§289. Institutional review boards; ethics guidance program

(a) The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter 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 chapter. The process shall include procedures for the receiving of reports of such information from recipients of funds under this chapter and taking appropriate action with respect to such violations.

(July 1, 1944, ch. 373, title IV, §491, as added Pub. L. 99–158, §2, Nov. 20, 1985, 99 Stat. 873 .)

Requirement for Additional Protections for Children Involved in Research

Pub. L. 106–310, div. A, title XXVII, §2701, Oct. 17, 2000, 114 Stat. 1167 , as amended by Pub. L. 106–505, title X, §1001(a), Nov. 13, 2000, 114 Stat. 2350 , provided that: "Notwithstanding any other provision of law, not later than 6 months after the date of the enactment of this Act [Oct. 17, 2000], the Secretary of Health and Human Services shall require that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services be in compliance with subpart D of part 46 of title 45, Code of Federal Regulations."

[ Pub. L. 106–505, title X, §1001(b), Nov. 13, 2000, 114 Stat. 2350 , provided that: "The amendment made by subsection (a) [amending section 2701 of Pub. L. 106–310, set out above] takes effect on the date of the enactment of the Children's Health Act of 2000 [Oct. 17, 2000].

Section Referred to in Other Sections

This section is referred to in sections 280e, 283f, 287c, 289a–1 of this title.