ROBERT J. LEVINE, M.D.
The drug regulation reform act of 1979 (S. 1075) has been passed by the Senate and is now on the agenda of the House of Representatives. Dorsen and Miller (1) recently reviewed some features of this bill and concluded that, although it is not perfect, it "merits support." They did not, however, point out that S. 1075 would create a statutory definition of "voluntary and informed consent," specify requirements for its documentation in most cases, extend consent standards designed for research into aspects of medical practice, and prescribe stern criminal penalties for noncompliance. Because of some serious flaws in the
LEVINE RJ. Proposed Statutory Definition of "Voluntary and Informed Consent". Ann Intern Med. ;92:699–700. doi: 10.7326/0003-4819-92-5-699
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Published: Ann Intern Med. 1980;92(5):699-700.
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