As part of the Department of Health and Human Services (HHS), the Office for Human Research Protections (OHRP) functions under the statutory authority provided by the United States Code Chapter 42 – The Public Health and Welfare. Specific authority derives from Chapter 6A – Public Health Service, Subchapter III – National Research Institutes, Part H – General Provisions. Section 289 provides the authority for OHRP operations. Other sections in Part H that relate to the work of OHRP include sections 289a-1, 289g, 289g-1, and 289g-2.
Other departments and agencies that have promulgated the Common Rule to include sections in their regulations identical to 45 CFR part 46, subpart A have done so under the authority of their particular titles of the United States Code.
(Links below are to the Government Printing Office website pages for the United States Code.)
The statutory structure can be shown as:
Title 42 - THE PUBLIC HEALTH AND WELFARE
CHAPTER 6A - PUBLIC HEALTH SERVICE (sections 201 - 300mm-61)
SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES (sections 281 - 290b)
Part H - General Provisions (sections 289 - 290a)
Sec. 289 - Institutional review boards; ethics guidance program
Sec. 289a-1 - Certain provisions regarding review and approval of proposals for research
Sec. 289g - Fetal research
Sec. 289g-1 - Research on transplantation of fetal tissue
Sec. 289g-2 - Prohibitions regarding human fetal tissue
The text of the foundational Section 289, enacted in 1985, is as follows:
§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.)
