Background In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices. Methods The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child (...) health researchers and research assistants in Southern Ontario. Transcribed interviews were analysed for common themes. Results Procedures for assessing capacity varied considerably from the use of age cutoffs to in-depth engagement with each child. Three key issues emerged from the accounts: (1) requirements that consent be provided by a single person thwarted researchers' abilities to support family decision-making; (2) little practical distinction was made between assessing if a child was capable, versus determining if study information had been adequately explained by the researcher; and (3) participants' perceived that review boards' requirements may conflict with what they considered ethical consent practices. Conclusion The results suggest that researchers' consent and capacity knowledge and skills vary considerably. Perceived discrepancies between ethical practice and ethics boards' requirements suggest the need for dialogue, education and possibly ethics board reforms. Furthermore we propose, where appropriate, a ‘family decision-making’ model that allows parents and their children to consent together, thereby shifting the focus from separate assent and consent procedures to approaches that appropriately engage the child and family. (shrink)

Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals’ exclusion from research as a result of such regulation risks condemning such populations to poor quality care as (...) a result of ‘evidence biased’ medicine. This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs. The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented. (shrink)

Transgender and gender expansive (TGE) youth often seek a variety of gender-affirming healthcare services, including pubertal suppression and hormone therapy requiring that TGE youth and their parents participate in informed consent and decision making. While youth must demonstrate the ability to understand and appreciate treatment options, risks, benefits, and alternatives as well as make and express a treatment choice, standardized approaches to assess the capacity of TGE youth to consent or assent in clinical practice are not routinely (...) used. This scoping review identified the currently available data regarding adolescent capacity to consent to gender-affirming medical treatments. Articles relevant to assessing adolescent capacity for clinical decision-making were identified using OVID Medline, Web of Science, and PubMed. Articles were reviewed and thematically analyzed. Eight relevant articles were identified using three tools for measuring adolescent clinical decision-making capacity: Measure of Understanding, Measure of Competence, and MacArthur Competence Assessment Tool (MacCAT). These studies explored hypothetical treatment decisions, mental health treatment decisions, HIV treatment decisions, genetic testing decisions, and gender-affirming medical decisions. Only one study specifically examines the capacity of TGE youth to consent to medical treatments. Age was correlated with capacity in most, but not all studies. Other studies found cognitive measures (IQ, literacy, numeracy) may impact important aspects of capacity (understanding and reasoning). For clinicians caring for TGE youth, tools such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) may prove useful, in conjunction with consideration of youth developmental abilities and utilization of shared decision-making practices. A standardized, collaborative approach to assessing TGE youth capacity would benefit TGE youth and their parents, and allow clinicians to more easily resolve ethical concerns. (shrink)

BackgroundAssessment of capacity to consent to treatment is an important legal and ethical issue in daily medical practice. In this study we carefully evaluated the capacity to consent to treatment in patients admitted to an acute medical ward using an assessment by members of the medical team, the specific Silberfeld's score, the MMSE and an assessment by a senior psychiatrist.MethodsOver a 3 month period, 195 consecutive patients of an internal medicine ward in a university hospital were (...) included and their capacity to consent was evaluated within 72 hours of admission.ResultsAmong the 195 patients, 38 were incapable of consenting to treatment (unconscious patients or severe cognitive impairment) and 14 were considered as incapable of consenting by the psychiatrist (prevalence of incapacity to consent of 26.7%). Agreement between the psychiatrist's evaluation and the Silberfeld questionnaire was poor (sensitivity 35.7%, specificity 91.6%). Experienced clinicians showed a higher agreement (sensitivity 57.1%, specificity 96.5%). A decision shared by residents, chief residents and nurses was the best predictor for agreement with the psychiatric assessment (sensitivity 78.6%, specificity 94.3%).ConclusionPrevalence of incapacity to consent to treatment in patients admitted to an acute internal medicine ward is high. While the standardized Silberfeld questionnaire and the MMSE are not appropriate for the evaluation of the capacity to consent in this setting, an assessment by the multidisciplinary medical team concurs with the evaluation by a senior psychiatrist. (shrink)

Following a Canadian Supreme Court ruling invalidating an absolute prohibition on physician assisted dying, two reports and several commentators have recommended that the Canadian criminal law allow medical assistance in dying (MAID) for persons with a diagnosis of mental disorder. A key element in this process is that the person requesting MAID be deemed to have the ‘mental capacity’ or ‘mental competence’ to consent to that option. In this context, mental capacity and mental competence refer to ‘decision-making (...) capacity’, which is a distinct area of clinical study and research in the theory of informed consent. The purpose of this discussion is to bring several controversial but insufficiently acknowledged problems associated with decision-making capacity to the forefront of the proposed extension of MAID to persons diagnosed with mental disorders. Open-ended access to MAID by persons who suffer from mental health conditions already exists in Belgium and the Netherlands, where the issues raised here are equally relevant. In this paper, we highlight the serious limitations of relying on capacity assessments to allow access to MAID/Euthanasia. (shrink)

