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Draft Guidance Document on Transferring a Previously-Approved Research Project

Links to the Draft Guidance and Federal Register Notice of Availability:

The draft guidance can be accessed at: http://www.hhs.gov/ohrp/newsroom/rfc/transferdraftdoc.html and in PDF format at http://www.hhs.gov/ohrp/newsroom/rfc/pdftransferdraftdoc.pdf


A copy of the Federal Register notice announcing the availability of the draft guidance for comment can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2012-06-12/html/2012-14287.htm or http://www.gpo.gov/fdsys/pkg/FR-2012-06-12/pdf/2012-14287.pdf.

 

 Background:

OHRP is seeking comment on a draft guidance document entitled, “Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution.”  The draft guidance document, when finalized, will represent OHRP’s current thinking on this topic and will represent OHRP’s first formal guidance on this topic and would apply to non-exempt human subjects research conducted or supported by HHS.  OHRP will consider comments received before issuing the final guidance document.

The draft document is intended primarily for institutional review boards (IRBs), institutions, and investigators that are responsible for the review, conduct, or oversight of human subjects research conducted or supported by HHS. It presents common scenarios for transfer of a previously-approved research project to another institutional review board (IRB) or to a new engaged research institution, and outlines the administrative actions to be considered by IRBs, engaged institution(s), and investigators.   In particular, the draft guidance addresses the following questions:

  1. What is the regulatory background for research project transfer?
  2. What actions may apply when the research project remains at the same institution, but responsibility for IRB review is transferred either from an internal to an external IRB, or from an external IRB to another external IRB ?
  3. What actions may apply when the research project remains at the same institution, but responsibility for IRB review is transferred from one internal to another internal IRB?
  4. What actions may apply when the research project is transferred to a new engaged institution?

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.

 FDA has simultaneously published in the same issue of the Federal Register notice of availability of a draft guidance document entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors, Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board” that is similar to OHRP’s draft document

When and How to Submit Comments:

Submit comments by August 13, 2012.

You may submit comments, identified by docket ID number HHS-OPHS-2012-0005, by one of the following methods:

  • Federal eRulemaking Portal: http://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]: Irene Stith-Coleman, Ph.D, 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 http://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:

Irene Stith-Coleman, Ph.D, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Irene.Stith-Coleman@hhs.gov.