Human experimentation: Protecting patient autonomy through informed consent

Journal of Legal Medicine

Volumn 18, Issue 2, 1997, Pages 221-250

  Tuthill, Kathryn A ^a  

^a SOUTHERN ILLINOIS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; PATIENT COUNSELING; PATIENT INFORMATION; PATIENT RIGHT; REVIEW;

EID: 0030741448     PISSN: 01947648     EISSN: 1521057X     Source Type: Journal    
DOI: 10.1080/01947649709511033     Document Type: Note

References (30)

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2. Cotton. 1992. Gulf War Symptoms Remain Puzzling. J.A.M.A., 268:2619
3. 1990. Black's Law Dictionary, 6th ed. 779 [A] general principle of law that a physician has a duty to disclose what a reasonably prudent physician in the medical community in the exercise of reasonable care would disclose to his patient as to whatever grave risks of injury might be incurred from a proposed course of treatment, so that a patient, exercising ordinary care for his own welfare, and faced with a choice of undergoing the proposed treatment, or alternative treatment, or none at all, may intelligently exercise judgment by reasonably balancing the probable risks against the probable benefits
4. Schuchardt. 1992. Walking a Thin Line:Distinguishing Between Research and Medical Practice During Operation Desert Storm. Colum. J.L. & Soc. Probs., 26:7793
5. National Commission for the Protection of Human Subjects of Biomédical and Behavioral Research. 1978. The Belmont Report:Ethical Principles and Guidelines for the Protection of Human Subjects of Research Schuchardt, supra note 4, at 92. See
6. Delgado and Leskovac. 1986. Informed Consent in Human Experimentation:Bridging the Gap Between Ethical Thought and Current Practice. UCLA L. Rev., 34:6797
7. Katz. 1993. Human Experimentation and Human Rights. St. Louis U. L.J., 38:715
8. Jones, J., 1993. Bad Blood:The Tuskegee Syphilis Experiment
9. Schwartz. 1985. Informed Consent to Participation in Medical Research Employing Elderly Human Subjects. J. Contemp. Health L. & Pol'y, 1:115120
10. 1986. Regulation of Informed Consent to Human Experimentation. Loy. U. Chi. L.J., 17:507525 Note
11. Nightingale. 1995. Challenges in Human Subject Protection. Food & Drug L.J., 50:493499
12. Moore. 1991. Recurrent Issues in the Review of Medical Research on Human Subjects. Alb. L.J. Sci. & Tech., 1:1
13. Levine, R., 1986. Ethics and Regulation of Clinical Research, 2d ed. 327 ("[T]he IRB should be highly attentive to the interests of institutions and investigators, as well as those of research subjects. When IRBs are functioning at the best levels, they harmonize these interests to the extent there is no conflict.”)
14. 1974. Fed. Reg., 39:18,917 The rules published in 1974 by the Department of Health, Education and Welfare included the following definition of informed consent:‘''Informed consent’ means the knowing consent of an individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion.
15. 1981. Fed. Reg., 46:8389–90. This definition caused much public debate and was not included in the regulations until 1981. Instead, the regulations listed eight elements of informed consent and six additional optional elements
16. 1996. Informed Consent:Class Status Granted to Suit Over Unwilling Participation in Experiments. BNA Health L. Rep., 5:14
17. Hanlon, Steve. Case History:Flora Diaz v. Tampa General Hospital. 1 (on file with author)
18. Annas. 1991. Mengele's Birthmark:The Nuremberg Code in the United States Courts. J. Contemp. Health L. & Pol'y, 7:1720–21.
19. Annas and Grodin. Mar.-Apr. 1991. “Commentary”. In Hastings Center Rep. Mar.-Apr., 24 The Department of Defense (DOD) adopted the Nuremberg Code as official policy in 1953. For reasons that remain unclear, the DOD classified the policy “Top Secret” until August 22, 1975
20. 1949. Triels of War Criminals Before the Nurenberg [sic] Military Trials Under Control Council Law No. 10 171–78.
21. Visscher, M., 1975. Ethical Constraints and Imperatives in Medical Research Edited by:Slovenko, R., 102
22. Sept. 29 1996. 60 Minutes:The Pill Sept. 29, (CBS television broadcast
23. Neergaard. 1996. Dying Patients May Get Drugs Without Consent. Chi. Sun-Times, Dec. 24:10
24. 1996. Protection of Human Subjects. Fed. Reg., 61:51,498
25. 1996. Protection of Human Subjects. Fed. Reg., 61:51,498 (to be codified at 21 C.F.R. §§ 50, 56, 312, 314, 601, 812, & 814). The FDA's new rules on informed consent were created “in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.
26. Levine. 1995. Research in Emergency Situations:The Role of Deferred Consent. J.A.M.A., 273:1300
27. Marwick. 1996. FDA Gets Feedback on Informed Consent Waiver. J.A.M.A., 275:347
28. Schwartz. 1996. Rules Eased for Emergency Therapy. Wash. Post, Sept. 27:A11
29. Kolata. 1996. Doctors Can Now Experiment Without the Patient's Consent. San Diego Union-Trib., Nov. 5:A1
30. Second-year student at Southern Illinois University School of Law. Address correspondence to Ms. Tuthill at Southern Illinois University School of Law, c/o Law Journal Office, Lesar Law Building, Carbondale, Illinois 62901.