The Mental Capacity Act 2005 has stipulated that in England and Wales the ethical implications of carrying out research with people who are unable to consent must be considered alongside the ethical implications of excluding them from research altogether. This paper describes the methods that were used to enable people with severe and profound intellectual disabilities, who lacked capacity, to participate in a study that examined their experience of receiving intimate care. The safeguards that were put in (...) place to protect the rights and well-being of participants are described, and it is argued that the approaches used in this study met the requirements set out in the Mental Capacity Act 2005. Although this paper is based on research involving people with intellectual disabilities, it has implications for research involving other groups who may also lack capacity to consent, including people with mental health problems, head injuries and dementia. (shrink)

OBJECTIVES: Cognitive and sensory difficulties frequently jeopardize informed consent of frail elderly patients This study is the first to test whether preliminary research experience could enhance geriatric patients' capacity to consent. DESIGN/SETTING: A step-wise consent procedure was introduced in a study on fluid balance in geriatric patients. Eligible patients providing verbal consent participated in a try-out of a week, during which bioelectrical impedance and weight measurements were performed daily. Afterwards, written informed consent was requested. (...) Comprehension, risk and inconvenience scores (ranges: 0-10) were obtained before and after the try-out by asking ten questions about the study's essentials and by asking for a risk and inconvenience assessment on a ten-points rating scale. SUBJECTS AND RESULTS: Seventy of the 78 eligible subjects started the try-out and 53 (68%) provided written consent. The comprehension score increased from 5.0 (+/- 2.3) to 7.0 (+/- 1.9) following the try-out (P < 0.001). The number of subjects capable of weighing risks and inconveniences increased from 32 to 48 (P < 0.001). CONCLUSIONS: Research experience improved the capacity to consent, still enabling an acceptable participation rate. Therefore, experienced consent seems a promising tool to optimize informed consent in frail elderly subjects. (shrink)

The Mental Capacity Act 2005 has stipulated that in England and Wales the ethical implications of carrying out research with people who are unable to consent must be considered alongside the ethical implications of excluding them from research altogether. This paper describes the methods that were used to enable people with severe and profound intellectual disabilities, who lacked capacity, to participate in a study that examined their experience of receiving intimate care. The safeguards that were put in (...) place to protect the rights and well-being of participants are described, and it is argued that the approaches used in this study met the requirements set out in the Mental Capacity Act 2005. Although this paper is based on research involving people with intellectual disabilities, it has implications for research involving other groups who may also lack capacity to consent, including people with mental health problems, head injuries and dementia. (shrink)

This integrative review aims to provide a synthesis of research findings of health-care professionals’ knowledge, attitudes and behaviours relating to patient capacity to consent to or refuse treatment within the general hospital setting. Search strategies included relevant health databases, hand searching of key journals, ‘snowballing’ and expert recommendations. The review identified various knowledge gaps and attitudinal dispositions of health-care professionals, which influence their behaviours and decision-making in relation to capacity to consent processes. The findings suggest that (...) there is tension between legal, ethical and professional standards relating to the assessment of capacity and consent within health care. Legislation and policy guidance concerning capacity assessment processes are lacking, and this may contribute to inconsistencies in practice. (shrink)

Dunn and colleagues (2011) present a balanced article, which makes the following important points about the use of deep brain stimulation (DBS) in the case of treatment-resistant major depression (...

Infectious disease outbreaks in residential care are complex to manage and difficult to control. Research in this setting that includes individuals who lack capacity must conform to national legislation. We report here on our study that is investigating outbreaks of scabies, an itchy skin infection, in the residential care setting in the southeast of England. There appears to be a gap in legislative advice regarding the inclusion of people who lack capacity in research that takes place during time-limited (...) acute scenarios such as outbreaks. We received inconsistent advice from experts regarding, in particular, the role of nominated consultees. There is a potential inequality for vulnerable populations who cannot themselves provide informed consent in terms of their access to participation in a range of health-related research. (shrink)

Research involving adults who lack capacity to consent relies on proxy (or surrogate) decision making. Proxy decisions about participation are ethically complex, with a disparity between normative accounts and empirical evidence. Concerns about the accuracy of proxies’ decisions arise, in part, from the lack of an ethical framework which takes account of the complex and morally pluralistic world in which proxy decisions are situated. This qualitative study explored the experiences of family members who have acted as a research (...) proxy in order to develop an understanding of the ethical concepts involved, and the interactions between those concepts. Proxies described a complex process of respecting the wishes and preferences of the person they represented, whist integrating preferences with what they viewed as being in the interests of the person. They aimed to make a decision that was ‘best’ for the person and protected them from harm; they also aimed to make the ‘right’ decision, viewed as being authentic to the person’s values and life. Decisions were underpinned by the relationship between the person and their proxy, in which both trust and trustworthiness were key. Proxies’ decisions, based both on respect for the person and the need to protect their interests, arose out of their dual role as both proxy and carer. The findings raise questions about accounts which rely on existing normative assumptions with a focus on accuracy and discrepancy, and which fail to take account of the requirement for proxies to make authentic decisions that arise out of their caring obligations. (shrink)

