Informed Consent in Psychiatry Research Paper

1. Elements Of Informed Consent

Informed consent does not occur in isolation or in a moment, nor is it reducible to a signature on a legal document. It is a shared, significant process between people—one of whom faces a series of evolving choices critical to his or her mental and physical health, the other of whom is a professional person entrusted with helping to define these choices astutely and present them truthfully, respectfully, and compassionately. In clinical care, promoting the health and alleviating the suffering of the individual patient will be the basis of any treatment considered in the consent process. Consent in this situation focuses on the patient’s personal values, is based on the overall goals for care, and hinges on trust in the clinician–patient relationship.

1.1 Information

The sharing of appropriate information is the first of three core elements of informed consent. The patient should be provided with accurate and balanced information in understandable language. This information should include the anticipated risks and benefits of a given treatment, the procedures involved, and its alternatives and their expected outcomes. Alternatives may include implementation of another treatment or additional treatment, or it may involve no intervention upon the course of illness at all. While every minute detail cannot be reviewed in this discussion, rare but serious risks should be characterized in a manner that conveys their relevance and reality. Furthermore, the omission of information in the disclosure process should not be intended to deceive or mislead the person undertaking the decision.

Ideally information related to a matter requiring consent will be disclosed in a manner that fosters dialogue, allows for clarification of complex issues and the identification of misunderstandings, and keeps opportunities open for subsequent discussion as new issues emerge. In obtaining informed consent for treatment of mild depression, for instance, the clinician should discuss the variable course of depressive illnesses, including the potential for symptom resolution in the absence of treatment and the chance of recurrence without intervention. The clinician should review the rationale for a proposed antidepressant agent given the symptoms of the patient and the patient’s attitudes and values. The discussion should cover the medication’s known possible side effects, potential adverse effects, and their relative likelihood. The clinician should explicitly anticipate the choices that will be faced by the patient in the future in light of the therapeutic alternatives discussed and the nature of the illness. This discussion should be documented by the clinician as an important element of the care process.

Consent forms that accurately and completely describe a treatment and outline patient rights represent an important tool in the consent process. Consequently, consent forms should be developed carefully in terms of their understandability (e.g., simple but precise language), readability (e.g., size of font), content (e.g., purpose, risks and benefits, rights, responsibilities of the clinician researcher), and related issues. Consent forms, furthermore, signify the importance of a new decision for the patient, and they give specific focus to the dialogue between the professional and the patient. Even general consent forms such as those for hospitalization or for initiating medication—which may or may not confer legal protection when a medico-legal conflict occurs—have this value. From a legal perspective, notes written by the clinician reflecting the disclosure dialogue with the patient may be far more salient and can carry greater weight.

1.2 Decisional Capacity

Decisional capacity, the second element of informed consent, represents a sophisticated clinical assessment of an individual’s global and specific cognitive abilities within a particular context and in relation to a particular choice. It is distinct from ‘competence’ which is a legal determination, i.e., a formal assessment by a judge or other officer of the court regarding a person’s ability to function within a general domain of one’s life such as financial or medical decisions (Appelbaum and Gutheil 1991). The presence of a serious symptom (e.g., delusions, memory loss, suicidal ideation, diminished cognitive functioning) or of a serious diagnosis (e.g., schizophrenia, dementia, major depression, developmental disability) does not mean that an individual lacks decisional capacity. Similarly, being a young adolescent or a very elderly person does not, a priori, preclude one from being decisionally capable. In the context of mental illness, decisional capacity assessment may be subtle, complex clinical work that entails constructing a cohesive sense of the individual’s strengths and deficits in light of a number of factors. The type of decision to be made, the nature, time course, and severity of the person’s symptoms, the patient’s situation, and past experiences, personal values, psychological defenses or coping ‘style,’ and other factors should all be considered.

Decisional capacity itself has four principal components, each of which should be viewed on a continuum and not as ‘all or none’ phenomena (Appelbaum and Grisso 1988). The first component is the individual’s ability to express a preference (i.e., capacity for expression or communication). On the extreme end of the continuum will be severely ill psychiatric patients who are mute or catatonic, or who manifest complete language and thought disorganization, and therefore may be intermittently ‘incapable’ of communication. In the medical context, a patient who is comatose due to metabolic disturbances, aphasic secondary to a stroke, delirious, or unconscious after a head injury will also lack this most fundamental ability. There are times when this component of decisional capacity is very difficult to assess, such as in the spinal cord injured patient who communicates only through eye blinks, or the dysphoric person with Broca’s aphasia who is frustrated by the process of generating words but has the capacity to understand and indicate choices. For these reasons, while the ability to communicate is often obvious, this assessment in many situations will require careful interactions with patients and astute observational and listening skills on the part of the clinician.

