Informed Consent: VI. Issues of Consent in Mental Healthcare

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Since the 1970s informed consent has been at the center of an evolving doctor-patient relationship whose characterization has shifted from strict paternalism to information exchange, shared decision making, and patient-centered care. In research, informed consent operates in concert with research regulations to protect human subjects while enabling research participation that is regarded, alternatively, as a burden or potential benefit to subjects. Concerns about informed consent in mental health treatment and research touch upon all of these issues.

Informed Consent in Mental Healthcare

The dual ethical goals of informed consent are the protection of the welfare and promotion of the autonomy of patients. As a legal doctrine, informed consent guarantees certain rights of patients in determining their treatment. Informed consent's legal history can be traced to the Supreme Court case of Schloendorff v. Society of New York Hospitals (1914), in which Justice Benjamin Cardozo declared that "every human being of adult years and sound mind has a right to determine what shall be done with his body" (Schloendorff, p. 126). The questions of what constitutes a sound mind and the rights of those with unsound minds remain central to discussion of informed consent in the context of mental healthcare.

At the beginning of the twentieth century, in the earliest stage of what would become the informed consent doctrine, battery provided the legal theory for a cause of action; physicians were required to obtain consent to invasive treatment (Katz). Informed consent's second stage was marked by increasing judicial pressure for consent to be not only free, but also informed; physicians were to disclose treatment alternatives and the risks of the proposed treatment, and then to obtain consent. Still, the California court in Salgo v. Leland Stanford Junior University Board of Trustees (1957), which ushered in this second stage, failed to articulate precisely the type of information that was required by this duty to disclose. The decision in Canterbury v. Spence (1972) initiated the third stage of informed consent doctrine by articulating a patient-oriented standard of disclosure that required physicians to disclose to patients what a reasonable person would find material to making treatment decisions. Since 1972, the literature on informed consent has burgeoned (e.g., Appelbaum, Lidz, and Meisel; Berg, Appelbaum, and Lidz; Faden and Beauchamp; Meisel, Roth, and Lidz).

Informed consent serves to protect individual autonomy, respect the patient's status as a human being, avoid fraud or duress, encourage doctors to carefully consider their treatment decisions, foster rational decision making by the patient, and involve the public in medicine (Capron). The law of informed consent is based on guaranteeing patients the right to receive sufficient information to make informed choices about treatment, and the right to accept or decline the physician's recommendations. As a process, informed consent involves active exchange of information between patient and physician. Elements fundamental to this process are disclosure of the risks and potential benefit of treatment options (or of participation in a research protocol), comprehension by the patient (or subject) of such information, competence of the decision maker, voluntariness of the decision, and the consent (or refusal) itself (Beauchamp and Childress). Competence and voluntariness have special import in the mental health context.

COMPETENCE. Determination of competence functions as a gatekeeping mechanism for informed consent in any healthcare context, because a decision maker's competence is a prerequisite for being able to give informed consent and thus have his/her treatment preferences or decisions respected. In bioethical analyses, competence pertains to a specific task (e.g., making a particular decision); it is not a general quality of persons (Buchanan and Brock). Conceived as decision-relative, competence is a variable or sliding-scale standard; in other words, the greater the degree of risk to patient welfare associated with a particular decision(e.g., to refuse likely life-saving treatment), the higher the standard of competence required of the patient choosing that option (Buchanan and Brock). Nevertheless, determination of competence is based on evaluation of the patient's process of decision making, not the acceptability or reasonability of its outcome. The capacities requisite for competent decision making are the ability to understand and appreciate the risks and benefits of treatment options, the ability to reason and deliberate about those options, and the ability to weigh options against a relatively stable set of values (Buchanan and Brock).

The difference between competence and capacity can be confusing, and the terms are often used interchangeably (Wolpe, Moreno, and Caplan). Medical or mental health professionals determine patient capacity, whereas incompetence is a legal construct, a legal determination that a patient is incapable of making decisions. The standards for determining incompetence are vague given the lack of judicial consensus. Although courts are available to make the determination, it is typically made by the attending physician. Whether the final determination of incompetence must be made by a court or in the clinical setting with judicial consideration remains unsettled (Berg, et al.; Berg and Appelbaum). Despite attempts to establish standardized means for assessing decisional capacity and competence, in clinical practice such judgments are still highly dependent on individual psychiatric evaluations (and attending physicians' judgments). Competence assessment remains difficult, especially when a patient's decision seems contrary to his/her ostensible best interests.

