Consent Forms,Readability,and Comprehension: The Need for New Assessment Tools

Bergler J. H. , Informed Consent: How Much Does the Patient Understand? Clinical Pharmacology and Therapy 27(4): 27 (April 1980); Cassileth B.R. , Informed Consent: Why Are Its Goals Imperfectly Realized? New England Journal of Medicine 302(16): 896–900 (April 17, 1980); Howard J. M. DeMets D. , How Informed is Informed Consent? The BHAT Experience, Controlled Clinical Trials 2: 287–303 (1981); Kennedy B. J. Lillehaugen A. , Patient Recall of Informed Consent, Medical and Pediatric Oncology 7: 173–78 (1979); Muss H.B. , Written Informed Consent in Patients with Breast Cancer, Cancer 43(4): 1549–56 (April 1979); Riecken H.W. Ravitch R. , Informed Consent to Biomedical Research in Veterans Administration Hospitals, Journal of the American Medical Association 248(3): 344–48 (July 16, 1982).

Grundner T.M. , On the Readability of Surgical Consent Forms, New England Journal of Medicine 302(16): 900–02 (April 17, 1980); Doak L.G. Doak C.C. , Patient Comprehension Profiles: Recent Findings and Strategies, Patient Counseling and Health Education, pp. 101–06 (1980).

Flesch R. . The Art of Readable Writing (Harper&Row, New York, N.Y.) (1976).

Fry E. A. , A Readability Formula that Saves Time, Journal of Reading 11: 512–16, 575–78 (1968).

McLaughlin G. H. , SMOG Grading—A New Readability Formula, Journal of Reading 12: 639–46 (1969).

Public Health Service, U.S. Dept, of Health&Human Services, Important Information about Polio and Polio Vaccine (1979).

President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Making Health Care Decisions: Volume One: Report (U.S. Gov't Printing Ofc., Washington D.C.) (1983) at 44–51; Meisel A. , The Expansion of Liability for Medical Accidents: From Negligence to Strict Liability by Way of Informed Consent, Nebraska Law Review 56(1): 51–152 (1977). See, e.g., Schloendorff v. Society of New York Hosp., 105 N.E. 92, 98 (N.Y. 1914) (every human being of adult years and sound mind has a right to determine what shall be done with his own body).

E.g., Salgo v. Board of Trustees of Leland Stanford Jr. Univ., 317 P.2d 170, 181 (Cal. App. 1957).

See, e.g., Natanson v. Kline, 354 P.2d 670, 673 (Kan. 1960).

Canterbury v. Spence, 464 F.2d 772, 786-87 (D.C. Cir. 1972); Cobbs v. Grant, 502 P.2d 1, 11 (Cal. 1972).

LeBlang T.R. , Informed Consent—Duty and Causation: A Survey of Current Developments, Forum 18: 280, 281 (1983).

See generally Rosoff A.J. , Informed Consent: A Guide for Health Care Providers (Aspen Systems Corp., Rockville, Md.) (1981).

Canterbury v. Spence, supra note 10; Cobbs v. Grant, supra note 10.

Exceptions include research with human subjects governed by the United States Department of Health and Human Services, the United States Food and Drug Administration regulations, and state statutes pertaining to abortion and sterilization. New Drugs, Antibiotic and Biologic Drug Project Regulations: Expert Provisions, 49 Fed. Reg. 2095 (January 18, 1984) (to be codified at 21 C.F.R.§312); Protection of Human Subjects: Informed Consent, 48 Fed. Reg. 11,430 (March 18, 1983) (to be codified at 21 C.F.R. §1003); Mass Gen. Laws Ann. c. 272 §21B (West 1984) (sterilization).

Note, Informed Consent to Immunization: The Risks and Benefits of Individual Autonomy, California Law Review 65: 1286–1314 (1977); Prosser and Keeton on the Law of Torts (West Publishing Co., St. Paul, Minn) (5th ed. 1984) §99 at 694–702 (general products liability law).

Restatement (Second) of Torts §402A comment k (1965).

Davis v. Wyeth Laboratories, Inc., 339 F.2d 121, 130–31 (9th Cir. 1968) (vaccine dispensed to all patients in mass immunization program at clinics without individualized balancing by physician of risks involved); Reyes v. Wyeth Laboratories, Inc., 498 F.2d 1264, 1276 (5th Cir. 1974), cert. denied, 419 U.S. 1096 (1974); Givens v. Lederle, 556 F.2d 1341 (5th Cir. 1977).

Reyes, supra note 17, at 1276; Davis, supra note 17, at 130.

Givens v. Lederle, supra note 17, at 1345; Note, Mass Immunization Cases: Drug Manufacturers’ Liability for Failure to Warn, Vanderbilt Law Review 29(1): 235–66 (January 1976).

See McLaughlin , supra note 5.

See generally Flesch, supra note 3.

Powers R.D. Sumner W.A. Kearl B.E. , A Recalculation of Four Adult Readability Formulas, Journal of Educational Psychology 49(2): 49 (April 1958).

Id.

Spadaro D.C. Robinson L.A. Smith L.T. , Assessing Readability of Patient Information Materials, American Journal of Hospital Pharmacy 37: 215–21 (1980).

See McLaughlin , supra note 5.

Doak C.C. Doak L.G. Root J. , Patient Comprehension Assessment Study (U.S. Government Printing Ofc., Washington D.C.) (1979) (report issued to Bureau of Medical Services, Public Health Service).

See Flesch , supra note 3, at 161–65.

See Doak , supra note 26.

Hoar N. Hoar M.E. , Readability Formulas: Are They Enough? Contemporary Pharmacy Practice 4: 145–49 (1981).

See Doak , supra note 26.

Since our study began, the Public Health Service form studied here, “Important Information about Polio and Polio Vaccine,” has been revised. Despite its changes, many of the problems with the level of language remain. Its readability level, as measured by SMOG, is now at 10.5 (at or near “average”). Yet, it still fails to explain fully some phrases (“wild polio”) and gives elaborate, even overdrawn, explanations of others (mechanism of infection). It appeals for consent on the basis of a negative emotional load (“even though we may not have much wild polio virus spreading here now, there is so much of it in the rest of the world that there is great risk of it being re-established if our children are not vaccinated”). Is this form more comprehensible than the old one? Will it improve informed consent? These questions cannot be answered by a readability formula for it tests only one aspect of the comprehension process.

Kaufer D.S. Steinberg E.R. Toney S. , Revising Medical Consent Forms: An Empirical Model and Test, Law, Medicine&Health Care 11(4): 155–62 (September 1984).

Davidson A. , Limitations of Readability Formulas in Guiding Adaptations of Texts: Technical Report No. 162 (Center for the Study of Reading, University of Illinois (1970).

Manning D. , Writing Readable Health Messages, Public Health Reports 95(5): 464–65 (1981); Revising Medical Consent Forms, supra note 32, at 160.

See, e.g., Doak , supra note 26.

See Meisel A. Roth L. , What We Do and Do Not Know about Informed Consent, Journal of the American Medical Association 264(21): 264, 2476 (November 27, 1981).