84: Informed Consent, Competency, Treatment Refusal, and Civil Commitment

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CHAPTER 84 Informed Consent, Competency, Treatment Refusal, and Civil Commitment

AN INTRODUCTION TO INTERACTIONS WITH THE LEGAL SYSTEM

The American legal system is composed of parallel systems of state and federal constitutions, statutes, and courts. The United States Constitution is the controlling body of law, and any law, state or federal, that conflicts with the Constitution will be struck down if challenged. The rulings of the United States Supreme Court, which interprets the Constitution, are therefore controlling on Constitutional and federal law matters. States are free to provide greater protections of Constitutional rights than the Supreme Court interprets the Constitution as requiring, but may not provide less. On purely state law matters, including most civil matters, the decisions of state courts and state statutes are controlling.

Litigation is divided into two general categories: civil and criminal. Civil matters are those in which a dispute arises in which one party claims to have been injured by another, or some other transgression has occurred, that can be remedied by the payment of money (damages) or performance or cessation of certain activities (injunctive relief). Criminal matters are those in which a party has committed an act in violation of a statute, and for which the penalty may be a monetary fine, incarceration, or both. Both civil and criminal trials can be before a judge alone (bench trials) or before a judge and jury (jury trials). In a jury trial, the jury decides the issues of fact, for example, guilty or not guilty, liable or not, and the judge rules on the principles of law, for example, what evidence is admissible. In a bench trial, the judge both rules on the law and is the fact-finder.

In all litigation, the party bringing the action can only prevail by supplying evidence that meets the standard of proof. That standard varies with the type of legal action involved (Table 84-1). In personal injury cases, such as malpractice claims, the plaintiff (the party claiming to have been injured) must prove his or her case by a preponderance of the evidence. That is, the plaintiff must convince the fact-finder that his or her claims are more likely true than not. This is the lowest standard of proof. At the other end is the standard used in criminal prosecutions: the prosecution must prove the defendant’s guilt beyond a reasonable doubt. In other types of cases, such as civil commitment, a standard of proof between these extremes is required: clear and convincing evidence, per the United States Constitution.

Table 84-1 Standards of Proof in Legal Cases

There are two basic types of witnesses: fact witnesses and expert witnesses. Psychiatrists may be called on to serve in either role. Anyone who has firsthand knowledge of events and facts relevant to the case can be asked to serve as a fact witness. Fact witnesses may testify only as to the information they have obtained firsthand; they may not introduce hearsay evidence, that is, information they have heard from others, except under certain limited circumstances. Most important, fact witnesses may not give opinion testimony. Thus, a treating clinician testifying as a fact witness for a patient may testify about his observations obtained in treatment, but may not offer an opinion regarding negligence by a previous treater.1

Where evidence is to be introduced on a subject that is outside the realm of knowledge of the average juror or judge, testimony by an expert witness may be allowed or required in order to meet the burden of proof. To qualify as an expert, a witness must have knowledge of the subject in question beyond that of the average layperson by virtue of education, training, and experience. Unlike fact witnesses, expert witnesses may offer opinion testimony and are generally allowed to use hearsay evidence.1

From time to time, psychiatrists may be asked to serve as either fact witnesses or expert witnesses in litigation matters in which their patients are involved. While a patient can generally insist that the treating clinician provide copies of records and testify as a fact witness, the psychiatrist need not, and should not, serve as an expert witness. It is generally accepted that treating clinicians should not serve as expert witnesses on behalf of their own patients because the two roles are incompatibile.24 For example, clinicians have a fiduciary duty to act in the best interests of their patients, whereas expert witnesses have an ethical obligation to be objective, regardless of the impact on the litigant’s position. In addition, in forming an objective opinion, experts must assess the litigant’s claims against information obtained from collateral sources and be prepared to reject the litigant’s claims. In other words, a treating clinician serving as an expert witness must challenge his or her patient’s version of events, an activity that poses great risk for the therapeutic relationship. Clinicians who agree to serve as experts but who do not follow the proper methodology for conducting forensic evaluations may find their testimony excluded under the rules of evidence.5,6

BASIC CONCEPTS

It is important to keep in mind that the Western notion of individual autonomy is not accepted in all other cultures, and that this has important implications for patient care.7,8

The principle of autonomy has multiple sources in Western philosophy,9 with the Scottish philosopher and economist John Stuart Mill quoted widely in writings about informed consent, treatment refusal, and civil commitment.10 Among Mill’s most quoted passages are the following:

Mill’s libertarian notions had their limitations, however. He did not believe that his principles applied to the mentally ill,11 nor did he believe that the ultimate goal of autonomy relieved the rest of society from an obligation to help the individual choose the course that others believe to be in his or her best interests.

