Psychiatry and Clinical Neurosciences 2015; 69:

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1 Psychiatry and Clinical Neurosciences 2015; 69: doi: /pcn Review Article Informed consent procedures with cognitively impaired patients: A review of ethics and best practices Lindy Marie Fields, MA* and James Douglas Calvert, PhD, MSCP Department of Psychology, Southern Methodist University, Dallas, USA Aims: The objectives of this article are to discuss ethical issues of informed consent in cognitively impaired patients and review considerations for capacity determination. We will also discuss how to evaluate capacity, determine competence, and obtain informed consent when a patient is deemed incompetent. This review emphasizes how to carry out informed consent procedures when capacity is questionable and discusses measures supported for use when determining cognitively impaired patients ability to consent. Methods: Information was gathered from medical and psychological codes of ethics, peer-reviewed journals, published guidelines from health-care organizations (e.g., American Medical Association), and scholarly books. Google Scholar and PsycINFO were searched for articles related to informed consent and cognitive impairment published in English between 1975 and Relevant sources referenced in retrieved publications were subsequently searched and reviewed. Results: We selected 49 sources generated by our search. Sources were included in our review if they presented information related to at least one of our focus areas. These areas included: review of informed consent ethics and procedures, review of cognitive impairment evaluations, recommendations for measuring cognitive capacity, and alternative forms of informed consent. Conclusions: Patients cognitive impairments can hinder the ability of patients to understand treatment options. Evaluating the capacity of patients with cognitive impairment to understand treatment options is vital for valid informed consent and should be guided by best practices. Thus, proper identification of patients with questionable capacity, capacity evaluation, and determination of competence, as well as reliance upon appropriate alternative consent procedures, are paramount. Key words: cognition disorders, ethics, informed consent, neuropsychiatry, neuropsychology. INFORMED CONSENT, OR the right of adult patients to decide whether to consent to treatment, is ethically paramount and has become a topic of much discussion among clinicians and researchers. 1 4 The central role informed consent plays in health care is evidenced by multiple ethical codes related to informed consent in the codes of ethics for organizations such as the American Medical Association, 5 American Psychiatric Association, 6 and American *Correspondence: Lindy Marie Fields, MA, Department of Psychology, Southern Methodist University, P.O. Box , Dallas, TX , USA. lloneman@smu.edu Received 26 August 2014; revised 15 December 2014; accepted 6 March Psychological Association. 7 These guidelines specify the ethical standards that must be upheld when informing patients of treatment information and alternatives, including possible risks and benefits, to obtain consent. Westernized informed consent procedures, such as those developed and implemented in the USA, are increasingly being adopted around the globe, as they provide a standardized way of balancing beneficence, medical expertise, and patient autonomy in the decision-making process. 8 The increasing focus on informed consent in health care can be seen in discussions regarding informed consent in the context of various issues. For example, recent publications address topics such as how informed consent relates 462

2 Psychiatry and Clinical Neurosciences 2015; 69: Informed consent review 463 to legal issues in Japan, 9 ethical standards across Europe, 10 and patient autonomy in the USA. 8 Due to the current movement toward implementation of informed consent procedures that are so systematically ingrained in the American health-care system, we generally reference ethical codes, scholarly publications, and legal standards that originated from the USA. These sources form the foundation of the informed consent movement and provide guidance for the implementation and utilization of informed consent procedures in other countries. Therefore, the cultural or national background of our information sources is not pertinent in the present review, as our intent is not to review the state of consent practices throughout the world, but is instead to discuss ethics, guidelines, and recommended best practices for informed consent procedures, regardless of nation or country. Guidelines and standards of obtaining consent continue to evolve and have come a long way since reliance upon simple consent, in which consent was presumed if the patient did not explicitly dissent. 3 Current standards of informed consent address problems inherent in the use of simple consent and traditional methods of medical decision-making, as they emphasize patient education, self-determination, therapeutic alliance, mutual respect, and patient autonomy. 8 However, current ethical guidelines are often too basic for informed consent situations encountered in health-care settings and there is large variability in how these decision-making and consent procedures are carried out, both within and between countries. 