In mental health contexts, competence determinations may be especially complicated. Although an ethical, legal, and medical consensus now exists that a competent adult's voluntary informed choices must be respected in the course of treatment and research, it is not entirely clear how to proceed when a person's decision-making capacity may be compromised by mental illness. Historically there has been an erroneous presumption that mental illness obviates the patient's ability to make competent decisions and that either professional paternalism or surrogate decision making is therefore warranted. While some mental disorders may impair the cognitive faculties upon which the capacities for competent decision making rest, a blanket generalization regarding such an adverse effect of mental illness on decisionmaking capacity is unwarranted. A person with Alzheimer's disease or late life dementia, for example, may be incapable of making some decisions at some times, but at other times may ably comprehend information and weigh options; a patient with bipolar disorder may be quite capable of decision making while medication controls his/her illness, but be incapable if such medication becomes inadequately adjusted to control symptoms of depression or mania. In reality, many people with mental illness may be competent to make medical decisions at least much of the time (Buchanan and Brock; NBAC).

Responses to patient incompetence—specifically, decision making by a surrogate (or proxy) or by a court—serve as an exception to the usual process of informed consent. Nevertheless, surrogate decision making pursues the dual ethical goals of informed consent: the promotion of patient autonomy and protection of patient welfare. Customarily, the surrogate decision-making process involves obtaining informed consent for treatment (or its refusal) from a surrogate named by the patient in an advance directive, or in the absence of such a directive, by the patients' family members. In the absence of such family members, or in the case of irresoluble conflict among them, courts may appoint a guardian to make healthcare decisions on behalf of an incompetent patient. Advance directives for psychiatric treatment allow for a currently competent person to make plans for a future period during which he/she may lose decisionmaking capacity due to mental illness. These advance directives may include choices about treatment (including electroconvulsive therapy and emergency interventions), medications, hospitalization, research participation (discussed below), and, through the vehicle of a durable power of attorney, the appointment of a surrogate decision maker. Persons who have reason to think they may lose decisional capacity or be subject to involuntary psychiatric commitment may complete such advance directives to guide their psychiatric care and even to help arrange such necessities as temporary custody for their children.

VOLUNTARINESS. In order to constitute an informed consent (or refusal), a competent patient's decision must be both informed and voluntary. Legal discussions of conditions that would impugn the voluntariness, and thus validity, of informed consent focus on undue pressures, threats, and coercion imposed by external factors. However, the medical setting is replete with pressures stemming from the experience of illness (e.g., pain, discomfort, and fear), as well as physicians' recommendations and family dynamics. These situational factors may be especially intense in mental health settings, especially inpatient psychiatric settings, and their effect on the voluntariness of patient decision making must be examined. Philosophical accounts of voluntariness differ, but for the purposes of the informed consent process, a decision is considered voluntary if it is made in the absence of substantially controlling influences (Faden and Beauchamp).

The practice of involuntary psychiatric commitment presents a unique challenge to the doctrine of informed consent, as it entails involuntary hospital admission, while consent to admission is usually sought in other (at least, nonemergency) contexts. The ethical and legal justification of the practice of involuntary commitment resides in balancing the patient's right of self-determination, the patient's wellbeing, and the protection of third parties from harm. Although statutes may differ, most states permit at least temporary involuntary commitment when there is reason to believe that a patient poses a danger to him/herself or to others, or is unable to take care of him/herself as a result of profound mental illness.

