The Journal of Contemporary Health Law and Policy, Volume 17: Pages 61-133, Fall 2000.
A. How does consent work when the patient is a competent adult?
Competent adult patients are entitled to make the decisions regarding their medical care themselves.17 This uncontroverted principle is fundamental to medical practice. The entitlement arises from the principle of individual self-determination that lies at the core of our political system and moral beliefs.18 To facilitate self-determination in the medical setting, a process of "informed consent" has evolved. "[I]nformed consent is an autonomous authorization of medical intervention… by individual patients."19 Proper respect for the individual patient and for his right to control his own life requires that physicians refrain from surgical interventions, unless they are authorized by the patient based on an understanding of the best available information pertaining to a proposed procedure.20 In legal terms, securing consent without providing adequate information constitutes legally redressable negligence.21
Thus, while patients necessarily rely on physicians to find the source of a malady if there is one,22 once physicians have identified a problem and delineated treatment options, the patient's right of consent requires that the patient actively participate in the process of deciding which option to choose. Accordingly, the physician has a legal and ethical duty to engage the patient in the consent process.23 Specific requirements for informed consent have become increasingly stringent, reflecting modern society's greater skepticism toward medical authority and increased concern with safeguarding bodily integrity and personal autonomy.24 Today those requirements fall into three categories: disclosure, capacity and voluntariness.25
1. Disclosure
The duty of disclosure arises from the principle that an individual's right to self-determination entails a right to know the truth and to receive any and all information that is available, so that the treatment decision is the individual's own decision rather than someone else's decision.26 Patients have a relatively high desire for information.27 An uninformed decision to follow the recommendation or suggestion of a medical professional is in effect a choice coerced by the medical professional. In addition to honoring the patient's ability to cope with the consequences of the procedure chosen.28 In contrast, a patient's discovery after the fact that he was not given all the information he would have wanted can undermine his ability to deal effectively and positively with any adverse effects of the procedure.29
Medical professionals do not always fulfull this duty of disclosure, even when treating competent adult patients, and with respect to some procedures it may be common practice to give the patient much less information than he or she would need to participate meaningfully in the decision-making. Forty years ago, a physician might have been insulated from liability for non-disclosure if this was the common and accepted practice among medical professionals in connection with the particular procedure.30 Today, a rule more respectful of patients prevails, requiring disclosure of all information that the patient would deem relevant in reaching a decision without regard to what the traditional common practice has been.31
Thus, before obtaining consent to a medical procedure, a physician must provide adequate information to the patient in a manner that the patient can comprehend.32 "Adequate" means the amount and kind of information that the average person in the patient's position would want to have in reaching an informed decision.33 Typically this means that the clinician must fully explain the proposed procedure, the expected short-term risks and long-term consequences, the available alternatives and their risks and benefits and the consequences of declining or delaying treatment.34 The patient should be made aware of both short-term costs - for example pain, length of confinement in a hospital, recovery time and potential complications. - and long term costs - such as loss of functioning, restriction of activities and physical scarring. In general, the test "for determining whether a potential peril must be divulged is its materiality to the patient's decision."35 Physicians must disclose all material information, that is, all "information which the physician knows or should know would be regarded as material by a reasonable person when deciding to accept or reject a recommended medical procedure."36 Importantly, the physician has an obligation to provide all significant information that is available, even if he or she were previously unaware of it. In other words, the duty of disclosure entails an obligation on the part of the physician to acquire information as it becomes available.37 Naturally, there is a limit to how much and what kind of information medical professionals must provide. The physicians duty is to provide information that the average person would need to make an intelligent decision. This suggests that information that is not relevant need not be provided. Relevant information is that information which would have a bearing from the patient's perspective on medical care.38 The materiality criterion suggests that physicians need not provide information that would not influence the average patient's decision-making. However, even very slight risks generally must be disclosed to patients, particularly if the consequences are severe. In a recent Australian case, for example, a patient who underwent an elective operation on her right eye and who had persistently questioned the physician concerning potential complications was never informed that there was a one in 14,000 chance that the operation would leave here blind. The operation did in fact leave her virtually blind.39 The High Court of Australia ruled that the physician was negligent in not revealing the risk of this complication, even though the risk was slight.40 This ruling is consistent with patients' expectations; a 1988 study in Australia found that 77% of patients said they wanted more information about their treatment.41
In addition to requirements as to the content of the information provided, a physician's duty of disclosure entails a requirement as to how he or she provides the information in a manner conducive to patient comprehension. Studies have found that some form of written disclosure, either alone or in combination with verbal disclosure, imparts greater knowledge than verbal disclosure alone.42 This suggests that physicians should provide full written explanations of procedures to their patients when practicable. Presumably, this would be practicable with respect to any procedures performed routinely or in non-emergency situations.