8 Further, many clinical guidelines regarding informed consent originated from rigorously controlled research studies aimed to investigate how to most thoroughly and accurately assess patients cognitive ability to give informed consent. Such guidelines are sometimes viewed as too inflexible and timeconsuming, thereby leading to variability across clinical sites in the extent to which they are used in clinical practice. 8,10 This presents a potential ethical dilemma of how closely clinical praxis must follow research recommendations, as it may be in the patient s best interest to utilize informed consent procedures grounded in research recommendations, but that are fine-tuned by clinical judgment (e.g., extent of evaluation) and carried out efficiently and effectively in clinical practice. 8 Given the lack of standardization in clinical praxis 10,11 and the potential dilemmas of melding research recommendations with practical clinical application, comprehensive guidelines for how to evaluate the ability to consent and how to proceed with alternative consent procedures with cognitively impaired patients are needed. Thus, we aim to review ethical dilemmas related to informed consent with patients who may be cognitively impaired, best practices for evaluating whether a patient is able to provide consent, and how to proceed if a patient is deemed unable to consent. We conducted a review of literature regarding cognitive impairment and how it may impact informed consent procedures. Information was gathered from medical and psychological codes of ethics, peer-reviewed journals, published guidelines from health-care organizations (e.g., American Medical Association), and scholarly books. Google Scholar and PsycINFO were searched for articles related to informed consent and cognitive impairment published in English between 1975 and Additionally, we reviewed articles that were referenced within these sources. Ultimately, we selected 49 of these information sources based on their relevancy to our topic. We selected sources based on whether they addressed at least one of our focus areas: review of informed consent procedures, review of cognitive impairment evaluations, recommendations for measuring cognitive ability to consent, and alternative forms of informed consent. The current review synthesizes information from these sources in order to inform considerations and recommendations for obtainment of informed consent with cognitively impaired patients. Though part of a larger discussion of patient rights, informed consent in the context of this review refers to autonomous decision-making related to medical treatments and interventions and, thus, is not intended to discuss right to die or other controversial end-of-life care decisions. First, we will examine the ethical quandaries inherent in obtaining informed consent when working with cognitively impaired patients. Such patients include those who are experiencing a non-reversible, chronic, and progressive cognitive decline (e.g., Alzheimer s) and those who lack the cognitive ability to make informed decisions only temporarily (e.g., medication effects). Though there are numerous causes of cognitive impairment, we will often refer to diagnoses, such as various dementias, as these are common diagnoses in adults. Additionally, some form of cognitive impairment is inherent in dementia, whereas impairment is not always present in other diagnoses that only sometimes lead to impairment (e.g., brain injury, infection). Regardless of

3 464 L. M. Fields and J. D. Calvert Psychiatry and Clinical Neurosciences 2015; 69: etiology, deficits in memory, executive functioning, and attention can have detrimental effects on decision-making abilities The importance of optimizing the consent process with this population is more evident than ever as the number of patients with cognitive impairments (e.g., dementia) continues to increase as the population of individuals over age 65 grows. 15 Thus, providers must be educated in ethical considerations with this population, evaluating and determining competency (legal designation based on professional judgment regarding decisionmaking ability), and obtaining consent when patients lack the cognitive ability to consent. Ethics of informed consent The principle of informed consent rests in the ethical standards of autonomy and self-determination. Effective informed consent includes information disclosure, voluntary choice, and decision-making capacity. 16 Capacity can be defined as the ability to understand and reason through the decision-making process so that a rational choice can be made about whether or not to consent to treatment (see Appendix S1). 2 Clinicians must inform individuals of potential risks and benefits of treatment and patients must be able to ask questions and voice concerns before deciding whether to consent. Such precautions help ensure that patients desires are valued and that competent patients maintain the ability to make their own treatment decisions. 1,3,17,18 Ultimately, the decision of whether to participate in treatment lies with the patient and, in some cases, his or her legal proxies (individuals with legal ability to make treatment decisions for the patient), and providers are ethically required to ensure that adequate informed consent is received. 