Mrs. A is an 85-year-old woman living at home with her husband, who has moderately severe Alzheimer disease and for whom she provides daily care. She has an 8.5 cm abdominal aortic aneurysm. Three months ago she consulted a vascular surgeon, who recommended surgical repair of her aneurysm. However, another physician told Mrs. A that she “would never survive the operation.” Mrs. A decided to “take her chances” and refused surgery, primarily because of her wish to provide uninterrupted care for her husband; however, she agreed to discuss the decision further with the surgeon at a future visit. Before such a visit can take place, however, Mrs. A is taken to the emergency department after collapsing at home with abdominal pain. Physical examination reveals a systolic blood pressure of 50mmHg and a tender pulsatile abdominal mass. Mrs. A is moaning and barely conscious. The surgeon diagnoses a ruptured aortic aneurysm and believes that Mrs. A will die without emergency surgery.
Mr. B is a 25-year-old man affected by extensive muscular atrophy resulting from Guillain–Barré syndrome. For two years he has been dependent on a ventilator and his prognosis indicates no chance of recovery. One day he announces that he wants the ventilator support withdrawn and that he be allowed to die because he considers his life intolerable. Those caring for him disagree with his decision and the reasons for it because he is not terminally ill and because others with his condition have meaningful and fulfilling lives. Their arguments do not convince Mr. B and he demands that the ventilator be withdrawn.
Consent can be defined as the “autonomous authorization of a medical intervention … by individual patients” (Beauchamp and Faden, 2004, p. 1279). There is a widespread consensus in both ethics and law that patients have the right to make decisions about their medical care and to be given all available information relevant to such decisions. Obtaining consent is not a discrete event; rather, it is a process that should occur throughout the relationship between clinician and patient (Arnold and Lidz, 2004). Although the term “consent” implies acceptance of a suggested treatment, the concept of consent applies also to choice among alternative treatments and to refusal of treatment.
Consent has three components: disclosure, capacity, and voluntariness. Disclosure refers to the communication of relevant information by the clinician and its comprehension by the patient. Capacity refers to the patient’s ability to understand the information and to appreciate those consequences of his or her decision that might reasonably be foreseen. Voluntariness refers to the patient’s right to come to a decision freely, without force, coercion, or manipulation.
Consent may be explicit or implied. Explicit consent can be given orally or in writing. Consent is implied when the patient indicates a willingness to undergo a certain procedure or treatment by his or her behavior. For example, consent for venipuncture is implied by the action of rolling up one’s sleeve and presenting one’s arm. For treatments that entail risk or involve more than mild discomfort, it is preferable to obtain explicit rather than implied consent.
A signed consent form documents but does not replace the consent process. There are no universal rules as to when a signed consent form is required. Some hospitals may require that patients sign a consent form for surgical procedures but not for other equally risky interventions. If a signed consent form is not required, and the treatment carries risk, clinicians should write a note in the patient’s chart to document that consent has been given.
This chapter will discuss the concept of patient consent and exceptions to the requirement to obtain consent. Subsequent chapters will provide detailed discussions of disclosure, capacity, voluntariness, and truth telling, as well as consent for incapable patients, requirements for consent to participation in medical research, and involving children in medical decisions.
The notion of consent is grounded in the fundamental ethical principles of patient autonomy and respect for persons. Autonomy refers to the patient’s right to make free decisions about his or her healthcare. Respect for persons requires that healthcare professionals foster patients’ control over their own lives and refrain from carrying out unwanted interventions.
Fully informed consent is an ethical ideal that is seldom realized in practice. Obstacles include diagnostic uncertainty, the complexity of medical information, linguistic and cultural differences between clinicians and patients, overworked medical personnel, and psychological barriers to rational decision making. However, given the fundamental importance of patient autonomy and respect for persons, clinicians have an ethical obligation to seek the highest degree of informed consent that can be reasonably achieved in the specific situation.
There are two exceptions to the requirement for informed consent by competent patients.
In many jurisdictions, obtaining the patient’s consent to medical care is a legal requirement. Under UK common law, treating a patient without his or her consent constitutes battery, whereas treating a patient on the basis of inadequately informed consent constitutes negligence. The Council of Europe’s (1997) Convention on Human Rights and Biomedicine states:
An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time.
In most jurisdictions, law recognizes that the emergency treatment of incapable persons is an exception to the requirement for consent. An emergency exists when immediate treatment is required in order to save the life or preserve the health of the patient. The rationale for this exception is that a reasonable person would consent to the treatment and that a delay in treatment would lead to death or serious harm.
The emergency exception to the requirement to obtain consent has important limitations. Clinicians should not administer emergency treatment without consent if they have reason to believe that the patient would refuse such treatment if he or she were capable. A signed and dated advance directive (“living will”) can provide evidence of such a decision.
A patient’s incapacity does not necessarily exempt the clinician from the requirement to obtain consent. In some jurisdictions, if a patient is mentally incapable of making medical decisions, the clinician must obtain consent from a substitute decision maker.
Some jurisdictions permit non-consensual treatment in specific circumstances, such as the involuntary admission of psychiatric patients and the treatment of irresponsible patients with communicable disease. Non-consensual treatment will be discussed in the chapter on voluntariness.
