Page:United States Statutes at Large Volume 99 Part 1.djvu/896

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PUBLIC LAW 99-000—MMMM. DD, 1985

99 STAT. 874

PUBLIC LAW 99-158-NOV. 20, 1985 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

Regulations. 42 USC 289a. Grants. Contracts.

Regulations. Grants. Contracts.

Ante, p. 820.

Ante, pp. 823, 826.

"SEC. 492. (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 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). PROTECTION AGAINST SCIENTIFIC FRAUD

Regulations. Grants. Contracts. 42 USC 289b.

Report.

"SEC. 493. (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 submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that such entity— "(1) has established (in accordance with regulations which the Secretary shall prescribe) an administrative process to review reports of scientific fraud in connection with biomedical and behavioral research conducted at or sponsored by such entity; and "(2) will report to the Secretary any investigation of alleged scientific fraud which appears substantial. "(b) The Director of NIH snail establish a process for the prompt and appropriate response to information provided the Director of NIH respecting scientific fraud in connection with projects for