Informed consent and the gastrointestinal endoscopist

0016-5107/85/3103-0218$02.00 GASTROINTESTINAL ENDOSCOPY Copyright © 1985 by the American Society for Gastrointestinal Endoscopy

Special Report

Informed consent and the gastrointestinal endoscopist Peter A. Plumeri, DO, JD, LLM Sewell, New Jersey

The gastrointestinal endoscopist should be familiar with the Doctrine of Informed Consent. Although the concept is difficult to apply clinically, a reasonable approach is presented to the endoscopist. The ultimate goals of informed consent are shared decision making and self-determination, but it is important that the endoscopist also consider the potential legal liability when obtaining informed consent.

Gastrointestinal endoscopists are involved on a daily basis with the Doctrine of Informed Consent. The obligation to obtain informed consent is a difficult one for the endoscopist because of the ambiguity of the Doctrine as defined legally coupled with the potential for legal liability in the event of failing to obtain adequate consent. I hope to provide a better understanding of the Doctrine of Informed Consent for the endoscopic so that he or she can participate in it without feelings of frustration and fears of legal reprisal. MORAL AND ETHICAL CONSIDERATIONS

The concept of informed consent is based upon the principles of inviolability of the body and self-determination. These notions are rooted in the natural law, which is based on man's innate moral sense. The natural law is comprised of rules, discoverable by reason, of conduct supposedly inherent in the relations between human beings. 1 Self-determination or autonomy may be viewed as an individual's exercise ofthe capacity to form, revise, and pursue personal plans for life. 2 The principle of self-determination mandates that the endoscopist obtain a patient's consent before carrying out a procedure. The failure to obtain the patient's consent would infringe on this principle. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research asserts that self-determination, which is best understood as respecting people's right to define and pursue their own view of what is good, is the bedrock upon which the concept of shared decision Reprint requests: Peter A. Plumeri, Washington Medical Arts Building, RDI, Egg Harbor Road, Sewell, New Jersey 08080. 218

making in health care rests. The Commission envisions the promotion of health care through shared decision making based on consent, which rests upon mutual respect and participation of both the physician and the patient. The Commission concludes that while the Doctrine of Informed Consent is substantially founded in law, it is essentially an ethical imperative. 3 LEGAL DEVELOPMENT

American jurisprudence developed from the framework of the English legal system. Under the writ of trespass, medical treatment rendered without consent constituted a harmful or offensive touching, which was remediable. 4 The first case dealing with consent to medical treatment was reported in 1767.5 The first American cases regarding consent for medical procedures arose at the turn of the 20th century.6 These cases usually involved the performance of unauthorized procedures. For example, in Mohr v. Williams,7 the surgeon obtained consent to remove the patient's ear but removed the wrong one. He was found liable under the legal theory of battery. Battery is a tort in which an intentional act must cause and be intended to cause an unpermitted contact. The gist of battery is the absence of consent on the part of the plaintiff. 8 As long as the physician obtained the patient's consent to the intended procedure, there could be no battery. An often quoted judicial phrase was asserted in 1914 by Judge Cardozo in Schloendorff v. Society of New York Hospitals. 9 He said, "Every human being of adult years and sound mind has a right to determine what shall be done with his own body, and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages." GASTROINTESTINAL ENDOSCOPY

The President's Commission3points out that although this case stands for the proposition of self-determination, the patient was denied recovery and there was no concern with the degree of disclosure the patient would need to make the determination. A few cases that discussed the physician's duty to disclose information or risks of a proposed procedure in obtaining the patient's consent are reported before the beginning of the modern era in 1957 and are of historical interest. lO• 11 The Nuremberg Code, which was elaborated in the latter half of the 1940s, articulated the elements of informed consent. The Code was a response to the medical atrocities committed by the Nazis in World War II. Principle One of the Code is remarkably similar in content to modern definitions of informed consent. 12 The seminal case, Salgo v. Leland Stanford Jr., University Board of Trustees,13 introduced the concept of informed consent as a new legal doctrine. The court defined a legal duty to warn the patient of the risks of a procedure through disclosure so that the consent obtained would be informed. The major shortcoming of the Salgo decision was the failure of the court to delineate a standard by which adequate disclosure could be measured. At present, there are two standards of disclosure applied. The majority or professional standard of disclosure was defined in 1960 in Natanson v. Kline. 14 It required that the physician disclose to the patient the nature and risks of the proposed procedure to the extent that other professionals in good standing within the community would. This standard is criticized because it permits the profession to set the standard of disclosure 15 and it requires the use of an expert witness. 16 Also, Myers asserts that there is no real community standard. 16 Lastly, it is contended that the standard is ineffective due to inadequate self-policing of the medical profession. 17 The second standard of disclosure was defined in 1972 in Canterbury v. Spence 18 and other contemporaneous cases.19.20 It is known as the minority or lay standard. It required that the physician disclose to the patient all of the material risks of the proposed procedure. The scope of disclosure included the hazards of the procedure, any alternatives and expected results. Materiality was defined in terms of the reasonable person who in the patient's position "would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.,,20 Other courts have defined materiality in terms of what the patient himself or herself would consider significant in making a treatment decision. 21 The distinction in defining materiality becomes important when litigating an informed consent case under the lay or minority standard of disclosure. The issue of VOLUME 31, NO. 3,1985

