Notice2023-12924
Draft Guidance on Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 16, 2023
Issuing agencies
Health and Human Services Department
Abstract
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a draft guidance document titled, "Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions."
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 116 (Friday, June 16, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 116 (Friday, June 16, 2023)]
[Notices]
[Pages 39438-39439]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12924]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. HHS-OASH-2022-0014]
Draft Guidance on Frequently Asked Questions: Limited
Institutional Review Board Review and Related Exemptions
AGENCY: The Office for Human Research Protections, Office of the
Assistant Secretary for Health, Office of the Secretary, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Office for Human Research Protections (OHRP), Office of
the Assistant Secretary for Health, is announcing the availability of a
draft guidance document titled, ``Frequently Asked Questions: Limited
Institutional Review Board Review and Related Exemptions.''
DATES: Submit written comments by August 15, 2023.
ADDRESSES: You may send comments, identified by docket number HHS-OASH-
2022-0014, by any of the following methods:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments.
<bullet> Email: <a href="/cdn-cgi/l/email-protection#b9f6f1ebe9f9d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="bbf4f3e9ebfbd3d3c895dcd4cd">[email protected]</span></a>.
<bullet> Fax: 240-453-8420.
<bullet> Mail/Hand Delivery/Courier: Division of Policy and
Assurances, Office for Human Research Protections, 1101 Wootton
Parkway, Suite 200, Rockville, MD 20852.
Instructions: All submissions received must include the docket
number. All comments received, including attachments and any personal
information, will be posted without change to <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit written requests for a single copy of the guidance document
titled, ``Frequently Asked Questions: Limited Institutional Review
Board Review and Related Exemptions'' 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 access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Natalie Klein, Ph.D., Office for Human
Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD
20852, 240-453-6700; email <a href="/cdn-cgi/l/email-protection#335d5247525f5a561d585f565a5d735b5b401d545c45"><span class="__cf_email__" data-cfemail="452b243124292c206b2e29202c2b052d2d366b222a33">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
OHRP is announcing the availability of a draft guidance document
for public comment titled ``Frequently Asked Questions: Limited
Institutional Review Board Review and Related Exemptions.'' The draft
guidance document applies to research activities involving human
subjects that are conducted or supported by HHS. It is intended
primarily to help
[[Page 39439]]
entities implement the requirement for limited review of research by an
IRB to meet the conditions of four exemptions found at 45 CFR 46.104(d)
of the 2018 Requirements (the Common Rule). The draft guidance
discusses the concept of limited IRB review, which appears in these
exemptions, and provides information about how limited review may be
conducted. When finalized, this will provide OHRP's first formal
guidance on this topic. This draft guidance was developed after taking
into consideration input received from HHS and other Common Rule
departments and agencies.
II. Equity and Justice Considerations
OHRP is particularly interested in public comments on any impact
this guidance may have on considerations for equity and justice in
human research protections.
III. Electronic Access
Persons with access may obtain the draft guidance documents on
OHRP's website at <a href="https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html">https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html</a>.
Julie A. Kaneshiro,
Acting Director, Office for Human Research Protections.
[FR Doc. 2023-12924 Filed 6-15-23; 8:45 am]
BILLING CODE 4150-36-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 16, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.