
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document affected by Public Law 106-505 Section 1001(a)]
[Document affected by Public Law 106-310 Section 2701]
[Document affected by Public Law 106-505 Section 1001(b)]
[Document affected by Public Law 107-109 Section 12]
[CITE: 42USC289]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
              SUBCHAPTER III--NATIONAL RESEARCH INSTITUTES
 
                       Part H--General Provisions
 
Sec. 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, Sec. 491, as added Pub. L. 99-158, 
Sec. 2, Nov. 20, 1985, 99 Stat. 873.)

                  Section Referred to in Other Sections

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