There has been renewed interest in whether we should understand standards of decision-making capacity (DMC) to be risk-relative. Critics of risk-relative standards often highlight a puzzling asymmetry that they imply; a patient may have the requisite DMC to consent to a treatment that is in their best interests, whilst lacking the requisite DMC to refuse that same treatment, given the much higher risk that this would entail. Whilst some have argued that this asymmetry suggests that risk-relative standards are (...) nonsensical, in this paper I defend a ‘quality of evidence’ view of such standards. I begin by outlining DMC’s purported gate-keeping role in medical ethics, and identifying three key normative claims that undergird this role. I then explain how two competing theories of risk-relative standards are incompatible with at least one of these claims. Drawing on Douglas’ distinction between standards of ‘true capacity’ and standards invoked in the ‘test’ for capacity, I then outline my ‘quality of evidence’ view. I explain how the view is compatible with the aforementioned normative claims, and outline the nature of the asymmetry it implies. I conclude by responding to the objection that there is no meaningful distinction between ‘true capacity’ and the ‘test’ for capacity. (shrink)

Informed consent procedures for participation in psychiatric genomics research among individuals with mental disorder and intellectual disability can often be unclear, particularly because the underlying ethos guiding consent tools reflects a core ethical tension between safeguarding and inclusion. This tension reflects important debates around the function of consent tools, as well as the contested legitimacy of decision-making capacity thresholds to screen potentially vulnerable participants. Drawing on human rights, person-centred psychiatry and supported decision-making, this paper problematises the (...) use of consent procedures as screening tools in psychiatric genomics studies, particularly as increasing normative emphasis has shifted towards the empowerment and participation of those with mental disorder and intellectual disabilities. We expound on core aspects of supported decision-making, such as relational autonomy and hermeneutic competence, to orient consent procedures towards a more educative, participatory framework that is better aligned with developments in disability studies. The paper concludes with an acknowledgement of the pragmatic and substantive challenges in adopting this framework in psychiatric genomics studies if this participatory ethos towards persons with mental disorder and intellectual disability is to be fully realised. (shrink)

Introduction: Healthcare practitioners have a legal, ethical and professional obligation to obtain patient consent for all healthcare treatments. There is increasing evidence which suggests dissonance and variation in practice in assessment of decision-making capacity and consent processes. Aims: This study explores healthcare practitioners’ knowledge and practices of assessing decision-making capacity and obtaining patient consent to treatment in the acute generalist setting. Methods: An exploratory descriptive cross-sectional survey design, using an online questionnaire, method was employed with (...) all professional groups invited via email to participate. Data were collected over 3 months from July to September 2015. Survey content and format was reviewed by the liaison psychiatry team and subsequently contained five sections (demographics, general knowledge and practice, delirium context, legal aspects and education/training). Descriptive, univariate and bivariate analysis of quantitative data and qualitative content analysis of qualitative data were undertaken. Ethical considerations: The study was approved by the institutional Human Research and Ethics Committee and informed consent was taken to be provided by participants upon completion and submission of the de-identified survey. Results: In total, 86 participants engaged the survey with n = 24, exiting at the first consent question. Almost two-thirds of respondents indicated that all treatments required patient consent. Knowledge of consent and decision-making capacity as legal constructs was deficient. Decision-making capacity was primarily assessed using professional judgement and perceived predominantly as the responsibility of medical and psychology staff. A range of patient psychological and behavioural symptoms were identified as indicators requiring assessment of decision-making capacity. Despite this, many patients with delirium have their decision-making capacity assessed and documented only sometimes. Uncertain knowledge and inconsistent application of legislative frameworks are evident. Many participants were unsure of the legal mechanisms for obtaining substitute consent in patients with impaired decision-making capacity and refusing treatment. Conclusion: The legal context of decision-making capacity and consent to treatment appears complex for healthcare practitioners. Professional, ethical and legal standards of care in this context can benefit from structured education programmes and supportive governance processes. An understanding of why ‘duty of care’ is being used as a framework within the context of impaired decision-making capacity is warranted, alongside a review of the context of Duty of Care within health policy, guidance and faculty teaching. (shrink)

Consent's capacity to legitimise actions and claims is limited by conditions such as coercion, which render consent ineffective. A better understanding of the limits to consent's capacity to legitimise can shed light on a variety of applied debates, in political philosophy, bioethics, economics and law. I show that traditional paternalist explanations for limits to consent's capacity to legitimise cannot explain the central intuition that consent is often rendered ineffective when brought about by (...) a rights violation or threatened rights violation. I argue that this intuition is an expression of the same principles of corrective justice that underlie norms of compensation and rectification. I show how these principles can explain and clarify core intuitions about conditions which render consent ineffective, including those concerned with the consenting agent's option set, his mental competence, and available information. (shrink)

