

OHRP strongly encourages commenters to submit comments via the Federal eRulmaking Portal. Comments received, including any personal information, will be posted without change to the docket at https://www.regulations.gov as they are submitted, usually within 1 week after submission. While the comment period remains open, individuals may also provide comments in response to already submitted comments that have been posted to the docket.

For Further Information Contact:

Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Michael.Carome@hhs.gov.