Abstract
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.
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Notes and References
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.”].
See Ibid. Section 46.111.
G. CALABRESI & P. BOBBITT, TRAGIC CHOICES 41 passim (1978).
See Fed. Regs. Section 46.116, supra note 2.
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).
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.
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).
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).
Ibid. at 427.
Fed. Regs. Section 46.116(a)(2)-(4), supra note 2.
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).
See J. KATZ, EXPERIMENTATION WITH HUMAN BEINGS 305–306 (1972).
See 271 N. ENG. J. MED. 473 (1964).
US DEPT OF HEALTH, EDUCATION & WELFARE, Protection of Human Subjects, 39 Fed. Reg. 18,914 (May 30, 1974).
Fed. Regs., supra note 2.
Ibid. Section 46.116(a)(1)-(4).
Ibid. Section 46.116(a)(5)-(8).
I bid. Section 46.116(a).
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).
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.
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).
See Superintendent of Belchertown State School v. Saikewicz, 370 N.E.2d 417 (Mass. 1977).
Cf. In re Storar, 52 N.Y.2d 363, 420 N.E.2d 64 (1981).
Fed. Regs. Section 46.111(b), supra note 2.
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Meisel, A. (1985). Assuring Adequate Consent. In: Melnick, V.L., Dubler, N.N. (eds) Alzheimer’s Dementia. Contemporary Issues in Biomedicine, Ethics, and Society. Humana Press. https://doi.org/10.1007/978-1-4612-5174-3_16
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