This Element examines three related topics in the field of bioethics that arise frequently both in clinical care and in medico-legal settings: capacity, informed consent, and third-party decision-making. All three of these subjects have been shaped significantly by the shift from the paternalistic models of care that dominated medicine in the United States, Canada, and Great Britain prior to the 1960s to the present models that privilege patient autonomy. Each section traces the history of one of these topics (...) and then explores the major ethics issues that arise as these issues are addressed in contemporary clinical practice, paying particular attention to the role that structural factors such as bias and social capital play in their use. In addition, the volume also discusses recent innovations and proposals for reform that may shape these subjects in the future in response both to technological advances and changes in societal priorities. (shrink)

Inherent in providing healthcare for youth lie tensions among best interests, decision-making capacity, rights, and legal authority. Transgender youth experience barriers to needed gender-affirming care, often rooted in ethical and legal issues, such as healthcare provider concerns regarding youth capacity and rights to consent to hormone therapy. Even when decision-making capacity is present, youth may lack the legal authority to give consent. The aims of this paper are therefore to provide an empirical analysis of minor (...) trans youth capacity to consent to hormone therapy and to address the normative question of whether there is ethical justification for granting trans youth the authority to consent to this care. Through qualitative content analysis of interviews with trans youth, parents, and healthcare providers, we found that trans youth demonstrated the understandings and abilities characteristic of the capacity to consent to hormone therapy and that they did consent to hormone therapy with positive outcomes. Employing deontological and consequentialist reasoning and drawing on a foundation of empirical evidence, human rights, and best interests we conclude that granting trans youth with decisional capacity both the right and the legal authority to consent to hormone therapy via the informed consent model of care is ethically justified. (shrink)

ABSTRACT Persons generally must give their informed consent to participate in research. To provide informed consent persons must be given information regarding the study in simple, lay language. Consent must be voluntary, and persons giving consent must be legally competent to consent and possess the capacity to understand and appreciate the information provided. This paper examines the relationship between the obligation to disclose information regarding risks and the requirement that persons have the capacity (...) to understand and appreciate the information. There has been insufficient attention to the extent to which persons must be able to understand and appreciate study information in order to have their consent deemed valid when the information is provided in simple, lay language. This paper argues that (1) the capacity to understand and appreciate information that should be deemed necessary to give valid consent should be defined by the capacity of the typical, cognitively normal adult and (2) the capacity of the typical, cognitively normal adult to understand and appreciate the concept of risk is limited. Therefore, (3) all things being equal, potential subjects must possess a limited capacity to understand and appreciate risk to be deemed competent to consent to research participation. (4) In some cases investigators ought to require that persons possess a greater than typical capacity to understand and appreciate risk. (shrink)

Informed consent is valid only if the person giving it is competent. Although allegedly informed consents are routinely tendered, there are nonetheless serious problems with the concept of competence as it stands. First, conceptual work upon competence is incomplete: the concept is unanalyzed and no logic of competence has been identified. It is thus virtually impossible to reliably discern who is competent. ;Traditional work on competence has explicated three dichotomies from which the necessary conditions for the possibility of competence (...) will be identified, viz., that competence is either a global or a specific notion; is present in varying degrees or in virtue of a threshold; and may or not include appeals to consequences. Past efforts have failed to notice a fourth dichotomy: competence as an affective or cognitive notion. Failure to designate the appropriate arms of these dichotomies is responsible for there being, at present, no reliable test for competence. The inadequacies of a highly regarded particular test for competence, the mental status examination, are examined in light of this failure. ;Competence is located within the rule-governed practice of informed consent. That practice and hence, competence, is justified through a Kantian analysis of respect for persons. This analysis reveals that the logic of competence requires assessment in terms of specific rather than global concerns; degrees of ability rather than a threshold; both cognitive and affective abilities; and no appeal to consequences. ;Based upon the analyses of consent as an example of decision making within the practice of informed consent and of respect for persons, the capacities which jointly comprise competence are identified. These are the capacities to receive, recognize, and retrieve information; to reason about, relate to oneself, and rank options; to choose among alternatives; and, under certain circumstances, to defend one's choice. ;Identification of the logic of competence and explication of and justification for the capacities that comprise competence to consent provide a conceptual foundation for the crucial concept of competence that the informed consent process currently lacks. It should facilitate construction of a test for competence. (shrink)

The Mental Capacity Act 2005 came into force in England and Wales in 2007. Its primary purpose is to provide “a statutory framework to empower and protect people who may lack capacity to make some decisions for themselves.” Examples of such people are those with dementia, learning disabilities, mental health problems, and so on. The Act also gives those who currently have capacity a legal framework within which they can make arrangements for a time when they may (...) come to lack it. Toward this end, it allows for them to make advance decisions or to appoint proxy decision makers with lasting powers of attorney. (shrink)

Objective: To evaluate moral development as an indicator of the capacity to consent among two groups of patients from the Hospital de Clínicas in Porto Alegre, RS, Brazil.Method: Fifty-nine adolescents and 60 patients over 60 years of age participated in a cross-sectional study to assess moral development using Loevinger’s model of ego stages.Results: Age and moral development showed no association, with most participants in the two groups being in the conscientious phase.Conclusions: Age is probably not an adequate variable (...) to measure decision-making capacity, because questions of medical consent relate to participants’ own personal health. Decision-making capacity should be viewed as a continuous function. While the age of the person whose consent is needed should be considered, age alone, from a moral perspective, is not the main determinant of this capacity. (shrink)