The law has long protected individuals from being touched or otherwise intruded on by others, initially through the common law (case or judge-made law) and later through statutes and regulations. The early English common law (judge-made law or case law), which forms the basis for the jurisprudence of many nations (including the United States and Canada), had well-established principles of trespass, which is now referred to as personal injury or tort law.13 Among the forms of trespass was “battery,” the touching of another person without his or her consent or justification. Battery was at the heart of early malpractice cases.

Battery is just one of many legal principles designed to preserve our autonomy. That principle extends to all interactions among people, including medical treatment. American courts have long recognized the right of individuals to make their own medical decisions.14 This right has been protected in many ways over the years, including the United States Supreme Court’s decision in Cruzan v. Director, Missouri Department of Health, in which the Court declared the right to make individual health care decisions to be a fundamental liberty interest.15

It should be noted that autonomy is only one of four ethical principals considered to be the foundation of clinical care. The others are beneficence, justice, and nonmalfeasance.16 Of these ethical principles, autonomy receives the greatest attention and protection from the legal system, however, and thus will be the focus of this chapter.

INFORMED CONSENT

The development of the doctrine of informed consent extended the principle of individual autonomy to medical treatment. Both ethically and legally, the purpose of the doctrine of informed consent is to give meaning to individual patient autonomy within the doctor-patient relationship.17 When the patient is unable to provide informed consent, it may be obtained from an alternative decision-maker.

Informed consent is best described as a process in which one person, the patient, agrees to allow another person, the treater, to do something to, or for, him or her. The emphasis in this definition of informed consent is on the process, that is, the interactions between patient and clinician, during which there is an exchange of information and acceptance or rejection of the proposed treatment. The role of forms in the informed consent process is commonly misunderstood. The patient’s signature on a consent form does not constitute informed consent itself; it is merely evidence that the informed consent process occurred.

Informed consent evolved from simple consent, which was one of the two basic defenses to a common law claim of battery. Simple consent required only that the would-be patient explicitly or implicitly agree to treatment by the physician; little or no explanation was required. The move toward requiring more substantive consent was fueled by a number of forces, including increased professionalization of medicine, a decline in religious fatalism, and an increased belief that health could be improved through individual effort and through science and technology.18 Informed consent was a logical result of the civil liberties movement and the shift toward autonomy in medical ethics.

The modern era of informed consent was marked by a series of American court decisions in the middle of the twentieth century; however, it was not an American invention. Like seminal ideas in all fields, the complicated principle of informed consent did not arise suddenly. In fact, like many other enlightened principles, informed consent was a known concept in Ancient Greece, Byzantium, and Rome,19 only to be lost during the Dark Ages and rediscovered centuries later. In 1767, an English court held that a surgeon and his assistant could be held liable for battery after rebreaking a patient’s leg to fix a mal-union, without first informing him of their intention to do so. The court held that “it is reasonable that a patient should be told what is about to be done to him, that he may take courage and put himself in such a situation as to enable him to undergo the operation.”20

The following language from Judge Benjamin Cardozo’s opinion in the Schloendorff decision in 1914 signaled the coming of informed consent later in the twentieth century: “Every human being of adult years and sound mind has a right to determine what shall be done with his body.”14 However, the next major decisions in informed consent in American courts did not come until the 1950s and 1960s. In 1957, the California Court of Appeals held in Salgo v. Leland Stanford University, Jr. Board of Trustees that

Subsequent cases held that consent to treatment is valid only if it is an intelligent consent22 that represents an “informed exercise of choice”23 and that failure to obtain that consent constituted professional negligence or malpractice.

In order for consent to treatment to be valid in the eyes of the law, it must be based on a defined amount and quality of information, must be given voluntarily, and must be given by someone who has the legal capacity to consent (Table 84-2).24 The amount of information that must be provided varies by the jurisdiction in which the clinician is practicing. A small majority of states follow the “reasonable professional standard,” which requires the clinician to provide the amount of information that a reasonable professional would provide under similar circumstances. A substantial minority of states use a patient-centered or “reasonable patient” standard, which requires the clinician to provide the information that would allow a reasonable or average patient to make an informed decision. Within the patient-centered school, a smaller group of states apply a standard that is more individualized: what would this particular patient find material in making an informed decision?25 Two states, Minnesota and New Mexico, have hybrid standards.26

Table 84-2 Elements of Informed Consent

From both clinical and risk management perspectives, it is generally the case that the more information provided, the better. The shared decision-making model, which involves open discussion and exchange of information between doctor and patient, is believed by many to epitomize the ideals of informed consent.26 Whatever the jurisdiction, clinicians who provide patients with all of the information listed in Table 84-3 can feel confident that sufficient information has been provided.27

Table 84-3 Important Information to Discuss with a Patient Regarding Consent

Data from Precourt v. Frederick, 481 N.E.2d 1144 (Mass. 1985).

