[Federal Register Volume 88, Number 183 (Friday, September 22, 2023)]
[Notices]
[Pages 65398-65399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.

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 https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html.

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: [email protected].

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 
[email protected] 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]
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