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

(a) Institutional Review Boards required. The Secretary must, by regulation, require that any entity applying for a grant, contract, or cooperative agreement under this chapter, for a project or program involving biomedical or behavioral research on human subjects, submit assurances — satisfactory to the Secretary and following the Secretary's regulations — that it has set up a board known as an "Institutional Review Board." That Board's job is to review biomedical and behavioral research on human subjects that happens at, or is supported by, that entity, in order to protect the human subjects' rights. (b) Ethics guidance and reporting. The Secretary must set up a program within the Department of Health and Human Services to respond promptly and properly to requests for clarification or guidance on ethical issues that come up in biomedical or behavioral research on human subjects. The Secretary must also set up a process to respond promptly and properly whenever the Director of NIH gets information about violations of human subjects' rights in research funded under this chapter. That process must include ways to receive reports of such information from people who got funding under this chapter, and to take appropriate action about those violations.