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

Summary

The Secretary, through the NIH Director, must make rules that require scientific peer review for applications for grants, cooperative agreements, and for biomedical and behavioral research contracts handled by NIH. The rules should, when practical, follow the peer review system and use review groups that were in place on November 20, 1985. The NIH Director must set up regular review procedures that give reviewers a written description of the research and require the reviewers to give that description and their results to the institute’s advisory council. For clinical research, reviewers must check the scientific quality and whether the proposal follows the rules in section 289a–2, except for studies that section 289a–2(b) says are exempt from the inclusion requirement in 289a–2(a).

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