Informed consent is a pre-requisite to diagnosis or treatment in both medical and mental health settings. Indeed, most mental health ethics codes, e.g., American Psychological Association Ethical Principles of Psychologists and Code of Conduct (American Psychological Association, 2002),1 specify that clients must provide informed consent before engaging in therapy, assessment, or research. By administrative rule, the Texas State Board of Examiners of Psychologists requires written informed consent prior to initiation of services (TSBEP Rule 465.11). Likewise the Texas Medical Board make it a violation of the guidelines to fail to obtain a patient’s consent “before performing tests, treatments, or procedures.” (Texas Medical Board Rule 190.8(1)(I). Regardless of these rules, some Texas mental health and medical professionals overlook the importance of informed consent in their daily practice, subjecting themselves to civil damages under a ‘negligence’ theory for “failing to disclose the risks or hazards that could have influenced a reasonable person in making a decision to give or withhold consent.”2

There are some groups for whom providing informed consent is especially problematic, including children and persons with medical, neurological, and psychiatric conditions that might compromise the capacity to provide informed consent. For this article, we will provide a review of the basics of informed consent and its relationship to the construct of capacity and competence. This will be followed by a discussion of medical and psychiatric populations which may have compromised capacity to provide consent. Finally, we suggest several recommendations to improve the informed consent process. This information will help guide practicing attorneys who work with or hire mental health and medical practitioners regarding when to raise the issue of capacity and recommendations on how to handle cases in which the person may be incapable of providing informed consent.

At its core, informed consent is the duty to disclose the risks, benefits, and alternatives of taking part in psychological treatment or research. Thus, informed consent is more of a process of disclosure than a list of specific contents. Informed consent implies that the individual autonomously decides to participate in treatment or research.3 Autonomy, a cardinal ethical principle underlying informed consent, requires full disclosure from medical care providers and understanding from the prospective patient. Consequently, autonomy requires that individuals apply uncoerced and well-informed decision-making in the process. Insofar as these conditions are met, professionals may be confident that they can initiate treatment in an ethically sound manner; otherwise treatment may be considered coercive, exploitative, or unethical. Consent for medical or surgical procedures is especially important given the severity of harm that may be involved if the process is not completely understood. For the most part, informed consent is obtained before any psychological or medical service is initiated with only limited exceptions. For example, American Psychological Association allows psychologists to forego informed consent in three situations: 1) where testing is mandated by law or governmental regulations, 2) where consent is implied such as routine educational, institutional, or organizational activity, and 3) situations involving decisional capacity. Similar exclusions apply to participation in research activities (American Psychological Association Ethical Principles of Psychologists and Code of Conduct 9.03(a).

One question that attorneys might ask is whether the person has the capacity to provide informed consent and ultimately whether they are competent to make various medical, financial, or personal decisions. The terms capacity and competence can be easily confused, but they each represent different domains in the informed consent process. Adults are presumed competent, and the burden of proving otherwise rests upon those who would overturn the decisions of the individual.4 Competence is decided by the courts; judgments regarding capacity to make treatment decisions are clinical opinions.5 As noted by Marson,6 competence to make treatment decisions is a legal concept, decided by a court. Capacity to make a treatment decision is evaluated by a clinician who will rely on the patient’s mental status, cognitive abilities, and symptom severity. Also, capacity and competence are not universal and static, but are situationally determined states. Ethics and law view individuals as being capable of making decisions for particular purposes.7 Capacity will vary with the demands of the situation and can change over time. For instance, a person could be competent to execute financial decisions but incompetent to make treatment decisions. Additionally, a medically-ill patient with compromised mental status may be incompetent to make a treatment decision. After recovering from their illness, however, the patient’s mental status may return to normal, thereby returning the capacity to make treatment decisions. Ultimately, the clinician makes an informed decision based upon a formal evaluation of a person’s capacity, but it is wise for attorneys to become familiar with standards of practice in this area. The clinician’s opinion is then used to inform the court’s judgment about specific areas of competence.

In most treatment situations, the clinician provides the client with a written informed consent document that describes the professional’s scope of practice, limits of confidentiality, fees, and legal standards that define the professional relationship. The proposed patient is generally asked to read this document, understand its contents, and then make an informed decision. Usually the consent form is signed to document an acceptance of its conditions. Deciding whether or not to embark upon a particular course of treatment rests upon a person’s ability to process and utilize this information.