There are limits to the disclosure requirements, even under the materiality standard. In Precourt v. Frederick, the Massachusetts Supreme Judicial Court held that there must be a balancing, an accommodation, among the patient’s right to know, fairness to physicians, and society’s interest that medicine be practiced “without unrealistic and unnecessary burdens on practitioners.”27 In that case, the court rejected a plaintiff’s argument that he should have been warned of a very remote, but real, risk of a medication when the side effect in question had never been reported when used for the treatment in question.

As noted earlier, informed consent is not a universal concept, and individuals from some cultures may find application of the Western model to be inhumane.7,28,29 Clinicians should be aware of this possibility, but remember that the process is ultimately governed by the legal and ethical requirements in the jurisdiction in which they practice. The solution to this potential conflict is to explore the issue with the patient and his or her family. Patients who have the capacity to give informed consent can also waive it and direct the clinician to discuss the illness and proposed treatment with family members.

The second essential element of informed consent is that the consent be voluntary. For the consent to be valid, it must be given voluntarily and free from direct or implied coercion.24,30 Coercion is generally defined as an external force that limits the ability of an individual to make a choice.31 Thus, a homeless patient who is threatened with expulsion from the hospital if he or she refuses a specific treatment has been subjected to coercion. The line between overt coercion and more subtle influences that fall within the range of everyday influences blurs rapidly, however, and draws us into philosophical discussions of free will and personhood.32 For example, consent given by a patient who is subjected to coercion from family members (e.g., “If you don’t take the medicine, we will not be able to have you live at home.”) is generally deemed to meet both ethical and legal standards for valid consent.33,34 Individuals who are totally dependent on their caregivers, such as residents of long-term care facilities and prisoners, may be deemed unable to grant true informed consent to research or treatment due to the coercion inherent in their relationships with those running the institutions.3537 The notion that all individuals in such situations are incapable of truly voluntary consent is open to challenge, however.38

The third and perhaps most critical element of informed consent is that the person giving consent must have the capacity to do so. In the absence of decision-making capa-city, there is no informed consent, regardless of how much detailed information was provided or the patient’s assent to treatment.

It is important to distinguish between the legal concept of competency and the clinical concept of capacity, between global and task-specific competence, and between different specific types of capacity.

In the eyes of the law, all adults are considered competent, giving them status as legal persons. This means that there is a presumption that individuals have the requisite capacity to engage in activities that are necessary and common elements of everyday life, for example, making personal decisions regarding health care and finances, or entering into contracts (such as credit card transactions, marriage, and voting). Only a court can declare an individual to be legally incompetent.39 While evaluation of a patient’s decision-making capacity by a physician or mental health professional is commonly referred to as a “competency evaluation,” the evaluating clinician has no authority to change the patient’s legal status. The clinician’s assessment of the patient’s decision-making capacity, which is then presented to the judge as evidence to be considered in making a judicial judgment regarding competence, is of great importance, however. In the wake of a clinical finding of incapacity, and in the absence of an emergency or other exception to informed consent, clinicians are obligated to obtain informed consent from an alternative decision-maker.

Courts make an important distinction between global and specific incompetence. A declaration of global incompetence strips the individual of status as a legal person, rendering him or her unable to make any of life’s normal decisions. As a result, courts are reluctant to declare someone globally incompetent. Instead, wherever possible, courts will limit declarations of incompetence to specific activities, for example, making decisions about specific treatments. This is consistent with the principal that an individual may be competent to engage in some activities but not in others.

Once an individual is declared incompetent, either globally or with regard to specific decision-making activities, an individual becomes a “ward” and another person is appointed as a guardian to make all decisions on his or her behalf. There is some variation in terminology among various jurisdictions. In some states, a “guardian” is the individual appointed to make decisions related to the person of the ward, while the “conservator” is one who is appointed to control the ward’s financial affairs. In other jurisdictions, for example, California, the individual appointed to make decisions is referred to as a conservator of the person or the estate (financial affairs), and the ward is referred to as the “conservatee.”

