[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]
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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2018 Requirements; Draft Guidance; When Continuing Review Is Not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January 20, 2019: 2018 Requirements; Draft Guidance Elimination of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Proposals: 2018 Requirements; Draft Guidance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.
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[[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three draft guidance documents titled, ``Scholarly and Journalistic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ADDRESSES: Submit written requests for single copies of the draft
guidance documents titled ``Scholarly and Journalistic Activities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for information on electronic access to the draft guidance documents.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 [email protected].
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]
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