(Waisel) Attending Anesthesiologist, Wilford Hall Medical Center.
(Truog) Director, Multidisciplinary Intensive Care Unit, Children's Hospital, and Associate Professor of Anaesthesiology & Pediatrics, Harvard Medical School.
Received from the Department of Anesthesiology, Wilford Hall Medical Center, Lackland Air Force Base, Texas, and the Department of Anesthesiology, Children's Hospital, Harvard Medical School, Boston, Massachusetts. Submitted for publication October 10, 1995. Accepted for publication April 21, 1997. The views expressed in this article are those of the authors and do not reflect the official policy of the Department of Defense or other departments of the US government.
Address reprint requests to Dr. Waisel: 59th MDW/MKAA, 2200 Bergquist Dr., Suite 1, Lackland AFB, Texas 78236–5300. Address electronic mail to: waisel@texas.net.
Anesthesiology October 1997, Vol. 87, 968–978.David B. Waisel , Robert D. Truog; Informed Consent . Anesthesiology 1997; 87:968–978 doi: https://doi.org/10.1097/00000542-199710000-00033
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toolbar searchInformed consent is a relatively new concept. Hippocrates proscribed informing the patient:“conceal(ing) most things from the patient while you are attending to him … revealing nothing of the patient's future or present condition.”[1] Medieval physicians considered themselves extensions of God and did not deign to confer with patients about their care. [2] The American Medical Association's first code of medical ethics in 1847 did not mention patient-physician interaction or informed consent. [3] In the early 1900s, physicians routinely obtained assent, the agreement of the patient to have a procedure, but not consent, the informed authorization by the patient to have a specific procedure. As long as the physician acted in accordance with accepted standards of care, informed consent was not legally required. This standard held until the 1950s, when a new rights orientation-civil rights and consumer rights-brought about a new interpretation of individual liberties and autonomy. [2]
The 1957 Salgo case launched the current concept of informed consent. After translumbar aortography, Mr. Salgo suffered permanent paralysis, a known risk of the procedure about which he had not been informed. The judge deciding this case clarified the difference between informed consent and assent by stating, “A physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form [the] basis of an intelligent consent by [a] patient to a proposed treatment ….”* In other words, having the patient agree to a procedure without having knowledge of the relevant risks and benefits is inappropriate. [4]
The 1960 Natanson case established the professional practice standard. After radiotherapy, Ms. Natanson suffered severe radiation burns, a risk that had not been disclosed to her. The court asserted that the disclosure to the patient should be to the extent “a reasonable practitioner would make under the same or similar circumstances.”**[5] The professional practice standard, also known as the physician-based standard and the “reasonable doctor standard,” requires the level of disclosure to be dictated by the practices of the local physician community.
The next major shift occurred in the 1972 Canterbury case. Mr. Canterbury underwent a cervical laminectomy and subsequently became quadriplegic. The surgeons had followed the customary local practice of not informing the patient about this unlikely risk. The court held that such disclosure was insufficient without extenuating circumstances and suggested basing the extent of the disclosure on what is material to the patient's decision and not customary local practice.***[5] This established the “reasonable person standard,” which requires disclosure of all material information to the extent that would satisfy the hypothetical reasonable person. [6] Information is material if a reasonable person would consider it important for decision making. This standard is also called the “reasonable patient standard” or the general standard. Most jurisdictions today use either the professional practice or reasonable person standards. [7]
An outgrowth of the reasonable person standard is the “subjective person standard,” in which disclosure is tailored to the particular patient's wants and needs. Although difficult to use as a legal standard, the subjective person standard does establish the ideal level of disclosure. [6] The discussion of the risk of death in the anesthesia preoperative interview illustrates the use of these standards. The professional practice standard bases the disclosure on the prevalent practice in the local physician community. Practitioners following the reasonable person standard advocate informing every patient about the risk of death because most decision makers want to know. [7] Because not all patients want to know the risk of death, however, an anesthesiologist using the subjective person standard would, during the course of the preoperative discussion, determine whether the patient prefers only to know the more likely but less significant risks. [8]
As with many guidelines, one can fulfill the “letter of the law” without fulfilling the ethical spirit of obtaining informed consent. Institutional policies specify mechanisms and procedures for obtaining informed consent, yet a signed legal document does not necessarily achieve the goal of informed consent. [9] Patients or surrogates, for instance, may sign documents they do not understand. [8,10] Anesthesiologists, then, should consider the need to achieve informed consent in two symbiotic senses: the legal sense and the ethical sense.
The best way to fulfill both senses is to be vigilant in pursuing the spirit of informed consent. Establishing the patient-physician relationship, tailoring the disclosure of risks, and making the patient a full partner in decision making will improve the quality of the informed consent process and, as a result, decrease the likelihood of litigation. [11] Components of informed consent include an ability to participate in care decisions, to understand pertinent issues, and to be free from control by others in making decisions. The informed consent process culminates in an active autonomous request by the patient to receive a chosen perianesthetic course within the advice and guidance of the anesthesiologist. Some suggest it is unrealistic to expect to achieve these components, and thus true informed consent can never be obtained. If that is so, they argue, then why try to obtain informed consent at all? Beauchamp [12] responds to this argument best:
"It has sometimes been claimed that informed consent, so understood, has a mythical quality because true informed consent is never obtained under such a high ideal-that is, most patients and subjects cannot comprehend enough information or appreciate its relevance sufficiently to make decisions about medical care …. This objection, however, springs from a serious misunderstanding of the nature and goals of informed consent, in part because of unwarranted standards of full disclosure and full understanding. The ideal of complete disclosure of all possibly relevant knowledge needs to be replaced by a more acceptable account of how patients and subjects understand relevant information. Merely because one's actions fail to be fully informed, voluntary or autonomous is no indication that they are never adequately informed or autonomous."
