---
kind: "section"
citation: "42 U.S.C. § 289a–1"
title: "42"
title_heading: "The Public Health and Welfare"
number: "289a–1"
heading: "Certain provisions regarding review and approval of proposals for research"
release: "119-102"
url: "https://uscodex.org/usc/42/289a-1"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter III — National Research Institutes"
  - "Part H — General Provisions"
---

# §289a–1. Certain provisions regarding review and approval of proposals for research

- (a) **Review as precondition to research—**
  - (1) **Protection of human research subjects—**
    - (A) In the case of any application submitted to the [Secretary](/usc/42/201.md?p=c) for financial assistance to conduct research, the [Secretary](/usc/42/201.md?p=c) may not approve or [fund](/usc/42/12854.md?p=3) any application that is subject to review under [section 289(a) of this title](/usc/42/289.md?p=a) by an Institutional Review [Board](/usc/42/10261.md?p=2) 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](/usc/42/10261.md?p=2) conducting such review.
    - (B) In the case of research that is subject to review under procedures established by the [Secretary](/usc/42/201.md?p=c) for the protection of human subjects in [clinical research](/usc/42/284d.md?p=b) conducted by the National Institutes of Health, the [Secretary](/usc/42/201.md?p=c) 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](/usc/42/201.md?p=c) may not approve or [fund](/usc/42/12854.md?p=3) any proposal that is subject to technical and scientific peer review under [section 289a of this title](/usc/42/289a.md) 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](/usc/42/274l–1.md?p=1) under [section 284a of this title](/usc/42/284a.md), or as applicable, of the [advisory council](/usc/42/274l–1.md?p=1) under [section 282(k) of this title](/usc/42/282.md?p=k), 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)](#a), the [Secretary](/usc/42/201.md?p=c) may not withhold [funds](/usc/42/12854.md?p=3) for the research because of [ethical considerations](#b-6) unless—
    - (A) the [Secretary](/usc/42/201.md?p=c) convenes an advisory [board](/usc/42/10261.md?p=2) in accordance with [paragraph (5)](#b-5) to study such considerations; and
    - (B)
      - (i) the majority of the advisory [board](/usc/42/10261.md?p=2) recommends that, because of such considerations, the [Secretary](/usc/42/201.md?p=c) withhold [funds](/usc/42/12854.md?p=3) for the research; or
      - (ii) the majority of such [board](/usc/42/10261.md?p=2) recommends that the [Secretary](/usc/42/201.md?p=c) not withhold [funds](/usc/42/12854.md?p=3) for the research because of such considerations, but the [Secretary](/usc/42/201.md?p=c) finds, on the basis of the report submitted under [paragraph (5)(B)(ii)](#b-5-B-ii), that the recommendation is arbitrary and capricious.
  - (2) **Rules of construction—** [Paragraph (1)](#b-1) may not be construed as prohibiting the [Secretary](/usc/42/201.md?p=c) from withholding [funds](/usc/42/12854.md?p=3) 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](/usc/42/12854.md?p=3) from the [Secretary](/usc/42/201.md?p=c)), 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)](#a), all findings regarding such qualifications made in such process are conclusive; or
    - (B) the priorities established by the [Secretary](/usc/42/201.md?p=c) for the [allocation](/usc/42/2021b.md?p=2) of [funds](/usc/42/12854.md?p=3) among [projects](/usc/42/11360.md?p=20) of research that have been so recommended.
  - (3) **Applicability—** The limitation established in [paragraph (1)](#b-1) regarding the authority to withhold [funds](/usc/42/12854.md?p=3) because of [ethical considerations](#b-6) shall apply without regard to whether the withholding of [funds](/usc/42/12854.md?p=3) 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](/usc/42/201.md?p=c) makes a determination that an advisory [board](/usc/42/10261.md?p=2) should be convened for purposes of [paragraph (1)](#b-1), the [Secretary](/usc/42/201.md?p=c) shall, through a statement published in the Federal Register, announce the intention of the [Secretary](/usc/42/201.md?p=c) to convene such a [board](/usc/42/10261.md?p=2).
    - (B) A statement issued under [subparagraph (A)](#b-4-A) shall include a request that interested individuals submit to the [Secretary](/usc/42/201.md?p=c) recommendations specifying the particular individuals who should be appointed to the advisory [board](/usc/42/10261.md?p=2) involved. The [Secretary](/usc/42/201.md?p=c) shall consider such recommendations in making appointments to the [board](/usc/42/10261.md?p=2).
    - (C) The [Secretary](/usc/42/201.md?p=c) may not make appointments to an advisory [board](/usc/42/10261.md?p=2) under [paragraph (1)](#b-1) until the expiration of the 30-day period beginning on the date on which the statement required in [subparagraph (A)](#b-4-A) is made with respect to the [board](/usc/42/10261.md?p=2).
