On February 16, 2003, Professor Winick spoke at a conference on “PATIENTS’ RIGHT TO SELF-DETERMINATION AND INFORMED CONSENT” at Kumamoto University School of Medicine, Kumamoto, Japan
Informed Consent as a Therapeutic Opportunity: A Therapeutic
Jurisprudence Analysis of Informed Consent and the Process for Obtaining
it
By Bruce J. Winick
Professor of Law, University Of Miami
The requirement of informed consent contemplates a therapist who discloses relevant information to the patient concerning the risks and benefits of a proposed course of treatment and a competent patient who voluntarily makes a decision to accept or refuse the recommendation. The elements of informed consent include disclosure of information, competency, understanding, voluntariness, and decision-making. Under these principles, if the decision process is sufficiently free of coercion and undue influence, a patient who receives sufficient information concerning the possible risks and side effects of a proposed therapy and alternative approaches, and who possesses sufficient competence and intelligence to comprehend the information, may make a voluntary choice whether to participate in the proposed treatment.
This paper will examine the elements of informed consent ?- competency, knowledge, and voluntariness. It will present a therapeutic jurisprudence analysis of how these elements should be defined and applied in a manner that maximizes both the autonomy values underlying the doctrine and the therapeutic opportunities that satisfying the legal requirement presents. Therapeutic jurisprudence is an interdisciplinary field of legal scholarship and law reform that sees the law itself and how it is applied as having therapeutic and antitherapeutic consequences. It seeks to minimize these antitherapeutic consequences and maximize the potential that the law and how it is applied can increase psychological well-being. Therapists should understand the therapeutic potential that the informed consent doctrine presents, and administer it so as to foster the therapeutic alliance and increase the likelihood that the treatment they administer will achieve the hoped-for effect. The informed consent process provides an opportunity for the therapist to establish trust and confidence, thereby setting in motion forces that can facilitate a positive therapeutic outcome. Handled properly, the informed consent process thus can have significant therapeutic value.
A. Competency
The law generally allows people to make important decisions for themselves, including decisions concerning their own health. Individual choice is frustrated only when we think individuals lack the ability to make decisions about their own well-being. In such cases, the government may invoke its parens patriae power, using an incompetency label to veto such choices and substituting the decision of another concerning what is best for them. Application of an incompetency label generally precludes the individual from making choices concerning the activity in question. This paternalistic response is often perceived as offensive by those labeled incompetent, as an affront to their dignity and personhood. Moreover, labeling people as incompetent may produce a variety of negative psychological effects.
Several tests of competency are used, sometimes in combination: the patient’s ability (1) to make and express a decision; (2) to actually understand the information disclosed about the treatment and alternatives to treatment; (3) to engage in decision-making in a rational manner, i.e., to rationally manipulate the available information and appreciate the implications of alternative choices; and (4) to make a decision about treatment that is reasonable in itself. Should inability to appreciate and understand be the test both in cases of (1) patient objection to treatment and (2) patient assent to treatment based on the therapist’s recommendation? Rather than applying a rigid, unilateral approach to competency that treats all cases alike, I propose a flexible, sliding?scale approach that takes account of the important distinctions between assent and objection, and between low and high-risk treatments. Recognizing these distinctions is consistent not only with medical practice, but would best serve the policies underlying the informed consent doctrine and the therapeutic interests of patients. In addition to defining competency differently based on the assent/objection distinction and the relative riskiness of the intervention in question, the law should utilize a presumption of competence in determining the competency question.
B. Knowledge
To provide informed consent, patients must have knowledge about the choices they confront. The exact scope of disclosure demanded of the therapist is not clear, but most courts require that the patient be told the diagnosis, the nature of the proposed treatment, the risks and benefits of the procedure, the available alternative procedures and their risks and benefits, and the consequences of not having the suggested treatment. A therapist does not have to disclose risks that the patient already is aware of or that an average patient is likely to know.
Two standards have emerged to define the therapist’s duty to disclose information. Both the “professional standard,” and the “lay standard,” (or “material risk” approach) will be discussed, and the therapeutic advantages of following the “lay standard” will be analyzed.
The manner in which the risk probabilities of a procedure are communicated to the patient can have a significant impact on patient understanding and hence on whether consent is truly informed. Simple language and techniques designed to foster understanding should be used by the therapist. Moreover, information should be disclosed a second time and part-by-part, rather than being disclosed as a whole and only once. Instead of requiring patients to read a lengthy and technical description of risks, an attempt should be made to explain or “teach” the information to the patient. Attempts to convey information that result in better patient understanding can increase patient trust and confidence in the therapist, as well as patient motivation and treatment compliance.
Therapists too often misperceive the informed consent requirement, treating it as a technical hurdle that must be contended with to avoid liability. In fact, the doctrine and its disclosure requirement present significant therapeutic opportunities. Rather than going through the motions of technical compliance with legal requirements, therapists should use the process of obtaining consent to secure the patient’s trust and confidence, which are essential to the basic mission of the therapeutic relationship. The disclosure of information provides an opportunity to meet patient concerns that might otherwise prevent the patient from engaging whole-heartedly in the therapeutic process and to bolster patient confidence in the therapist and in the treatment recommended. Information disclosure practices should convey information desired by the patient in a manner that treats the patient as a full participant in treatment decision-making.
C. Voluntariness
To be voluntary, the patient’s choice must be free of coercion, force, fraud, duress, or other forms of compulsion. There may be cases in which the forces of institutionalization render a particular patient incapable of making voluntary choices regarding treatment, or in which threats or promises are so potent that the particular patient’s consent is virtually assured. Nevertheless, this does not mean that institutionalization or the opportunity of early release renders consent impossible.
Therapists need to understand the psychological aspects of coercion. Even if legal standards of voluntariness are satisfied, treatment efficacy will be enhanced to the degree that the patient experiences his or her choice as voluntary and non-coerced. Coercion, with its potential for a negative psychological reactance, is at its greatest when people feel unfairly treated. When trust and the perception that the therapist has the patient’s best interests at heart are present, pressure to accept treatment may well be experienced by the patient as non-coercive. Therapists will enhance the patient’s perception of voluntariness to the extent that they treat their patients with dignity and respect, in good faith and with intentions that appear to the patient to be benevolent, and who give their patients a sense of “voice,” the opportunity to have their say, and “validation,” the feeling that what they have said is taken seriously.