Researchers have found that decisional capacity is comprised of four primary parts. Namely, the individual must be able to 1) express a treatment choice, 2) appreciate the personal consequences of their choice, 3) make a rational decision concerning treatment, and 4) understand the treatment, its risks, and benefits.8 Among these four requirements, capacity to express a treatment choice is perhaps the most basic requirement of competent decision-making. It is also readily observable and easily tested (yes or no decision). Appreciation of consequences concerns validity of the patient’s beliefs about their illness and proposed treatment choices. Individuals who fail to appreciate their condition may deny illness or show little insight concerning their symptoms. They may also hold irrational beliefs concerning treatment efficacy, mechanisms, or consequences.  Regarding the reasoning requirement, individuals must demonstrate logical processes in making a treatment decision. To do so, they must attend to their choice, evaluate their treatment options, imagine the consequences of their choices, assess the likelihood of various potential outcomes, and deliberate upon these issues. The understanding criterion requires that a person receive, remember, and comprehend information regarding treatment. Each of these four capacities may be diminished by cognitive impairment or emotional duress, thereby rendering an individual unable to demonstrate appropriate decision-making capacity.9

Research using both normal participants and individuals with medical and psychiatric conditions has revealed some problems in obtaining competent informed consent from patients. Generally, individuals with intact mental faculties are assumed able to make reasoned and informed decisions to participate. Although this presumption is intuitively appealing, it has been tested only recently. Notably, among medical patients, few are able to recall details of proposed medical procedures, even shortly after consenting to treatment. For instance, among a sample of 55 men undergoing prostate surgery, only 18% could recall risks of the procedure after consenting to treatment.10 Patients awaiting surgery recall only 35-40% of information concerning their treatment.11 Also, about 69% out of 265 patients about to undergo surgery admitted that they had not read the consent form before signing it.12  Although these cognitively-intact patients were probably able to make a competent decision, they seemingly failed to weigh carefully the information provided to them. As such, even if they made poor choices, they would not be considered incompetent of making decisions.

Such considerations notwithstanding, individuals with brain damage are more apt to have significant difficulties understanding, attending to, or exercising good judgment when making complex decisions; consequently, they may make poor choices. Indeed, a growing literature suggests that a person’s level of cognitive functioning is a key determinant in their capacity to provide informed consent. In particular, across several diseases, clinically impaired abstract reasoning, attention, and memory skills correspond with a patient’s incapacity to understand, reason, appreciate, or express a choice regarding medical decisions. For instance, cognitive deficits have predicted an incapacity to make good medical treatment decisions in people with schizophrenia13, HIV infection14, major depression15, multiple sclerosis16, and both cortical17 (Alzheimer’s disease) and subcortical dementias18 (Parkinson’s disease). Specifically, in people with dementing illnesses such as Alzheimer’s disease, studies estimate that as many as 60–70% are incapable of providing informed consent. This compares to about 20% of persons with schizophrenia, 12% for persons with depression, and 4% for those persons with HIV infection19.

These findings suggest that patients with diseases affecting the brain are at increased risk of making poor medical decisions and attorneys have every right to ask questions about the consent process with these groups. Clinicians who fail to appreciate this fact may be liable to accusations of unethical practice, patient exploitation, or disregard for the rights of their clients.

For attorneys who are involved with mental health or medical practitioners, we would like to emphasize the following points. First, regardless of whether the person is at risk of making an incompetent treatment decision, we recommend prospective patients receive treatment information in writing that contains simple, understandable language and words. For instance, materials should be written so that someone with a fifth or sixth grade reading level can comprehend them. Practically, an attorney could ask to see the person’s consent form in order to review its content and language.

In terms of understanding, elaborating upon the material with an oral explanation will enhance the person’s comprehension, as would encouraging and answering questions in a deliberate and patient manner20. In persons who are at risk of making incompetent treatment decisions, some investigators present treatment information repeatedly, and patient understanding, appreciation, and reasoning of the material is assessed with each presentation. This is done until the patient shows an understanding of the treatment details21. Other investigators use cued patient recall of treatment details and correct erroneous beliefs22. This facilitates autonomous and capable medical decision-making in people with diseases affecting the brain. Other investigations have provided medical treatment information in provocative or entertaining ways (i.e., videos, colorful slide shows), thereby enhancing the person’s ability to attend and remember the information23. Regardless of what is done, if questions arise in the area of capacity, the professional should document their concerns, observations, and remedies used in the consent process. Thus, attorney may want to pay close attention to the informed consent document itself and the procedure used to ensuring the patient’s understanding.