Exceptions to the disclosure requirement, if any, are legally tenuous. A patient may voluntarily forego some elements of disclosure, but it is not clear that this "waiver' provides the physician any protection from a negligence suit.43 The so-called therapeutic privilege." Adopted in the past by the Supreme Court of Canada as sometimes permitting the withholding of information in order to lessen the patient's suffering44 is increasingly disfavored, and, in fact, has more recently been ruled unacceptable in that country.45 The High Court of Australia has similarly ruled, "Except in those cases where there is a particular danger that the provision of all relevant information will harm an unusually nervous disturbed or volatile patient, no special medical skill in involved in [complying with legal mandates that require] disclosing the information, including the risks attending the proposed treatment."46 By comparison, the therapeutic privilege doctrine has never received much support in the United States; just a smattering of lower courts have on rare occasions endorsed it.47 As early as 1972, in the leading case of Canterbury v. Spence, the District of Columbia Circuit tersely observed that the "physician's privilege to withhold information for therapeutic reasons must be carefully circumscribed… for otherwise it might devour the disclosure rule itself."48 The rule is that physicians must provide accurate and complete information to all patients, even though a small percentage might prefer not to know about the risks of surgery.49 The only generally recognized exception, which is narrowly construed, applies to situations where, because of the patient's emotional condition, disclosure is very likely to cause physical or mental harm.50
2. Capacity
Capacity is the patient's ability to understand information relating to treatment decisions and to appreciate the consequences of a decision.51 The capacity requirement reflects the belief that persons unable to make rational decisions about their medical care should be protected from making decisions that are harmful or that they would not make if they were able. The requirement imposes on physicians a duty to assess whether a person is capable of making a rational decision based upon that information. To accomplish this, the clinician should provide full disclosure about a proposed procedure and then evaluate whether the patient does in fact understand the information disclosed. In dealing with competent adults, medical professionals must presume that the adult has the requisite capacity and proceed with full disclosure unless and until they determine that a patient actually is not capable of understanding. Non-disclosure cannot be justified by a suspicion or uncertainty concerning the adult's capacity for understanding.
Unfortunately, a patient's understanding is often limited not so much by his inherent inability to comprehend, but by the clinician's inability to convey information understandably. The capacity requirement precludes doctor's from obtaining consent without full disclosure based on the doctor's determination of incapacity, where any incapacity can be cured by reasonably improving the manner in which information is presented. In fact, this requirement suggests a duty on the part of medical professionals to make greater efforts to communicate information when initial efforts are unsuccessful.
3. Voluntariness
The voluntariness requirement protects the patient's right to make health care choices free from manipulation or undue influence.52 Manipulation occurs where medical personnel distort and/or omit information in order to induce the patient's acceptance or rejection of a procedure.53 Full disclosure can obviate manipulation by omission, but not the danger of manipulation by distortion.
The power inbalance between doctor and patient creates a great danger of undue influence. A patient cannot obtain treatment without an agreeable medical professional, and typically can do little more than respond to treatement the physician offers. Patients are often ill and anxious at the time that consent is sought, making them even more vulnerable to influence by medical professionals. Because of the inherent imbalance of power in the physician-patient relationship, the manner and order in which physicians present information can greatly influence the importance patients attach to different considerations and can, intentionally or otherwise, persuade the patient to select the option favored by the physician.
