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Module 1 – Chapter 3

Informed Consent 1. 2. 3. 4.

Overview The Legal Doctrine of Informed Consent The Legal Elements of Informed Consent Legal Standards of Disclosure i. The Reasonable Physician Standard ii. The Reasonable Patient Standard iii. The Subjective Patient Standard 5. The Ethical Elements of Informed Consent 6. Ethical Standards of Disclosure i. The Meaning of “Materiality” ii. The Subjective Patient Standard from an Ethical Perspective iii. Understanding and Decision-making Capacity iv. The Incompetent Patient v. Potential Vulnerabilities Needing Special Safeguards 7. The U.S. FDA Warnings and Standards of Materiality 8. Procedural and Mechanical Aspects of Informed Consent 9. Pediatric Informed Consent 10. Informed Consent for Clinical Trials and in Experimentation with Human Subjects 11. Summary

1. Overview The idea of informed consent provides a central value in all of contemporary healthcare. Physicians and surgeons traditionally obtained some rudimentary form of consent. A rare insight into mid-nineteenth century practice is to be found in the circumstances surrounding the amputation of Lieutenant General Thomas J. (“Stonewall”) Jackson’s left arm on May 3, 1863 (See separate Module in Section III for the full account of this). The exchange between Jackson and his physician was characteristic of the best that might have been anticipated between a surgeon and an educated patient: a brief statement of diagnosis, a brief statement of the procedure, and a verbal consent. The contemporary ideas of consent are highlighted in the case of Schloendorff v. Society of New York Hospital in 1914.1 This case was framed in terms of a battery. The plaintiff, Mary Schloendorff, consented to an examination under anesthesia to determine whether a previously diagnosed fibroid tumour was malignant. She withheld consent for removal of the tumour. The physician determined that the tumour was malignant and removed it, thereby violating the patient’s instructions. Justice Benjamin Cordozo of the New York State Supreme Court wrote in the Court’s opinion that an operation to which the patient did not consent constituted medical battery:

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“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. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained.” In 1960, the term “informed consent” entered the lexicon after a case known as Natanson v. Kline.2 3 2.

The Legal Doctrine of Informed Consent

The legal doctrine of informed consent has evolved over the years to include two distinct components: (1) a patient’s right to determine what happens to his or her body; and (2) a physician’s duty to provide a patient with enough information to make an educated decision regarding his or her condition and proposed treatment.4 The legal doctrine of informed consent is primarily concerned with liabilities associated with breach. Breach of the doctrine of informed consent may be actionable. It may constitute battery, an unconsented form of touching, which medical liability insurance does not cover, or professional malpractice, which medical liability insurance does cover. Informed consent claims are often coupled with a claim for medical malpractice and typically arise when a patient experiences an adverse outcome from a treatment or surgery. The standard allegation in a claim for lack of informed consent is that the patient was never informed, or was inadequately informed, about the possibility of the adverse outcome. The majority of informed consent claims turn on the element of causation. To prove causation and ultimately succeed on such a claim, the patient must demonstrate that had he or she known of the possibility of the adverse outcome allegedly not disclosed, he or she would not have chosen to proceed with the treatment or surgery. 3. The Legal Elements of Informed Consent Complete informed consent from a legal perspective generally requires discussion of the following: (a) the patient’s diagnosis; (b) the nature and purpose of a proposed treatment or procedure; (c) the risks and benefits of a proposed treatment or procedure; (d) alternatives and associated risks and benefits; and (e) the risks and benefits of not receiving or undergoing a treatment or procedure.5 It is essential that this information be discussed in plain terminology that can be readily understood by the patient. It is also essential that the patient be given an opportunity to ask questions about his or her condition and the proposed treatment or surgery. Finally, a physician should thoroughly document the communications process in the patient’s chart. A timely and thorough documentation in the patient’s record can be a strong piece of evidence in a court of

