42 U.S.C. § 289a–1 — Certain provisions regarding review and approval of proposals for research

submitted 82 years ago by Pub. L. 103-43 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 1,272 words · no verdicts yet

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Before NIH can fund human-subject research, it must be reviewed and approved by an Institutional Review Board (or, for NIH's own clinical research, under the Secretary's separate procedures). Before NIH can fund or run a research proposal, it must also pass peer review and get advisory-council approval. Once research clears that process, the Secretary generally cannot pull its funding purely for ethical reasons unless a special ethics advisory board first reviews it and either recommends withholding funds, or recommends against withholding funds but the Secretary finds that recommendation arbitrary and capricious. The Secretary can still withhold funds for other reasons, like an institution's poor qualifications or funding priorities. This section also spells out, in detail, how these ethics advisory boards are appointed, staffed, and run.

(a) Review required before funding. (1) Protecting human research subjects. If an application for federal research funding must go through Institutional Review Board review under section 289(a) of this title, the Secretary cannot approve or fund it unless that review happened and a majority of the Board recommended approval. For NIH clinical research subject to the Secretary's own human-subject-protection procedures, the Secretary cannot allow the research to proceed unless those procedures recommended approval. (2) Peer review. For any NIH research proposal subject to technical and scientific peer review under section 289a of this title, the Secretary cannot approve or fund it unless that review happened, a majority of the reviewing group recommended approval, and a majority of the relevant advisory council's voting members also recommended approval. (b) Withholding funds for ethical reasons. (1) When funds can be withheld. Even after research clears subsection (a)'s review, the Secretary cannot withhold its funding because of ethical considerations unless the Secretary first convenes an "ethics advisory board" under paragraph (5) to study those considerations, and then either a majority of that board recommends withholding funds because of the ethical considerations, or a majority recommends against withholding funds but the Secretary finds — based on the board's report — that this recommendation is arbitrary and capricious. (2) What this doesn't limit. Paragraph (1) does not stop the Secretary from withholding funds because an entity involved (including the one that would directly get the money) is not adequately qualified — though findings about qualifications made during the subsection (a) review process are final — or because of the Secretary's own funding priorities among approved research projects. (3) Applies no matter how it's labeled. Paragraph (1)'s limit on withholding funds for ethical reasons applies regardless of whether that withholding is called a disapproval, a moratorium, a prohibition, or anything else. (4) Setting up an ethics board. Before convening a board, the Secretary must publish, in the Federal Register, a statement announcing plans to do so, and must ask interested people to recommend individuals for appointment to the board. The Secretary must consider those recommendations, and cannot make appointments until 30 days after that statement is published. (5) How the ethics board works. Such a board is called an "ethics advisory board" or "ethics board." It advises and makes recommendations to the Secretary about the ethics of the specific research project it was convened for. Within 180 days of the announcement statement, it must send the Secretary, plus the House Energy and Commerce Committee and the Senate Labor and Human Resources Committee, a report describing its findings and recommending whether the Secretary should or shouldn't withhold funds, including the information behind its findings. The board must have between 14 and 20 members, none of whom can be federal officers or employees, chosen for their special qualifications on ethical matters in biomedical or behavioral research — including at least one attorney, one ethicist, one practicing physician, one theologian, and between one-third and one-half scientists with substantial research accomplishments. Members serve for the board's whole life, with a vacancy filled for the remainder of the term. The Secretary can remove a member for neglecting their duties, misconduct, or other good cause. The Secretary picks one member to chair the board. The board must hold inquiries and public hearings, and has access to all relevant information the Department of Health and Human Services has, or that the Secretary can get from other agencies. Members are paid for each day of board work, including travel, up to the maximum pay rate for a GS–18 federal employee. The Director of NIH must give each board reasonable staff and support. A board ends 30 days after it submits its report to the Secretary and to the specified congressional committees. (6) Meaning of "ethical considerations." In this subsection, "ethical considerations" means whether the nature of the research is such that conducting or supporting it would be unethical.

the actual law source: uscode.house.gov ↗public domain

(a) Review as precondition to research

(1) Protection of human research subjects

(A)

In the case of any application submitted to the Secretary for financial assistance to conduct research, the Secretary may not approve or fund any application that is subject to review under section 289(a) of this title by an Institutional Review Board unless the application has undergone review in accordance with such section and has been recommended for approval by a majority of the members of the Board conducting such review.

(B)

In the case of research that is subject to review under procedures established by the Secretary for the protection of human subjects in clinical research conducted by the National Institutes of Health, the Secretary may not authorize the conduct of the research unless the research has, pursuant to such procedures, been recommended for approval.

(2) Peer review

In the case of any proposal for the National Institutes of Health to conduct or support research, the Secretary may not approve or fund any proposal that is subject to technical and scientific peer review under section 289a of this title unless the proposal has undergone such review in accordance with such section and has been recommended for approval by a majority of the members of the entity conducting such review, and unless a majority of the voting members of the appropriate advisory council under section 284a of this title, or as applicable, of the advisory council under section 282(k) of this title, has recommended the proposal for approval.