causation under the former, objective or reasonable person definition of materiality is more difficult to meet than under the latter or subjective definition of materiality. Under the subjective definition, the injured patient can always be expected to assert that if the realized risk had been disclosed, he or she would have foregone the proposed procedure. 22 Criticisms of the lay or minority standard of disclosure include vague guidelines for disclosure,23 poor utilization of physician time in disclosing material risks,24 unnecessary arousal of patient anxiety, the encouragement of patient hindsight under the subjective definition of materiality,22 and the failure of lay persons to comprehend the disclosure. The legal development of informed consent occurred entirely within the common law until 1974, when the states began legislating a variety of informed consent statutes. By 1982 about half of the states enacted such statutes. 25,26 These statutes lack uniformity not only in their details, but also in the fundamental aspect of the standard of disclosure prescribed. Most apply the majority standard, while the remaining states use the minority standard or none at all. 25 Meisel and Kabnick assert that the statutes have not succeeded in making any significant changes in the common law concept of informed consent and are little more than window dressing. 25 FAILURE TO OBTAIN INFORMED CONSENT-A VIABLE CAUSE OF ACTION

The failure to obtain informed consent is reported to be a cause of action in 3 to 6% of medical malpractice cases. 27,28 As of 1982,37 states recognized a legal right of recovery for lack of informed consent. 26 There have been only about 90 American cases in which consent has been a major issue. 28 It usually represents an add-on type of action and until quite recently was generally believed to be an inadequate theory upon which an award would be granted. That is, some form of medical malpractice needed to be present in order to gain a monetary award. In Harwell v. Pittman,29 a case in which there was no medical negligence except for inadequate informed consent, a Louisianna appellate court awarded the plaintiff over $265,000 because he sustained injuries related to gall bladder surgery for which he was inadequately informed. He was not warned of the risks of infection, hernia and anesthetic death. The court said that a prudent person in the plaintiffs position would have declined the surgery at that time if he had been informed. The negligent failure to obtain informed consent has become a viable cause of action. The fact that there is no concomitant medical malpractice will no longer necessarily save the practitioner who experiences a complication of a procedure or treatment. The 219

message is clear for gastrointestinal endoscopists. The next section discusses a reasonable approach toward the accomplishment of informed consent. PRACTICAL CONSIDERATIONS IN INFORMED CONSENT

The Doctrine of Informed Consent can be presented in a functional, pragmatic perspective so that the gastrointestinal endsocopist can effectively participate in the consent decision. The five rules,30 which are discussed below, are (1) obtain the informed consent personally, (2) adhere to the disclosure requirements, (3) solicit and answer questions, (4) use witnesses wisely, and (5) develop and use specific forms. Personal disclosure

It is the primary responsibility of the gastrointestinal endoscopist to make sure that patients are adequately informed regarding proposed procedures. In a survey done by the President's Commission, 80% of the physicians and 80% of the public surveyed said that it was the physician's primary responsibility.3 There is little doubt that the process of informed consent is time consuming. One of the arguments against providing informed consent is that it consumes time better spent on more meaningful endeavors such as treating the il1. 31 Other arguments are that patients really do not understand what is being disclosed32- 34 and that the disclosure makes little difference in patients' decision making, since they usually agree to the proposed treatment or procedure. 35 Also, it is contended that patients do not wish to be informed36 and that they are needlessly frightened by the disclosure. Not surprisingly, the President's Commission found that most patients are desirous of being informed of their medical problems and that they want to know about the risks and complications of proposed treatments or procedures. 3 Also, in the Commission's survey, most doctors believed that their patients could understand and comprehend what was disclosed to them. The Commission said that the types of recall tests, which are the basis for the belief that patients cannot comprehend what was being disclosed to them, were an inaccurate measure of the effectiveness of informed consent. The real test is not whether the patient can recall the complications of a proposed treatment or procedure at some point in the future, but rather whether the physician and patient shared in the decision making and whether the patient's right to self-determination was preserved. 3 The Commission was unable to find that patients were needlessly frightened by the disclosure made to them or that they refused therapy or treatment based on fear induced by disclosure. The major reason for gastrointestinal endoscopists to obtain informed consent from their patients per220

