[Federal Register Volume 85, Number 141 (Wednesday, July 22, 2020)]
[Notices]
[Page 44311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Guidance on Elimination of Institutional Review Board (IRB) 
Review of Research Applications and Proposals: 2018 Requirements

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

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 
guidance document titled, ``Guidance on Elimination of Institutional 
Review Board (IRB) Review of Research Applications and Proposals: 2018 
Requirements.'' The guidance document provides OHRP's first formal 
guidance on this topic. The document, which is available on OHRP's 
website at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/index.html, is intended primarily for institutions, IRBs, 
investigators, HHS funding agencies, and others that may be responsible 
for the review, conduct, or oversight of nonexempt research involving 
human subjects conducted or supported by HHS. The guidance document 
announced in this notice finalizes the draft guidance that was made 
available for public comment through a notice in the Federal Register 
on July 25, 2018 (83 FR 35278). OHRP received 2 comments from 
individuals or organizations on the draft document and those comments 
were considered as the guidance was finalized.

DATES: Comments on OHRP guidance documents are welcome at any time.

ADDRESSES: Submit written requests for a single copy of the guidance 
document titled ``Guidance on Elimination of Institutional Review Board 
(IRB) Review of Research Applications and Proposals: 2018 
Requirements'' 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 guidance document.
    Submit written comments to: Comments on Elimination of 
Institutional Review Board (IRB) Review of Research Applications and 
Proposals: 2018 Requirements Guidance, Office for Human Research 
Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. 
Comments also may be sent via email to [email protected] or via facsimile at 
240-453-8420.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Ph.D., Office for 
Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, 
MD 20852, 240-453-6700; email [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    OHRP is announcing the availability of a guidance document titled 
``Guidance on Elimination of Institutional Review Board (IRB) Review of 
Research Applications and Proposals: 2018 Requirements.'' The guidance 
document provides OHRP's first formal guidance on this topic. The 
document is intended primarily for institutions, IRBs, investigators, 
HHS funding agencies, and others that may be responsible for the 
review, conduct, or oversight of nonexempt research involving human 
subjects conducted or supported by HHS.
    The guidance document applies to nonexempt research involving human 
subjects that is conducted or supported by HHS. It provides guidance on 
the elimination of the requirement in section 45 CFR 46.103(f) of the 
pre-2018 Requirements that each application or proposal for research 
undergo IRB review and approval as part of the certification process. 
This guidance also addresses the requirement in the 2018 Requirements 
for certification of each proposed research study prior to initiation. 
In particular, the guidance addresses the following two topics: (1) 
Pre-2018 Requirements; and, (2) 2018 Requirements.
    The guidance document announced in this notice finalizes the draft 
guidance that was made available for public comment through a notice in 
the Federal Register on July 25, 2018 (83 FR 35278).

II. Electronic Access

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

    Dated: July 16, 2020.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. 2020-15808 Filed 7-21-20; 8:45 am]
BILLING CODE 4150-36-P