[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 34949-34950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14287]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Draft Guidance on Considerations in Transferring a Previously-
Approved Research Project to a New IRB or Research Institution

AGENCY: Department of Health and Human Services (HHS), Office of the 
Secretary, Office of the Assistant Secretary for Health, Office for 
Human Research Protections.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Office for Human Research Protections (OHRP), Office of 
the Assistant Secretary for Health, is announcing the availability of a 
draft guidance document entitled ``Draft Guidance on Considerations in 
Transferring a Previously-Approved Research Project to a New IRB or 
Research Institution,'' and is seeking comment on the draft guidance. 
The draft guidance document, when finalized, would provide OHRP's first 
formal guidance on this topic. The draft document, which is available 
on the OHRP Web site at http://www.hhs.gov/ohrp/newsroom/rfc/index.html, is intended primarily for institutional review boards 
(IRB), institutions, and investigators that are responsible for the 
review, conduct, or oversight of human subjects research conducted or 
supported by HHS. OHRP will consider comments received before issuing 
the final guidance document.

DATES: Submit written comments by August 13, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance on Considerations in 
Transferring a Previously-Approved Research Project to a New IRB or 
Research Institution'' to the Division of Policy and Assurances, Office 
for Human Research Protections, 1101 Wootton Parkway, Suite 200,

[[Page 34950]]

Rockville, MD 20852. Send one self-addressed adhesive label to assist 
that office in processing your request, or fax your request to 301-402-
2071. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance document.
    You may submit comments identified by docket ID number HHS-OS-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 page, click 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., Office for Human Research 
Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

Comments received, including any personal information, will be posted 
without change to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Ph.D., Office for 
Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, 
MD 20852, 240-453-6900; email [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

A. Overview

    OHRP, Office of the Assistant Secretary for Health, is announcing 
the availability of a draft guidance document entitled ``Draft Guidance 
on 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 provide OHRP's first formal guidance on this topic. 
The draft document is intended primarily for IRBs, institutions, and 
investigators that may be responsible for the review, conduct, or 
oversight of human subjects research conducted or supported by HHS.
    The guidance document would apply to non-exempt 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 
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 (FDA) have been actively working 
to harmonize the agencies' regulatory requirements and guidance for 
human subjects research.
    FDA has simultaneously published in this same issue of the Federal 
Register a draft guidance document entitled ``Guidance for IRBs, 
Clinical Investigators, and Sponsors, Considerations When Transferring 
Clinical Investigation Oversight to Another IRB'' that is similar to 
OHRP's draft document.
    FDA and OHRP recognize that the two documents may appear somewhat 
different as there are minor variations in formatting and some 
necessary variations due to differences in the regulated entities under 
FDA's and OHRP's jurisdiction. The agencies wish to stress, however, 
that our intent was to provide harmonized guidance to IRBs, sponsors, 
institutions, investigators, and other entities involved in the study 
oversight transfer process. FDA and OHRP will continue to work closely 
in the development of final guidance and appreciate comments from 
interested parties.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document on OHRP's Web site at http://www.hhs.gov/ohrp/newsroom/rfc/index.html or on the Federal eRulemaking Portal at http://www.regulations.gov/.

    Dated: June 7, 2012.
Ivor Pritchard,
Senior Advisor to the Director, Office for Human Research Protections.
[FR Doc. 2012-14287 Filed 6-11-12; 8:45 am]
BILLING CODE 4150-36-P