The second component of decisional capacity is the individual’s ability to understand relevant information (i.e., capacity for comprehension). In talking with the clinician, the patient with this ability will be able to take in factual information regarding the nature of the illness, the need for intervention, the kinds of treatments under consideration, their relative risks and benefits, and the possible consequences of not intervening. Comprehension is influenced by intelligence, educational level, and prior experience. In assessing this dimension, it is critical that the patient state his or her understanding of the situation and the choices at hand in their own words. Otherwise it is difficult to know if the patient is using terms and phrases of the clinicians without truly knowing their meaning.

Third is the individual’s ability to think through the decision in a way that is ‘rational’ and deliberate (i.e., capacity for reasoning or rational thinking). This component of decisional capacity relates to the person’s analytical abilities given a specific set of facts or data and, like comprehension, is affected by intelligence and educational level. For instance, the ‘rational’ person, all other factors being equal, will consistently choose a medication that has a 75 percent likelihood of treating the illness effectively over one that has a 50 percent chance. Similarly, the ‘rational’ person will consistently choose a medication that poses fewer risks and promises fewer adverse side effects than another medication. In essence, this dimension of decisional capacity has to do with the ability to use objective information.

Fourth, and often most important, is the person’s ability to make meaning of the decision and its consequences within the context of his or her personal history, values, emotions, and life situation (i.e., capacity for appreciation). Deeply dependent upon psychological insight, this is the most sophisticated component of decisional capacity. It can be very difficult to assess clinically. In some individuals with early dementia, for instance, a person’s social graces and cognitive skills may be only superficially affected and yet these individuals may be unable to think through the meaning of an important treatment decision and its repercussions. In some patients suffering from either anxiety or affective disorders, the negative cognitive distortions inherent to their illnesses may interfere with their abilities to interpret information within a personal context, although other components of decisional capacity may be intact. Importantly, in people with severe mental illnesses such as schizophrenia, the simple presence of psychotic symptoms such as hallucinations or delusions may not interfere with the individual’s overall decisional capacity, but the cognitive and insight deficits associated with the illness may interfere with their capacity for appreciation of the situation at hand. Alternatively, even the most gravely ill individuals may have difficulty expressing themselves and an incomplete sense of the factual information but may truly appreciate the severity of the situation and possess a deep and consistent sense of who they would like to make decisions for them.

Decisional capacity is therefore a rich construction, not simply reducible to an individual choosing a predetermined ‘right answer’ when making a decision of importance. It is the person’s ability to gather, assimilate, and use information, to truly see the reasons for and against a given option, and to develop a meaningful decision in the larger context of one’s life. The seriousness and complexity of any specific decision will govern how rigorously these criteria are applied. In the context of serious mental illness, a person may be fully capable of deciding whether or not to begin a new psychotropic medication but, on a given day, may be incapable of deciding whether to enroll in a clinical protocol involving a medication- free interval and potential randomization to placebo. The standard for decisional capacity is also robust when a very ill patient refuses treatment that is highly recommended because of the benefit it is likely to bring to him (see discussion in Sect. 2). This is not to say that patients cannot refuse treatment; when the risks of refusal are great, however, there is a greater responsibility on the caregiver to assure that the patient is genuinely capable of this decision and to manage its consequences.

1.3 Voluntarism

Beyond information disclosure and decisional capacity, the final element of informed consent is voluntarism or autonomy. Autonomy represents the expression of the authentic preferences of the individual in the absence of coercive pressures. Voluntary preferences may be tempered by the realities of the situation such as the presence of a serious diagnosis and the lack of ‘curative’ treatments for many mental illnesses, but should reflect the person’s sustained and genuine wishes as evidenced in their expressed values and prior life decisions. Autonomous wishes may be deeply influenced by social and cultural expectations and psychological history. For instance, a patient who has been in the military may be oriented to hierarchical power relationships and may view a clinician’s recommendation as an ‘order’ to be obeyed. Similarly, a seriously mentally ill person who has been institutionalized involuntarily in the past may see themselves as no longer possessing the right to their own choices. Illness processes may also affect patient preferences as well as the ability to express autonomous wishes. A person who suffers deeply either psychologically or physically may feel desperate and desolate, phenomena that can generate inherent internal coercive pressures. A person who has been the victim of violence may see themselves as relatively powerless. Finally, clinical syndromes that involve apathy, alexithymia, amotivation, or cognitive slowing may render ill individuals less able to identify and express their true wishes.