Historically, the involuntary commitment and treatment of mentally ill patients was an exception to the theory of informed consent (Appelbaum). Prior to the 1960s, involuntary commitment to psychiatric facilities on the basis of a mental disorder was considered ipso facto a determination of mental incompetence. As the grounds for psychiatric commitment evolved in the 1960 and 1970s from criteria based on the perceived need for treatment to criteria based on perceived dangerousness to self or others, the grounds for commitment came to be distinguished from the justification for treatment. Judicial scrutiny of involuntary hospitalization has led to the widespread opinion that institutionalization is not always in the service of treatment, that it is certainly not equivalent to a determination of incompetence, and that therefore at least some involuntarily committed patients have the right to refuse treatment (Berg, et al.). In short, some individuals who meet criteria for involuntary commitment—to prevent harm to themselves or others— may nevertheless be competent to refuse (or consent to) treatment for their symptoms and/or underlying condition. Even if competent to refuse treatment, however, involuntarily committed patients may feel substantial pressure to agree to the recommendations of healthcare providers. The context of their treatment may unduly pressure them to consent in the (sometimes accurate) belief that only by agreeing to and undergoing treatment will they be permitted to leave and remain outside the institution. Further complicating this issue is the fact that some courts recognize a state interest in reducing the danger a patient poses to others and in restoring a patient sufficiently to warrant his/her discharge from the hospital. In some jurisdictions, then, treatment may be imposed without the patient's consent, although some jurisdictions at least require legal review of the medical appropriateness of the proposed intervention or the patient's competence, or both (Berg, et al.).

Informed Consent for Research in the Mental Health Context

Reflecting the Belmont Report's 1979 articulation of the ethical principles underlying research ethics and human subjects' protections, as well as provisions of the Nuremberg Code (1947) and the Declaration of Helsinki (1964, subsequently revised), federal regulations governing federallyfunded research with human subjects consistently give priority to research subjects' rights and welfare over the pursuit of scientific and social interests (Title 45, Code of Federal Regulations). Informed consent's goal of welfare protection assumes prominence in research, because the right to refuse participation functions as an ultimate line of (self-) protection, in concert with other human subjects protections, or in the event that other protections prove inadequate. "Legally effective informed consent" is required of all research subjects (or their legally authorized representatives [LAR]).

Eight informational elements must be disclosed: a statement that the study involves research, as well as a description of the research and its purposes; a description of reasonably foreseeable risks; a description of reasonably expected benefits; disclosure of appropriate alternatives; a statement about maintenance of confidentiality; for research involving more than minimal risks, an explanation about possible compensation if injury occurs; information about how the subject can have pertinent questions answered; and a statement that participation is voluntary (i.e., the refusal to participate involves no penalties or loss of benefits). Subjects should also be given information regarding: unforeseeable risks; circumstances under which the subject's participation will be terminated; additional costs that the subject may incur; the consequences of a subject's decision to withdraw; the dissemination of findings developed during the study that relate to a subject's willingness to continue; and the approximate number of total subjects (Berg, at al.; Title 45, Code of Federal Regulations). Because the consent must be in writing, there has been a tendency to equate giving informed consent with signing a consent form; in reality, informed consent is a legally-mandated process that is merely documented by signing the consent form. During the informed consent process, care must be taken to prevent the therapeutic misconception (Appelbaum, Roth, and Lidz) or institutional and psychosocial factors from undermining subjects' understanding and voluntariness.

One of Belmont Report's principles is that individuals should be respected as autonomous agents and that those with diminished autonomy should be afforded additional protection in research. Mental health research is conducted on a diverse range of mental health conditions, and only some of these conditions diminish autonomy by impairing the decision-making capacity requisite for the informed consent process.

Guidelines that have been developed to protect mentally or cognitively impaired research participants—whether in mental health research projects or not—are relevant for understanding aspects of informed consent in mental health research. Simultaneously, the conflation of mental illness or impairment with incapacity or incompetence must be avoided, not only for conceptual clarity and ethical appropriateness, but also to avoid further stigmatizing those with mental illness. Indeed the 1998 report of the National Bioethics Advisory Commission (NBAC), "Research Involving Subjects with Mental Disorders That May Affect Decision-Making Capacity" has been criticized for perhaps perpetuating discriminatory attitudes by focusing on persons with mental disorders rather than selecting all incapacitated persons as the focus of concern (Oldham, Haimowitz, and Delano, 1999a).