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law that the communications process in fact took place and that the physician made an adequate disclosure to the patient. 4. Legal Standards of Disclosure While simple in theory, the application of the doctrine of informed consent has proven to be complex in operation. The complexity lies in the fact that what constitutes adequate disclosure of information often varies from state to state. State courts, in whose jurisdiction these matters lie, have developed different standards to judge the adequacy of a physician’s disclosure of information to a patient for purposes of obtaining informed consent. i. The Reasonable Physician Standard The reasonable physician standard, also known as the professional standard, places a duty on a physician to disclose information to a patient that any reasonably prudent physician with the same background, training, and expertise and practicing in the same community would have disclosed to a patient in the same or similar situation.6 7 Expert testimony is used to establish the content of information that a reasonable physician would have disclosed under similar circumstances. ii. The Reasonable Patient Standard The reasonable patient standard requires a physician to disclose information based on the point of view of the patient rather than that of the physician. Courts that have adopted this standard require physicians to disclose risks that a reasonable person in the patient’s position would have considered significant in deciding whether or not to consent to a proposed surgery, treatment, or procedure.8 iii. The Subjective Patient Standard Some courts have applied a standard that asks what this particular patient, based on his or her particular set of circumstances or conditions, would need to know and understand to make an informed consent. A growing number of state courts are applying the reasonable patient standard. Although a number of courts find the reasonable physician standard to be appealing because it is the same standard applied to other claims of alleged malpractice, it is increasingly viewed as inconsistent with the goals of informed consent because the focus is on the physician rather than on precisely what the patient needs to know. The subjective patient standard is rarely applied given the difficulties of tailoring information to each patient. 5. The Ethical Elements of Informed Consent The ethical doctrine of informed consent also consists of two elements: (1) a duty of disclosure incumbent upon the physician, and (2) a requirement that the physician obtain uncoerced competent consent.

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The ethical standard is very sympathetic to the idea that there will be differences among patients in terms of what they need to learn and know before consenting to a procedure. If the ethical doctrine does not explicitly accept a subjective patient standard it is, at the very least, quite sympathetic to it. 6. Ethical Standards of Disclosure Ethical standards of disclosure address materiality, comprehension, and competence. Consent is considered adequate when the physician discloses all material information, when all questions are answered, and when the patient understands sufficiently to provide competent consent. This is an ideal but very difficult standard to meet, because it is difficult to determine whether the patient comprehends fully what the physicians has disclosed fully, and it may be even more difficult to determine whether the patient has sufficient capacity to act upon the information that he or she has been presented for purposes of giving consent. In this section, the test of adequate material disclosure is referred to as the first standard, and the test of patient comprehension and competence is referred to as the second standard. i.

The Meaning of “Materiality”

The word “material,” applied to information, means “germane” or “pertinent.” It may also be understood as relevance of a special kind. It describes information of such dispositive pertinence or consequence that it is capable of changing the outcome of a deliberation. Materiality is no less a concern in formulating ethical standards for disclosure than in formulating legal standards. The information considered material according to the ethical doctrine of informed consent is essentially the same as that dictated by the courts: diagnosis, prognosis, available treatments, recommended treatments and alternatives, and the risks and benefits of choosing any of the courses open to the patient. Materiality is not the same as completeness. One might possess all material information without necessarily possessing all information. ii.

The Subjective Patient Standard from an Ethical Perspective

It seems simple enough to define materiality in terms of the information someone would expect, want, or need to make a decision. This construction of materiality, however, leads to a subjective and therefore a variable patient standard of disclosure. It becomes very complicated. What one patient requires may differ radically from what another patient may need, and yet the surgeon has to respond to all. Materiality to a patient with pathologically obsessive character traits may be something different still. It may include elements that a less obsessive but still very prudent individual would not consider pertinent.

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Sometimes patients ask for information that challenges the limits of privacy for the surgeon. This becomes particularly troublesome when connected with potential stereotypes and biases unrelated to skill and responsibility, such as religion, race, sexual preference, or culture. Because the subjective patient standard can become open-ended, particularly when the psychological needs of specific individuals come into play, the subjective standard is usually restrained by a standard of reasonableness. As intuitively attractive as a standard of reasonableness might be, it does not always suffice to clarify the smaller details of the duty to disclose. iii.

Understanding and Decision-making Capacity

The second standard for informed consent addresses the matter of the patient’s understanding and decision-making capacity. Rather than focusing on the physician, this standard dwells on the patient’s capacity to understand and capacity to consent. Should any doubt arise about the patient’s comprehension and competence, it is useful to speak to all caregivers and to family members to try and determine the extent of the patient’s comprehension and ability to consent competently. It may be helpful and important to introduce a third party to the patient and the patient’s family to discuss the situation and offer an additional opinion. Most institutions have a psychiatric consultation service with expertise in this process, whereas in others, a clinical ethics consultation service performs this service. Patients should not be dismissed as incompetent for purposes of consent without trying to determine whether they really are and whether they cannot be helped to achieve competence by some means. iv.