Background: Many people participating in dementia research may lack capacity to give informed consent and the relationship between cognitive function and capacity remains unclear. Recent changes in the law reinforce the need for robust and reproducible methods of assessing capacity when recruiting people for research.Aims: To identify numbers of capacitous participants in a pragmatic randomised trial of dementia treatment; to assess characteristics associated with capacity; to describe a legally acceptable consent process for research.Methods: As (...) part of a pragmatic randomised controlled trial of Ginkgo biloba for mild-moderate dementia, we used a consenting algorithm that met the requirements of existing case law and the exigencies of the new Mental Capacity Act. We decided who had capacity to give informed consent for participation in the trial using this algorithm and sought predictors of capacity.Results: Most participants with mild-moderate dementia in this trial were unable to give informed consent according to the legal criteria. When adjusted for confounding, the Mini Mental State examination did not predict the presence of capacity.Conclusion: Cognitive testing alone is insufficient to assess the presence of capacity. Researchers and clinicians need to be aware of the challenging processes regarding capacity assessment. We outline a procedure which we believe meets the ethical and legal requirements. (shrink)

This paper considers the meaning of the term ‘intrusive research’, as used in the UK Mental Capacity Act 2005, in relation to studies in which an informant is asked to provide information about or on behalf of a person who lacks capacity to consent, and who is not otherwise involved in the study. The MCA defines ‘intrusive research’ as research that would legally require consent if it involved people with capacity. The relevant ethical principles are (...) that consent should be sought from people who would be affected by a piece of research and that this requirement should be implemented proportionately. The critical question, for investigators and research ethics committees, is: would provision of the personal information specified in the research protocol significantly affect a person whose capacity is not impaired? If the answer to this question is ‘no’, then the study falls outside the definition of ‘intrusive research’, and the MCA does not apply. (shrink)

Despite substantial research on overall decision-making capacity levels in schizophrenia, the factors that cause individuals to make errors when making decisions regarding research participation or treatment are relatively unknown. We examined the responses of 84 individuals, middle-aged or older, with schizophrenia or schizoaffective disorder. We used a structured decision-making capacity measure, the MacArthur Competence Assessment Tool for Clinical Research, to determine the frequency and apparent cause of participants’ errors. We found that most errors were due to difficulty recalling (...) the disclosed information, particularly the study’s procedures, potential risks, and purpose. Errors attributable to concrete thinking, psychotic symptoms, or perceived coercion were rarer. These results suggest that informed consent procedures for this population might be improved by providing information in a way that facilitates learning and memory, such as iterative disclosure of the information, corrective feedback, and emphasis of key points of the study—for instance, its purpose, procedures, and potential risks. (shrink)

Hospitalized patients lacking the mental capacity to consent to treatment may demand to be discharged from the hospital against medical advice. Forced custody of these patients, including the use of restraints, may be required if the plan is to proceed with treatment. This raises ethical concerns with regard to depriving people of their liberty. The determination of the wishes and values of the patient and her best interests may sometimes vary, depending on the assessor or the clinical team (...) entrusted to perform the evaluation. We therefore propose the following triad for clinicians when determining the best interests for this group of patients to ensure ethical and legal soundness as well as in providing consistency in approach. Firstly, the treatment should serve as a rescue response. Secondly, any restraint deployed must be proportionate with a foreseeable end. Her liberty and autonomy interests should be enhanced by the treatment. Thirdly, the patient’s family must be supportive. This paper analyzes the use of the triad approach on two clinical cases, both assessed as lacking in mental capacity to decide on treatment and insisting to be discharged. Using this approach, we could justify how the contrasting outcomes, one in which the voluntary discharge was acquiesced versus the other, which was not acquiesced, were reached. We also examine the compatibility of the triad approach with the obligations under the United Nations Convention on the Rights of Persons with Disabilities (UNCRPD). (shrink)

Children's competence to refuse or consent to medical treatment or surgery tends to be discussed in terms of the child's ability or maturity. This paper argues that the social context also powerfully influences the child's capacity to consent. Inner attributes and external influences are discussed using an analogy of the genes and the stars.

