Release Date: December 23, 2019
Office of The Director, National Institutes of Health (OD)
The purpose of this notice is to inform the research community and other interested parties of the plan by the U.S. Department of Health and Human Services (HHS) to publish a statement in early 2020 in the Federal Register that announces the intention to convene an NIH Human Fetal Tissue Research Ethics Advisory Board for fiscal year 2020 (Ethics Board or Board), as authorized by Section 492A of the Public Health Service (PHS) Act, as amended. This notice in early 2020 will also request that interested individuals submit recommendations specifying the individuals who should be considered for appointment to the Ethics Board. NIH is providing the public with this Guide Notice, prior to the publication of the HHS statement in early 2020, so that the public can have additional time to consider nominations. The Ethics Board will be governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. app.), which sets forth standards for the formation and use of advisory committees.
The Ethics Board will advise, consult with, and make recommendations to the Secretary of HHS (Secretary) regarding the ethics of research involving human fetal tissue (HFT) proposed 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. For purposes of the Ethics Board’s review, “research involving HFT” is defined as set forth in NOT-OD-19-128, “Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research”.
The Federal Register statement in early 2020 will solicit nominations for the Board for consideration by the Secretary. The Board will be composed of at least 14, but no more than 20, individuals who are not federal employees. The appointed members of the Board will include 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 will be scientists with substantial accomplishments in biomedical or behavioral research.
Depending on the number of relevant applications received, HHS and NIH contemplate forming an Ethics Board and holding at least one meeting of such Board each fiscal year. Meetings will be 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. Notice of all meetings will be given to the public. In accordance with Section 492A(5)(B)(ii) of the PHS Act, no later than 180 days after the date on which the statement announcing the intention of the Secretary to convene the Ethics Board and soliciting nominations is published in the Federal Register, the Board will submit to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor and Pensions of the Senate, a report describing the findings of the Board regarding the project(s) of research involved and recommendations regarding whether the Secretary should or should not withhold funds for the project(s). As required by Section 492A(b)(5)(K) of the PHS Act, the Ethics Board will terminate 30 days after the date on which the required report is submitted to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor and Pensions of the Senate.
NIH Office of Science Policy