19,20 Opinions vary regarding what is sufficient informed consent, emphasizing the importance of ongoing evaluation of consent procedures, particularly when working with patients lacking competence. 21 Informed consent is often viewed as a formality and obtained by presenting the patient with a written document, but this approach is ineffective. 22 Informed consent should be an interactive process between providers and those giving consent and not just a one-time event. 3,18,23 There are various components to the process of obtaining sufficient informed consent. Providers must communicate to the patient accurate information and expectations regarding treatment. 3,24,25 Information regarding possible consequences (both direct and indirect) of treatment should also be thoroughly communicated. 18 Proper informed consent requires that the patient understand the information presented and this can be difficult to verify and document, as it requires the patient to receive, remember, and comprehend the information, as well as appreciate the impact of any decision, and communicate the final decision. 1,13,20 Therefore, the patient must be able to orient toward, attend to, and focus on the information, and must be able to understand the meaning of the information and infer consequences of treatment. Patients must also understand they can opt out of treatment at any time. 24 When a patient is competent, understanding can be verified through discussing the patient s decision and reasoning. However, evaluation of whether a cognitively impaired patient is able to understand and consent to treatment becomes difficult and invites more provider involvement. Obtaining informed consent from a cognitively impaired patient begins with an evaluation of cognitive capacity to consent. Consent can only be obtained after it is determined that the patient has the cognitive capacity to consent. If the patient is deemed incompetent to consent, patient assent (a form of simple approval) and consent based on legal proxies or advance directives must be obtained. Patients wishes, consent, and cognitive functioning must be continually assessed throughout treatment. 26 To obtain informed consent, providers must determine whether the patient is competent to make a decision, determined by the patient s decisionmaking capacity. 2 Competency should be viewed as dynamically changing. For example, Marson and colleagues 20,27 reported that people with Alzheimer s and Parkinson s disorders often show progressively decreasing capacity to appreciate the consequences of and make rational decisions about treatment. Additionally, the complexity of the treatment choices (e.g., medication vs surgery) presents further difficulties for these patients decision-making abilities. 28 Therefore, informed consent should be viewed on a continuum where competency and ability to consent are viewed in the context of treatment complexity and risk, 29 as well as patient capacity at the time of consent. 2 Levels of treatment decision complexity Three levels of treatment have been outlined in the Journal of the American Medical Association, where

4 Psychiatry and Clinical Neurosciences 2015; 69: Informed consent review 465 Drane 29 published the President s Commission guidelines for determining competency based on treatment risks and benefits. These three levels differ in the likelihood and seriousness of potential outcomes and can help providers to weigh the autonomy and best interests of the patient in the context of potential outcomes. The first level of treatment complexity refers to treatments that are generally beneficial and carry low risk, or when treatment choices are limited. 29 Often, these treatment decisions must be made quickly, as they are common in hospitals with patients requiring immediate treatment. 3 Here, patient assent and awareness (consciousness) are sufficient for treatment to commence. 29 This lower threshold for competency focuses on the beneficence and the expectation that treatment in such cases is in the patient s best interests. Capacity is not given as much weight at this level, as the costs and benefits are easier to assess and the best interests of the patient require immediate attention. The second level involves riskier treatments or situations for which alternative treatments are available. Here, patients must show capacity in order to give informed consent 29 and must understand that they have a choice to make. 24 Most patient services are provided at this level and this is where ethical dilemmas often arise, so informed consent guidelines are especially applicable at this level. The third level involves decisions in which an individual would see treatment as the only viable option, such as when a decision to forego treatment would likely result in death or negative consequences. 29 Consent is often reasonably assumed because there are no other viable treatment options and treatment is in the patient s best interests. However, it is still possible for patients to refuse treatment, and such decisions can be honored if the individual is deemed competent. 