This study explores the ways in which adolescents, even so-called “mature minors”, lack adequate development of the intellectual, affective, and emotional capacities necessary morally to consent to medical research on their own behalf. The psychological and neurophysiological data regarding brain maturation supports the conclusion that adolescents are qualitatively different types of agents than mature adults. They lack full adult maturity and personal agency. As a result, in addition to the usual requirements for IRB approval, one or both parents, or (...) a legal guardian, should provide informed consent for minor children to participate in medical research. (shrink)

The age of maturity of children to consent for medical research is under debate, as different authorities regard the capacity of young teenagers as either satisfactory or not to grant consent without parental participation in the process. The present paper contrasts the generally accepted guideline for ethics in paediatric research in Canada with what the same children are allowed and expected to be able to do as babysitters. This comparison reveals deep incongruences in the way the maturity (...) of the same children is appreciated for two different tasks. (shrink)

Community based research is conducted by, for, and with the participation of community members, and aims to ensure that knowledge contributes to making a concrete and constructive difference in the world (The Loka Institute 2002). Yet decisions about research ethics are often controlled outside the research community itself. In this analysis we grapple with the imposition of a community confidentiality clause and the implications it had for consent, confidentiality, and capacity in a province-wide community based research project. Through (...) untangling these implications we provide recommendations for reframing how to think about research ethics and strategies for enabling research ethics’ processes to be more responsive to and respectful of community-based research. (shrink)

A series of studies investigated the capacity of children between the ages of 7 and 12 to give free and informed consent to participation in psychological research. Children were reasonably accurate in describing the purpose of studies, but many did not understand the possible benefits or especially the possible risks of participating. In several studies children's consent was not affected by the knowledge that their parents had given their permission or by the parents saying that they would (...) not be upset if the children refused. In contrast, other studies found that children were much more likely to stop their participation if the experimenter said explicitly that she would not be upset if they stopped. We suggest that experimenters should pay more attention to describing the possible risks and benefits of participation in research, and that they should also make it clearer to children that they are free to stop once they have begun. (shrink)

As a study involving diabetes care demonstrates, children sometimes have a much more sophisticated capacity for taking charge of their own health care decisions than is usually recognized in bioethics. Protecting these children from their disease means involving them in their treatment as much as possible, helping them to understand it and take responsibility for it so that they can navigate the multitude of daily decisions that become part of the diabetes medical regimen.

BackgroundFor many decades, the debate on children’s competence to give informed consent in medical settings concentrated on ethical and legal aspects, with little empirical underpinnings. Recently, data from empirical research became available to advance the discussion. It was shown that children’s competence to consent to clinical research could be accurately assessed by the modified MacArthur Competence Assessment Tool for Clinical Research. Age limits for children to be deemed competent to decide on research participation have been studied: generally children (...) of 11.2 years and above were decision-making competent, while children of 9.6 years and younger were not. Age was pointed out to be the key determining factor in children’s competence. In this article we reflect on policy implications of these findings, considering legal, ethical, developmental and clinical perspectives.DiscussionAlthough assessment of children’s competence has a normative character, ethics, law and clinical practice can benefit from research data. The findings may help to do justice to the capacities children possess and challenges they may face when deciding about treatment and research options. We discuss advantages and drawbacks of standardized competence assessment in children on a case-by-case basis compared to application of a fixed age limit, and conclude that a selective implementation of case-by-case competence assessment in specific populations is preferable. We recommend the implementation of age limits based on empirical evidence. Furthermore, we elaborate on a suitable model for informed consent involving children and parents that would do justice to developmental aspects of children and the specific characteristics of the parent-child dyad.SummaryPrevious research outcomes showed that children’s medical decision-making capacities could be operationalized into a standardized assessment instrument. Recommendations for policies include a dual consent procedure, including both child as well as parents, for children from the age of 12 until they reach majority. For children between 10 and 12 years of age, and in case of children older than 12 years in special research populations of mentally compromised patients, we suggest a case-by-case assessment of children’s competence to consent. Since such a dual consent procedure is fundamentally different from a procedure of parental permission and child assent, and would imply a considerable shift regarding some current legislations, practical implications are elaborated. (shrink)

This pilot randomized controlled trial explored the feasibility, acceptability, and potential utility of an intervention to improve the decisional capacity (DC) for research consent/assent among youth living with HIV (YLWH). We randomly assigned 30 YLWH aged 13–24 to a control (paper-based) or intervention (multimedia) consent/assent condition. Using a between- and within-subjects design, participants completed a demographic questionnaire and measures of DC, acceptability/feasibility, and voluntary self-consent perceptions after undergoing a hypothetical consent/assent process for a biomedical HIV (...) study. Findings suggest participants found the intervention feasible and acceptable. Participants in the intervention condition scored higher on a DC measure; however, scores did not meet the predetermined cutoff score for adequate DC in either group. The potential implications of these findings for research with youth, including YLWH, are discussed. (shrink)