Therefore, the physician has a duty to distance himself as much as possible from his personal preferences and values and to present interests at stake for the patient. Physicians also must be sensitive to the fact that patients are likely to interpret a suggestion, or even the mere mention of an option, as a recommendation. To counteract this danger, bioethicists recommend that physicians actively and explicitly encourage physicians to make decisions independently.54
The timing of disclosure is also important. The immediacy of the need for a medical procedure can interfere with the patient making a voluntary decision.. The patient may have little time to digest information and reflect on alternatives; he or she is likely to be emotionally overwrought and be especially reliant on the physician to make decisions for him or her. Certainly with an elective procedure that can be performed at any time, it would be inexcusable for a physician not to provide a patient with full disclosure far in advance to allow the patient sufficient time to reflect on whether to undergo the procedure.
In sum, an adult patient's decision to undergo a procedure must truly be his or her decision, a true reflection of his or her autonomy an right to self-determination. This will only be true if the physician fully and objectively discloses all information relevant and material to the decision. Doing so ensures that the patient understands the information, encourages the patient to make the decision independently and steers clear of any actions that could amount to undue influence and/or manipulation.55
B. How does informed consent work when compentent adults request non-medically indicated procedures?
A physician's obligation regarding the content of information provided to a patient is even greater in connection with procedures such as cosmetic surgery, that are not "medically indicated," i.e., that are not undertaken to secure a medical benefit.56 Because the procedure entails no medical benefit, the only possible medical result is harm, so a physician must proceed with particular caution.
The literature addressing consent for cosmetic surgery is fairly sparse; the American Medical Association Code of Ethics, for example, does not address it.57 However, a general principle running through the limited discussion available holds that the more elective a procedure, the more important the role of full disclosure.58 Because the patient is often eager to proceed prior to consulting the physician, the physician needs to temper the this enthusiasm with an enumeration of all possible complications. The clear disclosure of all significant health considerations is a prerequisite to the patient's ability to make a rational decision about whether to proceed.59
Naturally, the physician should also ensure that someone requesting a procedure that is not medically indicated is fully competent and acting voluntarily. It would be particularly troubling if a physician not only failed to ensure fully informed and uncoerced reflection on the potential costs of a non-medically indicated procedure but also in fact suggested the procedure or presented information about it in a way that could possibly be interpreted as a recommendation. Encouraging a patient to undergo a procedure that has no medical benefit is presumptively inconsistent with medical ethics.60
A strong concern regarding voluntariness may arise in situations where the cultural practices of some group dictates that individuals undergo a physical alteration that does not benefit them medically, particularly where those individuals are subordinate within the group. Indeed, a physician will often be ethically and legally barred from performing such procedures that might cause harm and that are without medical benefit.
One example is a Muslim woman's request that a doctor circumcise her daughter. Probably already covered by common law assault statutes, the procedure is now specifically banned by a number of statutes passed in the past few years. Any physician who performs such a procedure violates medical ethics and, in many states, criminal and civil law as well.61 Recently, a Seattle hospital agreed to perform a minor, largely symbolic genital cutting on a Muslim woman who requested it, but subsequently reversed itself in the face of public outcry.62 This event reflects the widespread understanding that doctors should refuse to become complicit in physically cultural practices and that consent should be treated with skepticism when it comes from persons who historically have been less than fully autonomous. At least two authors have noticed the dramatic disparity between the treatment of female genital cutting and circumcision, commenting emphatically on the violation of equal protection created by current statutoryl law.63
C. Can adults consent to prohylactic removal of healthy tissue?
What if a procedure is not needed to correct an existing problem, but might reduce or eliminate risk of medical problems in the future? Current practices and attitudes with respect to risk of cancer in women are instructive. Genetic tests can now detect genes that predispose women to breast and ovarian cancer. Women with the relevant mutations would significantly reduce the risk of contracting these cancers if they underwent prophylactic mastectomy and/or oophorectomy. These women could thereby increase their lifespan by an average of 2.9 to 5.3 years.64 Even in the average woman without these genetic markers, prophylactically removing both breasts and ovaries would result in average gain of six to eight months of life expectancy.65 Without providing their reasoning, the authors concluded that "prophylactic surgery obviously unreasonable for these women."66 Although such prophylactic surgery is generally deemed inappropriate,67 given the substantial benefits and assuming fully informed consent could be provided by the patient herself, it may be legally and ethically permissiable. By contrast, it clearly would be impermissible in the case of an incompetent individual, where permission would have to be provided by a surrogate.68
