2024-24147. Meeting of the Secretary's Advisory Committee on Human Research Protections

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Department of Health and Human Services

AGENCY:

Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health.

ACTION:

Notice.

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

DATES:

The meeting will be held on Tuesday, October 22, 2024, 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 as this information becomes available.

ADDRESSES:

This meeting will be held via webcast. Members of the public may ( print page 83895) 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: [phone]; fax: [phone]; email address: [e-mail].

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 SACHRP Advisory Subcommittee was established by in August 2024 and is charged with assessing and drafting recommendations for consideration by SACHRP pertaining to the language and interpretation of 45 CFR part 46, existing relevant HHS guidance documents and the development of new HHS guidance documents, and cultural, ethical, or international issues of concern which may impact HHS funded human subjects protections.

The SACHRP meeting will open to the public at 11:00 a.m., on Tuesday, October 22, 2024, followed by opening remarks from Julie Kaneshiro, currently Acting Director of OHRP. Ms Kaneshiro will introduce Dr. Molly Klote, newly appointed Director of OHRP. Dr. Douglas Diekema, SACHRP Chair, will make opening remarks. The meeting will begin with a discussion of the draft recommendation, Considerations for Uninformative Research. This will be followed by panel presentations and discussion of a new SACHRP topic on Equivalent Protections and Procedural Requirements in International Research. The day will adjourn at approximately 4:30 p.m.

Time will be allotted for public comment. SACHRP materials will be publicly posted at HHS-OASH-2024-0013. The public may submit written public comment in advance to [e-mail] no later than midnight October 18th, 2024, ET. Written comments will be shared with SACHRP members and may read aloud during the meeting. Comments which are read aloud are limited to three minutes each. Public comment must be relevant to topics currently being addressed by the SACHRP.

Dated: September 26, 2024.

Julia G. Gorey.

Executive Director, SACHRP, Office for Human Research Protections.