[Federal Register Volume 87, Number 126 (Friday, July 1, 2022)]
[Notices]
[Page 39534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14123]



[[Page 39534]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Use of a Single Institutional Review Board for Cooperative 
Research Draft Guidance

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of the Assistant Secretary for Health.

ACTION: Notice.

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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draft guidance document entitled, ``Use of a Single Institutional 
Review Board for Cooperative Research Draft.''

DATES: Submit written comments by August 30, 2022.

ADDRESSES: Submit written requests for a single copy of the draft 
guidance document entitled ``Use of a Single Institutional Review Board 
for Cooperative Research Draft Guidance,'' to the Division of Policy 
and Assurances, Office for Human Research Protections, 1101 Wootton 
Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed 
adhesive label to assist that office in processing your request, or fax 
your request to 240-453-8420. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the draft guidance documents.
    You may submit comments identified by docket ID number HHS-OASH-
2022-0011 (Use of a Single Institutional Review Board for Cooperative 
Research Draft Guidance), by one of the following methods:
    [ssquf] Federal eRulemaking Portal: http://www.regulations.gov. 
Enter the docket ID number and click on ``Search.'' On the next page, 
click the ``Comment Now'' action and follow the instructions.
    [ssquf] Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Natalie Klein, 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: Natalie Klein, Ph.D., Office for Human 
Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, 
Maryland 20852; telephone: 240-453-8141; fax: 240-453-6909; email 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    OHRP is announcing the availability of a draft guidance document 
for public comment titled ``Use of a Single Institutional Review Board 
for Cooperative Research.'' The document is intended primarily for 
institutions, institutional review boards (IRBs), investigators, 
institutional officials, and other human research protection staff.
    The draft guidance document applies to activities that are 
conducted or supported by HHS. It is intended primarily to help 
entities implement the requirement for use of a single IRB for 
cooperative research (subpart A of 45 CFR part 46.114). In particular, 
the draft guidance addresses the following topics:
    (1) What is cooperative research?
    (2) When must an institution rely on a single IRB for approval of 
cooperative research?
    (3) Who decides which IRB will be the IRB of record for the 
purposes of regulatory compliance?
    (4) Can an institution that is not required to comply with 45 CFR 
46.114(b)(1) for a particular study still choose to rely on a single 
IRB for review of cooperative research?
    (5) Can an institution involved in cooperative research choose to 
conduct its own IRB review of the research even though review is 
required by a single IRB that is located elsewhere?
    (6) Are there documentation requirements for use of a single IRB in 
cooperative research?
    (7) What are some of the operational capacities an IRB should have 
in order to serve as a single IRB?
    (8) What are the responsibilities of the reviewing IRB with respect 
to information pertaining to sensitivity to community attitudes and the 
local context for proposed research?
    (9) What are the responsibilities of the reviewing IRB pertaining 
to applicable State and local laws?

II. Electronic Access

    Persons with access may obtain the draft guidance documents on 
OHRP's website at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html.

Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. 2022-14123 Filed 6-30-22; 8:45 am]
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