D. How does informed consent work in contexts involving incompetent adults?
Although the doctrine of informed consent is predicated on respect for the autonomy of the patient, the doctrine applies even when the patient is not competent. The effect of applying the doctrine to incompetent adult patients is not to give the physician or anyone else a right to decide for the patient.69. Rather, in such cases, under the principle of "substituted judgment," a surrogate for the patient, typically a relative, is legally permitted to stand in the place of the patient; this means that the surrogate can make decisions on behalf of the patient in furtherance of the rights of the patient.70 Surrogates are under a legal obligation to decide not on the basis of how they want the patient to be treated, but rather on the basis of how the patient would choose to be treated if he or she were capable of choosing.71 As a general rule, the more a surrogate seems influenced in here decision-making by her personal values and preferences, the less willing a physician should be to accept the surrogate's authorization for a procedure.
Where the patient was formerly competent, the substitute decision-makers typically must present clear and convincing evidence as the wishes of the patient before he or she became incompetent.72. For example, where a once-competent adult has become disabled by trauma or old age and is on life support surrogates must demonstrate that, when competent, the patient indicated a preference not to have his or her life prolonged by medical means if there was no hope of recovery.73 Where such evidence is lacking or where the patient was never competent, the surrogate must provide evidence as to what a rational person would likely want for himself or herself in light of the relevant aspects of the situation.74 In other words, the patient's best interests must be proved by the surrogate.75. The substitute decision-maker's judgment is subject to review and challenge if it appears irrational or self-interested.76
The question whether to perform a medical procedure on an adult who has never been competent arises most often when mentally disabled women have guardians who wish to sterilize them.77 These guardians typically believe that sterilization will benefit the disabled women by preventing a pregnancy that could have serious physical, psychological, and social consequences.78. Nevertheless, in light of the presumption of bodily integrity and the difficulty of attributing contrary preferences to an adult that has never been competent, courts and legislators have become increasingly unwilling to allow such sterilization.79
In general, to authorize surgery on an incompetent adult patient, a surrogate must clearly demonstrate that the benefits of the surgery outweigh the short- and long-term costs for the patient. The incompetent person's presumptive right against invasion of his or her bodily integrity places the burden on anyone who would infringe that right to prove that it is necessary for the incompetent person's welfare. Importantly, the costs and benefits relevant to an assessment of an incompetent person's interests is connection with a medical procedure are only temporal, earthly interests such as physical and mental health, social relationships and finances. Assessment of costs and benefits on behalf of an incompetent person cannot justifiably include what the surrogate decision-maker believes to be spiritual or other worldly costs and benefits for the patient. There is no assurance that the patient would share that perception. The law gives no one authority to decide what another person's spiritual interests are, regardless of whether the latter person is or ever has been competent.80 This principle is rarely tested, but in In re Quinlan,81 which involved a once-competent woman in a persistant vegetative state, the New Jersey Supreme Court involked the principle to reject a claim by the woman's parents that the hospital must withdraw life support because the claim was inconsistent with the parent's religious values.82 The court stated emphatically that the parents had no right, based on religious freedom or parenthood, to make that decision for their daughter.83
Within these constraints the surrogate is legally authorized to grant permission (the more precise terminology) to medical intervention for an incompetent adult. However, for a competent adult making decisions regarding his own care, such permission must be informed. The physician's professional and legal duties are at least as stringent as in the case of an autonomous adult. Because the patient - the person with the greatest stake in the operation-is not able himself to insist upon receiving and then evaluating all the relevant information, more care must be taken to ensure that decisions are made in the correct way. Hence, when a surrogate is faced with a decision on whether an incompetent adult should undergo surgery, medical personnel have a duty to the patient to fully disclose to the surrogate all available information that a reasonable competent adult would want before deciding whether to undergo the procedure.84 Physicians also have a duty to ensure that the surrogate is capable of understanding the information provided and of fully appreciating the consequences of a decision at the moment of decision making. Likewise, physicians also have an obligation not to manipulate the surrogate by presenting the information in a manner designed to secure permission, rather than facilitating an objective evaluation of the risks and benefits of the procedure. In addition to these requirements, which also arise in securing permission for a surgical procedure from a competent patient, a physician seeking permission for a surgical procedure on an incompetent adult must ensure that the substitute decision-maker is not acting out of self-interest but rather is deciding on the basis of what is best for the patient.