The Incompetent Patient

Should the patient not prove competent to consent, because either material comprehension, material competence, or both are absent, it may prove necessary to invoke other means to protect the patient’s interests. Many patients have a durable power of attorney for medical care. The relatives or friends appointed to speak for the patient under such circumstances are authorized to represent the patient in the event the patient cannot speak for him- or herself. In many cases, they may carry this authority even when a patient’s cognitive impairment is only partial; however, if the impairment is only partial, then the patient is expected to continue to be involved in the decision-making process to the degree they are able. Where there is no durable power of attorney or appropriate next of kin, it may be prudent to petition the courts to provide a guardian ad litem to protect the interests of the patient. This is especially important when conflicting interests are present. It is expected that the patient’s interests can and will be adequately protected by any surrogate decision maker. v.

Potential Vulnerabilities Needing Special Safeguards

Discussions about competence generally focus upon the cognitive and emotional state of the patient and the circumstances under which patients might be unable to process the information

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necessary to provide informed consent. A similar situation arises when there are insurmountable gaps in language, culture, or general knowledge. Language It is always dangerous to assume that patients have fluency in medical vocabulary, irrespective of their level of education. Most native English speakers are not familiar with common medical terms such as “trismus,” “ICP,” “herniation,” or “edema.” Beyond that, there are two types of linguistic gaps. The first occurs when the patient and the physician do not share a native language. The second is when they share a common language but not a common idiom or dialect. Thus, Castilian Spanish may not be fully understood in some regions of Central America, and Parisian French is not the same as Creole. A more educated idiom, moreover, may in some cases convey a social status or power that discourages questions. This is a more complex example of the commonly articulated principle that physicians are authority figures who must exercise great caution in speaking to patients lest they inhibit autonomy, even unwittingly. For this reason, it is important for the surgeon to assume he or she is not immediately understood and to illustrate and explain medical terms in ways that can be and that are understood by the patient. Professional medical translators should be used to bridge linguistic gaps. There are many ethical challenges in only relying upon family members and friends to provide this type of translation. Culture Different cultures regard disease and illness quite differently. For instance, in some cultures families will request physicians not disclose a diagnosis, particularly if it involves malignancy, infection, or chronic disease with social overtones. Any of these may invoke severe opprobrium. It is impossible to overstate the difficulty of these circumstances. Right or wrong with respect to the patient’s actual wishes, families and cultures that hold such beliefs and act in this manner may constrain the patient to and within a disempowered role inconsistent with the principles of medical ethics broadly held in North America. Patients have the privilege of authorizing others to decide, speak, and act on their behalf. However, patients should always be given the opportunity to determine the extent to which they want information themselves since they have the option of opting out of any set of circumstances that they understand as unjust. Nevertheless, there may be a minimum amount of information that is necessary to provide a patient about a proposed procedure to ensure they have appropriate expectations of what is going to happen to them. This is an excellent example of a situation in which the offices of an ethics committee can be highly beneficial. This is only one of many cultural issues that might arise. It is important to respect the wishes of patients themselves to the degree possible while still practicing conscientious medicine.