Perhaps recognizing that special protections may themselves be stigmatizing, the Federal Code or "Common Rule" does not identify the mentally ill as a vulnerable group in need of such protections. Special guidelines do address research with children (considered a vulnerable group) and on substance abuse (Office for Protection From Research Risks). As part of the informed consent process, researchers must be prepared to address, perhaps with federal certificates of confidentiality (Title 42, Code of Federal Regulations), and at least in disclosure of the psychosocial and economic risks of participation (McEnvoy and Keefe), the stigma that attaches to mental illness and to substance abuse (Gorelick, Rickens, and Bonkovsky). Because substance abuse and mental illness may impugn both decisional capacity and behavior control (and thus voluntariness), researchers may need to turn to surrogate decision makers in the consent process. Further, researchers must be cognizant that parents of children with mental disorders are also frequently stigmatized (Jensen, Fisher, and Hoagwood).

Thus, informed consent for mental health research is complicated, first, by the need to determine when mental illness or impairment renders patients incapable of giving informed consent (or refusal) and when it does not; second, by the institutional contexts of much psychiatric research and the myriad pressures that may impugn the voluntariness of such decisions; third, by the need for research to develop effective treatment for mental illness to alleviate the suffering it causes; and finally, by the difficulty that surrogates might have in appreciating the situation of those with mental illness so that they may decide as prospective subjects would if they were competent to do so.

Recognizing that some research potentially benefiting the mentally infirm cannot be conducted with any other group, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, created in 1974, sought ethical means to include in research subjects incapable of giving consent. In two reports (1977 and 1978), the Commission recommended that research involving children and the institutionalized mentally infirm be placed in three categories according to level of risk presented: minimal risk, minor increase over minimal risk, and more than a minor increase. Contrary to provisions in both the Nuremberg Code and the Declaration of Helsinki, the Commission concluded that subjects incapable of giving informed consent could be enrolled in both studies that offered the potential of direct benefit and studies that did not offer such a prospect, so long as the burdens and risks of participation did not exceed a certain level. Also proposed were provisions for incapable participants to assent or object to study participation (i.e., to say "yes" or "no" when asked about willingness to participate); such a recommendation is in keeping with the current Council for International Organizations of Medical Sciences (CIOMS) comment that incapable subjects' objections to participation must be respected except in the rarest instance involving direct therapeutic benefit to the subject and the absence of alternative therapy. The Commission also recommended that institutional review boards (IRBs) appoint an auditor to assure the adequacy of the consent process for research involving more than minimal risk, and that informed consent be obtained from the incompetent patient's legal guardian, which parallels provisions of the current version of the Declaration of Helsinki. While a substantial number of the Commission's recommendations regarding research with children were adopted as part of the Common Rule, due to a lack of consensus and concerns about auditing the informed consent process, its recommendations regarding the mentally infirm were not adopted.

Concerns about review and audit of research also plagued reception of the 1998 NBAC report, including its recommendations that a qualified expert "independent of the research team" assess subjects' decision-making capacity and that an "independent consent auditor" observe and approve the informed consent process with decisionallyimpaired subjects. Most contentious, however, was the NBAC's proposed categorization of research based on risk levels, coupled with its recommendation that a Special Standing Panel (SSP) be created at the Department of Health and Human Services to which IRBs could submit some protocols for prospective review and authorization.

NBAC proposed adhering to a two-tier categorization of risks for research involving decisionally-incapacitated subjects: (1) minimal risk and (2) greater than minimal risk. NBAC recommended that IRBs approve protocols involving minimal risk, or greater than minimal risk that is potentially beneficial to the subject, only if the subject gives informed consent, or has given prospective authorization and his/her LAR also gives permission, or if the subject's LAR gives permission, and if there is no dissent by the subject. (IRBs may also waive the consent requirement for some minimal risk protocols.) LARs are to make decisions about participation based on "a best estimation of what the subject would have chosen if capable of making a decision," and must monitor the subject's participation to make decisions about continuing or withdrawing from participation. Patients with mental illness or with other conditions that may at some time(s) impair their decision-making capacities may execute research advance directives giving prospective authorization to research participation and naming a LAR (Sunderland and Dukoff). Prospective authorization cannot be a blanket authorization and must be limited to specific classes of research about which the (then capable) subject understood the relevant risks, potential benefits, and other conditions (NBAC). The degree of specificity of the prior prospective authorization must increase as the risk presented by a particular protocol increases. For research presenting greater than minimal risk and not holding out the prospect of direct medical benefit, NBAC recommended that IRBs approve such protocols under the same conditions, or if the protocol is approved by the SSP or falls within its guidelines and the potential subject's LAR gives permission for participation. This final provision drew criticism from two sides.

