Bioethics for clinicians: 1. Consent

Edward Etchells, MD, MSc, FRCPC; Gilbert Sharpe, BA, LLB, LLM; Phil Walsh, BSc, LLB; John R. Williams, PhD; Peter A. Singer, MD, MPH, FRCPC
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Canadian Medical Association Journal 1996; 155: 177-180

[résumé]

Drs. Etchells and Singer are from the University of Toronto Joint Centre for Bioethics, the Department of Medicine, University of Toronto, and The Toronto Hospital, Toronto, Ont. Mr. Sharpe is a professor in the Faculty of Health Sciences, McMaster University, Hamilton, Ont., and director of the Legal Services Branch, Ontario Ministry of Health, Toronto, Ont. Mr. Walsh is completing his articles at the Legal Services Branch, Ontario Ministry of Health, Toronto, Ont. Dr. Williams is director of the Department of Ethics, Canadian Medical Association, Ottawa, Ont.

Dr. Singer's work is supported by the National Health Research and Development Program through a National Health Research Scholar award. The views expressed here are the authors' and not necessarily those of their supporting groups or employers.

This is the first in a series of 14 articles on bioethics for clinicians. Subsequent articles will appear monthly.
Paper reprints of the full text may be obtained from Dr. Edward Etchells, Division of General Internal Medicine, Toronto Hospital, Rm. EN G-248, 200 Elizabeth St., Toronto ON M5G 2C4; eetchells@torhosp.toronto.on.ca

Series editor: Dr. Peter A. Singer, University of Toronto Joint Centre for Bioethics, 88 College St., Toronto, ON M5G 1L4; fax 416 978-1911; peter.singer@utoronto.ca

© 1996 Canadian Medical Association (text and abstract/résumé)

See also

Contents

Abstract

 Patients are entitled to make decisions about their medical care and to be given relevant information on which to base such decisions. The physician's obligation to obtain the patient's consent to treatment is grounded in the ethical principles of patient autonomy and respect for persons and is affirmed by Canadian law and professional policy. A large body of research supports the view that the process of obtaining consent can improve patient satisfaction and compliance and, ultimately, health outcomes. An exception to the requirement to obtain consent is the emergency treatment of incapable persons, provided there is no reason to believe that the treatment would be contrary to the person's wishes if he or she were capable.

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Résumé

Les patients ont le droit de prendre des décisions sur leurs soins médicaux et d'obtenir des renseignements pertinents sur lesquels fonder ces décisions. L'obligation du médecin d'obtenir du patient qu'il consente au traitement est fondée sur les principes éthiques de l'autonomie du patient et du respect de la personne et est confirmée par la loi canadienne et les politiques de la profession. Un important corpus de recherches appuie l'opinion selon laquelle l'obtention du consentement peut améliorer la satisfaction du patient, l'observation du traitement et, en bout de ligne, les résultats sur la santé. On peut passer outre à l'obligation d'obtenir le consentement pour le traitement d'urgence d'une personne inapte, à condition qu'il n'y ait pas lieu de croire que le traitement serait contraire aux désirs de la personne en cause si elle était en possession de ses moyens.

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Introduction

 Mr. A is an 85-year-old man living at home with his wife, who has moderately severe Alzheimer disease and for whom he provides daily care. He has an 8.5-centimetre abdominal aortic aneurysm. Three months ago he consulted a vascular surgeon, who recommended surgical repair of his aneurysm. However, another physician told Mr. A that he "would never survive the operation." Mr. A decided to "take his chances" and refused surgery, primarily because of his wish to provide uninterrupted care for his wife; however, he agreed to discuss the decision further with the surgeon at a future visit. Before such a visit takes place, however, Mr. A is taken to the emergency department after collapsing at home with abdominal pain. Physical examination reveals a systolic blood pressure of 50 mm Hg and a tender pulsatile abdominal mass. Mr. A is moaning and barely
conscious. The surgeon diagnoses a ruptured aortic aneurysm and believes that Mr. A will die without emergency surgery. No relatives can be reached for consultation.

Mr. B, a 69-year-old resident of a nursing home, has severe Alzheimer disease. He is dependent on others to carry out all activities of daily living and is incontinent of urine and feces. He does not recognize his family members, and his speech is limited to moaning and crying. He has had fever, a cough producing green sputum and shortness of breath for 48 hours. He is transferred to hospital for treatment of suspected pneumonia. His wishes regarding treatment for pneumonia have not been documented. The nursing home has already notified Mr. B's wife, who is now driving to the hospital and will arrive in about 30 minutes.

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What is consent?

Consent is the "autonomous authorization of a medical intervention . . . by individual patients."[1] Patients are entitled to make decisions about their medical care and have the right 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.[2] Although the term "consent" implies acceptance of treatment, the concept of consent applies equally to refusal of treatment. Patients have the right to refuse treatment and to be given all available information relevant to the refusal.

Consent has three components: disclosure, capacity and voluntariness. "Disclosure" refers to the provision of relevant information by the clinician and its comprehension by the patient. "Capacity" refers to the patient's ability to understand the relevant 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.[3] 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 behaviour. 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, explicit rather than implied consent should be obtained.

