Respecting Patient Rights

Basic Bioethics For Residents, CCF Residency Programs, November 28, 2000

I. Communicating with Patients and Families

II. Informed Consent: Empowering Patient Participation in Decision Making

III. Assessing Patients' Decisional Capacity

IV. Maintaining Patient Confidentiality

V. Honoring Patients' Advance Directives

II. Informed Consent: Empowering Patient Participation in Decision Making

The process of informed consent for treatment or a procedure has several essential elements. Informed consent requires:

• The patient's capacity for understanding and decision making.
• Adequate information presented in a balanced, understandable manner.
• The patient's ability to make a voluntary decision without coercion.

Physicians should be attentive to the types of information that should be disclosed. Patient (or their surrogates, in cases of patients who lack decisional capacity) should be informed about

• Nature and purpose of the diagnostic procedure or treatment.
• Risks and benefits of the diagnostic procedure or treatment.
• Alternatives, including no testing or no treatment.

The process of informed consent should never be reduced to "getting the patient's signature on a consent form" or to documenting that "informed consent" was obtained in the chart. Rather, informed consent is an educational process between physician and patient. Physicians, using their medical expertise, help to educate patients about their medical condition, recommended diagnostic and treatment options, and prognosis. This information must be integrated with the patient's own beliefs and values. Be clear about the goal of treatment. Your clinically focused goal needs to be consistent with the patient's life goals and purposes for seeking treatment.

Let the patient educate you about their personal values, goals, and preferences. To occur fully this process takes time and ideally occurs within multiple encounters. In acute care situations or when the patient is unknown to you, ask about the patient's expectations about treatment and outcome.

Although physicians have ultimate responsibility for assuring that patients are well-informed, it is very appropriate for physicians to utilize the skills and knowledge of other professionals (e.g., nurses) and various educational tools (e.g., brochures, video-tapes, pictures and models of the human body) to aid the informed consent process.

Pediatric patients present special problems. Very young children cannot consent. Instead, parents or legal guardians of the child give informed consent which the American Academy of Pediatrics calls "informed permission." (Pediatrics 1995; 95(2):314-317) Older pediatric patients (i.e., approximately ages 7-14) can provide "assent," which means that they can accept or agree to treatment. Because they lack full decisional capacity, they are not able to give a true informed consent. A true or valid informed consent can be given only by an emancipated or a mature minor.

There is a large literature on issues related to informed consent. One study on patient participation in decision making (Guadagnoli, Ward, 1998) showed that patients want information, but may vary in how active a role they desire to actually make decisions. Research has also shown that patients want to be informed a) so that they are better able to comply with treatment; b) as a way of being shown respect; c) so that they have an option to overrule physicians' decisions; and d) so that they can play an active role in decision making (Strull, Lo, Charles, 1984).

Other authors have identified important "myths" about informed consent that often lead physicians astray in dealing with this important ethical obligation. One source of the myths of informed consent is the law. The following myths should never shape your communicative interactions with patients:

• Informed consent is a static, discrete, one-time event. Actually, informed consent is ideally viewed as a process in which patients receive information and have time to reflect on it. Simply signing a consent form is not adequate.
• It is sufficient to inform patients of the risks of treatment. Patients should be informed about their therapeutic options and the likely outcomes of treatment and non-treatment, and not simply informed about the risks.
• Physicians must operate a medical cafeteria, i.e., give options only, and then let patients choose. Most patients want advice and recommendations from their physicians in addition to information. Informed consent involves collaborative decision making between patients and physicians.
• Patients must be told everything about treatment. The guiding questions for how much information to disclose are: What would a reasonable physician disclose, and what would a reasonable patient want to know? Focusing on goals of treatment will guide the answers to these questions.
• Full disclosure is required only if patients consent. Information about therapeutic options should be provided before, not after decisions are made. In addition to informed consent, physicians are also obligated to obtain "informed refusal."
• Patients cannot give consent because they cannot understand complex medical information. Patients generally cannot understand information in the same way that physicians understand it. But patients' choices should make sense in terms of their values.
• Patients must be given information whether they want it or not. A patient may waive the right to decide, but a conversation about therapeutic options must still take place in order to determine what role the patient wants in decision making. If patients waive the right to decide, they should still be given information.
• Information may be withheld if it will cause the patient to refuse treatment. Information may be upsetting to patients. But information should only be withheld if it upsets patients so much that they would be unable to engage in rational decision making.

(Meisel, Kuczewski, Arch Intern Med, 156, 1996.)

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