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7. The U.S. FDA Warnings and Standards of Materiality Surgeons have historically concerned themselves more with surgical consent than with the side effects of medications, even though medical treatment also requires consent and adverse events (AEs) are also a source of liability. There are many sources of information about drugs, and the role of informing patients about drug interactions is generally assumed by the pharmacist. On the other hand, surgeons should make sure that they are informed about their patients’ medication lists and that their patients are informed about important drug interactions. Communication with primary care providers is also part of the process of protecting patients from AEs and drug interactions. The FDA issues special warnings known as “black box” warnings when drugs carry a particularly high risk of certain hazards. This is the strictest form of warning. The warning is enclosed in a black box in the drug insert. The surgeon should keep abreast of such warnings on the drugs he or she prescribes. Black box warnings, as well as other serious AEs, fall into the category of material information that must be disclosed. 8. Procedural and Mechanical Aspects of Informed Consent In many practices, informed consent is obtained by residents and by physician extenders. This is often a very effective way to obtain informed consent as long as the surgeon responsible has determined that his representatives in the process are well prepared to communicate with and inform the patient and to meet the standards of disclosure and informed consent. The prudent surgeon will speak to the patient at an appropriate time to confirm that the patient has the necessary understanding to give consent, that the patient has no lingering questions, and that the patient has consented. In pursuit of efficiency, many practices have adopted protocolized consent documents. These may range from the rudimentary to the very elaborate and encyclopedic. They can be very useful as long as they are accompanied and amplified by discussion with a trained member of the medical staff. All documents are impersonal and limited by the ability of the patient to read, comprehend, and assimilate the material. The surgeon also retains the duty of confirming that the patient understands the material and that the result of the process is valid informed consent. It should go without saying that informed consent should be obtained under non-threatening circumstances, when the patient is awake and unsedated, and when the surgeon, the resident, or the physician extender has adequate, undistracted time to spend with the patient and discuss the procedure. Patients should not be asked for consent in the holding area just prior to surgery or after receiving medications that might affect their state of wakefulness or cognition. Emergency Situations When Fully Informed Consent Cannot Be Obtained When true, life-threatening emergency circumstances require the neurosurgeon to act without having first obtained consent, he or she should make every effort to have other professionals reach and inform the patient’s family and document both the reasons it was necessary to proceed without consent and what efforts were made to obtain consent after

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the emergency has been contained. The burden of documentation is necessarily strict under these circumstances. 9. Pediatric Informed Consent Although many of the issues pertaining to the ethics of informed consent in pediatric neurosurgery are similar to those applicable in adult neurosurgery, several unique aspects of pediatric neurosurgical practice merit a focused discussion. It is generally assumed that parents will act in the best interests of their children absent evidence to the contrary. In fact, the common expression, “to act in loco parentis [in place of the parent]” has come to mean not only “to act as a surrogate for the parent,” but also, implicitly, “to act with the devotion, motivation, and dedication of the parent” in the best interest of the child. Parents have the legal right and obligation to make decisions on behalf of their children in matters of health and well being. For that reason, parental consent is required in pediatric care and in the care of unemancipated minors. Consent, as we have seen, is a both a legal and an ethical concept. Assent, another term meaning “agreement,” does not have a well-defined legal standing. Nevertheless, as children mature, their wishes and opinions become increasingly relevant, and as adolescents mature, their opinions, their assent, and also their consent become ethically and practically, if not legally, required. As the child or adolescent matures, the process of obtaining assent becomes indistinguishable from the process of obtaining fully informed consent. Emancipated minors are legally authorized to give informed consent, and, concomitantly, providers have a duty to obtain informed consent from emancipated minors. The criteria for emancipation vary by state, but typically include: 1. minors who are self-supporting, married, pregnant, or parents; 2. minors in military service; 3. minors declared emancipated by a court. Full or partial emancipation may be recognized legally on a state-by-state basis for the purpose the treatment of certain medical conditions. Obtaining the assent of a minor is an important part of the practice of pediatric medicine and surgery. It may be very difficult to obtain cooperation if assent has not been obtained in advance and if the neurosurgeon or the physician does not continue to communicate with a child or a minor during the course of the treatment. Nevertheless, the idea that the assent of a child or a minor is ethically and humanly desirable does not circumvent requirement that the parent or legal guardian provide informed consent. Refusal, the word “no,” is a powerful tool and sometimes the only one left to the child. The tension between the autonomy of the minor and paternalism, even in the best of all possible senses, is sometimes inescapable. What should be done when a child or adolescent refuses the treatment to which the parents have consented and the surgeon determines to be in his or her best interests? Three things to be avoided if at all possible are deception, compulsion, and alienation