A child is a developing person with evolving capacities that include autonomy, mental capacity and capacity to assume responsibility. Hence, children are entitled to participatory rights in South Africa as observed in the Children’s Act 38 of 2005. According to section 129 of the Act a child may consent to his or her own medical treatment provided that he or she is over the age of 12 years and is of sufficient maturity and decisional capacity to (...) understand the various implications of the treatment including the risks and benefits thereof. However, the Act does not provide a definition for what qualifies as ‘sufficient maturity’ nor does it stipulate how health professionals ought to assess the decisional capacity of a child. In addition, South Africa is a culturally diverse country. The Western liberal notion of autonomy may not necessarily find equal prominence in the mores of people with a different worldview. Hence we demonstrate a few salient comparisons between legal liberal moral theory and African communitarianism as pertinent to the autonomy of the child. Children are rights-holders by virtue of their humanity. Their dignity as individual human persons affords them the entitlement to human rights as contemplated under the Constitution of the Republic of South Africa. However, contrary to the traditional Western notion of individual autonomous persons African societies hold a communalistic notion of person hence there is less regard for individual autonomy and rights with more emphasis on the communal good and maintaining the continuity of relationships and interdependencies shared within a community. A child considered in this view is not regarded as a full person. This implies that decisions concerning the child, including consent to medical treatment are discussed and determined by the community to which the child belongs. Lastly, in this article, we draw on the notion of capacity for responsibility to produce a pragmatic definition of sufficient maturity. It seems reasonable to suggest a move away from a general legal age of consent for medical treatment toward more individualised, context-specific approaches in determining the maturity of a child patient to consent to medical treatment. Perhaps, decision-making with respect to consent to the medical treatment of a child belonging to a traditional African community where the notion of a person is embedded in communitarianism ought to involve the child’s parents/guardians/caregivers where possible provided that the best interests of the child are awarded priority. (shrink)

BackgroundDelirium is highly prevalent in the general hospital patient population, characterized by acute onset, fluctuating levels of consciousness, and global impairment of cognitive functioning. Mental capacity, its assessment and subsequent consent are therefore prominent within this cohort, yet under-explored.AimThis study of patients with delirium sought to determine the processes by which consent to medical treatment was attempted, how capacity was assessed, and any subsequent actions thereafter.MethodA retrospective documentation review of patients identified as having a delirium for (...) the twelve months February 2013 to January 2014 was undertaken. Inclusion and exclusion criteria were used; demographic and descriptive data collected. A total of n=1153 patients were identified with n=310 meeting inclusion criteria.ResultA random sample of one hundred patients were subsequently reviewed. One third of patients had documentation relating to consent, while four patients had documentation relating to capacity. Median delirium duration was three days, with treatment refusal occurring in twenty-two patients and “duty of care” being used as an apparent beneficent related treatment framework in twelve patients.ConclusionsWhile impaired decision-making was indicated, the review was unable to indicate what patient characteristics flag the need for capacity assessment. Documentation relating to consent processes appeared deficient for this cohort. (shrink)

Informed consent is the single most important concept for understanding decision-making capacity. There is a steady pull in the clinical world to transform capacity into a technical concept that can be tested objectively, usually by calling for a psychiatric consult. This is a classic example of medicalization. In this article I argue that is a mistake, not just unnecessary but wrong, and explain how to normalize capacity assessment.Returning the locus of capacity assessment to the attending, (...) the primary care doctor, and even to ethics consultation in today's environment will require a substantial effort to undo a strong but illusory impression of capacity assessment. Hospital attorneys as well as clinical ethicists with a sophisticated understanding of health law can be in the vanguard of this reorientation. (shrink)

BackgroundBased on an actual case in which a psychiatrist was called in to assess a patient’s capacity to refuse treatment, the aim of this study is to discuss how to manage this ethical and clinical issue and the dilemmas faced by the medical team.Case presentation: The case involved a 45-year-old female patient diagnosed with breast cancer who refused treatment. Since the mastology team had doubts about the patient’s mental state and given that she refused to consent to surgery, (...) a forensic psychiatric consult was requested.ConclusionThe forensic psychiatry team concluded that the patient’s decision-making capacity was preserved. The team suggested some actions to help the specialists deal with the ethical conflict. A reflection is proposed about the role of psychiatrists when an ethical dilemma involving decision-making capacity emerges in clinical situations, elucidating their work not only as physicians who determine diagnoses and conducts, but also as agents of transformation in the doctor–patient re... (shrink)

The Mental Capacity Act 2005 gives statutory force to the common law principle that all adults are assumed to have capacity to make decisions unless proven otherwise. In accord with best practice, this principle places the evidential burden on researchers rather than participants and requires researchers to take account of short-term and transient understandings common among some research populations. The aim of this paper is to explore some of the implications of the MCA 2005 for researchers working with (...) 'vulnerable' populations in health and social care settings. The Cyclical Consent Model is described and offered as a process by which researchers might develop good practice when engaged in research involving vulnerable people. (shrink)

The authors of the feature article argue against implied consent in all episiotomy cases, but allow that opt-out consent might be appropriate in limited circumstances.1 However, they do not indicate how clinicians should assess whether the pregnant person is capable of consenting in this way during an obstetric emergency. This commentary will focus on how capacity should be determined during these circumstances, suggest next steps for clinicians if capacity is deemed uncertain or absent, and discuss the (...) appropriate role for opt-out consent in labour. Previous studies investigating the extent to which pregnant persons retain decision-making capacity during labour have shown poor recall, a component of capacity, about consent processes during obstetric emergency procedures in 14%–49% of cases.1 2 As the feature article acknowledges, this does not mean that pregnant persons should be assumed to lack decision-making capacity during labour. Although pain, labour intensity, exhaustion and medications can make consenting processes during labour more difficult and it is possible that these factors will result in the impaired ability of the pregnant person to make informed and voluntary decisions about treatment options, this possibility of impaired capacity should not be taken as the expected outcome nor should it be used as an excuse to skip consenting procedures.1 2 The default to treat labouring patients as able to make their own decisions still stands, although signs that a person lacks …. (shrink)

