[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4160-01-P