(b) Ethical review of research

(1) Procedures regarding withholding of funds

If research has been recommended for approval for purposes of subsection (a), the Secretary may not withhold funds for the research because of ethical considerations unless—

(A)

the Secretary convenes an advisory board in accordance with paragraph (5) to study such considerations; and

(B)

(i)

the majority of the advisory board recommends that, because of such considerations, the Secretary withhold funds for the research; or

(ii)

the majority of such board recommends that the Secretary not withhold funds for the research because of such considerations, but the Secretary finds, on the basis of the report submitted under paragraph (5)(B)(ii), that the recommendation is arbitrary and capricious.

(2) Rules of construction

Paragraph (1) may not be construed as prohibiting the Secretary from withholding funds for research on the basis of—

(A)

the inadequacy of the qualifications of the entities that would be involved with the conduct of the research (including the entity that would directly receive the funds from the Secretary), subject to the condition that, with respect to the process of review through which the research was recommended for approval for purposes of subsection (a), all findings regarding such qualifications made in such process are conclusive; or

(B)

the priorities established by the Secretary for the allocation of funds among projects of research that have been so recommended.

(3) Applicability

The limitation established in paragraph (1) regarding the authority to withhold funds because of ethical considerations shall apply without regard to whether the withholding of funds on such basis is characterized as a disapproval, a moratorium, a prohibition, or other characterization.

(4) Preliminary matters regarding use of procedures

(A)

If the Secretary makes a determination that an advisory board should be convened for purposes of paragraph (1), the Secretary shall, through a statement published in the Federal Register, announce the intention of the Secretary to convene such a board.

(B)

A statement issued under subparagraph (A) shall include a request that interested individuals submit to the Secretary recommendations specifying the particular individuals who should be appointed to the advisory board involved. The Secretary shall consider such recommendations in making appointments to the board.

(C)

The Secretary may not make appointments to an advisory board under paragraph (1) until the expiration of the 30-day period beginning on the date on which the statement required in subparagraph (A) is made with respect to the board.

(5) Ethics advisory boards

(A)

Any advisory board convened for purposes of paragraph (1) shall be known as an ethics advisory board (in this paragraph referred to as an “ethics board”).

(B)

(i)

An ethics board shall advise, consult with, and make recommendations to the Secretary regarding the ethics of the project of biomedical or behavioral research with respect to which the board has been convened.

(ii)

Not later than 180 days after the date on which the statement required in paragraph (4)(A) is made with respect to an ethics board, the board shall submit to the Secretary, and to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report describing the findings of the board regarding the project of research involved and making a recommendation under clause (i) of whether the Secretary should or should not withhold funds for the project. The report shall include the information considered in making the findings.

(C)

An ethics board shall be composed of no fewer than 14, and no more than 20, individuals who are not officers or employees of the United States. The Secretary shall make appointments to the board from among individuals with special qualifications and competence to provide advice and recommendations regarding ethical matters in biomedical and behavioral research. Of the members of the board—

(i)

no fewer than 1 shall be an attorney;

(ii)

no fewer than 1 shall be an ethicist;

(iii)

no fewer than 1 shall be a practicing physician;

(iv)

no fewer than 1 shall be a theologian; and

(v)

no fewer than one-third, and no more than one-half, shall be scientists with substantial accomplishments in biomedical or behavioral research.

(D)

The term of service as a member of an ethics board shall be for the life of the board. If such a member does not serve the full term of such service, the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.

(E)

A member of an ethics board shall be subject to removal from the board by the Secretary for neglect of duty or malfeasance or for other good cause shown.

(F)

The Secretary shall designate an individual from among the members of an ethics board to serve as the chair of the board.

(G)

In carrying out subparagraph (B)(i) with respect to a project of research, an ethics board shall conduct inquiries and hold public hearings.

(H)

In carrying out subparagraph (B)(i) with respect to a project of research, an ethics board shall have access to all relevant information possessed by the Department of Health and Human Services, or available to the Secretary from other agencies.

(I)

Members of an ethics board shall receive compensation for each day engaged in carrying out the duties of the board, including time engaged in traveling for purposes of such duties. Such compensation may not be provided in an amount in excess of the maximum rate of basic pay payable for GS–18 of the General Schedule.

(J)

The Secretary, acting through the Director of the National Institutes of Health, shall provide to each ethics board reasonable staff and assistance to carry out the duties of the board.

(K)

An ethics board shall terminate 30 days after the date on which the report required in subparagraph (B)(ii) is submitted to the Secretary and the congressional committees specified in such subparagraph.

(6) “Ethical considerations” defined

For purposes of this subsection, the term “ethical considerations” means considerations as to whether the nature of the research involved is such that it is unethical to conduct or support the research.

Source credit: (July 1, 1944, ch. 373, title IV, § 492A, as added Pub. L. 103–43, title I, § 101, June 10, 1993, 107 Stat. 126; amended Pub. L. 109–482, title I, § 102(e), Jan. 15, 2007, 120 Stat. 3684.)

history & why it existsrecord from the source credit

1944Enacted · Pub. L. 103-43 · 107 Stat. 126
2007Amended · Pub. L. 109-482 · 120 Stat. 3684

A history note hasn’t been published yet. The record shows enactment by Pub. L. 103-43 on 1944-07-01.

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