Proposed Statutory Definition of "Voluntary and Informed Consent"

Editorial Notes1 May 1980Proposed Statutory Definition of "Voluntary and Informed Consent"ROBERT J. LEVINE, M.D.ROBERT J. LEVINE, M.D.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-92-5-699 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptThe 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...References1. DORSENMILLER NJ. The drug regulation process and the challenge of regulatory reform. Ann Intern Med. 1979;91:908-13. LinkGoogle Scholar2. LEVINE R. The Senate's proposed statutory definition of "voluntary and informed consent." IRB Rev Hum Subjects Res. 1980;2(4):8-10. Google Scholar3. LEVINE R. Clarifying the concepts of research ethics. Hastings Center Rep. 1979;9(3):21-6. CrossrefMedlineGoogle Scholar4. Federal Food, Drug, and Cosmetic Act, as amended October, 1976. Washington, D.C: U.S. Government Printing Office, 1976 (Stock No. 017-012-00239-1.) Google Scholar5. LEVINE R. The institutional review board. In : THE NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RESEARCH: Report and Recommendations: Institutional Review Boards (Appendix). Washington, D.C: U.S. Government Printing Office; 1978:4.1-4.73. (DHEW Publication No. (OS) 78-0009.) Google Scholar6. LEBACQZLEVINE KR. Respect for persons and informed consent to participate in research. Clin Res. 1977;25:101-7. MedlineGoogle Scholar7. BRADY J. A consent form does not informed consent make. IRB Rev Hum Subjects Res. 1979;1 (7):6-7. Google Scholar8. INGELFINGER F. The unethical in medical ethics. Ann Intern Med. 1975;83:264-9. LinkGoogle Scholar This content is PDF only. To continue reading please click on the PDF icon. Author, Article, and Disclosure InformationAffiliations: PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics 1 May 1980Volume 92, Issue 5Page: 699-700KeywordsDrug regulationResearch design Issue Published: 1 May 1980 PDF DownloadLoading ...