Grisso and Appelbaum define incompetence as

We would add to this list of potential causes of incompetence the debilitating effects of all medical conditions and treatments that may render an individual unable to participate in the decision-making process in a meaningful manner, temporarily or permanently.

In conducting a clinical assessment of a person’s capacity to make treatment decisions, four elements should be examined. (1) Does the patient express a preference or choice? (2) Does the patient have a factual understanding, at the level of a layperson, of the basic relevant information concerning the medical condition and the proposed treatment, risks, and benefits? (3) Does the patient have an appreciation of the significance of the information to the situation at hand? (4) Can the patient arrive at a decision in a logical manner that considers the information provided in the context of other personal factors (i.e., is the patient rational)? It should be noted that the patient’s decision may still be rational, even if it is contrary to what a majority of individuals, and the caregivers, might choose. Competent people are entitled to make choices that others may deem inadvisable or irrational. Such is the essential nature of individual autonomy.39,40 These criteria are summarized in Table 84-4.

Table 84-4 Factors to Assess in Determining Capacity to Make Medical Decisions

Adapted from Appelbaum PS, Grisso T: Assessing patients’ capacities to consent to treatment, N Engl J Med 319:1635-1638, 1988.

Practicing clinicians must also be aware that the legal notions of competence and clinical concept of capacity are task specific, that is, they are assessed in relationship to the specific function or decision facing the patient. In addition, these concepts also apply to nonmedical decisions. For example, testamentary capacity (the ability to make a will) and the capacities to manage financial matters, execute an advance directive, and appoint a power of attorney all have their specific criteria for assessment. It is important to note that an individual may lack the capacity for one or more of these activities, but retain the capacity to engage in the others.41

Ethically and legally, we do not require the same level of decision-making capacity for all decisions.30 Clinicians and researchers may accept as competent the consent or refusal of an individual according to a sliding scale that takes into account the risk-benefit ratio of the proposed intervention and its possible consequences. This sliding scale approach requires less capacity for consent to low-risk/high-benefit treatments and refusal of high-risk/low-benefit treatments. Conversely, consent to high-risk/low-benefit treatments and refusal of low-risk/high-benefit treatments requires a higher level of decision-making capacity42,43 (Table 84-5).

Table 84-5 Risk/Benefit Ratio of Treatment

Patient’s Decision Favorable Unfavorable/Questionable
Consent Low level of competency High level of competency
Refusal High level of competency Low level of competency

Adapted from Roth LH, Meisel A, Lidz CW: Test of competency to consent to treatment, Am J Psychiatry 134:279-284, 1977.

In the event that a patient is deemed to lack decision-making capacity, several options are available, and these vary to some extent by jurisdiction, the nature of the treatment, and the degree and expected duration of incapacity. In situations where the treatment is low risk and routine, for example, provision of antibiotics to a demented patient with a urinary tract infection, it is permissible to proceed with consent from family members or the assent of the patient, if family members are not available. As proposed treatments become more aggressive, intrusive, and risky, the need to seek alternative decision-makers increases. It should be noted that whether or not a treatment is one that requires formal appointment of an alternative decision-maker is often determined by case law and legislation, and this view may be contrary to that of the treating clinician. In Massachusetts, for example, all antipsychotics are considered to constitute extraordinary and intrusive treatment, with no distinctions made for dosage. When incompetent individuals are to be treated with these medications, treaters are expected to obtain judicial approval, as will be described later in this chapter.44,45

An alternative decision-maker may be sought through a judicial declaration of incompetency, with the court appointing a guardian to make all or some decisions on behalf of the patient. In most cases, the guardian is charged with making decisions that he or she deems to be in the best interests of the ward. In contrast to the best-interests analysis, substituted judgment is an approach to decision-making for incompetent individuals that seeks to honor their autonomy and preferences when they lack the ability to express them.4648 Substituted judgment is an important aspect of decision-making for individuals who lack the capacity to make decisions regarding treatment with antipsychotic medication, as will be discussed later in this chapter.

