INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM

SEC. 491. 12891 (a) The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this Act for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an "Institutional Review Board") to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research.

(b)(1) The Secretary shall establish a program within the Department of Health and Human Services under which requests for clarification and guidance with respect to ethical issues raised in connection with biomedical or behavioral research involving human subjects are responded to promptly and appropriately.

(2) The Secretary shall establish a process for the prompt and appropriate response to information provided to the Director of NIH respecting incidences of violations of the rights of human subjects of research for which funds have been made available under this Act. The process shall include procedures for the receiving of reports of such information from recipients of funds under this Act and taking appropriate action with respect to such violations.

PEER REVIEW REQUIREMENTS

SEC. 492. [289a] (a)(l) 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 Act 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 the date of the date of enactment of the Health Research Extension Act of 1985 to grants under this Act for biomedical and behavioral research, and

(B) to the extent practical, by technical and scientific peer review groups performing such review on or before such date, and shall authorize such review to be conducted by groups appointed under sections 402(b)(6) and 405(c)(3).

(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, and shall authorize such review to be conducted by groups appointed under sections 402(b)(6) and 405(c)(3).

(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 492B.

(2) Paragraph (1) shall not apply to any proposal for clinical research that, pursuant to subsection (b) of section 492B, 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.

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