2. Clinical Application Of Informed Consent Concepts

Translation of informed consent concepts to clinical practice is affected by the clinical status and situation of the patient. In emergencies, for instance, there may be little time for information-sharing and mutual decision-making and the standard for consent is less rigorous than in other contexts. Acting beneficently, i.e., to save the life or preserve the health of the patient in an acute situation, is the clinician’s duty in such circumstances. This is held to be critical ethically and justifiable legally; it is presumed that in such emergency situations the patient wishes to be helped and that the clinician has permission to act with the patient’s well-being and best interests at heart. Often the patient, if alert and conscious, will explicitly assent to treatment in these circumstances, i.e., voluntarily accept the choice proffered by the clinician at the time. If the patient is unconscious or is unable to communicate at all, the clinician acts with the ‘implied consent’ of the patient.

When the patient refuses treatment in an emergent situation, however, a very rigorous standard for consent must be applied because of the likelihood of an adverse outcome and because there are many clinical factors that may be adversely affecting the judgment of the patient. Undiagnosed illness, delusional thinking, severe physical pain, emotional distress, and interpersonal pressure all may undermine the ability of the patient to make a fully informed, autonomous choice in an acute situation. Evaluation, hospitalization, and treatment, even against the apparent wishes of the patient, may be essential in such circumstances. Consider two illustrative patient cases:

Case Example 1. A man diagnosed with a serious mental illness characterized by psychotic and mood symptoms was brought to a psychiatric crisis unit after being found wandering on the street near his home. It was discovered that he had superglued his eyelids shut, and it was imperative that he receive medical attention immediately. He was outwardly calm, did not speak, answered questions through nodding, writing, and hand gestures, but actively refused to get into an ambulance to be taken to the medical emergency room. The clinician on duty that evening knew the patient well and was able to deduce that the patient’s peculiar behavior was linked to a recurrent delusion he had when entering a manic period. In this case, the patient’s ability to make a fully informed decision was impaired by his delusional belief that if he looked directly at people, they would be instantly destroyed by powerful lasers that had been implanted in his eyes. Once the clinician initiated a conversation about these beliefs with the patient, it was possible to clarify that the patient wanted help and that he was willing to accept treatment, but was terrified that he would hurt people or himself be killed. The patient thus had some decisional ability and could offer assent for emergency care. The clinical team opted to pursue a legal process that would allow involvement of a time-limited treatment guardian due to concerns over the patient’s compromised insight and judgment and the severity of his delusions.

Case Example 2. An agitated man demanded discharge from a surgical unit two days after an emergency appendectomy. He had elevated heart rate, blood pressure, and temperature, had signs of abdominal infection, and yet was insistent that he leave the hospital. The medical team was conflicted about granting the patient an ‘AMA discharge’ (‘Against Medical Advice’)—the nurses and residents believed this to be the patient’s ‘right to refuse treatment’ but the attending clinician did not agree. On initial psychiatric evaluation, the patient showed irritability and very subtle indications of diminished attention, was oriented except to day of the week, and had no other apparent abnormalities on an abbreviated mental status examination. He was noted to be tremulous. He was placed on involuntary ‘hold’ status. Within an hour, the patient was agitated, disoriented, and expressed disorganized thoughts. Additional history was then obtained that the patient drank one to two pints of vodka daily prior to admission. Post-surgical infection in combination with alcohol withdrawal had triggered a significant delirium, an early indication of which, ironically, was his treatment refusal and discharge demand. His most distressing symptoms and disorientation resolved rapidly with treatment, and he withdrew his request to leave the hospital.