3,29 These three levels of consent emphasize the importance of considering risks and benefits when determining patient competence. They also portray the fluid balancing act of patient autonomy and protection that occurs while obtaining consent. 1,3,29 Ongoing evaluation of capacity Providers should continually document capacity and consent. This is especially important when working with cognitively impaired individuals as they are prone to difficulties understanding treatment options. 3 Ongoing evaluation of capacity and consent allows patients who regain capacity (e.g., recovery from stroke) to make treatment decisions. The importance of ongoing evaluation is evident when considering the context in which treatment decisions are made. Patients and their caretakers are often overwhelmed by psychological distress related to the patient s situation, and this stress may fluctuate over time. Providers must acknowledge the difficulty patients and caretakers experience while making these decisions and allow them to opt out of treatment at any point. 3,24 Obtaining informed consent from cognitively impaired patients presents an ethical dilemma because providers must continuously balance a patient s right to autonomy and self-determination with the need to provide appropriate treatment, especially in the face of evolving medical concerns presented by patients with cognitive impairments. Awareness of this dilemma has prompted the development of consent procedures to address this complex situation. Determining patient competence and capacity to consent is complex. Providers are burdened with the responsibility to evaluate patient capacity (i.e., cognitive ability) to comprehend the situation and make a choice regarding whether to consent. 1,3,20,30 Capacity determination acts as the cornerstone of the legal determination of competence (whether or not one is legally able to make self-determining decisions), and it becomes nearly impossible to separate these concepts. 1,3 Capacity determination includes determining the extent to which a formal capacity assessment must be conducted. 13 It also involves evaluating whether the patient is able to understand treatment information, reason through it, and notify the provider of that decision. 19,30 Cognitively impaired patients may experience difficulty with any of these steps, 20 thus each needs to be assessed adequately. Formal capacity assessment is not necessary for every patient, as capacity evaluations can consume valuable resources and time. Economical efficiency, treatment considerations, and patient characteristics (e.g., diagnosis, age, education, abilities) must be considered. 13 While patient characteristics should be considered, their relations to capacity judgments are not uniform, emphasizing the importance of considering individual differences during capacity evaluations. 3,31

5 466 L. M. Fields and J. D. Calvert Psychiatry and Clinical Neurosciences 2015; 69: Assessing cognitive capacity Cognitively impaired patients may be unable to appropriately make educated treatment decisions because they lack the cognitive ability or capacity to adequately understand the situation and possible decisions. Cognitive capacity is a complex construct consisting of three global domains: conceptual, inferential and mnemonic competency. 18 Conceptual competency refers to the ability to understand the concepts being discussed and referenced while learning information regarding treatment options. 18 Inferential competency indicates the patient can infer implications and possible consequences of treatment information. Adequate inferential ability should be near the level expected for an average layperson. Thus, the patient must show they have capacity to make basic, logical sense of the concepts presented. 18 Mnemonic competency indicates the patient is aware that current decisions impact future care. 18 This indicates conceptual understanding that decisions will have future repercussions. An individual lacking mnemonic competence may be identified through tests of memory and mental status. An individual lacking these cognitive capacities may be identified through tests of cognitive ability and mental status. Neurocognitive tests can be used to evaluate capacity and determine competence. Attention, memory, and executive functioning (problemsolving and cognitive flexibility) are necessary for inferential and mnemonic competence. Specifically, adequate attention and executive function suggest inferential competence, while adequate memory and temporal orientation suggest mnemonic competence. 18 Therefore, evaluating neurocognitive abilities when ethically determining whether a patient is capable of making an informed consent decision is imperative in order to address theoretical and ethical concerns, as well as engage in careful clinical practice. Best practices in ethically assessing cognitive capacity will be reviewed next, in order to provide specific recommendations for clinical practice that will address and satisfy ethical dilemmas in the informed consent process. Best practices in evaluating patient ability to consent Quick screening measures can be helpful to decide whether more formal capacity assessment is required. Screening measures, such as the Mini-Mental State Exam (MMSE), 32 can be used as efficient screening tools in medical practice, as they briefly assess patients orientation (e.g., time, place), attention, and memory. Performance on screening tools can help to determine whether more comprehensive capacity evaluation is warranted. Performance on measures of attention and executive-functioning reflects patients ability to consent to treatment, as scores on the Mini-Mental State Exam (MMSE), 32 Trail Making Tests, and interactive interview measures, such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), 33 Hopemont Capacity Assessment Interview (HCAI), 34 and Capacity to Consent to Treatment Instrument (CCTI), 35 predict consent capacity. 