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Case example
Fifty-seven-year-old Mr. Evans arrives at the Emergency Department of a large teaching hospital complaining of chest pain, cough, and shortness of breath. Chest x-rays are obtained, and they reveal a large pleural effusion (a buildup of fluid between the layers of tissue that line the lungs and the chest cavity). Mr. Evans is admitted to the hospital and is assigned to a general internal medicine inpatient team. The team concludes that a thoracentesis (removal of accumulated pleural fluid with a needle inserted between the ribs) should be done to allow Mr. Evans’s lungs to expand more freely, making breathing easier, and to obtain a fluid sample for testing. The senior resident asks Dr. Collins, the first year resident on the team, to perform the thoracentesis, and she agrees. Dr. Collins has observed this procedure on multiple occasions, but she has never performed a thoracentesis before. In obtaining Mr. Evans’s consent, must she inform him that this will be the first time she has performed this procedure?
Origins and moral grounds
First introduced in the United States more than half a century ago, informed consent to medical treatment is now generally recognized as a fundamental moral and legal right of patients. This chapter will examine the origins, moral grounds, and essential elements of informed consent. It will also describe recognized exceptions to the professional duty to obtain the patient’s informed consent.
The concept of informed consent has its origins in medical law. Early twentieth-century cases in the United States recognized a right to consent to proposed treatment, articulated in a classic statement by Justice Benjamin Cardozo in 1914: “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.”1 Cardozo refers to assault, and early consent cases relied on legal concepts of assault and battery, understood in this context as the intentional, nonconsensual, and offensive touching of a patient by a physician.
In a series of cases beginning in 1957, US courts expanded the established duty to obtain a patient’s consent into a duty to obtain an informed consent, that is, to obtain consent after providing specific information about the proposed treatment to the patient.2 Most of these more recent informed consent cases rely on the legal concept of negligence, or failure to satisfy a professional standard of care, rather than assault and battery. The professional standard in these cases is a standard regarding what information should be given to patients about the proposed treatment and its expected benefits, risks, and alternatives.
Although its origins are in the law, leading scholars in the emerging field of medical ethics in the 1970s embraced the doctrine of informed consent and emphasized its importance as a remedy for paternalistic attitudes and practices then common among physicians.3 These scholars viewed informed consent as a valuable mechanism for encouraging a more equal relationship between patients and physicians and a more active role for patients in making treatment decisions.
What, then, are the moral grounds for recognizing a patient right to informed consent to medical treatment, and a provider duty to obtain that consent? Commentators acknowledge two primary moral grounds, namely, respecting patient autonomy and promoting patient well-being.4
The role and value of informed consent in respecting patient autonomy is readily apparent and thus needs little explanation. A right to informed consent (and its corollary, informed refusal of treatment) gives patients the final say regarding what treatment they will receive, recognizing that they are moral agents entitled to make important choices about their own lives. Informed consent thus expresses basic convictions about the distinctive moral status of human persons, as well as the fundamental value ascribed to individual freedom in democratic societies.
Informed consent also plays an important role in promoting patient well-being, or, in principle-based language, in fulfilling the principle of beneficence. Medical treatment decisions can have multiple and profound positive or negative consequences for patients, including life or death, mental and physical function or disability, beauty or disfigurement, and comfort or suffering. Patients clearly have a strong interest in these outcomes of treatment, but their treatment preferences can differ because they have different personal beliefs, values, and goals. Whether chemotherapy or amputation will be a better treatment option for a patient with sarcoma (a malignant tumor of the leg), for example, will likely depend on that patient’s beliefs and attitudes about physical function, longevity, disfigurement, pain, and risk-taking. Physicians have expert knowledge about the probable benefits and risks of different treatments, but patients are most knowledgeable about their own values, preferences, and goals. Because both of these kinds of knowledge are essential for making good medical treatment choices, a shared decision-making process will be most effective. Requiring informed consent enables the patient to make choices in light of his or her own values and interests, and treatments chosen based on those values and interests are most likely to achieve the best outcome for that patient.
Essential elements
In order for a patient to provide an informed consent to medical treatment, three essential elements must be present. First, the patient must have the capacity to make a treatment decision. Second, the patient must have the information he or she needs to make an informed choice. Third, the patient must make the treatment decision voluntarily. Let’s examine each of these three essential elements of informed consent in turn.
