Legal Parameters of Informed Consent Applied to Electroconvulsive Therapy

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Mentally Disabled Persons and Voluntary, Knowing, and Competent Consent

Informed consent is actually three concepts merged together: voluntary, knowing, and competent consent. In general, the principle of informed consent governs the administration of medical care, defining the legal relationship between the patient and the medical provider. Before major changes are recommended and implemented in the existing law of informed consent for mentally disabled persons, it is important to consider that substantial empirical data is missing on how the present laws operate as viewed by patients, the medical providers, and society.

To date, relatively few empirical studies have evaluated the elements of informed consent, particularly the adequacy of the information needed for mentally disabled persons to make informed medical choices. The most comprehensive study to date suggests that the provision of information is inadequate and many patients are not primarily concerned with utilizing available information to make their own decisions. However, even this study was limited in scope, focusing on just three psychiatric units, an evaluation center, a research ward, and an outpatient clinic, all associated with the same university hospital.

Voluntary Consent

The issue of whether consent is voluntarily given takes on particular significance for mentally disabled persons in institutions or hospital settings because so many different factors may undercut the voluntary nature of the consent. Threat of force, coercion, fraud, duress, deceit, and other kinds of overreaching jeopardize the element of voluntariness where decisions of patients or their substitute decisionmakers are improperly influenced.

Only a judge or jury can determine whether any particular actions taken by hospital staff, or conditions within the institution by themselves or in combination with other actions or conditions, constitute sufficient negative influences on the patient to legally invalidate the voluntariness of a decision. However, in a hospital or other institution in which the patients or residents are especially isolated and vulnerable, it seems unwise to presume that any decision is voluntary. While instances of physical abuse, coercion, and fraud appear to be less frequent in the modern mental hospital, such abuses are not yet uncommon, and other kinds of overreaching, including deceit, duress, and threat of force, are still documented as regular occurrences.

Informed or Knowing Consent

Except in a legitimate emergency or as reasonably modified by the application of therapists' privilege to withhold harmful information from their patients, knowing consent is required before any treatment may be administered. While liability of physicians for not obtaining informed consent is not a frequent occurrence, liability can occur under theories of negligence, or, more rarely, assault and battery.

The so­called community standard, or old rule, was set out in the landmark decision, Natanson v. Kline. In that case, the kind and quality of information a doctor is obliged to communicate to a patient was defined as that information that would be conveyed by typical medical practitioners, either in their specialty area of medicine, generally, or in the geographical area in which they practiced Basically, this standard emphasizes what other doctors would do in similar circumstances.

In contrast, the so called reasonable patient standard, or modern rule, as interpreted in Canterbury v. Spence, emphasizes the right of patients to make their own determinations about medical treatment by providing them with information sufficient to understand the risks and benefits of a given medical procedure and to identify and evaluate the available alternatives. It is the quality of the information that is critical under this standard.

Today, both standards are used, as well as schemes in various jurisdictions that mix elements of each standard. In a few states, entirely new approaches have been enacted such as the use of medical review boards in Texas and Hawaii. Nevertheless, there are case law and statutory modifications to all the schemes that limit the legal protections for patients and strengthen the defenses for doctors.

First, and foremost, is the existence of a medical emergency defined by the presence of two conditions: patients must be so incapacitated that they are incompetent to exercise their decisionmaking rights, and there must be a life­threatening disease or injury that requires immediate treatment. In certain jurisdictions, emergency also includes any condition that would substantially threaten the health of a patient, even if death were not a likely result.

A second defense is the therapeutic privilege. As defined in the case law and statutes, the privilege exists where the total disclosure of information to the patient will have a significant, negative effect on the patient's condition. In these limited situations, a physician looking at the circumstances from the patient's point of view may take reasonable steps to communicate or withhold information consistent with the patient's medical welfare.

A third defense relates to the burden of proof. Since it is the plaintiff who must convince the trier of fact of any wrongdoing on the part of the defendant, the reluctance of many physicians to; testify against their colleagues, no matter what the allegations, may make it difficult, if not impossible, to present a viable claim, even where liability would be certain otherwise.

In addition, a variety of other defenses exist in the case law or on occasion by statute. Medical liability may be denied if: (1) the undisclosed information is common knowledge, (2) there has been a waiver by the patient, (3) there is a written and signed consent form, (4) a reasonable, prudent person would have undergone the procedure anyway, (5) there was no expert medical testimony, or (6) the risk to the patient was insubstantial.

Competent Consent

Exactly what constitutes competent consent varies among jurisdictions and often has very little to do with clinical notions of competency. Even in the broadest formulations, today civil commitment is no longer equivalent to and does not normally include a competency determination. In the most precise formulations, favored by this writer, competency is limited to the specific decisionmaking question that is factually at issue, such as the ability to accept or refuse psychiatric treatment.

Although legal competency is taking on more of the characteristics of clinical competency, there is still a significant gap between the legal and medical conceptual frameworks that are used. These differences, of course, make evaluations of competency less consistent, and errors and disagreements are more likely for everyone concerned.