30 The role of cognitive abilities in capacity assessment is logical, as loss of executive functioning and memory are primary concerns in many common neurodegenerative diseases, such as Parkinson s disease and various dementias. 14,20 Thus, executive functioning and other cognitive abilities are important to consider when determining if the patient is competent to make selfdetermining decisions. 27 Screening and interview measures based on provider patient interactions are helpful in gauging patient competence. Among these tools are the MMSE, 32 the MacCAT-T, 33 the HCAI, 34 and the CCTI. 35 These will be briefly discussed below. The MMSE 32 is a brief screen used to assess cognitive capacity. While it does not assess each cognitive ability required for informed consent (reasoning, etc.), low (<17 out of 30) and high (>23 out of 30) scores suggest lack of capacity and presumed capacity, respectively. 19,36 Due to its abbreviated nature, the MMSE should not be used alone to evaluate capacity and is better suited as an initial screening tool to determine whether further evaluation is necessary. Evidence also suggests the use of various measures focused on evaluating the patient s ability to reason through hypothetical (or actual) treatment decisions through provider patient interaction while assessing the core components of informed consent (i.e., understanding, reasoning, appreciation, and deciding). 37 The MacCAT-T, 33 the HCAI, 34 and the CCTI 35 utilize this approach to assessing competence and have been recommended for use with cognitively impaired patients (see Table 1). 19,36 These interactive measures present treatment information to the patient and require the patient to make a choice (i.e., to consent or not) and explain how the decision was reached. For example, the provider may assess under-

6 Psychiatry and Clinical Neurosciences 2015; 69: Informed consent review 467 Table 1. Capacity assessment tools Measure Relevant domains Description Clinical utility Mini-Mental State Exam (MMSE) 32 MacArthur Competence Assessment Tool for Treatment (MacCAT-T) 33 Hopemont Capacity Assessment Interview (HCAI) 34 Capacity to Consent to Treatment Instrument (CCTI) 35 Attention Orientation Memory Language processing Understanding Appreciation of situation Reasoning Ability to express a choice Understanding Appreciation of situation Reasoning Ability to express a choice Understanding Appreciation of situation Reasoning Ability to express a choice Brief screening tool Assesses many cognitive abilities necessary for higher-level cognitive processes (e.g., making an informed consent decision) Interactive interview Uses hypothetical medical situations (e.g., amputation) to model consent process 37 Allows relevant domains to be discussed between provider and patient Interactive interview Uses hypothetical medical situations (e.g., eye infection, intervention related to heart and lungs) to model consent process 37 Allows relevant domains to be discussed between provider and patient Interactive interview Uses hypothetical medical situations (e.g., brain cancer, cardiac surgery) to model consent process 37 Allows relevant domains to be discussed between provider and patient Indicates whether or not a patient needs further screening of cognitive capacity Demonstrates level of cognitive capacity through the use of hypothetical situations presented from a first-person perspective, as if the patient was making a decision related to his or her own care Demonstrates level of cognitive capacity through the use of hypothetical situations (e.g., eye infection) presented from a third-person perspective, as if the patient was making a decision related to someone else s care Demonstrates level of cognitive capacity through the use of hypothetical situations (e.g., brain surgery) presented from a first-person perspective, as if the patient was making a decision related to his or her own care standing and reasoning ability by having the patient explain the diagnosis, the treatment options and their possible outcomes (e.g., risks), and how treatment alternatives compare. 33 The patient s appreciation of his or her role in the decision-making process and appreciation of the consequences of the decision are also evaluated. 