More seriously, if a person has known or suspected cognitive impairment which may lead to incompetent medical decisions, a formal examination of decisional capacity should be conducted. Attorneys who are involved in these types of cases can make a formal examination request or refer the person to a practitioner who specializes in capacity assessment. Guiding this area, according to the National Bioethics Advisory Commission, all patients with compromised neurobehavioral status should undergo a formal assessment of decision-making capacity before participating in medical research protocols deemed “more than minimal risk”24. By extension, medical treatments, especially those with potential risk, warrant a formal competency examination. Remember that competency, rather than incompetency, is presumed with the burden of proving that a person is incapable of making competent medical decisions resting upon the clinician.

Attorneys would benefit from being familiar with instruments used to assess decisional-capacity. In particular, the MacArthur Competency Assessment Tool-Treatment (MacCAT-T) facilitates the examinations of medical decision-making capacity. The MacCAT-T is a semi-structured interview where details concerning the person’s medical illness and treatment options are explained and the risks and benefits of potential treatment options described. After this material is provided, the patient is asked prescribed questions to assess their understanding, reasoning, and appreciation of the treatment information. Responses are scored according to established criteria, and the clinician judges whether there are indications of decisional incapacity.

If the person is judged as lacking capacity, then the clinician faces several choices. The clinician may attempt to repeat treatment-related information and erroneous beliefs corrected. The MacCAT-T could then be repeated, and the patient’s capacity reassessed. There is evidence that such repetition and correction can improve decisional capacity in patients with cognitive impairment. Ultimately, if the patient remains incapable of making a competent decision, the clinician may forgo treatment or pursue some form of substituted consent. In doing so, the patient’s assent to treatment will be considered. Ultimately, these considerations will increase the likelihood that vulnerable patients are protected and treated in an ethical and compassionate manner.

Dennis R. Combs, Ph.D., is a professor in the Department of Psychology at the University of Texas at Tyler.
Michael R. Basso, Ph.D., is a professor in the Department of Psychology at the  University of Tulsa

 