  - (5) **Ethics advisory boards—**
    - (A) Any advisory [board](/usc/42/10261.md?p=2) convened for purposes of [paragraph (1)](#b-1) shall be known as an ethics advisory [board](/usc/42/10261.md?p=2) (in this paragraph referred to as an “ethics [board](/usc/42/10261.md?p=2)”).
    - (B)
      - (i) An ethics [board](/usc/42/10261.md?p=2) shall advise, consult with, and make recommendations to the [Secretary](/usc/42/201.md?p=c) regarding the ethics of the [project](/usc/42/11360.md?p=20) of biomedical or behavioral research with respect to which the [board](/usc/42/10261.md?p=2) has been convened.
      - (ii) Not later than 180 days after the date on which the statement required in [paragraph (4)(A)](#b-4-A) is made with respect to an ethics [board](/usc/42/10261.md?p=2), the [board](/usc/42/10261.md?p=2) shall submit to the [Secretary](/usc/42/201.md?p=c), and to the Committee on [Energy](/usc/42/6311.md?p=7) and [Commerce](/usc/42/6311.md?p=7) of the House of [Representatives](/usc/42/3058f.md?p=5) and the Committee on Labor and Human Resources of the Senate, a report describing the findings of the [board](/usc/42/10261.md?p=2) regarding the [project](/usc/42/11360.md?p=20) of research involved and making a recommendation under [clause (i)](#b-5-B-i) of whether the [Secretary](/usc/42/201.md?p=c) should or should not withhold [funds](/usc/42/12854.md?p=3) for the [project](/usc/42/11360.md?p=20). The report shall include the information considered in making the findings.
    - (C) An ethics [board](/usc/42/10261.md?p=2) shall be composed of no fewer than 14, and no more than 20, individuals who are not officers or [employees](/usc/42/300gg–91.md?p=d-5) of the [United States](/usc/42/403.md?p=k). The [Secretary](/usc/42/201.md?p=c) shall make appointments to the [board](/usc/42/10261.md?p=2) 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](/usc/42/10261.md?p=2)—
      - (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](/usc/42/1320a–7h.md?p=e-11);
      - (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](/usc/42/201.md?p=a) as a member of an ethics [board](/usc/42/10261.md?p=2) shall be for the life of the [board](/usc/42/10261.md?p=2). If such a member does not serve the full term of such [service](/usc/42/201.md?p=a), 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](/usc/42/10261.md?p=2) shall be subject to [removal](/usc/42/9601.md?p=23) from the [board](/usc/42/10261.md?p=2) by the [Secretary](/usc/42/201.md?p=c) for neglect of duty or malfeasance or for other good [cause](/usc/42/9908.md?p=c-2) shown.
    - (F) The [Secretary](/usc/42/201.md?p=c) shall designate an individual from among the members of an ethics [board](/usc/42/10261.md?p=2) to serve as the chair of the [board](/usc/42/10261.md?p=2).
    - (G) In carrying out [subparagraph (B)(i)](#b-5-B-i) with respect to a [project](/usc/42/11360.md?p=20) of research, an ethics [board](/usc/42/10261.md?p=2) shall conduct inquiries and hold public hearings.
    - (H) In carrying out [subparagraph (B)(i)](#b-5-B-i) with respect to a [project](/usc/42/11360.md?p=20) of research, an ethics [board](/usc/42/10261.md?p=2) shall have access to all relevant information possessed by the Department of Health and Human [Services](/usc/42/201.md?p=a), or available to the [Secretary](/usc/42/201.md?p=c) from other agencies.
    - (I) Members of an ethics [board](/usc/42/10261.md?p=2) shall receive compensation for each day engaged in carrying out the duties of the [board](/usc/42/10261.md?p=2), 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](/usc/42/201.md?p=c), acting through the [Director](/usc/42/5061.md?p=1) of the National Institutes of Health, shall provide to each ethics [board](/usc/42/10261.md?p=2) reasonable staff and assistance to carry out the duties of the [board](/usc/42/10261.md?p=2).
    - (K) An ethics [board](/usc/42/10261.md?p=2) shall terminate 30 days after the date on which the report required in [subparagraph (B)(ii)](#b-5-B-ii) is submitted to the [Secretary](/usc/42/201.md?p=c) 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.)

## Notes

### Editorial Notes

### Amendments

2007—Subsec. (a)(2). Pub. L. 109–482 inserted before period at end “, 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”.

### Statutory Notes and Related Subsidiaries

### Change of Name

Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.

Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.

### Effective Date of 2007 Amendment

Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.

### References in Other Laws to GS–16, 17, or 18 Pay Rates

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.