42 U.S.C. § 289 - Institutional review boards; ethics guidance program

• Cite as: 42 U.S.C. § 289
• Currency: Current through P.L. 115-223

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(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.

Cite as 42 U.S.C. § 289

Source: July 1, 1944, ch. 373, title IV, §491, as added Pub. L. 99-158, §2, Nov. 20, 1985, 99 Stat. 873.

Notes from the Office of Law Revision Counsel

current through 4/10/2020

PROTECTION OF HUMAN RESEARCH SUBJECTS

Pub. L. 114-255, div. A, title III, §30233023,, 130 Stat. 1098, provided that:

"(a) IN GENERAL.-In order to simplify and facilitate compliance by researchers with applicable regulations for the protection of human subjects in research, the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall, to the extent practicable and consistent with other statutory provisions, harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations in accordance with subsection (b).

"(b) AVOIDING REGULATORY DUPLICATION AND UNNECESSARY DELAYS.-The Secretary shall, as appropriate-

"(1) make such modifications to the provisions of the HHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable populations rules as may be necessary-