Recognizing that research involving greater than minimal risk and not presenting the prospect of direct benefit to subjects may nevertheless promise "significant increases in understanding their conditions," and thus warrant further review, the NBAC envisioned that IRBs could refer such protocols to a SSP for case-by-case review through an open consensus process with the prospect that, over time, guidelines for conducting such research would emerge. NBAC viewed its recommendations as consistent with the two-tier risk-level scheme found in the majority of the Common Rule (and the National Institutes of Health Clinical Center Policy on the Consent Process in Research Involving Impaired Human Subjects), and stated that the SSP could evaluate research protocols that could not be approved otherwise under provisions of its 1998 report while providing patients, their families, and advocates with confidence that such protocols were receiving independent review (NBAC).

Some critics, however, argue that the NBAC's approach would greatly hamper valuable moderate-risk research that would otherwise be categorized as minor increase over minimal risk research (Miller and Fins; Oldham, et al., 1999a, 1999b). They argue that if federal regulations result from the NBAC recommendations, relatively low-risk research, including routine medical procedures such as positron emission tomographic scans and magnetic resonance imaging with sedation, would be subject to the same restrictions as research that is categorized at the highest level of risk (such as internal organ biopsies). In a statement appended to the NBAC report, similar concerns are voiced by two NBAC commissioners (Lo and Flynn). Some of these critics advocate a tri-level risk classification including an intermediary category of research presenting "a minor increase over minimal risk" derived from the National Commission's 1978 report and the Common Rule's regulations governing research involving children (Miller and Fins). Responding to these concerns, NBAC commissioners suggest that a SSP would only review those protocols involving persons incapable of giving informed consent and who have not provided advanced authorization (Childress and Shapiro). Yet, argue John M. Oldham and his coauthors, the number of protocols involving low-risk procedures that would require SSP review would be large, given the infrequency of advance directives for research and the inclusion of so many different protocols based upon the two-tier categorization of risk (1999b).

Although the majority of concerns expressed about the NBAC's recommendations take issue with allegedly unnecessary and cumbersome layers of oversight for research involving subjects with impaired capacity, a second line of criticism urges the opposite. Beverly Woodward argues that human research subjects are now threatened by increased research-related risks as a result of pressures to reduce restrictions on research involving subjects with impaired decision-making capacity. She charges that by downplaying the conflict between the progress of science and the protection of human subjects, and in departing from protections afforded by the Nuremberg Code and the Declaration of Helsinki to those who cannot give informed consent, the NBAC has endorsed the primacy of scientific interests over human subject welfare. Woodward finds particularly troubling NBAC's recommendation that would "permit a waiver of the consent requirement for research involving greater than minimal risk" that is without the prospect of direct benefit, so long as the subject's surrogate consents and the SSP also "grants permission based on a finding that the research 'offers the possibility of substantial benefit to the population under study'" and that the risks presented to subjects are commensurate with this possible benefit (p.1948). Woodward believes that in some of the NBAC's recommendations, the "rapid march of science" is being advanced over the interests of individual research subjects, which, if true, would constitute a serious departure from the consensus that has grounded research ethics and the requirements for informed consent in research since the Nuremburg Code. Much remains to be examined—both at the level of drafting regulations and at the point of their implementation—to determine whether any such shift is indeed occurring.

alan p. brown

troyen a. brennan (1995)

revised by lisa s. parker

kamran samakar

SEE ALSO: Autonomy; Competence; Institutionalization and Deinstitutionalization; Mental Health Services; Mental Health Therapies; Mentally Disabled and Mentally Ill Persons;Patients' Rights: Mental Patients' Rights; and other Informed Consent subentries


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Informed Consent: VI. Issues of Consent in Mental Healthcare

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