Signed consent forms document but cannot replace the consent process. There are no fixed rules as to when a signed consent form is required. Some hospitals require that a consent form be signed by the patient for surgical procedures but not for certain equally risky interventions. If a signed consent form is not required, and the treatment carries risk, clinicians should seriously consider writing a note in the patient's chart to document that the consent process has occurred.

In this article we will discuss the concept of patient consent and exceptions to the requirement to obtain consent. Subsequent articles in this series will provide a detailed discussion of disclosure, capacity and voluntariness, as well as requirements for patient consent to participation in medical research.

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Why is consent important?

Ethics

The notion of consent is grounded in the ethical principles of patient autonomy and respect for persons. "Autonomy" refers to the patient's right to make free decisions about his or her health care. Respect for persons requires that health care professionals refrain from carrying out unwanted interventions and that they foster patients' control over their own lives.

Law

Obtaining the patient's consent to medical care is a legal requirement. Under common law, treating a patient without his or her consent constitutes battery,[4] whereas treating a patient on the basis of inadequately informed consent constitutes negligence.[5] Ontario's Health Care Consent Act (1996) defines the elements of consent, describes how capacity should be determined, allows patients to challenge a finding of incapacity and defines who may give consent on behalf of the patient.[6] British Columbia[7] and Prince Edward Island[8] are in the process of enacting similar legislation.

Policy

The requirement to obtain patient consent is affirmed by professional organizations such as the Royal College of Physicians and Surgeons of Canada, the Canadian Council on Hospital Accreditation and the CMA. For example, the CMA's policy summary on informed decision making states:

Obtaining valid consent before carrying out medical, therapeutic and diagnostic procedures has long been recognized as an
elementary step in fulfilling the doctor's obligations to the
patient.[9]

Empirical studies

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 found that effective physician-
patient communication improved emotional health, symptom resolution, level of function, results of physiologic measures and pain control.[10] A meta-analysis 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.[11] Another demonstrated that information-giving by physicians was associated with small to moderate increases in patient satisfaction and compliance with treatment.[12]

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How should I approach the consent process in practice?

Problem solving and decision making

Clinicians often struggle with the question of how to apply the ethical and legal concept of consent in their daily practice. It is helpful to distinguish the process of problem solving from that of decision making.[13] Problem solving involves identifying the patient's presenting problem and developing a list of treatment options. Most patients expect the physician to assume the role of problem solver.[14,15] Decision making involves choosing from the treatment options. Several studies have shown that patients' desire for decision-making responsibility is variable.[16-23] Even patients who actively seek information do not necessarily wish to make the decision about which treatment option to follow.[24,25] Some, particularly those who are elderly or acutely ill, are predisposed to follow the physician's recommendation.[26-28]

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.

Exceptions

Common law recognizes that the emergency treatment of incapable persons is an exception to the requirement for consent. In common law, an emergency exists when immediate treatment is required in order to save the life or preserve the health of the patient.[29] 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. In some provinces an emergency may be defined differently in statutory law than in common law, and so clinicians should be aware of the legislation in their own province. In Ontario statutory law, for example, an emergency exists if a person is apparently experiencing severe suffering or is at risk, if the treatment is not administered promptly, of sustaining serious bodily harm.[30]

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. For example, in Malette v. Shulman4 the physician gave a blood transfusion to a patient who, because of shock and severe facial injuries, was unconscious. The patient carried a signed card indicating that she was a Jehovah's Witness who did not want to receive blood transfusions under any circumstances. Despite this information, blood transfusions were given. Although the transfusions probably saved the patient's life, the court found the clinician liable for battery, holding that the written instructions were "clear, precise and unequivocal"[31] and that the clinician was bound by them unless he had good reason to believe that they did not truly represent the patient's wishes.[31]

A patient's incapacity does not exempt the physician from the requirement to obtain consent. If a patient is mentally incapable of making medical decisions, the clinician must obtain consent from a substitute. Assessing capacity and obtaining substitute consent will be discussed in detail later in this series.

The statutory law of some provinces permits nonconsensual treatment in specific circumstances, such as the involuntary admission of psychiatric patients and the treatment of irresponsible patients with communicable disease. Nonconsensual treatment will be discussed in a later article on voluntariness.

There are other potential exceptions to the requirement to obtain consent. "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.[32] "Waiver" refers to a patient's voluntary request to forego one or more elements of disclosure. Therapeutic privilege and waiver will be discussed in the next article in this series.

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The cases

Mr. A' s physician must decide whether to perform surgical repair of the aneurysm. Mr. A. is now an incapable person in a medical emergency, and no substitute decision-maker is available. 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 Mr. A had previously refused elective repair of the aneurysm? Mr. A's refusal of elective surgery was based on his wish to continue caring for his wife. Therefore, Mr. A would likely want to undergo emergency surgery, because it would give him the best chance of continuing to care for his wife. Therefore, the surgeon may proceed without the patient's consent. If Mr. A had previously considered and refused emergency surgery, the surgeon would not be entitled to proceed.