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of the parents. Parents should be offered every form of assistance, ranging from pastoral counseling to pediatric psychiatric consultation, in the event of self-destructive behavior on the part of the child. While parents have a prima facie legal right to give and withhold consent, providers have legal and ethical duties to children and minor adolescents. These duties may displace or modify the rights of parents under circumstances when parents fail to act in the best interests of the child. Under such circumstances, the courts are likely to appoint a guardian ad litem. The failure to act in the best interests of the child need not necessarily be malicious. It can be based on deeply held cultural or even religious beliefs that are harmful. An example is the reluctance of some families to allow blood transfusion, even in life-threatening situations. While adults may decide to forego life-saving treatment, the courts have generally held that parents may act as surrogates for the benefit of the child, but not to its detriment. Parents are not authorized to make a decision that might result in the death of a child or a minor. Many pediatric hospitals have established preemptive policies to address such issues. The physician has a positive responsibility to administer life-saving treatment. A good summary of the principles involved has been published by the American Academy of Pediatrics.9 In short, the problems of consent in pediatric neurosurgery do have special features, but they are reflective more of the general problem of consent in pediatrics than of any special issues of consent in the neurosurgical care of adults. 10. Informed Consent for Clinical Trials and in Experimentation with Human Subjects The history of informed consent in clinical trials and experimentation with human subjects will be discussed in Module 5, Research Ethics. The primary goals of the process of obtaining informed consent in this setting are complete disclosure and fully informed and fully voluntary consent. The standard for disclosure is higher than it is for therapeutic interventions. Ideally, all risks, not just all material risks, are disclosed and expounded. The bar is pegged to a subjective patient standard rather than to a reasonable physician or reasonable patient standard. All efforts are made to confirm that the patient does not link participation in clinical trials or medical experimentation to a condition of treatment and that the discussion and decision process are truly free of coercion. Furthermore, patients must be told clearly that they are free to terminate their participation at any time and for whatever reason. Explicit, customized consent for innovative surgical procedures or for newly introduced by FDA-cleared medical devices has not been the rule. A reasonable argument can be made, however, that surgeons have a duty to disclose their intention to use innovative, non-standard procedures and technologies new to them or to the institution and that such disclosures ought to be included within standard consent forms. A stricter construction favors explicit forms of consent in such cases. 11. Summary Informed consent refers to the idea that physicians and surgeons are obligated to disclose certain information to their patients and obtain their consent to treatment. In the U.S., the information

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that must be disclosed includes, at a minimum, diagnosis, proposed course of treatment, material risks, benefits, and material alternatives. A patient has the right to determine what happens to his or her body, and physicians have corresponding duties to provide a patient with enough information to make an educated decision regarding his or her condition. Special efforts must be put into obtaining informed consent when patients come from linguistically and culturally disparate backgrounds, in children, and in experimental medicine. Consent in children is highly charged and complex. In the case of children and unemancipated minors, only parents or those appointed by the court as guardians can provide legally binding consent. Nevertheless, the assent of the child or minor should be obtained, in a manner and to a degree consistent with intellectual development and emotional maturity. 1

Mary Schloendorff v. Society of New York Hospital 211 N.Y. 125, 105 NE 92 (1914). This decision was overruled on grounds other than the legal principles of informed consent that were articulated in this case and that subsequently evolved. See Bing v. Thuning, 143 N.E.2d 3. 2

Irma Natanson v. John R. Kline and St. Francis Hospital and School of Nursing, Inc. Supreme Court of Kansas. 187 Kan. 186; 354 P2s 670; 1960 Kan. Lexis 398. Filed August 5, 1960. 3

Useful references on informed consent include: 1. Faden RR, Beauchamp TR: A History and Theory of Informed Consent. New York: Oxford University Press, 1986. 2. Berg JW: Informed Consent: Legal Theory and Clinical Practice. New York: Oxford University Press, 2001. 3. Doyal L, Tobias J (eds): Informed Consent in Medical Research. New York: BMJ Publications, 2001. 4. Byrne JA: Informed Consent. New York: McGraw-Hill, 1997.

For a discussion of neurosurgical informed consent see: Kondziolka DS, Pirris SM, Lunsford LD: Improving the Informed Consent Process. Neurosurgery 2006; 58:1184-89. 4 Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972). 5 Applebaum PS: Informed Consent: Legal Theory and Clinical Practice. New York: Oxford University Press, 1987. 6 Miller RD: Problems in Hospital Law. 5th ed. Rockville, MD: Aspen Publishers, 1986. 7 Havens v. Hoffman, 909 P.2d 219 (Wyo. 1995). 8 Miller RD: Problems in Hospital Law; Ketchup v. Howard, 543 S.E.2d 271 (Ga. Ct. App. 2000). 9 AAP Committee on Bioethics: Informed Consent, Parental Permission, and Assent in Pediatric Practice. Pediatrics 1995; 95:314-317.