33 Providers may have patients answer additional questions and give a final consent decision along with supporting information Though the MacCAT-T, HCAI, and CCTI are similar in their approach to evaluating competency, there are some differences to consider when choosing which instrument to use. For example, the MacCAT-T and CCTI require patients to evaluate treatment information as if it pertains to their own treatment, while the HCAI requires patients to evaluate treatment information from a third-party perspective. This may influence the HCAI s ability to validly assess patients ability to fully reason through and appreciate the information These measures also vary regarding the hypothetical situations they use (e.g., eye infection, heart surgery), and these differences should be considered when choosing an instrument. The choice of which instrument to use should be guided by conceptualization of the individual patient s characteristics and situation. Patients characteristics, such as age, values, and stage in life (e.g., young adult, older adult) may influence how they respond to various hypothetical situations. 37 For example, individuals with different life experiences (e.g., older, more global perspective) may competently consent to hypothetical, high-risk surgery that may lead to amputation, whereas others (e.g., younger, more mobile) may not. 37 Thus, it is imperative to consider patient characteristics (e.g., age, values, stage of life), 37 as well as the diagnosis and

7 468 L. M. Fields and J. D. Calvert Psychiatry and Clinical Neurosciences 2015; 69: potential treatments, when choosing which assessment tool to use. As hypothetical situations presented by interview measures vary in severity and complexity, ranging from eye infection (HCAI) 34 to brain cancer (CCTI), 35 it may be problematic to presume that a patient considering a complicated medical procedure has capacity to consent based on HCAI performance related to an eye infection vignette. 37 In such a case, performance on the HCAI may demonstrate adequate cognitive capacity to make some treatment decisions, but may not necessarily indicate competency to make other, more complex decisions. Thus, it is important to consider patient characteristics and the match between the patient s situation and hypothetical situations presented by interview measures, such as MacCAT-T, HCAI, and CCTI, when choosing an evaluation measure. The MMSE, MacCAT-T, HCAI, and CCTI measure aspects of cognition that are required in order to give adequate informed consent. The use of the MMSE and an interview measure (MacCAT-T, HCAI, and CCTI) helps to evaluate and document patients ability to pay attention to, memorize, comprehend, and process general information and information related to treatment, respectively. Additional neurocognitive tests of specific abilities (e.g., visual attention, auditory attention) can also be administered as supplemental evidence of cognitive abilities when needed. Using mental state exams, interview measures, and neurocognitive tests together helps providers comprehensively assess patients ability to consent. Thus, it is recommended that providers carefully select from among these and related measures when evaluating capacity and that this choice is guided by individual case conceptualizations based on patient and situation characteristics. Additional information regarding characteristics of these assessment tools has been presented elsewhere and, thus, is available for review. 11,37 The role of cognitive competency to consent is paramount 18,19 and, despite the strong focus on cognitive ability in determining informed consent, some argue for a broader conceptualization of competence beyond cognitive ability. It is important to evaluate emotional competence, which relates to the appropriateness (e.g., numbness instead of sadness) and intensity (e.g., hysterical reactions) of patients emotions in a given situation, when determining competency to consent. 18 Valuational competence, or the ability to make decisions aligned with one s values and beliefs, is also important to evaluate. 18 Together, patients cognitive, emotional, and valuational competencies should be considered when determining competence. Informed consent procedures for cognitively impaired patients Alternative consent must be sought when patients are deemed incompetent to consent and, thus, are unable to understand their condition, situation, treatment options, and treatment consequences (e.g., risks). 19 Foregoing appropriate informed consent procedures exposes providers to being accused of practicing unethically. 19 In these situations, advance directives or legal proxies must be considered. The provider must be aware of any medical advance directive the patient has. Advance directives regarding medical decisions are common in aging individuals and can indicate treatment wishes, as well as legal proxies who are able to make decisions related to the patient s medical care. 38,39 While advance directives benefit patient autonomy by communicating patients preferences related to their medical care, there is often confusion and debate surrounding their use 40 because the directive s validity can be questioned if the patient was of questionable competence at the time of drafting the directive. 38 Some argue against the use of advance directives altogether, as competent decision-making requires full understanding of the situation, and predicting one s treatment decisions based on future hypothetical situations may not indicate sufficient understanding needed to give informed consent. 40,41 Informed consent can also be obtained from a legal proxy legally designated to make treatment decisions for the patient. 19,28,42 Generally, if a patient is incompetent to consent, regardless of an advanced directive indicating desired treatment, then a legal proxy can make treatment decisions. Legal proxies are often family members or other individuals who have a close relationship with the patient. When a trusted individual, such as a spouse or other family member, acts as a legal proxy, that individual is able to make health-care decisions (with patient assent) that are based on the patient s best interests and known or assumed wishes. 43 Presentation of informed consent information The individual giving consent (a competent patient or legal proxy) must be given sufficient treatment

