Notice2021-13362
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
June 24, 2021
Issuing agencies
Health and Human Services Department
Abstract
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, 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 https://www.hhs.gov/ohrp/sachrp- committee/meetings/index.html.
Full Text
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<title>Federal Register, Volume 86 Issue 119 (Thursday, June 24, 2021)</title>
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[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33316-33317]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13362]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Secretary's Advisory Committee on Human Research
Protections
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary for Health.
ACTION: Notice.
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SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee
Act, U.S.C. Appendix 2, 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="https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html">https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html</a>.
DATES: The meeting will be held on Wednesday, July 21, from 11:00 a.m.
until 4:30 p.m., and Thursday, July 22, 2021, from 11:00 a.m. until
4:30 p.m. (times are tentative and subject to change). The confirmed
times and agenda will be posted on the SACHRP website when this
information becomes available.
ADDRESSES: This meeting will be held via webcast. Members of the public
may also attend the meeting via webcast. Instructions for attending via
webcast will be posted 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#8cdfcdcfc4dedccce4e4ffa2ebe3fa"><span class="__cf_email__" data-cfemail="c39082808b919383ababb0eda4acb5">[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 11:00 a.m., on
Wednesday, July 21, followed by opening remarks from Dr. Jerry
Menikoff, Director of OHRP and Dr. Douglas Diekema, SACHRP Chair. The
meeting will begin with presentation of recommendations on justice as
an ethical concept in 45
[[Page 33317]]
CFR 46, followed by an expert panel discussion on the impact of
artificial intelligence algorithms on Institutional Review Board
considerations for human subjects protections. The day will conclude
with discussion of a new SACHRP charge addressing the current system of
engagement and the interpretation of HHS support in 45 CFR 46. The
second day, July 22, will include discussion of consideration of risks
to third parties in research, and continue discussion of topics from
the first day's agenda. Other topics may be added; for the full and
updated meeting agenda, see <a href="https://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html">https://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html</a>. The meeting will adjourn by 4:30 p.m. July 22.
The public will have an opportunity to send comment to SACHRP
during the meeting's public comment session or to submit written public
comment in advance. Persons who wish to provide public comment should
review instructions at <a href="https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html">https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html</a> and respond by midnight July 16th, 2021, ET.
Individuals submitting written statements as public comment should
submit their comments to SACHRP at <a href="/cdn-cgi/l/email-protection#95c6d4d6ddc7c5d5fdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="095a484a415b594961617a276e667f">[email protected]</span></a>. Comments are limited
to three minutes each.
Time will be allotted for public comment on both days. Note that
public comment must be relevant to topics currently being addressed by
SACHRP.
Dated: June 14, 2021.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research
Protections, Office for Human Research Protections.
[FR Doc. 2021-13362 Filed 6-23-21; 8:45 am]
BILLING CODE 4150-36-P
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