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HHS - 84589 - NIH Human Fetal Tissue Research Ethics Advisory Board – FY2020 - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameNIH Human Fetal Tissue Research Ethics Advisory Board – FY2020Agency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number84589
Original Establishment Date3/6/2020Committee StatusTerminated
Actual Termination Date9/17/2020Committee URLhttps://osp.od.nih.gov/biotechnology/nih-human-...
New Committee This FYYesPresidential Appointments*No
Terminated This FYYesMax Number of Members*15
Current Charter Date3/6/2020Designated Fed Officer Position Title*Health Science Policy Analyst
Date Of Renewal Charter3/6/2022Designated Federal Officer Prefix
Projected Termination Date9/17/2020Designated Federal Officer First Name*Cari
Exempt From Renewal*NoDesignated Federal Officer Middle NameE.
Specific Termination Authority42 U.S.C. 289a-1Designated Federal Officer Last Name*Young
Establishment Authority*Authorized by LawDesignated Federal Officer Suffix
Specific Establishment Authority*42 U.S.C. 289a-1Designated Federal Officer Phone*(301) 594-3746
Effective Date Of Authority* Designated Federal Officer Fax*(301) 496-9839
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*caroline.young@nih.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Terminate
Legislation to Terminate RequiredNo
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The NIH Human Fetal Tissue Research Ethics Advisory Board - FY2020 reviewed applications proposing to use HFT from elective abortions (as defined in NOT-OD-19-128) within a fundable scoring range and proposals that had been identified through the Source Selection process as apparently successful offerors. The Ethics Board reviewed and verified the core ethical principles used in the process for obtaining informed consent for the donation of the tissue. The Ethics Board made findings and advised on whether HFT is being utilized for research only when scientifically justifiable, and in the least amount possible to achieve the scientific outcomes and provided a recommendation on whether the Secretary should withhold funds or not withhold funds from a proposed project because of ethical considerations.
How is membership balanced?*The NIH Human Fetal Tissue Research Ethics Advisory Board - FY2020 was composed of 15 members. The 15 members included no fewer than one attorney; no fewer than one ethicist; no fewer than one practicing physician; and no fewer than one theologian. No fewer than one-third, and no more than one-half of the appointed members were scientists with substantial accomplishments in biomedical or behavioral research.
How frequent & relevant are cmte mtgs?*The NIH Human Fetal Tissue Research Ethics Advisory Board - FY2020 met one time. The meeting was open to the public except as determined otherwise by the Secretary in accordance with subsection (c) of section 552b of Title 5 U.S.C. The Board met on July 31, 2020.
Why advice can't be obtained elsewhere?*The NIH Human Fetal Tissue Research Ethics Advisory Board - FY2020 was established by the U.S. Department of Health and Human Services (HHS). The Ethics Board advised, consulted with, and made recommendations to the Secretary of HHS (Secretary) regarding the ethics of research involving human fetal tissue (HFT) proposed in NIH grant and cooperative agreement applications and R&D contract proposals, as set forth in the NIH Guide Notice NOT-OD-19-128. Advice provided by the Ethics Board addressed whether HFT is being utilized for research only when scientifically justifiable, and in the least amount possible to achieve the scientific outcomes. No existing NIH advisory committee has the appropriate expertise and/or the ability to hold additional meetings to incorporate these new advisory duties stated in Section 492A. In order to meet legislative requirements in 492A, the NIH Human Fetal Tissue Research Ethics Advisory Board - FY2020 was created for this purpose.
Why close or partially close meetings?The meeting of the NIH Human Fetal Tissue Research Ethics Advisory Board - FY2020 was partially closed to the public for the review of grant applications. Sections 552b(c)(4) and 552b(c)(6) of the Government in the Sunshine Act permits the closing of meetings where discussion could reveal confidential trade secrets or commercial property such as patentable material and personal information, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Recommendation RemarksThe NIH Human Fetal Tissue Research Ethics Advisory Board - FY2020 was established on February 20, 2020 as part of the Intent of Notice to Convene and Call for Nominations Federal Register Notice as required by statue. The establishment charter was filed on March 6, 2020 in accordance with FACA.

This committee was terminated on 9/17/2020 in accordance with the statute.

There are no projected costs as the committee was established and terminated in the same fiscal year.

NIH Staff is in the process of archiving the committee website.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*NoAction Reorganize Priorities*No
Outcome Trust In GovernmentNoAction Reallocate ResourcesNo
Outcome Major Policy ChangesNoAction Issued New RegulationsNo
Outcome Advance In Scientific ResearchNoAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionNoAction CommentThe NIH Human Fetal Tissue Research Ethics Advisory Board – FY2020 submitted recommendations on 14 grant applications and contract proposals proposing to use human fetal tissue.
Outcome Implement Laws/Reg RequirementsNoGrants Review*Yes
Outcome OtherYesNumber Of Grants Reviewed0
Outcome CommentThe purpose of the NIH Human Fetal Tissue Research Ethics Advisory Board – FY2020 is to make recommendations to the Secretary of HHS regarding the ethics of research involving the use of human fetal tissue in competitive NIH grant and cooperative agreement applications that are within a fundable scoring range and R&D contract proposals that have been identified through the Source Selection process as apparently successful offerors, as set forth in NOT-OD-19-128.Number Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentGrants Review CommentThe Board reviewed the ethics of grant applications and contract proposals that proposed to use HFT. They did not perform a scientific review.
Number Of Recommendations*14Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe NIH Human Fetal Tissue Research Ethics Advisory Board – FY2020 submitted recommendations on 14 grant applications and contract proposals proposing to use human fetal tissue.Access Agency WebsiteNo
% of Recs Fully Implemented* Access Committee WebsiteYes
% of Recs Fully Implemented CommentAccess GSA FACA WebsiteYes
% of Recs Partially Implemented* Access PublicationsNo
% of Recs Partially Implemented CommentAccess OtherNo
Agency Feedback* Access Comment
Agency Feedback Comment*Narrative Description*The NIH Human Fetal Tissue Research Ethics Advisory Board - FY2020 was established on February 20, 2020 by the Secretary of the Department of Health and Human Services. This board operated in accordance of 42 U.S.C. 289a-1. The Ethics Board will consider the use of alternative models, and review and verify the core ethical principles and procedures used in the process to obtain written voluntary informed consent for the donation of the tissue. The ethical considerations the Ethics Board should consider are those related to whether the nature of the research involved is such that it is unethical to conduct or support the research.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$2,600.00Est Payments to Non-Fed Members Next FY*$0.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$98,799.00Estimated Payments to Federal Staff*$0.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$0.00Est Travel Reimb Non-Fed Members nextFY*$0.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$0.00Est Travel Reimb to Consultants Next FY*$0.00
Other Costs$15,994.00Est. Other Costs Next FY*$0.00
Total Costs$117,393.00Est. Total Next FY*$0.00
Date Cost Last Modified Est. Fed Staff Support Next FY*0.00
Federal Staff Support (FTE)*0.60Est Cost Remarks
Cost RemarksThere are no projected costs as the committee was established and terminated in the same fiscal year.  
Hide Section - Interest Areas

Interest Areas

Category
Area
Health
Health Care
Public Health
Medicine
Health and Health Research
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found