FACACLASSIC

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HHS - 9492 - Secretary's Advisory Committee on Human Research Protections - Authorized by Law

GENERAL INFORMATION

Committee Name	Secretary's Advisory Committee on Human Research Protections	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	9492
Original Establishment Date	10/1/2002	Committee Status	Terminated
Actual Termination Date	4/1/2025	Committee URL	http://www.hhs.gov/ohrp/sachrp
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	19
Terminated This FY	Yes	Designated Fed Officer Position Title*	Executive Director, SACHRP, Office for Human Research Protections
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	10/1/2022	Designated Federal Officer First Name*	Julia
Date Of Renewal Charter	10/1/2024	Designated Federal Officer Middle Name	G.
Projected Termination Date		Designated Federal Officer Last Name*	Gorey
Exempt From Renewal*	No	Designated Federal Officer Suffix	J.D.
Specific Termination Authority	Executive Order 14217	Designated Federal Officer Phone*	(240) 453-8141
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*	(240)453-6909
Specific Establishment Authority*	42 USC 217a, Section 222 of the PHS Act	Designated Federal Officer Email*	julia.gorey@hhs.gov
Effective Date Of Authority*	10/17/1962
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Terminate
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	The Committee is composed of members with varied expertise who provide advice on the development and management of guidance and communications between HHS and its operating and staff divisions and other pertinent elements of the federal government; the biomedical academic, and research communities; non-governmental entities; and other organizations as necessary to further the interests of the human subjects protection enterprise. In addition, the Committee provides counsel on opportunities to improve public awareness of the function and importance of human subjects protection activities.
How is membership balanced?*	The Secretary's Advisory Committee on Human Research Protections (SACHRP) is authorized to have 11 voting members, including the Chair. The voting members are selected from multi-disciplinary backgrounds that are pertinent to human subjects protection and/or clinical research, including law, medicine, genetics, consumer advocacy, IRB administration, research, bioethics and the social sciences. Representatives from the following seven HHS organizational components serve on the Committee as non-voting ex-officio members: Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Office of Civil Rights (OCR).
How frequent & relevant are cmte mtgs?*	The Committee meets three times per year for the purpose of providing advice on the development and management of human subjects research protections, and to further the interests of the human subjects protection enterprise. The Committee hears expert presentations from government agencies, professional organizations, advocacy groups, pharmaceutical companies, and academic research bodies, and responds to HHS' requests for discussion and comment on specific issues. Meetings are tailored to focus on time-sensitive topics, enabling SACHRP to provide recommendations quickly to the Secretary on sensitive issues.
Why advice can't be obtained elsewhere?*	The Committee uniquely addresses HHS human research subjects protection regulations and guidance, and focusing on specific regulatory issues such as provisions of the 2018 Revised Common Rule. The Committee provides advice on the development and management of guidance and harmonization between HHS and its operating and staff divisions, and other pertinent elements of the federal government. Meetings frequently include the biomedical, academic, and research communities, non-governmental entities, and other organizations as necessary to further the interest of the human subjects protection enterprise. No other Federal Advisory Committee provides this advice.
Why close or partially close meetings?	N/A; all committee meetings are open to the public.
Recommendation Remarks	Per Executive Order (E.O.) 14217, "COMMENCING THE REDUCTION OF THE FEDERAL BUREAUCRACY" this FACA Committee has been terminated. SACHRP met three times in FY 2024. Please note: costs for this fiscal year reflect actual costs to the extent possible. Funds must be budgeted for payment of members, though members may ultimately not bill for their time. The "Other" column as projected for the future fiscal year necessarily includes costs of minutes and AV. Other than ensuring that the SACHRP report posted in the FACA database is accurate and complete, there is no annual reporting requirement to which the Committee must comply.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	Yes	Action Reallocate Resources	No
Outcome Major Policy Changes	Yes	Action Issued New Regulations	No
Outcome Advance In Scientific Research	No	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	No	Action Comment	The majority of SACHRP's recommendations are under consideration by OHRP, and may result in changes to HHS guidance, regulation, or agency policy. SACHRP recommendations may also be directed towards other components of HHS such as NIH or FDA.
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	NA	Number Of Grants Recommended	0