sonally is to observe the principle of preservation of self-determiantion. Another compelling argument is that the physician-patient relationship will be strengthened by the time spent in the informed consent process. A strong physician-patient relationship acts as a deterrent to potential malpractice litigation. Disclosure requirements

The crux of the process of informed consent is the disclosure made by the physician to the patient to enable the patient to make an informed decision regarding the proposed treatment or procedure. Although the disclosure requirements vary as outlined above, a safe approach would be to describe the following: (1) the nature of the proposed procedure, (2) the reason(s) that it is necessary, (3) the expected results, (4) the material risks of the procedure, and (5) the available alternatives to the procedure. The most difficulty arises with the definition of a material risk. It is clear, however, that it is unnecessary to disclosue every possible medical complication. The court in Cobbs 19 said that informed consent did not require a medical minicourse with a description of a medical litany of possible complications. Rather, the gastrointestinal endoscopist should consider material risks that occur with greater frequency, such as a scratchy throat after gastroscopy, and those that occur with less frequency but are of greater significance, such as the potential for a colonic perforation during colonoscopy. The disclosure of alternatives is an important part of the informed consent process. The patient should be apprised of the possible options available so that the decision making process is enhanced. This is not to say that the endoscopist should not tell the patient his or her preference and the reasons for it. The physician has a duty to help the patient in the shared decision making. In the event that there are no viable alternatives, the patient should be so instructed. Questions

The gastrointestinal endoscopist should encourage and elicit questions from the patient during the informed consent interview. This practice will permit the patient an opportunity to express fears and apprehensions and to clarify uncertainties about the proposed procedure. The family should be included when appropriate. Witnesses

If possible, the informed consent interview should be witnessed. A witness, such as a nurse, may prove invaluable in the event that the patient later asserts that there was a failure to obtain informed consent. The witness may serve a useful role for evidentiary purposes. GASTROINTESTINAL ENDOSCOPY

The witness must be present during the discussion. Merely witnessing the signing of a consent form is of no value. 3o Many times family members are present during the interview and they may serve as witnesses as well as participants in the discussion. Informed consent forms

There has been a considerable amount of energy spent in designing forms for informed consent. The forms have been attacked on the basis of their readability37-39 and value. 32 - 35,37 Suggestions for improvement have been made,30, 38, 40-42 but there is no simple solution. There is no general rule that a written form or a writing is even necessary to satisfy the mandate of the Doctrine of Informed Consent. The form or writing may be required by the hospital bylaws or rules, but there are no legal requirements for the form except in 13 states with informed consent statutes. 3 The form or writing does serve a useful purpose in that it forces at least a modicum of disclosure and lends some gravity to the procedure for which it is used. It also may be construed as a piece of evidence that informed consent was obtained, but this is arguable. Interestingly, the President's Commission found that 79% ofthe public and 55% of physicians surveyed said that the purpose and effect of the consent form was to protect the physician from lawsuits. 3 Unfortunately, the idea that the consent form exemplified shared decision making and preservation of the patient's self-determination was not appreciated. As far as the gastrointestinal endoscopist's practice is concerned, the forms should function as a means to inform the patient about the proposed procedure, its risks and benefits, and alternatives, if any. The form should therefore be written in plain and simple language. Medical and legal terminology should be avoided. The forms should describe the foregoing elements as clearly as possible. Blank space should be provided for physician or patient comments or clarifications. Other forms of illustrative data such as videotapes,43 pamphlets, or other preparatory materials44 are useful and can be made a part of the presentation. Specific consent forms are less confusing than the generic type of forms found in most hospitals, and since endoscopists do a limited number of procedures, specific forms should be used.

