Protection of Human Subjects Act

Summary

Protection of Human Subjects Act - Establishes, within the Department of Health, Education and Welfare, the National Commission for the Protection of Human Subjects of Biomedical and Behavorial Research. Sets forth the membership composition of such Commission and their rates of compensation. Directs the Commission to: (1) investigate the ethical, social and legal implications of advances in biomedical and behavorial research; (2) develop ethical principles underlying the conduct of such research involving human subjects and implement regulations assuring that such research is carried out in accordance with those principles; (3) develop procedures for the certification of Institutional Review Boards; (4) develop sanctions for failure of the review boards to respond to Commission rules; and (5) develop a means for compensating individuals and their families for injuries or death proximately caused by such individual's participation in a biomedical or behavorial research program. Sets forth the subjects the Commission shall consider in carrying out these duties. Provides that no institution may receive assistance from the Department of Health, Education and Welfare to conduct biomedical or behavorial research involving human subjects unless such institution has established an Institutional Review Board certified by the Commission. Requires that until certification of such Boards has been established, each institution shall protect the welfare of subjects involved in research and attain, by adequate methods, their informed consent. Defines the term "informed consent." Stipulates that no exculpatory language of the agreement shall waive the subject's legal rights or release the institution or its agents from liability for negligence. Prescribes the duties of the Institutional Review Boards. Provides for inspection of facilities involved in biomedical and behavorial research programs involving human subjects. Sets forth recordkeeping requirements to be met by every biomedical research program under the Commission's jurisdiction. Authorizes appropriations of such sums as may be necessary to carry out this Act.

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1 official file

• Introduced in Senate

  summary · EN · 26 June 1973

  Open at official source

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