When a patient refuses treatment there may be a significant clinical issue that requires close attention, and involuntary treatment may be imperative. Clarification of underlying clinical considerations in such circumstances is the caregiver’s primary responsibility—a duty grounded in the bioethics principles of respect for persons, clinical standards of care, fidelity, and beneficence. Careful evaluation of the patient’s true strengths and abilities is important so that he or she may exercise choice in every area possible. The intent is not to undermine the patient’s autonomy. Rather, it is to empower the clinician only insofar as to help advance the health and well-being of the patient and to assure that the patient is optimally able to express his or her true wishes to accept or decline a given therapeutic approach. In sum, in situations where clinical decisions may have very serious or irreversible health consequences, including death, informed refusal of treatment must fulfill the most stringent standards.

The goal of informed, voluntary decision-making may be more clearly fulfilled in the context of care for chronic illness. Over the course of time, the clinician may come to know the patient—their symptoms, their values and concerns, their responsiveness to treatment interventions, and their personal supports. In turn, the patient may have a greater sense of trust, express themselves with greater openness, and gather more complete information about the illness and potential therapeutic interventions. The patient with a chronic illness also lives out the consequences of side effects, adverse reactions, and benefits of treatments in a manner different from the patient with a time-limited health problem. In this context, the patient may better appreciate how their illness and treatment affect other aspects of their life, and it is possible to come to know their preferences and concerns with greater certainty. Expressing autonomous wishes and deciding upon specific treatment approaches and the overall goals of therapy through mutual understanding and dialogue are more intrinsically possible in the context of chronic illness. The standard for consent in chronic illness, thus, is very rigorous in terms of the patient’s level of information, opportunities to enhance decision-making, and creating a circumstance in which patients may indicate their wishes and hopes.

In clinical practice, psychiatric advance directives may be valuable in translating concepts of informed consent to patient care decisions. Advance directives articulate patient preferences for future care. Advance directives are often formal written papers created and signed by the patient; they may also consist of a body of documentation developed by the patient, family members, and clinicians regarding his or her wishes and values concerning personal health care. Advance directives are helpful in that they serve as a reference for the clinician if the patient becomes decisionally incapable or compromised. For example, knowing that they had a pattern of developing compromised judgment during periods of mania, a patient with bipolar disorder completed an advance directive requesting that treatment be instituted despite their (anticipated) protests. Advance directives also provide evidence of the patient’s past personal healthcare preferences that may result in controversial clinical decisions, e.g., when patients refuse treatment based on deeply and consistently held personal convictions such as the refusal of blood transfusions by a patient who is a Jehovah’s Witness. Ideally, these issues will not be addressed for the first time in a moment of great crisis. They should be anticipated, discussed, and documented carefully beforehand. Advance directives do not, under any circumstances, replace the wishes expressed by a patient who is currently decisionally capable. Moreover, there should be opportunities to adapt, or even reverse, earlier decisions as one cannot always tell prospectively how one will respond in a crisis situation. For these reasons, advance directives may guide but can never supplant prudent, reflective clinical decision-making.

In surrogate decision-making, healthcare choices are made for the decisionally impaired patient by another person. This person may be a spouse, sibling, adult child, friend, or a court-appointed guardian. The surrogate decision-maker has the responsibility of serving the best interests and well-being of the patient while seeking to make decisions that are faithful to the personal values and prior wishes of the patient. This can be difficult. In some situations, the patient’s wishes are not known. In other situations, the patient is too young or too cognitively compromised to have demonstrated their personal values. In yet other situations, these values and wishes are known and appear to conflict with accepted standards of clinical care. Consequently, in working with surrogate decision-makers, it is important for clinicians to clarify the goals and value system governing the choices made on behalf of the patient. It is also crucial that the patient’s decisional capacity be assessed accurately and, in most circumstances, the patient’s symptoms be treated aggressively so that they can contribute to the choices made to whatever extent possible.

3. Empirical Studies On Consent In Clinical Care

Nearly 400 studies performed since 1970 suggest that informed consent is an ideal that is often difficult to achieve in clinical and research practice involving people with physical and mental illness (Sugarman et al. 1999). These data indicate, however, that issues faced in clinical care for mental illness are not radically different in degree or kind from those encountered in the treatment of physical illness (Stanley et al. 1988). Moreover, an extensive body of evidence on consent consistently demonstrates the poor readability, understandability, and ineffectiveness of formal consent documents in clinical care (Grossman et al. 1994). An important recent advance in the informed consent field has been the development of the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) (Grisso et al. 1997). This is a structured interview designed to assess patients’ clinical care decision-making abilities based on empirical work conducted over ten years by Appelbaum and N Grisso. While this instrument is best utilized as a tool for approaching decisional capacity evaluation, not as a definitive ‘test’ of competence, it will introduce greater consistency of consent standards to both scientific and clinical arenas.