E. Would non-medically indicated surgery be allowed for a non-autonomous adult.
There are few situations in which a surrogate for an incompetent adult requests a non-medically indicated procedure. The most common are similar to the cases indicated above in which a concerned family member seeks to withdraw life support from a patient who is terminally ill or in a persistant vegetative state, or to take away a mentally disabled woman's ability to procreate.85 In all of these situations, the surrogate may perceive non-medical benefits for the patient that he or she believes outweigh any medical harm that might result from the decision. However, there is no assurance that the views of surrogates, often close family members, will necessarily be the same as the patient's had he or she been confronted with the situation while competent.86 As noted above, surrogates in both cases must present strong evidence as to the patient's preferences when competent or as to the patient's best interests.
With respect to the choice of physically invasive procedures, such as sterilization, courts and legislatures have been increasingly resistant to allow them and increasingly concerned that surrogates might choose such procedures out of self-interest rather than out of respect for the incompetent adult. In several states, sterilization is simply not permitted.87 A doctor today who performs a sterilization operation on an incompetent woman without court approval is vulnerable to criminal, civil and professional ethics charges, despite having permission from the woman's parents or other guardians.88 Typically, if a court chooses to grant approval of the procedure at all, it is only after a determination "that the condition of the conservatee `requires the recommended course of medical treatment,'" and that there are no alternative means of protecting the incompetent woman's physical well-being and interests.89 Consistent with this approach, the California Supreme Court found in Conservatorship of Valerie N.90 that parents of a mentally retarded woman could not have her sterilized, "inasmuch as there was neither evidence of necessity … nor sufficient evidence that less intrusive means … [were] not presently available to [the conservatee]."91 The Court based its decision upon the incompetent patient's fundamental "right … to be free of intrusive medical and surgical procedures."92
Unsurprisingly, courts have not been faced with claims by guardians to have incompetent adults in their care undergo surgery to remove a normal healthy non-diseased, un-injured part of the body simply for the sake of conforming to cultural norms or as a prophylactic measure to avoid some infinitesimal risk of disease to that part of the body. Were a guardian of an adult to seek such a procedure, doctors and lawyers would inform him without hesitation that his request in inappropriate and legally unsupportable. Imagine, for example, Muslim parents of a woman who was never competent asking a doctor to circumcise her; the doctor surely must refuse. Courts have even been hesitant when removal of healthy tissue has been sought for the purpose of transplantation—that is, to provide a medical benefit to (perhaps even save the life of) another person who may be a close relative of the incompetent adult. They have held that surrogates may not authorize this type of removal because it does not constitute medical treatment for the incompetent donor.93 In many such cases, an objective analysis would probably show that a transplant would maximize the overall good and that the average competent person would altruistically agree to donate the tissue or organ, but the law nevertheless prohibits that result because of grave concerns about violating a person's physical integrity without his consent.
The American Medical Association Code of Medical Ethics does not address a physician's ethical obligation in situations where guardians for an incompetent adult seek non-medically indicated medical intervention. However, the Code includes a more general mandate to physicians to help patients "make choices from among the therapeutic alternatives consistent with good medical practice."94 This might be read to imply that a physician must discourage a surrogate from seeking a procedure that would not be medically beneficial to the patient. Certainly, physicians have no affirmative obligation to undertake a non-medically indicated intervention when asked to do so. Therefore, it is no justification for violating an incompetent person's physical integrity that a surrogate might be asked to do so.95
There is no mention in the legal or ethical literature of physician's proposing non-medically indicated procedures to surrogates who have not themselves requested the procedure. This is unsurprising. Such a practice would so clearly offend the canons of ethics of the medical profession as to generate a reaction of horror and recrimination by legal and medical authorities. The prohibition of solicitation by doctors, based upon the impropriety of a physician putting his or her financial welfare above the welfare of the patients,96 would apply even more stringently to solicitation of surrogates for incompetent adults than it does to solicitation of competent adults. Any physician who proposed to a surrogate for an incompetent adult that the surrogate give permission for non-medically indicated surgery which the surrogate had not requested would jeopardize his or her license to practice medicine.
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