Most state statutes no longer equate civil commitment with incompetency as was standard 20 or 30 years ago. The law views the two concepts as separate and distinct, although a couple of states such as California and Utah, as well as the American Psychiatric Association's model commitment statute, make medical decisionmaking an issue to be decided at civil commitment hearings.

The major conceptual problems with making treatment competency an issue at a commitment hearing are the timing of the hearing, which may not be close to the treatment decision, the scope of the competency determination, which does not provide for distinctions among various kinds of treatments nor the capacities necessary to understand different treatment implications, and the possibility that those who are found to be capable of making their own decisions may no longer be committable, even if they are mentally ill and dangerous. To be most accurate, competency should be measured coincident to the decision in question, and be limited to one decision or a narrow range of decisions in which the capacities to be reviewed are very similar.

Except under the emergency conditions discussed previously, any legitimate question regarding a patient's competency demands court review. If incompetency is proven after evidence on both sides is heard, then the court should decide how the least intrusive treatment decision will be made, consistent with the ward's mental capacity, medical needs, and previously indicated treatment preferences.

Legally, after a person has been adjudicated incompetent to make a specific medical decision, the court should appoint a substitute consent giver to allow the patient to properly exercise his or her right of self­determination. In doing this, the court should review the decision of the patient's representative to ensure that the decision is not inconsistent with what the patient would have favored if competent. Such a review is not always required, however, and, in fact, often is opposed by medical providers.

As a practical matter, the traditional perception of the physician as the medical decision maker, irrespective of the contrary wishes or nonmedical interests of the patient, is difficult to overcome. If such a role for physicians was ever legally acceptable, it is no longer accepted in the modern law. A far more complete assessment of interests is required, and it is by no means clear that the physician plays a primary role in making such assessments, even when the patient is legally incompetent.

Courts faced with the need for a substitute consent giver have three basic options: (1) allow the physician to make the treatment decisions by either accepting the medical decision without review or assigning the physician the responsibility of making the decision on the patient's behalf; (2) appoint an independent consent giver to act as a limited guardian or plenary guardian with the patient as the ward; or (3) direct someone to represent the patient's interest but set out in specific terms what those interests might be and how they should be measured. In each of these situations, the courts may choose to instruct the substitute consent givers whether to apply one of the two leading assessment standardsÑthe patient's point of view or the patient's best interests Ñ and then choose to retain jurisdiction for subsequent review of the decision.

The overriding conflict in these treatment matters involves interrelated concerns: the theoretical nature of the decisionmaking at issue and the often competing professional jurisdictions of doctors and lawyers. On the one hand, the judges who interpret and apply the law on the basis of legal briefs and court testimony are unable to assess medical factors with the precision and accuracy of physicians, particularly the physician who is treating the patient. On the other hand, the medical decisionmaking best exercised by physicians does not address the patient's nonmedical interests, and, in fact, may be inconsistent with other patient interests such as self determination.

By training and experience, judges are better able than doctors to assess all of the legally relevant nonmedical factors, including the patient's preferences. Moreover, many judges are capable of assessing medical testimony so that it can be utilized in a reasonable way by the trier of fact in arriving at a legal opinion. Finally, regardless of the perceived medical quality of the legal decision, each citizen has the right to judicial review before fundamental liberties are compromised. The solution to the problem of inconsistent judicial decisionmaking must be to improve the judicial process, not to eviscerate Constitutional prerogatives by allowing doctors to assume judicial duties.

The law in recent times has endorsed the due process perspective, at least to the extent of eliminating the alternative in which the physician makes the decision unilaterally without obtaining permission from a guardian or the court. Similarly, the courts generally do not give the treating physician the authority to make the decision on the patient's behalf unless that authority is accompanied by specific limits on the doctor's discretion. By and large, courts now demand legal proceedings in which either some kind of guardian is appointed to represent the patient's interest or the court itself determines what those interests are.

There is one important exception to the right of judicial review and that, as we have discussed, occurs when a medical emergency exists in which the legal process may be too cumbersome to deal with the immediate health needs of a patient. A recurring area of conflict is the applicable definition of emergency and whether it should emphasize a broad medically­oriented standard or a more narrow due process standard for deciding where there is sufficient time to appoint a substitute consent giver. The law appears to be moving towards a compromise between allowing medical actions whenever the patient's health is at risk and requiring a showing of immediate and substantial threat of death to justify any unilateral actions.

One reasonable legal response to these two more extreme positions is to focus on those medical situations in which doing nothing will in all likelihood make the patient's long­term prognosis substantially worse. If continued treatment is required, then as soon as is practical a substitute consent giver should be appointed by a court. In essence, this is the standard in Massachusetts under the series of opinions known collectively as the Rogers case.

Regardless of who becomes authorized to make the treatment decision for the patient, there is still the equally ticklish problem of how to assess what is best for the patient. The traditional "best interest" standard, which in recent decisions has lost favor, attempts to measure the community's response, if collectively its members were in the same situation as the patient.

The predominant standard today is called "substituted consent" and attempts to measure the patient's response to the issue of treatment, assuming the patient were competent to make the decision. To a significant extent, both standards are legal fictions based on subjective judgments of what either the community or the patient would do in a particular situation. Yet, if self­determination is to be meaningfully retained for the incompetent patient, then substituted consent is the only standard that should be used.

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