IRB National Research Act
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PUBLIC LAW 93-48
JULY 12, 1974
INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM
Sec. 212. (a) Part I of title IV of the Public Health Service Act, as amended by section 103 of this Act, is amended by adding at the end the following new section:
INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM
Sec. 474 (a) The Secretary shall by regulation require that each entity which applies for a grant or contract under this Act 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 or contract 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 sponsored by such entity in order to protect the rights of the human subjects of such research.
(b) The Secretary shall establish a program within the Department 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.
(c) The Secretary of Health, Education and Welfare shall within 240 days of the date of the enactment of this Act promulgate such regulations as may be required to carry out section 474 (a) of the Public Health Service Act. Such regulations shall apply with respect to applications for grants and contracts under such Act submitted after promulgation of such regulations.
THE CODE OF FEDERAL REGULATIONS, 45 CFR 46, IMPLEMENTS THESE AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.