Page:United States Statutes at Large Volume 88 Part 1.djvu/393

 88 STAT. ]

PUBLIC LAW 93-348-JULY 12, 1974

349

COMMISSION DUTIES 42 USC 289M SEC. 202. (a) The Commissioii shall carry out the following: note. (1)(A) The Commission shall (i) conduct a comprehensive investi- Research ingation and study to identify the basic ethical principles which should volving human subjects, study; underlie the conduct of biomedical and behavioral research involving guideline develophuman subjects, (ii) develop guidelines which should be followed in ment. such research to assure that it is conducted in accordance with such principles, and (iii) make recommendations to the Secretary (I) for such administrative action as may be appropriate to apply such guidelines to biomedical and behavioral research conducted or supported under programs administered by the Secretary, and ( II) concerning any other matter pertaining to the protection of human subjects of biomedical and behavioral research. (B) I n carrying out subparagraph (A), the Commission shall consider at least the following: (i) The boundaries between biomedical or behavioral research involving human subjects and the accepted and routine practice of medicine. (ii) The role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects. (iii) Appropriate guidelines for the selection of human subjects for participation in biomedical and behavioral research. (iv) The nature and definition of informed consent in various research settings. (v) Mechanisms for evaluating and monitoring the performance of Institutional Review Boards established in accordance with section 474 of the Public Health Service Act and appropriate Post, p. 352. enforcement mechanisms for carrying out their decisions. (C) The Commission shall consider the appropriateness of applying the principles and guidelines identified and developed under subparagraph (A) to the delivery of health services to patients under programs conducted or supported by the Secretary. Consent re(2) The Commission shall identify the requirements for informed quirements. consent to participation in biomedical and behavioral research by children, prisoners, and the institutionalized mentally infirm. The Commission shall investigate and study biomedical and behavioral research conducted or supported under programs administered by the Secretary and involving children, prisoners, and the institutionalized mentally infirm to determine the nature of the consent obtained from such persons or their legal representatives before such persons were involved in such research; the adequacy of the information given them respecting the nature and purpose of the research, procedures to be used, risks and discomforts, anticipated benefits from the research, and other matters necessary for informed consent; and the competence and the freedom of the persons to make a choice for or against involvement in such research. On the basis of such investigation and study the Commission shall make such recommendations to the Secretary as it determines appropriate to assure that biomedical and behavioral research conducted or supported under programs administered by him meets the requirements respecting informed consent identified by the Commission. For purposes of this paragraph, the term "children" means Definitions. individuals who have not attained the legal age of consent to participate in research as determined under the applicable law of the jurisdiction in which the research is to be conducted; the term "prisoner" means individuals involuntarily confined in correctional institutions or facilities (as defined in section 601 of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3781)); and the term "institutionalized mentally infirm" includes individuals who are mentally

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