§289a — Title 42 The Public Health and Welfare | U.S. Code

Summary

The Secretary must make rules, through the NIH Director, that require expert technical and scientific peer review for biomedical and behavioral research. That includes grant applications, cooperative agreements, and research contracts. The rules should, as much as possible, follow the review system and use the review groups that were in place on November 20, 1985. The NIH Director must also set up regular peer review procedures for research done at the NIH. Reviewers must get a written description of the research. Reviewers must give that description and their review results to the institute’s advisory council. For clinical research, peer review must check if the proposal follows the rules in section 289a–2, unless the proposal is exempt under section 289a–2(b).

Title 42, §289a

The Public Health and Welfare — Source: USLM XML via OLRC

(a)(1)The Secretary, acting through the Director of NIH, shall by regulation require appropriate technical and scientific peer review of—

(A)applications made for grants and cooperative agreements under this chapter for biomedical and behavioral research; and

(B)applications made for biomedical and behavioral research and development contracts to be administered through the National Institutes of Health.

(2)Regulations promulgated under paragraph (1) shall require that the review of applications made for grants, contracts, and cooperative agreements required by the regulations be conducted—

(A)to the extent practical, in a manner consistent with the system for technical and scientific peer review applicable on November 20, 1985, to grants under this chapter for biomedical and behavioral research, and

(B)to the extent practical, by technical and scientific peer review groups performing such review on or before November 20, 1985,

(b)The Director of NIH shall establish procedures for periodic technical and scientific peer review of research at the National Institutes of Health. Such procedures shall require that—

(1)the reviewing entity be provided a written description of the research to be reviewed, and

(2)the reviewing entity provide the advisory council of the national research institute involved with such description and the results of the review by the entity,

(c)(1)In technical and scientific peer review under this section of proposals for clinical research, the consideration of any such proposal (including the initial consideration) shall, except as provided in paragraph (2), include an evaluation of the technical and scientific merit of the proposal regarding compliance with section 289a–2 of this title.

(2)Paragraph (1) shall not apply to any proposal for clinical research that, pursuant to subsection (b) of section 289a–2 of this title, is not subject to the requirement of subsection (a) of such section regarding the inclusion of women and members of minority groups as subjects in clinical research.

Notes & Related Subsidiaries

Editorial Notes

References in Text

section 282(b)(6) of this title, referred to in subsec. (b), was redesignated section 282(b)(16) by Pub. L. 109–482, title I, § 102(a)(3), Jan. 15, 2007, 120 Stat. 3681.

Amendments

2007—Subsec. (a)(2). Pub. L. 109–482 substituted “section 282(b)(16)” for “section 282(b)(6)” in concluding provisions. 1993—Subsec. (c). Pub. L. 103–43 added subsec. (c).

Statutory Notes and Related Subsidiaries

Effective Date

of 2007 AmendmentAmendment 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.

§289a Peer review requirements