Cost Savings*	None	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	NA	Grants Review Comment	NA
Number Of Recommendations*	727	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	Recommendations are provided to the Secretary of HHS in a series of letters from SACHRP to the Secretary through the Assistant Secretary for Health. These letters outline the committee's interpretation and conclusions on issues associated with HHS regulations for the protection of human subjects, including but not limited to the following: Considerations for the Inclusion of LGBTQI+ Participants in HHS Human Subjects Research, Interpretation of the Best Interests Standard for the Retention of Subjects in Human Subjects Research that Has Been Suspended or Terminated, and recommendations on GAO-23-104721, INSTITUTIONAL REVIEW BOARDS: Actions Needed to Improve Federal Oversight and Examine Effectiveness, as well as recommendations pertaining to research with children, prisoners, pregnant women, individuals with impaired decision-making, and areas within subpart A, known as the Common Rule. Note that the majority of these topics result in many sub-recommendations, while others may generate one or two overall considerations; therefore the overall number is difficult to quantify and separate; the number provided represents a best estimate based on SACHRP letters to the Secretary.	Access Agency Website	Yes
% of Recs Fully Implemented*	4.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	Note that many SACHRP recommendations impact issues not yet resolved within the Department, such as the use of artificial intelligence in human subjects research; therefore such recommendations, while meaningful to the Department, cannot be quantified as fully or partially implemented at this time. Among the fully implemented recommendations have been recommendations pertaining to: IRB acountability, the formation of a subcommittee to examine harmonization of Federal regulations and guidance affecting human subjejcts research; the addition of ex-officio representation from the Office of Civil Rights; the 45 CFR 46.407 review process for research involving children as subjects; the accreditation of human research protection programs; the interpretation of 45 CFR subpart C (protections for prisoners involved as subjects in human subjects research); a recommendation that a workshop be convened focusing issues pertaining to central IRB review; various FAQs on parental permission, child assent, and documentation of informed consent; IRB accoutability; and continuing review.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	10.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	Note that many SACHRP recommendations impact issues not yet resolved within the Department, such as the use of artificial intelligence in human subjects research; therefore such recommendations, while meaningful, cannot be quantified as fully or partially implemented at this time. Among partially implemented recommendations are those pertaining to: Justice as an Ethical Concept in 5 CFR 46; 45 CFR 46 subpart D, research involving children as subjects; subpart A continuing review, and expedited review categories; and recommendations calling for initial and continuing training of IRB members, IRB staff, and institutional officials.	Access Other	No
Agency Feedback*	Yes	Access Comment	N/A
Agency Feedback Comment*	The DFO communicates with the Chair and the full committee at open public meetings. Information about Committee-related matters is also available on the SACHRP website that is managed through the Office for Human Research Protections (OHRP).	Narrative Description*	SACHRP supports HHS by providing recommendations, interpretations and conclusions on issues associated with HHS regulations for the protection of human subjects.

COSTS

1. Payments to Non-Federal Members*	$0.00	1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*	$8,000.00	2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*	$100,000.00	3. Estimated Payments to Federal Staff*
4. Payments to Consultants*	$0.00	4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*	$0.00	5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*	$0.00	6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*	$0.00	7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*	$0.00	8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs	$33,000.00	10. Est. Other Costs Next FY*
11. Total Costs	$141,000.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/17/2025 1:55 PM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Civil Rights Equal Opportunity Minorities Computer Technology Technology Information Technology Internet Data Privacy Education Education Food and Drugs Biotechnology Food and Drugs Medical Devices Government Federal Government Health Health Care Hospitals Medical Education Medical Practitioners Public Health Justice Research and Statistics Legislation Regulations Medicine Diseases Health and Health Research Research Basic Research Research and Development Research and Statistics Science and Technology Science and Technology Social Sciences Risk Communication Social Sciences Veterans Benchmark and Clinical Trials Research Studies

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