By Jamie Nicole LaBuzetta, MD, MSc, MPhil
UC San Diego, Dept of Neurosciences, Division of Neurocritical Care
Informed consent is the complex basis of shared decision-making in the medical realm. It involves sharing information with a patient or surrogate decision-maker and asking for permission — without coercion — to proceed. Yet informed consent — and its corollary, informed refusal — is often misunderstood by patients and medical professionals. Informed consent is consistently explained in medical education as the process by which physicians achieve several important ends:
- Ensure decision-making capacity
- Disclose the risks and benefits of a procedure or treatment
- Discuss alternatives to the proposed treatment
- Evaluate comprehension of those risks and benefits
- Obtain voluntary agreement
The process of consent provides the decision-maker with autonomy over diagnostic and therapeutic decisions, while allowing them to incorporate their own value system into the decision-making process. Prior court cases have ruled that in non-emergent situations, “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.”1
The consent process also highlights the duty of the physician to explain the risks and benefits of proceeding with a course of action and to answer all questions the decision-maker may have. The decision-maker is in a dependent position insofar as they rely upon the physician to provide the necessary knowledge, and often do not have the medical wherewithal to understand all the nuances of medical details. Indeed, there are debates about whether a physician’s duty extends to providing even options that are physiologically non-beneficial, and many medical institutions have responded by adopting policies to limit their responsibility to provide ongoing aggressive care in non-beneficial circumstances. However, the overriding principle is that of a capable decision-maker’s informed autonomy.
The corollary to informed consent is informed refusal. There are no states that have rejected the idea of informed refusal. Although most often discussed in the context of Jehovah’s Witnesses’ refusal of blood transfusion,2 refusal of vaccination3 or refusal of recommended Cesarean section,4 we also encounter informed refusal of neurocritical care, for instance in the case of declining a decompressive hemicraniectomy because it is not consistent with overall goals of care. As a concept, informed refusal respects the same ethical principle of patient autonomy; a patient or their designated decision-maker may have a legitimate difference of opinion about how a proposed test or treatment fits into their larger goals for medical therapy. This can be very frustrating to some clinicians. In fact, a recent internal quality improvement project at our institution revealed that a not insignificant number of ethics service consults were placed for appraisal of whether a patient could decline medical diagnosis or therapy.
Unfortunately, when compared with informed consent, informed refusal disproportionately increases medicolegal risk. If a patient or surrogate with decision-making capacity refuses diagnostic tests or treatment, it becomes the legal duty of the physician to explain the risks of not proceeding with the recommended tests or treatments. The only exception is when the patient refuses the information, thus waiving their right to be informed of the consequences.5
The medicolegal risk most commonly occurs when patients who refuse a treatment are injured or die because of that refusal; the patient or their survivors can claim that there was inadequate information provided regarding the consequences of that refusal.
Therefore, when refusal of treatment may result in significant injury or death, the interaction needs to be documented, and include the following components:
- Capacity assessment
- An explanation of the risks and benefits of refusing treatment
- Alternatives to treatment
- Patient’s understanding of the risk of refusal and voluntary decision-making
A study evaluating documented elements of refusal noted that the most commonly missing component is decisional capacity.6 In a later Currents article, we will further delve into the criteria for decision-making capacity and how this capacity (or lack thereof) influences consentability.
In appropriately managing adult patients’ wishes to refuse medical care, we have to put aside our own biases and hold paramount the principle of autonomy, as well as remember that a patient’s refusal to pursue a diagnostic or treatment path does not necessarily mean they are incapable of making their own decisions. However, informed refusal also places additional responsibilities for assessing patients, informing them of risks and for documenting those assessment and informational processes.
- Schloendorff. v. Society of NY Hospital. New York Court of Appeals; 105 N.E. 92, 211 N.Y. 125. 1914.
- Berend K, Levi M. Management of adult Jehovah's Witness patients with acute bleeding. Am J Med 2009;122:1071-6.
- Schwartz JL, Caplan AL. Vaccination refusal: ethics, individual rights, and the common good. Prim Care 2011;38:717-28, ix.
- Malek J. Responding to refusal of recommended cesarean section: Promoting good parenting. Semin Perinatol 2016;40:216-21.
- Truman vs. Thomas. Supreme Court of California; 27 Cal. 3d 285, 165 Cal. Rptr. 308, 611. 1980.
- Schaefer MR, Monico EP. Documentation proficiency of patients who leave the emergency department against medical advice. Conn Med 2013;77:461-6.