Endnotes

1. American Psychological Association (2002). American Psychological Association Ethical Principles of Psychologists and Code of Conduct. Washington, D.C.: American Psychological Association. 2. TEX. CIV. PRAC. & REM. CODE ANN. § 74.101. 3. Berg, J. W. (1996). Legal and ethical complexities of consent with cognitively impaired research subjects: Proposed guidelines. Journal of Law, Medicine, & Ethics, 24, 18-35. 14. 4. Berg, J. W. (1996). Legal and ethical complexities of consent with cognitively impaired research subjects: Proposed guidelines. Journal of Law, Medicine, & Ethics, 24, 18-35. 14; Grisso, T., & Appelbaum, P. S. (1998). Assessing competence to consent to treatment: A guide for physicians and other health professionals. New York: Oxford University Press.; Department of Health and Human Services (1981).  Final regulations amending basic HHS policy for the protection of human research subjects. Federal Register, 46, 8366-8391 (codified as 45 C.F.R. pt. 46). 16 1. 5. Grisso, T., & Appelbaum, P. S. (1998). Assessing competence to consent to treatment: A guide for physicians and other health professionals. New York: Oxford University Press. 1. 6. Marson, D. C. (2001). Loss of competency in Alzheimer’s disease: Conceptual and psychometric approaches. International Journal of Law and Psychiatry, 24, 267-283. 7. Grisso, T., & Appelbaum, P. S. (1998). Assessing competence to consent to treatment: A guide for physicians and other health professionals. New York: Oxford University Press. 1. 8. Appelbaum, P. S., & Grisso, T. (1995). The MacArthur treatment competence study I: Mental illness and competence to consent to treatment. Law and Human Behavior, 19, 105-126; Appelbaum, P., Lidz, C., & Meisel, A. (1987). Informed consent: Legal theory and clinical practice. New York: Oxford; Grisso, T., Appelbaum, P. S., Mulvey, E. P., & Fletcher, K. (1995). The MacArthur Treatment Competence Study II. Law and Human Behavior, 19, 127-149. 9. Appelbaum, P. S., & Grisso, T. (1995). The MacArthur treatment competence study I: Mental illness and competence to consent to treatment. Law and Human Behavior, 19, 105-126; Grisso, T., & Appelbaum, P. S. (1998). Assessing competence to consent to treatment: A guide for physicians and other health professionals. New York: Oxford University Press. 1; Marson, D. C. (2001). Loss of competency in Alzheimer’s disease: Conceptual and psychometric approaches. International Journal of Law and Psychiatry, 24, 267-283; Marson, D. C., Ingram, K. K., Cody, H. A., & Harrell, L. E. (1995). Assessing the competency of patients with Alzheimer’s disease under different legal standards: A prototype instrument. Archives of Neurology, 52, 949-954; Marson, D. C., Schmitt, F. A., Ingram, K. K., & Harrell, L. E. (1994). Determining the competency of Alzheimer patients to consent to treatment and research. Alzheimer Disease and Associated Disorders, 8 (S4), 5-18. 10. Saw, K. C., Wood, A. 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R., Bartko, J. J., Kovnick, J., & Appelbaum, P. S. (2000). Decisional capacity for informed consent in schizophrenia research. Archives of General Psychiatry, 57, 533-538. 14. Moser, D., Schultz, S., Arndt, S., Benjamin, M., Fleming, F., Brems, C., et al. (2002). Capacity to provide informed consent for participation in schizophrenia and HIV research. American Journal of Psychiatry, 159, 1201-1208. 15. Appelbaum, P. S., Grisso, T., Frank, E., O’Donnell, S. & Kupfer, D. J. (1999). Competence of depressed patients for consent to research. American Journal of Psychiatry, 156, 1380-1384. 16. Basso, M. R., Ward, T., Shields, R., Shields, I., Candilis, P., Tracy, V., Combs, D., Nelson, A., Johnson, J., & Arnett, P. (2008). Informed Consent Capacity in Multiple Sclerosis: Some Improvement and Some Residual Incapacity.  Paper presented at the annual convention of the International Neuropsychological Society, Kona, Hawaii 17. Marson, D. C., Annis, S. M., McInturff, B., Bartolucci, A., & Harrell, L. E. (1999). Error behaviors associated with loss of competency in Alzheimer's disease. Neurology, 53, 1983-1992; Marson, D. C., Chatterjee, A., Ingram, K. K., & Harrell, L. E. (1996). Toward a neurologic model of competency: Cognitive predictors of capacity to consent in Alzheimer’s disease using three different legal standards. Neurology, 46, 666-672;Kim, S. Y. H., Caine, E. D., Currier, G. W., Leibovici, A., & Ryan, J. M. (2001). Assessing the competence of persons with Alzheimer’s disease in providing informed consent for participation in research. American Journal of Psychiatry, 158, 712-717. 18. Dymek, M. P., Atchison, P., Harrell, L., & Marson, D. C. (2001). Competency to consent to medical treatment in cognitively impaired patients with Parkinson’s disease. Neurology, 56, 17-24. 19. Moser, D., Schultz, S., Arndt, S., Benjamin, M., Fleming, F., Brems, C., et al. (2002). Capacity to provide informed consent for participation in schizophrenia and HIV research. American Journal of Psychiatry, 159, 1201-1208. 20. Carpenter, W. T., Gold, J. M., Lahti, A. C., Queern, C. A., Conley, R. R., Bartko, J. J., Kovnick, J., & Appelbaum, P. S. (2000). Decisional capacity for informed consent in schizophrenia research. Archives of General Psychiatry, 57, 533-538.; Dunn, L. B., & Jeste, D. V. (2001). Enhancing informed consent for research and treatment. Neuropsychopharmacology, 24, 595-607; Jensen, A. B., Madsen, B., Andersen, P., & Rose, C. (1993). Information for cancer patients entering a clinical trial—an evaluation of an information strategy. European Journal of Cancer, 29, 2235-2238. 21. Carpenter, W. T., Gold, J. M., Lahti, A. C., Queern, C. A., Conley, R. R., Bartko, J. J., Kovnick, J., & Appelbaum, P. S. (2000). Decisional capacity for informed consent in schizophrenia research. Archives of General Psychiatry, 57, 533-538. 22. Basso, M. R., Ward, T., Shields, R., Shields, I., Candilis, P., Tracy, V., Combs, D., Nelson, A., Johnson, J., & Arnett, P. (2008). Informed Consent Capacity in Multiple Sclerosis: Some Improvement and Some Residual Incapacity.  Paper presented at the annual convention of the International Neuropsychological Society, Kona, Hawaii.; Combs, D.R., Adams, S., Wood, T., Basso, M.R., & Gouvier, W.D. (2005). Informed consent in schizophrenia: The importance of cues on understanding. Schizophrenia Research, 77(1), 59-63.  23. Dunn, L. B., & Jeste, D. V. (2001). Enhancing informed consent for research and treatment. Neuropsychopharmacology, 24, 595-607 24. National Bioethics Advisory Commission (1998). Research Involving Persons with Mental Disorders That May Affect Decision Making Capacity. Washington D.C.: U.S. Government.