Under certain situations, treatment can proceed without informed consent. These exceptions are generally considered to include emergencies, waiver, and therapeutic privilege.49,50 An emergency is defined as a situation in which failure to treat would result in serious and potentially irreversible deterioration of the patient’s condition. The purpose of treatment in the emergency is to prevent further deterioration and to reverse the clinical process. Once the patient is stabilized, however, the emergency exception no longer applies, and the treater does not have license to continue treatment without getting appropriate consent. This is of particular importance in psychiatry, for example, where emergency treatment of an agitated psychotic patient does not give the clinician permission to initiate an ongoing course of treatment. A patient’s prior expressed preference regarding treatment, for example, refusal of particular treatments, cannot be ignored in the face of an emergency. For example, if a competent patient makes it clear that he never wants to have a specific treatment, that treatment refusal cannot be automatically overridden in the face of an emergency. Doing so puts the treater at risk of being sued for battery.51

Informed consent is not necessary where a patient competently waives consent, deferring to the judgment of the clinician or others.24 Clinicians are strongly advised to assess and document the patient’s capacity to make such a waiver, however.

The therapeutic privilege exception to informed consent allows treatment to proceed, with consent obtained from an alternative decision-maker, if the consent process would contribute to worsening of a competent patient’s physical or mental condition.23,52 These situations are unusual, especially in psychiatry. It should be noted that therapeutic privilege cannot be invoked merely because the information provided might dissuade the patient from accepting the recommended treatment.

Obtaining informed consent becomes difficult when the patient can no longer speak for himself or herself as a result of illness. The process of identifying and appointing an alternative decision-maker can be complicated and lengthy, leading to delays in treatment. This problem can arise either because there is no spokesperson or obvious candidate, or where there are several individuals who seek to control the treatment, often with conflicting views about the best treatment course. Advance directives, for example, health care proxies and durable powers of attorney, can be of great use in these situations. These instruments allow individuals to specify treatment preferences in the event that they lose the capacity to make their own choices. Originally developed for use in end-of-life treatment situations, advance directives have significant potential in the treatment of mental illness.53,54 They can be used by patients to both exclude certain treatments and to ensure that treatment will be provided if the illness leads them to refuse treatment; to date they have been underutilized for a variety of reasons.55,56 It is wise to specifically assess and document an individual’s capacity to execute such a document.57

Advance directives are not without their problems, including the fact that the principal (the person who executes the advance directive) may include instructions that no treatment is to be provided, may insist on specific (and potentially inappropriate) treatments, and can revoke the instrument at any time. It is possible to override advance directives where the provisions are in conflict with civil commitment statutes, or where adhering to the patient’s preferences would be inconsistent with ethical practice. In such cases, standard judicial mechanisms for involuntary treatment should be followed, as they provide due process protections for both patient autonomy and professional practice.58,59

TREATMENT REFUSAL

The doctrine of informed consent has slowly, but steadily, gained acceptance among clinicians and researchers. The idea that all competent adults have a right to make their own decisions about medical treatment is now well established, even if application of that principal continues to lead to certain ethical and legal dilemmas.15,60,61

The advancement of notions of autonomy, informed consent, and civil rights principles, combined with growing awareness of the side effects of psychotropic medications and judicial scrutiny of conditions in publicly funded psychiatric facilities, led to significant changes in how the rights of the mentally ill were protected. Chief among these were recognition that (1) the mentally ill have the same rights to make their own treatment decisions as those with other illnesses and (2) mentally ill individuals are entitled to have their treatment preferences honored even after loss of their capacity to express those preferences.

The introduction of these principles was met with considerable resistance.17 The notion of allowing an individual to refuse treatment for a mental disorder, when symptoms of the disorder render the individual unable to rationally weigh the risks and benefits of treatment or lead to involuntary hospitalization, appeared to strike at the very heart of ethical principals of beneficence, justice, and nonmalfeasance.62 Before the legal reforms in this area, patients lost all of their legal rights, including the right to make treatment decisions, on involuntary civil commitment. It was only after a series of legal cases in the late 1970s, both federal and state, that states began to recognize that individuals who require involuntary hospitalization can still retain the capacity to make treatment decisions.63

The primary focus of the debate over treatment refusal by mentally ill individuals has been antipsychotic medication. Not coincidentally, this issue came to the attention of the courts (and eventually legislatures) in the late 1970s—approximately 25 years after the introduction of chlorpromazine. While the widespread use of that drug and other dopamine-blocking antipsychotics allowed for the deinstitutionalization of thousands of patients, the courts turned their attention to the short- and long-term side effects of the medications (such as acute dystonic reactions, tardive dyskinesia, and tardive dystonia). In many cases, even after these side effects were known, they were not discussed with patients and their families, in part due to the presumption that the mentally ill were not entitled to participate in the informed consent process.