8 Psychiatry and Clinical Neurosciences 2015; 69: Informed consent review 469 information. The amount of information presented must be comprehensive. However, it must also be simple enough that it can be properly processed by a majority of patients. 3 Consent forms are often dense and contain words unfamiliar to the layperson. Informed consent documents have often been found to have readability levels ranging from the 10th grade through collegelevel. 44,45 Given that between 11 and 15 percent of adults in the USA fail to meet basic literacy standards set by the US Department of Education, 46 the typical informed consent form is written at a level that is incomprehensible to many people. Thus, more intuitively organized forms adhering to lower reading levels should be used. 13,47 The use of graphic organizers to preview information, multiple presentations of information, and summaries of the information are all useful in increasing understanding of treatment information. Further, multi-modality presentation of information and corrective feedback are also useful during the consent process. 13 Once information has been presented and understood, a choice regarding whether to consent must be expressed to the provider before treatment commences. It is imperative that the consent procedure (e.g., who gave consent) is noted and documented in the patient s file and corresponding reports. 48 As previously mentioned, ongoing evaluation and documentation of patient competence is crucial, as capacity can fluctuate over time 9,20,49 and adequate understanding of treatment information is important. 3 A patient who recovers capacity should be allowed to re-evaluate participation in treatment, especially when the initial consent was given by a proxy. This allows competent patients to have the final decision in their care. Ongoing evaluation of competence and consent serves to ensure that patients functioning and needs are continually evaluated, and that providers are adhering to ethical standards and best practices. CONCLUSION Obtaining informed consent in cognitively impaired populations is difficult as it leaves providers with the responsibility of delicately balancing patients autonomy and best interests. 29 This results in an ethical dilemma between autonomous and independent decision-making by the patient and a beneficent and protective influence of the provider. 2,8 Though there are similarities between informed consent and traditional ethical decision-making, as both emphasize the importance of patients wishes, medical expertise, and other factors, informed consent procedures provide a standardized framework that highlights patient autonomy. 8 Thus, according to informed consent conceptualizations, it is usually up to the patient to weigh various factors (e.g., risks, desires); however, the boundary between autonomy and patient protection becomes blurred when patients do not have the capacity to make informed decisions. To keep the focus on the patients best interests and allow patients to make their own treatment decisions when they have capacity to do so, proper capacity evaluation and competence determinations must occur. First, it must be determined whether a capacity assessment is warranted. If it is, the aforementioned guidelines are suggested regarding how to assess decision-making capacity and neurocognitive abilities. Indicators of cognitive capacity should be evaluated in the context of emotional and valuational competency, as well as treatment characteristics. Considering multiple aspects of each patient s unique situation can help to determine if the patient is competent to give informed consent 15 and if advance directives or legal proxies (with patient assent) need to be relied upon instead. 3,18 ACKNOWLEDGMENTS This article was supported by a grant from the Maguire Center for Ethics and Public Responsibility, Dallas, Texas. The authors have no conflicts of interest and no disclosures to declare. The authors have not presented this information previously. REFERENCES 1. Kim SYH. Competence for informed consent for treatment and research. In: Chatterjee A, Farah MJ (eds). Neuroethics in Practice: Medicine, Mind, and Society. Oxford University Press, New York, 2013; Sturman ED. The capacity to consent to treatment and research: A review of standardized assessment tools. Clin. Psychol. Rev. 2005; 25: Grisso T, Appelbaum PS. Assessing Competence to Consent to Treatment: A Guide for Physicians and Other Health Professionals. Oxford University Press, New York, Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment. CMAJ 2012; 184:

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