REFERENCES 1. Webster's New World Dictionary, 2nd ed., 1972. 2. Dworkin G. Autonomy and informed consent. In: Making health care decisions, vol. 3. Washington DC: US Government Printing Office, 1982. 3. President's Commission for the Study of Ethical Problems in Medical and Biomedical and Behavioral Research. In: Making health care decisions, 1982. 4. Harper and James, Law of Torts, 1956. 5. Slater v. Baker and Stapleton, 2 Wils. 359, 95 Eng. Rep. 860 (K.B. 1767).

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6. 7. 8. 9. 10. 11. 12.

Annotation, 56 A.L.R. 695 (1957). 95 Minn. 261, 104 N.W. 12 (1905). Prosser, Law of Torts, 1971. 211 N.Y. 125, 105 N.E. 92 (1914). Hunter v. Burroughs, 123 Va. 113,96 S.E. 360 (1918). Wall v. Brim, 138 F.2d 478 (5th Cir. 1943). United States v. Karl Brandt et al., United States Adjuvant General's Department, Trials of War Criminals before Nuremberg Military Tribunals under Control Law No. 10 (Oct. 1946April 1949). The Medical Case, vol. 2, 1947. 13. 154 Cal. App. 2d 560, 317 P.2d 170 (Dist. Ct. App. 1957). 14. 186 Kan. 393, 350 P.2d 1093 (1960). 15. Stansfield. Malpractice: toward a viable disclosure standard for informed consent. Okla Law Rev 1979;32:873. 16. Myers. Informed consent in medical malpractice, Cal Law Rev 1967;55:1405. 17. Note. Restructuring informed consent: legal therapy for the doctor-patient relationship. Yale Law Rev 1970;79:1533. 18. 464 F.2d 772, (D.C. Cir.1972), cert. denied, 409 U.S. 1064 (1972). 19. Cobbs v. Grant, 8 Cal.3d 229, 104 Cal. Rptr. 505, 502 P.2d 1 (1972). 20. Wilkenson v. Vesey, 101 R.I. 606, 295 A.2d 676 (1972). 21. McPherson v. Ellis, 287 S.E.2d 892 (1982). 22. Waltz and Scheuneman. Informed consent to therapy. NWU Law Rev 1970;64:628. 23. Note. Informed consent-a proposed standard for medical disclosure. NYU Law Rev 1973;48:554. 24. Weyandt. Valid consent to medical treatment: need the patient know?, Duq Law Rev 1966;4:455. 25. Meisel and Kabnick. Informed consent to medical treatment: an analysis of recent legislation. U Pitts Law Rev 1980;41:407. 26. Appendix L. Making health care decisions, vol. 3, 1982. 27. Report of the Secretary's Commission on Medical Malpractice, 129,1973. 28. Law and Polan. Pain and profit: the politics of malpractice, 1978. 29. 428 So.2d 1049 (La. App. 1 Cir. 1983). 30. Plumeri PA, The gastroenterologist and the doctrine of informed consent. J Clin GastroenteroI1982;5:185. 31. Demy NJ. Informed opinion on informed consent. JAMA 1971;217:696. 32. Beigler JH. Informed consent: how much does the patient understand? Clin Pharmacol Ther 1980;27:435. 33. Robinson G, Merav A. Informed consent: recall of patients tested postoperatively. Ann Thorac Surg 1976;22:209. 34. Cassileth B. Informed consent: why are its goals improperly realized? New Engl J Med 1980;302:896. 35. Roling G. An appraisal of patients' reactions to "informed consent" for peroral endoscopy. Gastrointest Endose 1977;24:69. 36. Alfidi R. Controversy, alternatives and decisions in complying with the legal doctrine of informed consent. Radiology 1975;114:233. 37. Baker M, Taub H. Readability of informed consent forms for research in a Veterans Administration Medical Center. JAMA 1983;250:2646. 38. Morrow G. How readable are subject consent forms? JAMA 1980;244:56. 39. Grunder T. On the readability of surgical consent forms. New Eng J Med 1980;302:900. 40. Moore RM. Consent forms-how or whether they should be used. Mayo Clin Proc 1978;53:393. 41. Morrow G, Gootnick J, Schmale A. A simple technique for increasing cancer patient's knowledge of informed consent to treatment. Cancer 1978;42:793. 42. Miller R, Willner H. The two-part consent form: a suggestion for promoting free and informed consent. New Engl J Med 1978;290:964. 43. Barbour G, Blumenkrantz M. Videotape aids informed consent decision. JAMA 1978;240:2742. 44. Saunderson GR. The effectiveness of two types of preparatory messages on the responses of patients undergoing sigmoidoscopy examination. Abstracts of Hospital Management Studies 1977;14:48.

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