Recognition that competent mentally ill individuals are entitled to the same informed consent process as other individuals, even if involuntarily committed, left open the issues of treatment refusal and acceptance by individuals who lacked decision-making capacity. In the United States, the approach to these issues has varied between federal and state systems, and among the states. For example, Utah incorporates a judicial finding that “the patient lacks the ability to engage in a rational decision-making process regarding the acceptance of mental treatment as demonstrated by evidence of inability to weigh the possible risks of accepting or rejecting treatment” as one of the criteria for civil commitment criteria, thus tying involuntary treatment to commitment.64 Civil commitment statutes in other states also established this issue as a component of committability.65

Other jurisdictions maintain a distinction between involuntary treatment and involuntary confinement. Among those other jurisdictions, there is still considerable variation in the approach to involuntary treatment. At one extreme are those jurisdictions that provide administrative review of treatment refusals, while ultimately preserving recourse to the courts. In federal jurisdictions, for example, antipsychotic drugs may be constitutionally administered to an involuntarily committed mentally ill patient whenever, in the exercise of professional judgment, such treatment is deemed necessary to prevent the patient from endangering himself or herself or others. Once that determination is made, professional judgment must also be exercised in the resulting decision to administer medication.66

Another approach is followed in Ohio, for example, which has a statute that prohibits hospitalized mentally ill individuals from being treated with surgical procedures, convulsive therapy, major aversive interventions (e.g., shocks), unusually hazardous treatment procedures, sterilization, or psychosurgery without their full informed consent. If the patient is incompetent, the treaters may seek consent from “the patient’s natural or court-appointed guardian, who may give an informed, intelligent, and knowing written consent.” In the absence of a natural or court-appointed guardian, the treaters may seek consent from the court for these treatments.67 Antipsychotic medications are considered to be routine medical treatments in Ohio, and require no special proceedings to allow forced medication. Ohio requires a guardian who is appointed to make decisions about treatment of the ward to apply a best-interests analysis with respect to the appropriateness of treatment with antipsychotic medications.68

With regard to involuntarily committed patients, the Ohio Supreme Court has held that the state’s interest in public safety overrides the right of an individual to refuse treatment. Forced medication of an involuntarily committed mentally ill patient with antipsychotic drugs can be ordered if a physician determines “that (1) the patient presents an imminent danger of harm to himself/herself or others, (2) there are no less intrusive means of avoiding the threatened harm, and (3) the medication to be administered is medically appropriate for the patient.”69 Where the involuntarily committed patient does not present an imminent threat of harm to himself or herself or others, but lacks the capacity to give informed consent, “the state’s parens patriae power may justify treating the patient with antipsychotic medication against his/her wishes.”69 The issue of competency to give or withhold consent is a matter for judicial, not medical, determination, however, and “a court may issue an order permitting hospital employees to administer antipsychotic drugs against the wishes of an involuntarily committed mentally ill person if it finds, by clear and convincing evidence, that (1) the patient does not have the capacity to give or withhold informed consent regarding his/her treatment, (2) it is in the patient’s best interest to take the medication, i.e., the benefits of the medication outweigh the side effects, and (3) no less intrusive treatment will be as effective in treating the mental illness.”69

In contrast, Massachusetts and some other states view antipsychotic medications as extraordinary and intrusive treatments, from which incompetent patients (both consenting and nonconsenting) must be protected unless their rights are secured through the application of full adversary proceedings.44 Massachusetts, for example, requires that in the absence of an emergency, an individual who lacks the capacity to provide informed consent or refuses treatment with antipsychotic medication can receive treatment only after a two-part proceeding. These are formal, adversarial proceedings, at which the patient is represented by counsel and sworn testimony is received. This process is required, regardless of dosage or purpose of the treatment. The proceedings may be conducted before the probate and family court for outpatients or hospitalized inpatients, or before a judge of the district court hearing a motion for civil commitment.

The first part of the hearing is a judicial determination of competence. If the court determines the patient to be competent to make decisions, the patient may continue to refuse the treatment, absent some adequate countervailing state interest,70 if that patient is subject to involuntary commitment. If the court finds the patient to be incompetent, the second stage of the hearing involves a determination as to whether or not the patient should receive the proposed treatment. The Massachusetts Supreme Judicial Court has determined that only a judge has the requisite degree of interest and objectivity to be able to render a substituted judgment decision that focuses on the preferences of the incompetent patient.45 Simply stated, the substituted judgment analysis attempts to determine what the incompetent patient would have decided if he or she were able to make an informed decision, taking into account all the circumstances. Those circumstances can include the likelihood that the individual will remain incompetent in the absence of treatment. The court considers, at minimum, the elements listed in Table 84-6.44,45

Table 84-6 Factors Considered by Massachusetts Courts in Conducting a Substituted-Judgment Analysis Regarding Treatment with Antipsychotic Medication

Data from In the Matter of Richard Roe III, 421 N.E. 2d 40 (Mass. 1981); Rogers v. Commissioner of Department of Mental Health, 390 N.E. 2d 489 (Mass. 1983).

