Page:United States Statutes at Large Volume 88 Part 1.djvu/396

 352 Membership.

5 USC 101 et seq.

Ante, p. 348. Term.

5 USC app. I. Effective date. 42 USC 218 note.

PUBLIC LAW 93-348-JULY 12, 1974

[88

STAT.

(hereinafter in this subsection referred to as the 'Council') which shall consist of the Secretary who shall be Chairman and not less than seven nor more than fifteen other members who shall be appointed by the Secretary without regard to the provisions of title 5, United States Code, governing appointments in the competitive service. The Secretary shall select members of the Council from individuals distinguished in the fields of medicine, law, ethics, theology, the biological, physical, behavioral and social sciences, philosophy, humanities, health administration, government, and public affairs; but three (and not more than three) of the members of the Council shall be individuals who are or who have been engaged in biomedical or behavioral research involving human subjects. No individual who was appointed to be a member of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (established under title II of the National Research Act) may be appointed to be a member of the Council. The appointed members of the Council shall have terms of office of four years, except that for the purpose of staggering the expiration of the terms of office of the Council members, the Secretary shall, at the time of appointment, designate a term of office of less than four years for members first appointed to the Council. "(2) The Council shall— " (A) advise, consult with, and make recommendations to, the Secretary concerning all matters pertaining to the protection of human subjects of biomedical and behavioral research; " (B) review policies, regulations, and other requirements of the Secretary governing such research to determine the extent to which such policies, regulations, and requirements require and are effective in requiring observance in such research of the basic ethical principles which should underlie the conduct of such research and, to the extent such policies, regulations, or requirements do not require or are not effective in requiring observance of such principles, make recommendations to the Secretary respecting appropriate revision of such policies, regulations, or requirements; and " (C) review periodically changes in the scope, purpose, and types of biomedical and behavioral research being conducted and the impact such changes have on the policies, regulations, and other requirements of the Secretary for the protection of human subjects of such research. "(3) The Council may disseminate to the public such information, recommendations, and other matters relating to its functions as it deems appropriate. "(4) Section 14 of the Federal Advisory Committee Act shall not apply with respect to the Council." (b) The amendment made by subsection (a) shall take effect July 1, 1976. 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 42 USC 289Z-3.

"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

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