Problems of Informed Consent with the Cognitively Impaired

  • Ruth Macklin


The doctrine of informed consent for treatment and research is by now firmly embedded in health law and medical ethics. Federal regulations govern all research conducted on human subjects and supported by federal funds (Code of Federal Regulations, 1981); many states have passed legislation that mandates informed consent for treatment (Meisel and Kabnick, 1980); and the common law contains an increasing number of cases dealing both with informed consent for therapy and for research. Although it is interesting to learn the philosophical bases for the doctrine of informed consent (Veatch, 1978; Donagan, 1977) and to trace its history in law in the United States (Simpson, 1981; Trichter and Lewis, 1981), this chapter will be devoted primarily to the concept of informed consent as a moral requirement in the biomedical domain.


Biomedical Domain Moral Requirement Legal Doctrine Actual Understanding Belmont Report 
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  1. Annas, G.J. (1981). Help from the dead:The cases of Brother Fox and John Storar. Hastings Center Rep. 11, 19–20.CrossRefGoogle Scholar
  2. Annas, G.J. (1980). Quinlan, Saikewicz, and now Brother Fox. Hastings Center Rep. 10, 20–21.CrossRefGoogle Scholar
  3. Appelbaum, P.S., and Gutheil, T.G. (1980a). Druge refusal:A study of psychiatric inpatients. Am. J. Psychiat. 137, 340–346.PubMedGoogle Scholar
  4. Appelbaum, P.S., and Gutheil, T.G. (1980b). Rotting with their rights on: Constitutional theory and clinical reality in drug refusal by psychiatric patients. Bull. A.A.P.L. 7, 306–315.Google Scholar
  5. Appelbaum, P.S., and Gutheil, T.G. (1980c). The Boston state hospital case: “Involuntary mind control,” the constitution and the “right to rot.” Am. J. Psychiat. 137, 720–723.PubMedGoogle Scholar
  6. Appelbaum, P.S., and Roth, L.B. (1982). Competency to consent to research:A psychiatric overview. Arch. Gen. Psychiat. 39, 951–958.PubMedGoogle Scholar
  7. Bentham, J. (1789). An introduction to the Principles of Morals and Legislation. London.Google Scholar
  8. Capron, A.M. (1982). The authority of others to decide about biomedical interventions with incompetents. In: Who Speaks for the Child: The Problems of Proxy Consent (Gaylin, W., and Macklin, R., eds.), pp. 115–152. Plenum, New York.Google Scholar
  9. Code of Federal Regulations (1981). 45 CFR 46 Protection of human subjects. OPRR Reports (revised as of January 26, 1981).Google Scholar
  10. Cross, A.W., and Churchill, L.R. (1982). Ethical and cultural dimensions of informed consent. Ann. Intern. Med. 96, 110–113.PubMedGoogle Scholar
  11. Donagan, A. (1977). Informed consent in therapy and experimentation. J. Med. Philosophy 2, 310–327.Google Scholar
  12. Dworkin, G. (1982). Consent, representation and proxy consent. In: Who Speaks for the Child, pp. 191–208.Google Scholar
  13. Dworkin, G. (1976). Autonomy and behavior control. Hastings Center Rep. 6, 23–28.CrossRefGoogle Scholar
  14. Dworkin, G. (1972). Paternalism. Monist 56, 64–84.Google Scholar
  15. Freedman, B. (1981). Competence, marginal and otherwise. Int. J. Law Psychiat. 4, 53–72.CrossRefGoogle Scholar
  16. Goldstein, J. (1982). Medical care for the child at risk: On state supervention of parental autonomy. In: Who Speaks for the Child, pp. 153–188.Google Scholar
  17. Kant, I. (1785). Fundamental principles of the metaphysics of morals. Originally published in 1785.Google Scholar
  18. Macklin, R. (1982). Return to the best interests of the child. In: Who Speaks for the Child, pp. 265–301.Google Scholar
  19. Meisel, A., and Roth, L. H. (1981). What we do and do not know about informed consent. JAMA 246, 2473–2477.PubMedCrossRefGoogle Scholar
  20. Meisel, A., and Kabnick, L. D. (1980). Informed consent to medical treatment: An analysis of recent legislation. Univ. Pitt Law Rev. 41, 407–564.Google Scholar
  21. Mill, J. S. (1863). Utilitarianism. London.Google Scholar
  22. Miller, B. L. (1981). Autonomy and the refusal of lifesaving treatment. Hastings Center Rep. 11, 22–28.CrossRefGoogle Scholar
  23. National Commission for the Protection of Human Subjects: The Belmont Report-Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Department of Health, Education, and Welfare, Government Printing Office, (OS)78-0012, Washington, D.C.Google Scholar
  24. Roth, L. B., Meisel, A., and Lidz, C. W. (1977). Tests of competency to consent to treatment. Am. J. Psychiat. 134, 279–284.PubMedGoogle Scholar
  25. Simpson, R. E. (1981). Informed consent: From disclosure to patient participation in medical decision-making. Northwestern Univ. Law Rev. 76, 172–297.Google Scholar
  26. Trichter, J. G., and Lewis, P. W. (1981). Informed consent: The three tests and a modest proposal for the reality of the patient as an individual. South Texas Law J. 21, 155–170.Google Scholar
  27. Veatch, R. M. (1978). Three theories of informed consent: Philosophical foundations and policy implications. In: National Commission for the Protection of Human Subjects: The Belmont Report, Appendix Volume. Department of Health, Education, and Welfare, Government Printing Office, Washington, D.C.Google Scholar

Copyright information

© Springer-Verlag New York Inc. 1983

Authors and Affiliations

  • Ruth Macklin
    • 1
  1. 1.Department of Community HealthAlbert Einstein College of MedicineBronxUSA

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