The adoption of these procedures had a significant impact on the treatment of the mentally ill in Massachusetts in terms of costs and energies devoted to the process, although the majority of treatment petitions submitted to the court are granted. Whether this represents greater care by clinicians in choosing the patients for whom involuntary treatment will be pursued, or reflects sensitivity by the judges to the appropriateness of treatment, or some other factors, is a matter of speculation.71,72

CONSENT TO PARTICIPATE IN RESEARCH

Patients with psychiatric disorders are frequently asked to participate in psychosocial and psychopharmacological re-search studies designed to identify new and effective treatments for their illnesses. This poses significant legal and ethical concerns. Psychiatric disorders may compromise cognition, emotional regulation, insight, and at times the ability to reason between treatment alternatives, calling into question the validity of their consent to participate.73 In the research context, goals such as scientific advancement may in some instances displace individualized care, and may involve a greater degree of risk to the patient or an uncertain benefit. Randomized controlled studies with double-blinded procedures are designed to protect the integrity of the study data rather than respond to the individual needs of the patient. Recent research has demonstrated that many patients with mental illnesses have difficulty appreciating the distinction between participation in a research study and receiving traditional individualized care. Several investigators have attempted to identify which patient characteristics predispose patients to this therapeutic misconception, and have identified low educational attainments and cognitive impairments as pertinent risk factors. It is not yet clear, however, whether severity of mental illness or the presence of psychosis correlates with a greater incidence of therapeutic misconception.74 In addition, structured assessment instruments are being evaluated for their usefulness in determining the capacity to consent to clinical research.75 Several leading researchers in this field have proposed a more careful and detailed consent procedure for patients considering enrollment in a research study. This discussion would highlight the nature and purpose of the research, the risks and benefits of being a subject, and whether the patient can obtain the same therapeutic interventions outside the research setting.76

A significant body of research has demonstrated that people with mental illnesses retain a certain amount of decision-making capacity, which can be enhanced with educational interventions.77 However, in the case of incompetent patients with mental illnesses, family members or substitute decision-makers are often called on to determine participation in a research study. In the treatment context, substitute decision-makers can focus solely on the best interests or preferences of the patient; however, consent to enroll in a research protocol has competing goals. As in the case of treatment consent, substituted consent for participation in low-risk clinical trials raises fewer ethical or legal concerns, but higher-risk studies require adherence to federal consent guidelines, state statutory guidelines, and ethical guidelines.77 Generally, incompetent patients have an absolute right to refuse participation in any study, and their refusal or expressed negative preferences are taken at face value. In the absence of such an expressed preference, substitute decision-makers are allowed to consent to research participation on the same basis as they would for treatment decisions, although these provisions vary from state to state and sometimes explicitly exclude patients who are hospitalized with mental illnesses.4,78

CIVIL COMMITMENT

Civil commitment is an administrative or judicial process by which the state’s power is used to identify and remove a mentally ill individual from society and place him or her in an institutional setting. The involuntary confinement of a person due to mental illness is one of the oldest clinical interventions, if not the original clinical intervention, for the mentally ill. Throughout the ages, the purpose and justification of such confinement has cycled between protection of the rest of society and the patient’s need for treatment. When the purpose is the protection of both the patient and society from the dangers associated with the illness, the state is considered to be using its police powers. The police powers approach focuses on the dangerousness of the patient to self or others. When the justification for commitment is the need of the patient for treatment, the state is using its parens patriae authority, that is, the state is acting toward the individual citizen with the same authority and responsibility as a parent toward a child. Under this rationale, the state takes a beneficent role toward its citizens and acts in their best interests to protect them from their incapacities or disabilities.70

With the increased focus on civil rights and autonomy in the 1970s, the best interest or parens patriae/need for treatment approach to civil commitment was replaced by the dangerousness/police powers approach in most jurisdictions. This approach allows an individual to be involuntarily committed to a mental institution only if the individual poses a danger to himself or herself through direct injury, if there is a direct threat of physical harm to others, or if the individual is gravely disabled and unable to care for himself or herself in the community.79,80

