Notice2023-20577
Meeting of the Secretary's Advisory Committee on Human Research Protections
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
September 22, 2023
Issuing agencies
Health and Human Services Department
Abstract
Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP, the full meeting agenda, and instructions for linking to public access will be posted on the SACHRP website at http://www.dhhs.gov/ohrp/sachrp-committee/meetings/ index.html.
Full Text
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<title>Federal Register, Volume 88 Issue 183 (Friday, September 22, 2023)</title>
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[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Notices]
[Pages 65398-65399]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20577]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Secretary's Advisory Committee on Human Research
Protections
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
[[Page 65399]]
ACTION: Notice.
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SUMMARY: Pursuant to the Federal Advisory Committee Act, notice is
hereby given that the Secretary's Advisory Committee on Human Research
Protections (SACHRP) will hold a meeting that will be open to the
public. Information about SACHRP, the full meeting agenda, and
instructions for linking to public access will be posted on the SACHRP
website at <a href="http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html">http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html</a>.
DATES: The meeting will be held on Wednesday, October 18, 2023, from
9:00 a.m. until 5:00 p.m., and Thursday, October 19, 2023, from 9:00
a.m. until 4:00 p.m. (times are tentative and subject to change). The
confirmed times and agenda will be posted on the SACHRP website as this
information becomes available.
ADDRESSES: This meeting will be held in person and webcast. Members of
the public may also attend the meeting via webcast. Instructions for
attending via webcast will be posted at least one week prior to the
meeting at <a href="https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html">https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html</a>.
FOR FURTHER INFORMATION CONTACT: Julia Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240-453-8141;
fax: 240-453-6909; email address: <a href="/cdn-cgi/l/email-protection#20736163687270604848530e474f56"><span class="__cf_email__" data-cfemail="61322022293331210909124f060e17">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a,
section 222 of the Public Health Service Act, as amended, SACHRP was
established to provide expert advice and recommendations to the
Secretary of Health and Human Services, through the Assistant Secretary
for Health, on issues and topics pertaining to or associated with the
protection of human research subjects.
The Subpart A Subcommittee (SAS) was established by SACHRP in
October 2006 and is charged with developing recommendations for
consideration by SACHRP regarding the application of subpart A of 45
CFR part 46 in the current research environment.
The Subcommittee on Harmonization (SOH) was established by SACHRP
at its July 2009 meeting and charged with identifying and prioritizing
areas in which regulations and/or guidelines for human subjects
research adopted by various agencies or offices within HHS would
benefit from harmonization, consistency, clarity, simplification and/or
coordination.
The SACHRP meeting will open to the public at 9:00 a.m., on
Wednesday, October 18, 2023, followed by opening remarks from Julie
Kaneshiro, Acting Director of OHRP and Dr. Douglas Diekema, SACHRP
Chair. The meeting will begin with an expert panel discussion on the
ethical and regulatory considerations for the inclusion of LGBTQI+
populations in HHS research. This will be followed by discussion of IRB
effectiveness, topic #4 of the recently published GAO report #GAO-23-
104721, Institutional Review Boards: Actions Needed to Improve Federal
Oversight and Examine Effectiveness. The meeting then will turn to a
discussion of the best interests standard for permitting continued
participation of subjects in a suspended or terminated research study.
Following this the committee will discuss IRB review of research that
may be considered uninformative.
On Thursday, October 19th, the committee will welcome ADM Rachel
Levine for commentary and remarks; this will be followed by continued
discussion of the previous day's topics. The meeting will adjourn by
4:00 p.m. October 19, 2023.
Time will be allotted for public comment on both days of the
meeting. The public may submit written public comment in advance to
<a href="/cdn-cgi/l/email-protection#ce9d8f8d869c9e8ea6a6bde0a9a1b8"><span class="__cf_email__" data-cfemail="dd8e9c9e958f8d9db5b5aef3bab2ab">[email protected]</span></a> no later than midnight October 13, 2023, ET. Written
comments will be shared with SACHRP members and may read aloud during
the meeting. Public comment must be relevant to topics being addressed
by the SACHRP.
Dated: September 13, 2023.
Julia G. Gorey,
Executive Director, SACHRP. Office for Human Research Protections.
[FR Doc. 2023-20577 Filed 9-21-23; 8:45 am]
BILLING CODE 4150-36-P
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