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Informed Consent: Its History, Meaning, and Present Challenges



The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.



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1. Percival, T.Medical Ethics; or a Code of Institutes and Precepts, Adapted to the Professional Conduct of Physicians and Surgeons. Manchester: S. Russell; 1803.

2. Salgo v. Leland Stanford Jr. University Board of Trustees, 317 P.2d 170 (1957).

3. Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972); Cobbs v. Grant, 104 Cal. Rptr. 505, 502 P.2d 1 (1972); Wilkinson v. Vesey, 295 A.2d 676 (R.I. 1972).

4. See note 3, Canterbury v. Spence, at 786.

5. Hershey, N, Bushkoff, SH.Informed Consent Study. Pittsburgh: Aspen Systems Corporation; 1969:4.

6. National Library of Medicine, 272 citations on informed consent in the period from January 1970 to April 1974, in Medical Literature Analysis and Retrieval System (MEDLARS), NLM Literature Search No. 74-16 (1974); Kaufmann, CL.Informed consent and patient decision making: Two decades of research. Social Science and Medicine 1983;17:1657–64.

7. Louis Harris and Associates. Views of informed consent and decisionmaking: Parallel surveys of physicians and the public. In: President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Making Health Care Decisions. Washington: U.S. Government Printing Office; 1982:vol. 2:302.

8. Siminoff, LA, Fetting, JH.Factors affecting treatment decisions for a life-threatening illness: The case of medical treatment for breast cancer. Social Science and Medicine 1992;32:813–8, at 817.

9. Faden, RR, Beauchamp, TL.A History and Theory of Informed Consent. New York: Oxford University Press; 1986:276–87.

10. Katz, J.The Silent World of Doctor and Patient. New York: Free Press; 1984.

11. For an example of how the legal doctrine is still today used by prominent authors in bioethics as a foundational starting point for theory and practice, see Appelbaum, PS, Lidz, CW, Klitzman, R.Voluntariness of consent to research: A conceptual model. Hastings Center Report 2009;39(1):30–9.

12. Buchanan, A. An ethical framework for biological samples policy. In: National Bioethics Advisory Commission. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, vol. II: Commissioned Papers. Rockville: National Bioethics Advisory Commission; January 2000; Pentz, RD, Billot, L, Wendler, D.Research on stored biological samples: Views of African American and White American cancer patients. American Journal of Medical Genetics. 2006 Mar 7; available at (last accessed 14 Sept 2010).

13. Harmon, A.Indian tribe wins fight to limit research of its DNA. New York Times. 2010 Apr 21; available at; Harmon, A.Havasupai case highlights risks in DNA research. New York Times. 2010 Apr 22; available at (last accessed 14 Sept 2010).

14. Harmon, A.Where’d you go with my DNA? New York Times. 2010 Apr 25; available at (last accessed 14 Sept 2010). Also see note 13, Harmon 2010 Apr 21; and Harmon 2010 Apr 22.


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