The process for civil commitment varies among jurisdictions. All states provide for an initial short-term emergency confinement without the necessity of judicial hearing. Generally, such emergency certification requires examination by a mental health professional (such as a psychiatrist, psychologist, or psychiatric nurse), who makes the clinical findings required by the applicable commitment statute. Following the initial emergency confinement, which varies in length from 2 days to 3 weeks among the states, the facility may release the patient, convert the admission to a voluntary hospitalization or petition a court for an order of civil commitment.4

Commitment hearings differ in their level of procedural safeguards. Some jurisdictions authorize administrative boards or hearing officers to conduct the proceedings, while others require a full hearing before a judge, with psychiatric examinations, witness testimony, and documentary evidence. In 1979, the United States Supreme Court ruled that the standard of evidentiary proof required for a civil commitment is clear and convincing evidence that the commitment meets statutory standards. Several states, however, have chosen to require a higher standard of proof in these proceedings, namely proof beyond a reasonable doubt, rather than offer the Constitutional minimum.

The length of these commitments also varies by jurisdiction. Most states specify a period of confinement varying from 6 months to 1 year, with the requirement that formal recommitment proceedings be initiated in order to extend the time period. A minority of states have no explicit commitment period and provide that the commitment terminates when the patient’s clinical condition no longer meets statutory standards.

Civil Commitment of Sex Offenders

During the 1980s, a series of highly publicized and horrifying sex crimes catalyzed the enactment of state statutes providing for the civil commitment of convicted sex offenders after the completion of their prison sentences. In 1990, Washington State enacted the first sexual predator law, and now 19 states have so-called sexual predator statutes that provide for indefinite confinement in specialized treatment centers.81 Although each state has a different standard for such commitment, these statutes generally provide for the detention of offenders with broadly defined mental abnormalities or mental illnesses that predispose them to commit sex crimes.82 A diverse array of interest groups have criticized these laws on various grounds, alleging that they violate civil rights, criminalize mental illness, depend on unreliable predictions of future behavior, and divert the focus away from longer or more effective prison sentences.83 In addition, critics observe that these statutes confine patients based on a treatment rationale when it is not clear that effective treatment for sex offenders exists.84 The Supreme Court subsequently upheld the constitutionality of these laws in three cases. In Kansas v. Hendricks85 the court determined that a “mental abnormality” such as pedophilia combined with a finding of dangerousness or the likelihood of reoffense was a sufficient rationale for an indefinite civil commitment. The court also upheld the validity of sexual predator laws against a claim that the treatment is so inadequate and punitive that it is the equivalent of a second prison sentence.86 Most recently, in Kansas v. Crane87 the court lowered the threshold for the behavioral dyscontrol, requiring only proof that the offender has difficulty controlling his dangerous behavior rather than a “total or complete lack of control.” In 1999 the American Psychiatric Association task force on sexually dangerous offenders produced a report opposing the penal use of commitment statutes, concluding that they pose a threat to the integrity of psychiatric diagnosis and the therapeutic basis for other civil commitment statutes.88

Outpatient Commitment

While involuntary hospitalization provided a treatment setting for people at imminent risk of harming themselves or others, it did not offer a treatment scheme for a significant population of chronically mentally ill people who were unwilling or unable to comply with outpatient treatment regimens. These patients were frequently rehospitalized, only to deteriorate immediately after discharge. In response to the problem of the “revolving door” patient and a series of highly publicized violent acts by persons with mental illness, several states decided to revitalize the seldom-used outpatient commitment statutes. These statutes, previously enacted in almost every state but rarely used, allowed judges to require patients to comply with outpatient treatment regimens or face involuntary hospitalization. Outpatient commitments could be ordered on discharge from the hospital or as an alternative to civil commitment.89 Outpatient commitment procedures were initially heavily criticized as a violation of Constitutional guarantees of equal protection and due process of law, and an unacceptable instrument of social control. Critics also voiced concerns that despite being ordered to comply with community mental health treatment, patients were provided with inadequate treatment in underfunded programs.90 Some of these concerns were ameliorated by two randomized trials of outpatient commitment undertaken in New York and North Carolina.91,92 The data from these two studies, examined in light of their methodological limitations, appear to support the use of outpatient commitment to stabilize and improve the quality of life for chronically mentally ill people. Although the debate over the legitimacy and efficacy of outpatient commitment is still unresolved, it appears to significantly improve adherence to medication regimens and is associated with decreases in substance use, rehospitalization, homelessness, and violent victimization among certain groups of severely mentally ill patients.93,94

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