Assuring Adequate Consent

Special Considerations in Patients of Uncertain Competence
  • Alan Meisel
Part of the Contemporary Issues in Biomedicine, Ethics, and Society book series (CIBES)


Disease, pursuit and application of knowledge, ethics, and law—these are the four component parts of the problem that this conference is attempting to address. My own efforts are directed primarily at the legal component, and more specifically, at one of its subcomponents.


Supra Note Research Procedure Decisional Autonomy Bodily Integrity Rational Reason 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Notes and References

  1. 2.
    See US DEPT OF HEALTH & HUMAN SERVICES, Final Regulations Amending Basic HHS Policy for the Protection of Human Subjects, 46 Fed. Reg. 8366, 8386–91 (January 26, 1981) [hereinafter cited as “Fed. Regs.”].Google Scholar
  2. 3.
    See Ibid. Section 46.111.Google Scholar
  3. 4.
    G. CALABRESI & P. BOBBITT, TRAGIC CHOICES 41 passim (1978).Google Scholar
  4. 5.
    See Fed. Regs. Section 46.116, supra note 2.Google Scholar
  5. 6.
    See Kaimowitz v. Dept of Mental Health No. 73–19434-AW (Mich. Cir. Ct., Wayne Cty., July 10, 1973), reported in 1 MDLR 147 (1976).Google Scholar
  6. 7.
    See generally Meisel, The Exceptions: to the Informed Consent Doctrine: Striking a Balance Between Competing Values in Medical Decisionmaking, 1979 WIS. L. REV. 413, 415n.8 & 419.Google Scholar
  7. 8.
    See In re Quinlan, 70 N.J. 10, 355 A.2d 647 (1976); In re Storar, 52 N.Y.2d 363, 420 N.E.2d 64 (1981); In re Spring, 405 N.E.2d 115 (Mass. 1980); Severns v. Wilmington Medical Center, Inc., 421 A.2d 1334 (Del. 1980); Superintendent of Belchertown State School v. Saikewicz, 370 N.E.2d 417 (Mass. 1977); Satz v. Perlmutter, 362 So.2d 160, 162 (Fla. Dis. Ct. App. 1978), aff’d, 379 So.2d 359 (Fla. 1980).Google Scholar
  8. 9.
    In general the states are divided about how to measure the adequacy of information given to a patient. Some require that patients be given what a reasonable patient would find “material” to making a decision about treatment while others require the physician to provide patients with that kind and amount of information which reasonable members of the medical profession customarily provide. See generally Meisel & Kabnick, Informed Consent to Medical Treatment: An Analysis of Recent Legislation, 41 U. PI’11. L. REV. 407, 421–426 (1980).Google Scholar
  9. 10.
    Ibid. at 427.Google Scholar
  10. 11.
    Fed. Regs. Section 46.116(a)(2)-(4), supra note 2.Google Scholar
  11. 12.
    See Meisel, The Expansion of Liability for Medical Accidents: From Negligence to Strict Liability by Way of Informed Consent, 56 NEB. L. REV. 51, 113–123 (1977).Google Scholar
  12. 13.
    See J. KATZ, EXPERIMENTATION WITH HUMAN BEINGS 305–306 (1972).Google Scholar
  13. 14.
    See 271 N. ENG. J. MED. 473 (1964).Google Scholar
  14. 15.
    US DEPT OF HEALTH, EDUCATION & WELFARE, Protection of Human Subjects, 39 Fed. Reg. 18,914 (May 30, 1974).Google Scholar
  15. 16.
    Fed. Regs., supra note 2.Google Scholar
  16. 17.
    Ibid. Section 46.116(a)(1)-(4).Google Scholar
  17. 18.
    Ibid. Section 46.116(a)(5)-(8).Google Scholar
  18. 19.
    I bid. Section 46.116(a).Google Scholar
  19. 20.
    Informed consent to non-experimental medical procedures need not be obtained in an emergency. See Meisel, The “Exceptions” to the Informed Consent Doctrine, supra note 7, at 434 438. Whether or not experimental medical procedures maybe performed in an emergency without obtaining informed consent is unclear. Section 46.116(f) of the Fed. Regs., supra note 2, purports to deal with this matter, but does not give any useful guidance. See Abramson, Meisel, & Safar, Informed Consent to Resuscitation Research, 246 JAMA 2828 (1981).Google Scholar
  20. 21.
    One of the few exceptions is State Dept. of Human Services v. Northern, 563 S.W.2d 197 (Tenn. Ct. App. 1978). In that case, the patient was able to communicate but was found incompetent nonetheless because of the inconsistency and illogic inherent in the directives that she was giving toher caretakers. The court failed to provide a universal or even a general standard by which incompetency is to be determined, confining itself narrowly to the facts of the case, and stating:[T]his Court has found the patient to be lucid and apparently of sound mind generally. However, on the subjects of death and amputation of her feet [which were the probable consequence and proposed procedure respectively], her comprehension is blocked, blinded or dimmed to the extent that she is incapable of recognizing facts which would be obvious to a person of normal perception. Ibid. at 209–210. What the court says amounts to little more than the patient is incompetent because she is not normal, hardly a helpful guide.Google Scholar
  21. 22.
    See In re Storar, 52 N.Y.2d 363, 420 N.E.2d 64 (1981); In re Spring, 405 N.E.2d 115 (Mass. 1980); Superintendent of Belchertown State School v. Saikewicz, 370 N.E.2d 417 (Mass. 1977); Custody of a Minor, 385 Mass. 697, 434 N.E.2d 601 (1982); In re Dinnerstein, 380 N.E.2d 134 (Mass. Ct. App. 1978); In re Roe, 421 N.E.2d 40 (Mass. 1981).Google Scholar
  22. 23.
    See Superintendent of Belchertown State School v. Saikewicz, 370 N.E.2d 417 (Mass. 1977).Google Scholar
  23. 24.
    Cf. In re Storar, 52 N.Y.2d 363, 420 N.E.2d 64 (1981).Google Scholar
  24. 25.
    Fed. Regs. Section 46.111(b), supra note 2.Google Scholar

Copyright information

© The Humana Press, Inc. 1985

Authors and Affiliations

  • Alan Meisel

There are no affiliations available

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