PRIA, Government Policy, Made Personal

Summary

Require the Secretary, acting through the NIH Director, to make rules that require scientific peer review of applications for biomedical and behavioral research grants, cooperative agreements, and contracts run by NIH. The rules must, when possible, follow the review system and use the review groups that existed on November 20, 1985, and may allow groups appointed under sections 282(b)(16) and 284(c)(3) to do the reviews. Require the NIH Director to set up regular peer reviews of research done at NIH. Reviewers must get a written description of the work and must send that description and their findings to the institute’s advisory council. For clinical research proposals, reviewers must check whether the plan meets the rules on including women and minorities in studies in section 289a–2, unless the proposal is exempt under subsection (b) of that section. Reviews may be done by groups appointed under sections 282(b)(6) and 284(c)(3).

Title 42, §289a

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

(a)Applications for biomedical and behavioral research grants, cooperative agreements, and contracts; regulations

(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,

and shall authorize such review to be conducted by groups appointed under section 282(b)(16) and 284(c)(3) of this title.

(b)Periodic review of research at National Institutes of Health

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,

and shall authorize such review to be conducted by groups appointed under section 282(b)(6) and 284(c)(3) of this title.

(c)Compliance with requirements for inclusion of women and minorities in clinical research

(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