[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)]
[Notices]
[Pages 35278-35279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15908]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Scholarly and Journalistic Activities Deemed Not To Be Research: 
2018 Requirements; Draft Guidance; When Continuing Review Is Not 
Required During the 6-Month Delay Period of July 19, 2018 Through 
January 20, 2019: 2018 Requirements; Draft Guidance Elimination of 
Institutional Review Board (IRB) Review of Research Applications and 
Proposals: 2018 Requirements; Draft Guidance

AGENCY: The Office for Human Research Protections, Office of the 
Assistant Secretary for Health, Office of the Secretary, HHS.

ACTION: Notice of availability.

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

[[Page 35279]]

SUMMARY: The Office for Human Research Protections (OHRP), Office of 
the Assistant Secretary for Health is announcing the availability of 
three draft guidance documents titled, ``Scholarly and Journalistic 
Activities Deemed Not to be Research: 2018 Requirements,'' ``When 
Continuing Review Is Not Required During the 6-Month Delay Period of 
July 19, 2018 through January 20, 2019: 2018 Requirements,'' and 
``Elimination of Institutional Review Board (IRB) Review of Research 
Applications and Proposals: 2018 Requirements,'' respectively.

DATES: Submit written comments by August 24, 2018.

ADDRESSES: Submit written requests for single copies of the draft 
guidance documents titled ``Scholarly and Journalistic Activities 
Deemed Not to be Research: 2018 Requirements,'' ``When Continuing 
Review Is Not Required During the 6-Month Delay Period of July 19, 2018 
through January 20, 2019: 2018 Requirements,'' and ``Elimination of 
Institutional Review Board (IRB) Review of Research Applications and 
Proposals: 2018 Requirements,'' respectively, 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 240-453-6909. 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for information on electronic access to the draft guidance documents.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-OS-OPHS-
2018-0012 (Scholarly and Journalistic Activities Deemed Not to be 
Research: 2018 Requirements), docket ID number HHS-OS-OPHS-2018-0013 
(When Continuing Review Is Not Required During the 6-Month Delay Period 
of July 19, 2018 through January 20, 2019: 2018 Requirements), and 
docket ID number HHS-OS-OPHS-2018-0014 (Elimination of Institutional 
Review Board (IRB) Review of Research Applications and Proposals: 2018 
Requirements), respectively, by one of the following methods:
     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.
     Mail/Hand Delivery/Courier [For Paper, Disk, or CD-ROM 
Submissions]: Irene Stith-Coleman, 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: Irene Stith-Coleman, Ph.D., Office for 
Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, 
MD 20852, 240-453-6900; email Irene.Stith-Coleman@hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

A. Overview

    OHRP, Office of the Assistant Secretary for Health, is announcing 
the availability of three draft guidance documents entitled ``Scholarly 
and Journalistic Activities Deemed Not to be Research: 2018 
Requirements,'' ``When Continuing Review Is Not Required During the 6-
Month Delay Period of July 19, 2018 through January 20, 2019: 2018 
Requirements,'' and ``Elimination of Institutional Review Board (IRB) 
Review of Research Applications and Proposals: 2018 Requirements.'' The 
draft guidance documents, when finalized, will represent OHRP's current 
thinking on these topics. OHRP obtained input from HHS agencies and the 
Common Rule departments and agencies in developing the draft guidance 
documents.
    The ``Scholarly and Journalistic Activities Deemed Not to be 
Research: 2018 Requirements'' draft guidance explains how certain 
scholarly and journalistic activities that focus directly on the 
specific individuals about whom the information is collected are deemed 
not to be research under the 2018 Requirements of the regulations for 
the protection of human subjects (45 CFR part 46), and consequently do 
not have to satisfy the requirements of those regulations. It is 
intended for IRB administrators, IRB chairpersons, relevant 
institutional officials, and investigators who may be concerned about 
whether scholarly or journalistic activities need to satisfy the 2018 
Requirements of the regulations.
    The ``When Continuing Review Is Not Required During the 6-Month 
Delay Period of July 19, 2018 through January 20, 2019: 2018 
Requirements'' draft guidance provides information on the HHS 
regulations for the protection of human research subjects at 45 CFR 
part 46 related to the circumstances in which continuing review of 
research is not required. In particular, this guidance applies to 
research that transitions to comply with the 2018 Requirements during 
the 6-month delay period from July 19, 2018 through January 20, 2019. 
This guidance only applies during the 6-month delay period. It is 
intended for Institutional Review Boards (IRBs), investigators, HHS 
funding agencies, and others that may be responsible for the review, 
conduct, or oversight of human subjects research conducted or supported 
by HHS.
    The ``Elimination of Institutional Review Board (IRB) Review of 
Research Applications and Proposals: 2018 Requirements'' draft guidance 
provides guidance on the elimination of the requirement in the pre-2018 
Requirements (45 CFR 46.103(f)) that each application or proposal for 
research undergo IRB review and approval as part of the certification 
process. It is intended 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.

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.

    Dated: July 19, 2018.
Jerry Menikoff,
Director, Office for Human Research Protections.
[FR Doc. 2018-15908 Filed 7-24-18; 8:45 am]
 BILLING CODE 4150-36-P