Draft Guidance on IRB Continuing Review of Research

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Links to the Draft Guidance and Federal Register Notice of Availability:

The draft guidance can be accessed at: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_rev.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A copy of the Federal Register notice announcing the availability of the draft guidance for comment can be accessed at: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/E9-26828.htm or http://edocket.access.gpo.gov/2009/pdf/E9-26828.pdf.

Background:

OHRP is seeking comment on a draft guidance document entitled, “Guidance on IRB Continuing Review of Research.” The draft guidance document, when finalized, will represent OHRP’s current thinking on this topic and will supersede OHRP’s January 15, 2007 guidance document entitled “Guidance on Continuing Review,” available at http://wayback.archive-it.org/org-745/20160209155616/http://archive.hhs.gov/ohrp/humansubjects/guidance/contrev0107.htm. 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.

To enhance human subject protections and reduce regulatory burden, OHRP and the Food and Drug Administration have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subjects research. The draft guidance document was developed as a part of these efforts.

The guidance document would apply to non-exempt human subjects research conducted or supported by HHS. It provides guidance on the HHS regulations for the protection of human research subjects at 45 CFR part 46 related to IRB continuing review of research. 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 14 recommendations regarding continuing review, 13 of which called for changes in OHRP’s current guidance on continuing review. These recommendations were the primary impetus for OHRP to draft an updated guidance document on IRB continuing review. The Federal Register Notice of Availability referenced above describes OHRP’s response to these SACHRP recommendations and identifies the section(s) of the draft guidance document that address specific recommendations. The notice also describes additional key changes and new content.

When and How to Submit Comments:

Submit comments by January 5, 2010.

You may submit comments, identified by docket ID number HHS-OPHS-2009-0016, 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.