[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29781-29782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11923]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0835]


Guidance for Institutional Review Boards, Clinical Investigators, 
and Sponsors: Considerations When Transferring Clinical Investigation 
Oversight to Another Institutional Review Board; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Guidance for IRBs, Clinical 
Investigators, and Sponsors: Considerations When Transferring Clinical 
Investigation Oversight to Another IRB.'' The guidance announced in 
this document discusses regulatory responsibilities of institutional 
review boards (IRBs), clinical investigators, and sponsors when 
oversight of a previously approved clinical investigation under FDA's 
jurisdiction is transferred from one IRB to another IRB. The guidance 
also addresses questions that have been previously raised concerning 
procedures and processes that are required and/or recommended by FDA 
when such oversight is transferred.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 2201, Silver Spring, MD 20993-0002 (1-888-463-6332 or 301-796-
3400); or the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448 (1-800-835-4709 or 301-827-1800); or the Division of Small 
Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4622, Silver Spring, MD 20993 (1-800-
638-2041 or 301-796-7100). Send one self-addressed adhesive label to 
assist the office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Managements (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Bridget Foltz, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 5174, Silver Spring, MD 20993, 301-796-8340.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled, 
``Guidance for IRBs, Clinical Investigators, and Sponsors: 
Considerations When Transferring Clinical Investigation Oversight to 
Another IRB.'' The guidance discusses the regulatory responsibilities 
of IRBs, clinical investigators, and sponsors when oversight of a 
previously approved clinical investigation under FDA's jurisdiction is 
transferred from one IRB to another IRB. In particular, the guidance 
discusses eight steps to be considered when transferring oversight of a 
previously approved clinical investigation from one IRB to another IRB. 
These include identifying those studies for which IRB oversight is 
being transferred; ensuring availability and retention of pertinent 
records; establishing an effective date for the transfer of oversight; 
conducting a review of the study(ies) by the receiving IRB, where 
appropriate; confirming or establishing the date for the next 
continuing review; determining whether the consent form needs to be 
revised; notifying the key parties; and updating IRB registration 
information. The IRB transfer process is expected to vary depending on 
the reasons for the transfer, the parties involved, and the number and 
risk of the studies being transferred.
    To enhance human subject protections and reduce regulatory burden, 
FDA and the Office for Human Research Protections (OHRP) have been 
actively working to harmonize the agencies' regulatory requirements and 
guidance for human subjects research. This guidance document was 
developed as a part of these efforts and in consultation with OHRP.
    In the Federal Register of June 12, 2012 (77 FR 34958), FDA 
announced the availability of the draft guidance of the same title. FDA 
received several comments on the draft guidance and considered them in 
preparing the final guidance. In response to the comments, FDA added a 
recommendation that the receiving IRB notify the sponsor if it decides 
to suspend or terminate study

[[Page 29782]]

approval. FDA also clarified both drug and device sponsor's reporting 
requirements related to such suspensions and terminations. Section 
III(6) was modified to recommend the use of a letter to provide 
currently enrolled subjects with any changes in contact information 
regarding subject rights or research-related injuries from a resulting 
IRB transfer. In addition, numerous editorial changes were made to 
improve clarity. The guidance announced in this notice finalizes the 
draft guidance dated June 2012.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on this topic. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 312 have been approved under 
OMB control number 0910-0014; the collections of information in 21 CFR 
part 812 have been approved under OMB control number 0910-0078; and the 
collections of information in 21 CFR part 56 have been approved under 
OMB control number 0910-0130.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm.

    Dated: May 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11923 Filed 5-22-14; 8:45 am]
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