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42 U.S.C. § 289aPeer review requirements

submitted 82 years ago by Pub. L. 99-158 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 388 words · no verdicts yet

in plain englishAI-generated · not legal advice

NIH grant, contract, and cooperative-agreement applications for biomedical and behavioral research must go through technical and scientific peer review, following rules the Secretary sets, generally keeping the review system and review groups that were already in place as of November 20, 1985. NIH's own in-house research must also go through periodic peer review, with a written description of the research shared with reviewers and results shared with the relevant advisory council. When reviewing clinical research proposals, reviewers must also check whether the proposal follows the separate rules on including women and minorities as subjects, unless that requirement doesn't apply to this particular proposal.

(a) Peer review of applications. The Secretary, acting through the Director of NIH, must require by regulation appropriate technical and scientific peer review of (A) applications for grants and cooperative agreements under this chapter for biomedical and behavioral research, and (B) applications for biomedical and behavioral research and development contracts administered through NIH. These regulations must require that review to be done, to the extent practical, consistent with the peer-review system that was already being used, as of November 20, 1985, for biomedical and behavioral research grants under this chapter, and, to the extent practical, by the same technical and scientific peer review groups that were doing that review on or before that date. The regulations must also allow this review to be conducted by groups appointed under sections 282(b)(16) and 284(c)(3) of this title. (b) Periodic review of NIH's own research. The Director of NIH must set up procedures for periodically reviewing, technically and scientifically, the research NIH conducts itself. These procedures must require that the group doing the review get a written description of the research being reviewed, and that the group share that description and its review results with the advisory council of the relevant national research institute. The regulations must allow this review to be conducted by groups appointed under sections 282(b)(6) and 284(c)(3) of this title. (c) Checking compliance on women and minorities in clinical research. When a clinical-research proposal goes through the peer review this section requires, that review (including the very first look at the proposal) must, with one exception, include checking the proposal's technical and scientific merit against the requirements of section 289a–2 of this title, on including women and minority groups as subjects. This checking requirement does not apply to a clinical-research proposal that section 289a–2(b) of this title exempts from the inclusion requirement in section 289a–2(a).
the actual law source: uscode.house.gov ↗public domain
(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 sections 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 sections 282(b)(6) 1 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.

Source credit: (July 1, 1944, ch. 373, title IV, § 492, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 874; amended Pub. L. 103–43, title I, § 132, June 10, 1993, 107 Stat. 135; Pub. L. 109–482, title I, § 102(f)(1)(B), Jan. 15, 2007, 120 Stat. 3685.)

history & why it existsrecord from the source credit
  • 1944Enacted · Pub. L. 99-158 · 99 Stat. 874
  • 1993Amended · Pub. L. 103-43 · 107 Stat. 135
  • 2007Amended · Pub. L. 109-482 · 120 Stat. 3685

A history note hasn’t been published yet. The record shows enactment by Pub. L. 99-158 on 1944-07-01.

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