Evidence on consent in the care of mental illness reveals many key challenges for clinicians (Roth et al. 1982). Studies of psychotic, affective, and dementia disorders, for instance, have shown that symptoms of mental illness may adversely impact information based or more strictly cognitive aspects of consent (Roberts 1998). In the 1995 MacArthur Treatment Competence Study (Appelbaum and Grisso 1995), the decisional abilities of patients with schizophrenia or major depression, patients with ischemic heart disease, and non-patient community volunteers (total n 498) were assessed. When acutely ill, the psychiatric patients in this study had greater difficulties with decision-making on several formal cognitive measures than did the medically ill patients and community participants. The problems were more severe for individuals with psychotic symptoms than for depressed individuals. Clinical treatment led to significant improvement of these deficits, resulting in closer resemblance across the three groups.

Smaller studies echo these findings. An early study by Schachter et al. (1994) involving 38 schizophrenia patients revealed that the presence of conceptual disorganization, delusions, and hallucinations was associated with patients’ poor performance on the information elements of consent. Appelbaum et al. (1981) assessed 50 people admitted to a mental health inpatient unit and found that most were unable to consent to hospitalization. Later this team evaluated 100 voluntarily hospitalized psychiatric patients, finding that a significant minority did not understand information presented to them on the purpose of hospitalization and discharge (Appelbaum et al. 1998). Beck (1988) evaluated the capacities of 56 psychiatric patients on antipsychotic medications, revealing that they had limited understanding and appreciation of their treatment. Stanley et al. (1988) compared the reasoning ability of elderly individuals suffering from major depression (n = 45) and dementia (n = 38) with elderly control subjects (n = 20). The cognitively impaired dementia patients and, to a lesser extent, the depressed patients had significant deficits on a number of decision-making items. Similarly, Marson et al. (1995) used a clinical vignette-based instrument to measure the level of competence exhibited in medical treatment decisions by individuals with dementia and healthy comparison subjects. Not unexpectedly, this work revealed that the severity of cognitive impairment in dementia correlated with lack of ability to formulate logical reasons for treatment choice, i.e., addressing the ‘rational reasons’ dimension of decisional capacity. Interestingly, global measures of dementia severity such as the Mini-Mental Status Exam were not predictive of clinical decision-making capacity.

Studies of advance directives and surrogate decision-making also have important implications for mental health care. Several survey and interview studies have revealed that advance directives are underutilized (Bradley et al. 1998) and that patient preferences are rarely identified prospectively (Seckler et al. 1991). In terms of surrogate decision-making, several studies have shown that most elderly patients would prefer that a family member such as a spouse or adult child serve as an alternative decision-maker (High 1989). Studies of hypothetical decision-making by proxies suggest that they may not assess patients’ wishes accurately, however Sachs et al. (1994) studied 42 decisionally capable dementia patients, 64 proxy decision-makers, and 60 well elderly individuals and found that the decision-makers’ predictions of patient preferences were overall discordant with the patients’ own stated wishes. Similarly, Warren et al. (1986) studied participation choices made by proxy decision-makers and 168 decisionally capable nursing home patients with respect to hypothetical, minimal risk research projects. The results demonstrated that the surrogate decision-makers used criteria other than the patient’s predicted preferences in making these choices.

Clear evidence is also emerging that the barriers to consent may be amenable to intervention, offering significant hope (Roberts et al. 2000). Interventions in which information is presented verbally and in writing, using clear and understandable language, have been shown to improve patients’ understanding of consent decisions (Carpenter et al. 2000). The timing of consent information and the provision of information in a relaxed manner or on repeated occasions is important to patients’ abilities to integrate and apply this data (Roberts 1998). Treatment of symptoms, ranging from hallucinations to physical pain, has been observed to improve the quality of patients’ decision-making. Finally, clinician behaviors that reflect how the consent process is valued, e.g., by giving time to the consent dialogue, have been found to be valued by patients and surrogate decision-makers (Roberts and Roberts 1999). The observation that educational efforts, symptom treatment, and attitudinal obstacles can be addressed suggests a number of constructive approaches to consent in the context of clinical care for the mentally ill.

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