The ability to participate in care decisions is called decision-making capacity. [6] This is distinct from the legal concept of competency, which only a judge has the authority to determine. [13,14] Decision-making capacity, on the other hand, can and should be assessed by anesthesiologists and other clinicians. Evidence that a person can make a decision includes the ability to understand the current situation, to use relevant information, and to communicate a preference supported by reasons. [6] Decision-making capacity may vary relative to age, situation, mental status, and level of risk in the decision.
Anesthesiologists encounter patients with limited decision-making capacity in at least three situations. The first is the patient who does not have decision-making authority, such as a patient who has been adjudged incompetent for health care decisions or a child who has not reached the age of majority. These patients should be allowed to make decisions commensurate with their capacity, and other decisions should be made by the legal surrogate. For example, an 8-yr-old child usually is capable of choosing between an intravenous and inhalational technique for induction of anesthesia, but the same child may not have the capacity to choose whether to have the operation. The second situation is the patient who usually can make decisions but whose decision-making capacity is temporarily altered by, for example, preoperative sedation or pain medicine for nonemergent surgical ailments such as kidney stones or a broken bone. Anesthesiologists must then decide whether a patient can consent to anesthesia. The clinician needs to use clinical judgment, balancing the medication given and its expected effects and the ability for the patient to show evidence of rational reasoning and understanding, to determine if the patient is able to make the specific decision. Anesthesiologists should remember that when the effect of preoperative sedation precludes substantial reasoning and understanding of the proposed anesthetic management options and risks, family members and spouses cannot consent for the patient unless they are recognized legal guardians. The third situation is the patient who appears to have baseline difficulties in decision-making capacity. Determining how to proceed requires some of the same clinical judgment needed in the patient who has temporarily altered decision-making capacity. The anesthesiologist may wish to seek assistance from colleagues in ethics consultation, psychiatry, and law in deciding whether the patient is sufficiently competent to proceed without legal adjudication of competency.
The situation is, in some sense, clearer when questions about consent arise for a patient who is already under general anesthesia. Although as a general rule consent should be obtained from the patient only after the patient has awakened and recovered from the anesthetic, extenuating circumstances may be important. If, for example, the anesthesiologist thought that unanticipated pulmonary artery catheter monitoring was urgently needed to appropriately manage intraoperative myocardial ischemia and delay would very likely result in harm to the patient, then it may be appropriate to proceed with insertion without having obtained informed consent for the procedure, appealing to the same justification as used in emergency situations (explained in sections that follow). This decision requires balancing the principles of autonomy and beneficence. Although the patient's spouse or family members would have no legal authority to give consent in this situation, seeking their understanding and agreement would be advisable and respectful of familial obligations and responsibilities.
A more difficult situation may be when an anesthesiologist believes a surrogate is making a decision that is not fully in the patient's best interests. The extent to which the clinician must intervene between a patient and his or her surrogate's decision depends primarily on how harmful the decision is to the patient, from the clinician's point of view. The extent of harm can be considered on a continuum. At one end is the classic example of a blood transfusion in the child whose parents are Jehovah's Witnesses. It is well recognized that a surrogate is rarely permitted by the court to refuse a medically necessary transfusion for a minor and an anesthesiologist in this situation should not hesitate to seek legal authorization for the transfusion. On the other end may be the use of postoperative epidural analgesia for a child having bilateral ureteral reimplantation. Although the pediatric anesthesiologist may strongly believe that the child would benefit from the epidural analgesia, adequate pain control can be obtained by other methods, and so the loss of benefit to the child is less significant. The obligation of the anesthesiologist to intervene is thus attenuated. But many dilemmas are less clear. What about the incompetent elderly patient with chronic obstructive pulmonary disease whose surrogate is insisting on a general anesthetic for heel ulcer debridement? The level of intervention that is appropriate depends on fairly imprecise estimates of the likelihood of problems with general anesthesia and being unable to extubate the trachea at the end of the procedure. This situation falls in between the two more clear-cut examples given before and illustrates the difficulty in knowing to what extent the anesthesiologist should intervene.
Anesthesiologists should be cautious in judging that a surrogate's decision is significantly harmful to the patient. In our heterogeneous society, people legitimately prioritize values differently and disagreement with a physician does not necessarily constitute mistreatment. [15] Physicians must be respectful of these decisions. Furthermore, intervening has significant psychological costs for both the surrogate and physician and should not be undertaken lightly. Resolving this kind of problem should begin with fully informing the surrogate (see Informed Refusal) about the benefits of the alternative approach. The physician should obtain, if appropriate, help from other care givers or ethics consultants with communicating with the surrogate or informally assessing the appropriateness of the surrogate's choice. The ultimate intervention is to ask for legal intervention to order a specific action or to have someone else assume surrogacy. The unpleasantness of this path, however, should not deter the anesthesiologist from pursuing it if necessary. The primary obligation is to the patient, not to the decision maker.
Institutional requirements are based on local statutes and define the appropriate information standard and the manner in which it must be documented. The most common theory of suit relating to informed consent is negligence (Table 1). [11,13]