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Revising Medical Consent Forms: An Empirical Model and Test

Published online by Cambridge University Press:  27 April 2021

David S. Kaufer ,
Erwin R. Steinberg  and
Sarah D. Toney
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Extract

Recent years have brought increasing pressure from the public and the courts for truly informed patient consents to medical treatment and surgical procedures. Many courts have recognized that a patient's signature on a consent form is no assurance that the patient has received sufficient information, much less that he or she truly understood the information. A Pennsylvania court articulated this principle this way:

[S]ince the patient must rely on the physician to tell her of all the appropriate risks, the physician cannot discharge this duty by having the patient execute a form which states that the risks have been explained. The courts will look beyond forms signed by patients to determine if the duty to inform has been discharged.

Type
Article
Information
Law, Medicine and Healthcare , Volume 11 , Issue 4 , September 1983 , pp. 155 - 184
Copyright
Copyright © American Society of Law, Medicine and Ethics 1983

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References

The history of the doctrine of informed consent is beyond the scope of this article. For further discussion of the history and goals of informed consent, see generally Schloendorff v. Society of New York Hosps., 105 N.E. 92 (N.Y. 1914) (the classic informed consent ruling by Judge Cardoza); President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Making Health Care Decisions: Volume I: Report (U.S. Gov't. Printing Ofc., Washington, D.C.) (1982); Cassileth, B.R., Informed Consent — Why are its Goals Imperfectly Realized? New England Journal of Medicine 302(16): 896 (April 17, 1983); Grundner, T.M., On the Readability of Surgical Consent Forms, New England Journal of Medicine 302(16): 900 (April 17, 1980); Morrow, G.R., How Readable Are Subject Consent Forms? Journal of the American Medical Association 224: 56 (July 4, 1980).Google Scholar
Quantification of the amount and type of information that the physician must provide to fulfill the duty to obtain an informed consent may vary in different jurisdictions. Compare Bly v. Rhoads, 222 S.E.2d 783, 785 (Va. 1976) (measured against customary disclosure practices of physicians), with Carman v. Dippold, 379 N.E.2d 1365, 1370 (Ill. App. 1978) (measured against what a reasonable physician would disclose under same or similar circumstances) and Canterbury v. Spence, 464 F.2d 772, 780 (D.D.C. 1972), cert. den., 93 S.Ct. 560 (1972) (duty measured by patients’ need for information to decide whether to reject or accept the treatment options); and Getchell v. Mansfield, 489 P.2d 953, 957 (Or. 19/1) (duty to disclose material risks and feasible alternatives exists as a matter of law). See generally Annot., 88 A.L.R.2d 1008.Google Scholar
Harrison v. Brodmerkel, No. 73-664 (Pa. C.P., Allegheny County, Pa. October 1979) cited in Pittsburgh Legal Journal 127:151, 152 (1979). See also Pegram v. Sisco, 406 F. Supp. 776, 779–80 (W.D. Ark. 1976).Google Scholar
The phrase “in laymen's terms,” which is found in the Pennsylvania Patient Bill of Rights, 25 Pa. Admin. Code §103.22(b)(8) (Shepard's 1981), does not appear in American Hospital Association, Patient's Bill of Rights (A.H.A., Chicago) (1972). However, the phrase seems to be implied. See Annas, G.J., Avoiding Malpractice Suits through the Use of informed Consent, Current Problems In Pediatrics 6(5): 1 (March 1976) at 20-22.Google Scholar
See Horty, J., Consents, in Hospital Law (Action Kit for Hospital Law, Pittsburgh, Pa.) (1981).Google Scholar
Bloom, B. Hastings, J. Madaus, G., Handbook on Formative and Summative Evaluation of Student Learning (McGraw-Hill, New York) (1971) at 28.Google Scholar
Atlas, M., The User Edit: Making Manuals Easier to Use, I.B.M. Technical Report No. 77.0067 (1980).Google Scholar
Hayes, J. Flower, L., Uncovering Cognitive Processes in Writing an Introduction to Protocol Analysis, in Research in Writing: Principles and Methods (Mosenthal, P., eds.) (Longman, New York) (in press); Swarts, H., Designing Protocol Studies of the Writing Process: An Introduction, in New Directions in Composition Research (Beach, R. Bridwell, L., eds.) (Guilford Press, New York) (in press).Google Scholar
See Flesch, R., The Art of Readable Writing (Harper & Bros., New York) (1949) at 213.Google Scholar
Davidson, R., Limitation of Readability Formulas in Guiding Adaptations of Texts, Technical Report 162 (Center for the Study of Reading, University of Illinois, Urbana, Ill.) (1981).Google Scholar
We are indebted to Davida Charney for performing the statistical tests.Google Scholar