A bill to amend the Public Health Service Act to establish the President's Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
President's Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Act - Amends the Public Health Service Act to establish the President's Commission for the Protection of Human Subjects of Biomedical and Behavorial Research.
Directs the Commission to: (1) conduct an investigation to identify the ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjects; (2) develop guidelines to be followed in such research; and (3) make recommendations to the appropriate agency or department 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 appropriate agency or department.
Requires the Commission to develop uniform policies, procedures, and guidelines to be followed in biomedical and behavioral research involving human subjects to assure that it is conducted in accordance with ethical principals identified by the Commission.
Directs the Commission to investigate and study biomedical and behavioral research conducted, supported or regulated under programs administered by any Government department or agency involving children, prisoners, military personnel, and the institutionalized mentally infirm to determine the nature of the consent obtained and the information given to such persons before such persons were involved in the research.
Directs the Commission to develop guidelines to be followed by each department or agency in establishing, implementing, certifying, and monitoring human investigation review boards in those entities which receive funds from or which are regulated by such department or agency.
Directs the Commission to undertake a comprehensive study of the ethical, social, and legal implications of advances in biomedical and behavioral research technology, including an analysis and evaluation of the implications of such advances both for individuals and for society.
Directs the Commission to identify the basic ethical principles which should underlie the delivery of health services.
Directs each Government department or agency, in cooperation with the Commission, to develop guidelines for the establishment and cooperation of human investigation review boards in entities which are supported by such department or agency. Makes it the duty of each human investigation review board to:(1) establish policies for the review of research sponsored in whole or part by Federal funds or required by Federal regulation; and (2) assume full responsibility to insure that biomedical and behavioral research involving human subjects is carried out under the safest possible conditions and with the fully informed consent of the subject or his family.
Requires each agency which has established a human investigation review board to establish and maintain such records as any such agency shall by regulation require in order to determine compliance with this Act.
States that personal data collected by the Commission or by an agency pursuant to this Act, may not be disclosed to any person or entity other than the individual who is the subject of the data.
Stipulates that until such time as a human investigation review board has been certified by a department, each department shall determine with respect to biomedical and behavioral research supported by each department that: (1) the rights of human subjects of such research are fully exercised; (2) the interests of human subjects of such research are fully protected; (3) the risks to a human subjects of such research are outweighed by the potential benefits to him or her or by the importance of the knowledge to be gained from such research; and (4) informed consent is given by each human subject.
Repeals the provisions for a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research of the National Research Act. Abolishes the National Advisory Council for the Protection of Subjects of Biomedical and Behavioral Research.
Introduced in Senate
Referred to Senate Committee on Human Resources.
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