There are other potential legal exceptions to the requirement to obtain consent. As noted above, “therapeutic privilege” refers to the physician’s withholding of certain information in the consent process in the belief that disclosure of this information would harm or cause suffering to the patient; however, the scope of therapeutic privilege has become smaller over the years in many jurisdictions. “Waiver” refers to a patient’s voluntary request to forgo one or more elements of disclosure.
The requirement to obtain patient consent is affirmed by most international and national health professional organizations. For example, the World Medical Association’s (2005) Declaration on the Rights of the Patient states:
The patient has the right to self-determination, to make free decisions regarding himself/herself. The physician will inform the patient of the consequences of his/her decisions. A mentally competent adult patient has the right to give or withhold consent to any diagnostic procedure or therapy. The patient has the right to the information necessary to make his/her decisions. The patient should understand clearly what is the purpose of any test or treatment, what the results would imply, and what would be the implications of withholding consent.
In the UK, both the General Medical Council (1998) and the British Medical Association (2003) have issued guidance documents on consent, and the codes of ethics of most, if not all, national medical associations contain provisions on consent.
Several meta-analyses and reviews have suggested that the process of obtaining consent can be an important component of a successful physician–patient relationship. One review (Stewart, 1995) found that effective physician–patient communication improved emotional health, symptom resolution, level of function, results of physiological measures, and pain control. A review of informed consent in psychotherapy concluded that its benefits include fostering a positive treatment outcome through enhancing patient autonomy, responsibility, and self-therapeutic activity; lessening the risks of regressive effects and therapist liability; and helping the practice of psychotherapy extend beyond particular parochialisms by providing checks and balances on therapist judgements (Beahrs and Gutheil, 2001). A meta-analysis by Suls and Wan (1989) showed that providing information about what the patient would feel and what would be done in the course of stressful and painful medical procedures consistently reduced negative feelings, pain, and distress. Another demonstrated that information giving by physicians was associated with small to moderate increases in patient satisfaction and compliance with treatment (Hall et al., 1988).
Other empirical studies have shown that many, but by no means all, patients expect the physician to assume the role of problem solver rather than decision maker (Siminoff and Fetting, 1991; Deber, 1994; Janz et al., 2004; Mazur et al., 2005). Problem solving involves identifying the patient’s presenting problem and developing a list of treatment options. Numerous studies have shown that patients’ desire for decision-making responsibility, which involves choosing from the treatment options, is variable (Ende et al., 1989; Larsson et al., 1990; Lerman et al., 1990; Mark and Spiro, 1990; Waterworth and Luker, 1990; Cohen and Britten, 2003; Ford et al., 2003; Hagerty et al., 2004). Even patients who actively seek information do not necessarily wish to make the decision about which treatment option to follow. Some, particularly those who are elderly or acutely ill, are predisposed to follow the physician’s recommendation (Emanuel and Emanuel, 1992; Pinquart and Duberstein, 2004; Levinson et al., 2005).
Obtaining valid consent requires that patients participate in problem solving as much as they wish. Patients should be free to ask questions and receive answers about treatment options not discussed by the clinician. The consent process also requires that patients actively participate in decision making and authorize the decision. Even if the patient is predisposed to follow the clinician’s recommendation, the clinician should actively engage the patient in the consent process.
Ethical and legal exceptions to the requirement to obtain consent for medical interventions are noted above. There may also be cultural differences in how this requirement is understood. In some cultures, it is widely held that the physician’s obligation to provide information to the patient does not apply when the diagnosis is a terminal illness. It is felt that such information would cause the patient to despair and would make the remaining days of life much more miserable than if there were hope of recovery. Throughout the world, it is not uncommon for family members of patients to plead with physicians not to tell the patients that they are dying. Physicians do have to be sensitive to cultural, as well as personal, factors when communicating bad news, especially of impending death. Nevertheless, the patient’s right to consent is becoming increasingly widely accepted, and the physician has a primary duty to help patients to exercise this right.
The principle of informed consent incorporates the patient’s right to choose from among the options presented by the physician. To what extent patients have a right to services not recommended by physicians is becoming a major topic of controversy in ethics, law, and professional policy. Until this matter is decided by governments, medical insurance providers, and/or professional organizations, individual physicians will have to decide for themselves whether they should agree to requests for inappropriate treatments.
Mrs. A’s physician must decide whether to perform surgical repair of the aneurysm. Mrs. A is now an incapable person in a medical emergency. In such a circumstance, the surgeon may proceed without the patient’s consent unless a clear wish to the contrary has been expressed earlier. Should the surgeon proceed, given that Mrs. A had previously refused elective repair of the aneurysm? Mrs. A’s refusal of elective surgery was based on her wish to continue caring for her husband. She would likely want to undergo emergency surgery because it would give her the best chance of continuing to care for her husband. Therefore, the surgeon may proceed without the patient’s consent. If Mrs. A had previously considered and refused emergency surgery, the surgeon would not be entitled to proceed.
If Mr. B is competent to make decisions about his medical treatment, his caregivers should respect this decision, even if refusing consent to the continued use of his ventilator will result in his death. In carrying out his wishes, they should provide appropriate palliative care.
An earlier version of this chapter has appeared: Etchells, E., Sharpe, G., Walsh, P., Williams, J. R. and Singer, P. A. (1996). Consent. CMAJ 155: 177–80.