Guidance on Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements, 44311 [2020-15808]

Download as PDF Federal Register / Vol. 85, No. 141 / Wednesday, July 22, 2020 / Notices Sherrette A. Funn, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. 2020–15786 Filed 7–21–20; 8:45 am] BILLING CODE 4150–49–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Guidance on Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements 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 AGENCY: 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-andpolicy/guidance/, 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 The guidance document announced in this notice finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on July 25, 2018 (83 FR 35278).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 jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:11 Jul 21, 2020 Jkt 250001 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 ohrp@hhs.gov 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 Irene.Stith-Coleman@hhs.gov. 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-andpolicy/guidance/. PO 00000 Frm 00044 Fmt 4703 Sfmt 9990 44311 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Initial Review Group Biobehavioral and Behavioral Sciences Subcommittee. Date: October 23, 2020. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: NIH/NICHD, 6710B Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Clayton W. Mash, Ph.D., Scientific Review Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH 6710B, Rockledge Drive, Rm. 2131A, Bethesda, MD 20892, (301) 496–6866, mashc@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: July 16, 2020. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–15783 Filed 7–21–20; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\22JYN1.SGM 22JYN1

Agencies

[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

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

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/, 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/.

    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
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