Decision-making capacity
The first essential element of an informed consent is patient decision-making capacity. In seeking a patient’s informed consent to a particular treatment, health care professionals must assess whether the patient has the ability to make that decision. The terms ‘competence’ and ‘incompetence’ are also frequently used in the medical literature and in practice settings to refer to patients’ abilities to make treatment decisions. It is important to recognize that the term ‘incompetence’ is also used to refer to a court’s determination that a person lacks the ability to make legally effective decisions, resulting in the appointment of a legal guardian with authority to act on behalf of the incompetent person. These clinical and judicial decisions have obvious similarities, but they are also significantly different. To avoid confusion, in this chapter I will use the term ‘decision-making capacity’ to refer to patients’ abilities to make medical treatment decisions.
How do health care professionals determine whether a patient has the capacity to make a treatment decision? In most situations, the answer is obvious – either the patient is clearly able to understand the choice at hand and to engage fully in the decision-making process, or the patient is clearly unable to participate in decision-making, due to unconsciousness, advanced dementia, delirium, or some other incapacitating condition. In still other situations, however, when patients are conscious but have compromised mental status, clinical judgments about capacity are more difficult. To guide capacity evaluation in these latter situations, scholars have identified the following four more specific abilities that are necessary for decision-making capacity:5
1. The ability to understand information relevant to the treatment decision at hand. Patients must have at least a basic grasp of their medical condition, treatment alternatives, and the expected benefits and risks of those alternatives, to make a treatment decision.
2. The ability to appreciate the significance of that information for one’s own situation. In addition to a theoretical understanding of treatment-related information, patients must recognize that this information applies to their own situation. A patient with severe anorexia nervosa, for example, may affirm the importance of nutrition for a starving person, but fail to recognize that this description applies to her own current condition.
3. The ability to reason, evaluating information about treatment options in a logical way to reach a decision based on one’s own preferences and values. Patients must be able to engage in a process of considering treatment options and choosing a treatment option based on its consistency with their beliefs and values and its ability to achieve their goals.
A variety of different capacity evaluation tools have been developed to assist clinicians in assessing a patient’s decision-making capacity.6 Questions in these evaluation tools enable a more systematic and structured assessment of the specific abilities listed above.
Several other features of decision-making capacity judgments are important to recognize. First, decision-making capacity is a threshold judgment – that is, a patient either has or does not have sufficient capacity to consent to a particular treatment. In this respect, decision-making capacity is like pregnancy; a patient cannot be “partially pregnant” or be “partially capable.” Second, decision-making capacity is a task- or context-specific judgment – that is, it is a determination that a patient can consent to this particular treatment in this particular context. Thus, a patient may have capacity to make a simple treatment decision, but lack the capacity to make a more complex decision. Because capacity judgments are context-specific, they are also time-specific – that is, a patient may lack capacity to make a treatment decision at one time, perhaps because he is acutely psychotic, and regain that capacity at a later time, after the psychotic episode has passed.
Finally, most (but not all) commentators maintain that capacity judgments should be consequence- or risk-specific – that is, the appropriate threshold for capacity to make a treatment choice should vary with the likely consequences of that choice.7 In other words, a higher threshold for capacity should be required when a patient makes a choice that poses a higher risk of harm. This “sliding scale” approach to capacity judgments has a result that some find paradoxical, namely, a patient may have sufficient capacity to consent to a highly beneficial treatment for a life-threatening medical condition, but lack the capacity to refuse the very same treatment. Thus, a patient with acute appendicitis may have sufficient capacity to consent to an appendectomy, but not to refuse that same procedure. The justification for this approach appeals to a tension between patient autonomy and patient well-being, the two major values underlying the determination of decision-making capacity and informed consent generally. On the one hand, we want to respect the autonomy of patients who have decision-making capacity by recognizing that capacity and obtaining their informed consent to treatment. On the other hand, we want to promote the well-being of patients who lack decision-making capacity by not honoring “incompetent” choices that will have predictably harmful consequences. A risk-specific, sliding-scale approach to capacity evaluation is intended to enable clinicians to strike an appropriate balance between those two moral goals.
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