Mr. B is obviously incapable of consenting to treatment of his pneumonia, and so the physician should obtain consent from Mr. B's wife. However, the clinician could administer emergency treatment such as oxygen and intravenous antibiotic therapy until Mr. B's wife
arrives.

We thank Ms. Sharon Smith for her careful preparation of the manuscript.

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References

  1. Beauchamp TL, Faden RR. Informed consent: II. Meaning and elements of informed consent. In: Reich WT, editor. Encyclopedia of Bioethics. rev ed. vol 3. New York: Simon & Schuster Macmillan, 1995:1240.
  2. Lidz CW, Appelbaum PS, Meisel A. Two models of implementing informed consent. Arch Intern Med 1988;148:1385-9.
  3. Canadian Medical Protective Association. Consent. A Guide for Canadian Physicians. Ottawa: The Association, 1989:7.
  4. Malette v. Shulman [1990] 67 DLR (4th) (Ont CA) at p 338.
  5. Reibl v. Hughes [1980] 2 SCR 880.
  6. Health Care Consent Act, SO 1996, c 2.
  7. Health Care and Care Facility Act, SBC 1993, c 48.
  8. Consent to Treatment and Health Care Directives Act, Stats PEI 1996, c 10.
  9. Informed decision-making [policy summary]. CMAJ 1986;135:1208A.
  10. Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ 1995;152:
    1423-33.
  11. Suls J, Wan CK. Effects of sensory and procedural information on coping with stressful medical procedures and pain: a meta analysis. J Consult Clin Psychol 1989;57:372-9.
  12. Hall JA, Roter DL, Katz NR. Meta-analysis of correlates of provider behavior in medical encounters. Med Care 1988;26:657-75.
  13. Deber RB. Physicians in health care management: 8. The
    patient-physician partnership: decision making, problem solving and the desire to participate. CMAJ 1994;151:423-7.
  14. Kraetschmer N. Preferences of patients undergoing angiograms for participation in treatment decisions: coping style and the problem solving-decision-making scale [master's thesis]. Toronto: University of Toronto, 1994.
  15. Siminoff LA, Fetting JH. Factors affecting treatment decisions for a life-threatening illness: the case of medical treatment of breast cancer. Soc Sci Med 1991;32:813-8.
  16. Cassileth BR, Zupkis RV, Sutton-Smith K, et al. Information and participation preferences among cancer patients. Ann Intern Med 1980;92:832-6.
  17. Ende J, Kazis L, Ash A, et al. Measuring patients' desire for autonomy: decision making and information-seeking preferences among medical patients. J Gen Intern Med 1989;4:23-30.
  18. Larsson US, Svardsudd K, Wedel H, et al. Patient involvement in decision-making in surgical and orthopaedic practice: the Project Perioperative Risk. Soc Sci Med 1990;28:829-35.
  19. Ende J, Kazis L, Moskowitz MA. Preferences for autonomy when patients are physicians. J Gen Intern Med 1990;5:506-9.
  20. Lerman CE, Brody DS, Caputo GC, et al. Patients' perceived involvement in care scale: relationship to attitudes about illness and medical care. J Gen Intern Med 1990;5:29-33.
  21. Mark JS, Spiro H. Informed consent for colonoscopy. Arch Intern Med 1990;150:777-80.
  22. Llewellyn-Thomas HA, McGreal MK, Thiel EC, et al. Patients' willingness to enter clinical trials measuring the association with perceived benefit and preference for decision participation. Soc Sci Med 1991;32:35-42.
  23. Waterworth S, Luker KA. Reluctant collaborators: Do patients want to be involved in decisions concerning care?
    J Adv Nurs 1990;15:971-6.
  24. Sutherland HJ, Llewellyn-Thomas HA, Lockwood GA, et al. Cancer patients: their desire for information and participation in treatment decisions. J R Soc Med 1989;82:260-2.
  25. Blanchard CG, Labrecque MS, Ruckdeschel JC, et al. Information and decision-making preferences of hospitalized adult cancer patients. Soc Sci Med 1988;27:1139-45.
  26. Emanuel EJ, Emanuel LL. Four models of the physician-
    patient relationship. JAMA 1992;267:2221-6.
  27. Strull WM, Lo B, Charles G. Do patients want to participate in medical decision making? JAMA 1984;252:2990-4.
  28. Beisecker AE, Beisecker TD. Patient information-seeking
    behaviors when communicating with doctors. Med Care 1990;28:19-28.
  29. Malette v. Shulman [1990] 67 DLR (4th) (Ont CA) at p 328.
  30. Health Care and Consent Act, SO 1996, c 2, s 25.
  31. Malette v. Shulman [1990] 67 DLR (4th) (Ont CA) at p 337.
  32. Meisel A, Roth LH, Lidz CW. Toward a model of the legal doctrine of informed consent. Am J Psychiatry 1977;134:285-9
| CMAJ July 15, 1996 (vol 155, no 2) / JAMC  le 15 juillet 1996 (vol 155, no 2) |
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