Conducting research with vulnerable populations involves careful attention to the interests of individuals. Although it is generally understood that informed consent is a necessary prerequisite to research participation, it is less clear how to proceed when potential research participants lack the capacity to provide this informed consent. The rationale for assessing the assent or dissent of vulnerable individuals and obtaining informed consent by authorized representatives is discussed. Practical guidelines for recruitment of and data collection from people (...) in the middle or late stage of dementia are proposed. These guidelines were used by research assistants in a minimal risk study. (shrink)

The use of coercive measures in mental health care is an issue of ongoing concern (Cf. Fisher 1994; Janssen et al. 2008; Paterson and Duxbury 2007; Prinsen and Van Delden 2009; Widdershoven and Berghmans 2007; Wynn 2006). On the one hand, coercive interventions seem to infringe the patient’s right to self-determination (principle of autonomy). However, professionals are also committed to providing the care they deem necessary (principle of beneficence). In other words, professionals in mental health care are often caught between (...) the two (opposing) ideals of beneficence and autonomy. In medical practice, the right of self-determination is operationalized in the principle of informed consent. A medical physician is .. (shrink)

Rapid advances in neuroscience may enable us to identify the neural correlates of ordinary decision making. Such knowledge opens up the possibility of acquiring highly accurate information about people’s competence to consent to medical procedures and to participate in medical research. Currently we are unable to determine competence to consent with accuracy and we make a number of unrealistic practical assumptions to deal with our ignorance. Here I argue that if we are able to detect competence to (...) class='Hi'>consent and if we are able to develop a reliable neural test of competence to consent, then these assumptions will have to be rejected. I also consider and reject three lines of argument that might be developed by a defender of the status quo in order to protect our current practices regarding judgments of competence in the face of the availability of information about the neural correlates of ordinary human decision making. (shrink)

Background: The ability to consent promotes children’s access to health services. Healthcare providers should assess and arrive at a clinical judgement about the child’s maturity and mental capacity to obtain valid consent. Research objective: The objective of the study was to determine practices employed by South African healthcare providers to obtain consent for treatment from children. Research design: A qualitative, explorative, descriptive research design was used and the study was contextual. Participants and research context: In all, (...) 24 healthcare providers (professional nurses and medical practitioners) were purposively sampled from a hospital and primary health clinics. Semi-structured interviews were used. Ethical consideration: Ethical approval was obtained from the Institutional Review Board and gatekeepers. Written informed consent was obtained from each participant. Findings: Healthcare providers’ current practices in obtaining consent from children revealed inconsistency in implementation as well as the yardstick used to determine children’s mental capacity. Building trust with children, sharing information and assessment were interlinked in obtaining consent. Discussion: The inconsistent practice has implications for children’s access to healthcare services. Conclusion: Inconsistent practices in the implementation of consent laws have the potential to violate children’s rights to bodily and psychological integrity, access to health services and having their opinions heard and be taken into consideration. Through uncovering the current perceptions and practices and a literature review, guidelines intended for use by the Department of Health could be developed. (shrink)

Sir—In their editorial, Hall, Carter & Morley [1] present an incorrect interpretation of my central argument. The point of my paper [2] is that there are solid reasons to suspect that the capacity of heroin addicts to consent to heroin therapy is compromised because of their addiction. As one medical commentator on my paper states, if active heroin addicts can give voluntary and competent consent to heroin therapy without any problems, then we need a new conceptualization of (...) addiction: they are not addicted, almost by definition [3]. Yet obviously there are problems and grey zones. The solution is to investigate the issue empirically in order to determine the extent of the problem. (As we have done for consent to research on depression and other mental illnesses.) Ultimately, the question can only be solved on a case by case basis, using standardized assessment tools adapted for this purpose. The MacArthur Competence Assessment Tool (MaCAT‐T) is the particular assessment tool I chose to discuss. [4] It is the most promising candidate available, and it has proved its merits in the areas of depression and schizophrenia. -/- At no point do I condemn heroin therapy and endorse an abstinence model of treatment, as the authors state. On the contrary, I note the success of heroin therapy and make suggestions about how to facilitate the consent process. Ironically, it may be Hall et al . who have oversimplified the issues. What we need here are empirical studies on the decisional capacity of heroin addicts to consent to heroin therapy. Only then will we be able to refute the naive view they have no ‘free will’, or say how much they have; but really my paper is not about ‘free will’ at all. This is a philosophical concept. The topic I chose to discuss is ‘decisional capacity’, also called ‘mental competence’. This is a clinical concept with complex legal and ethical associations that often vary across jurisdictions. My point was that although the Swiss Heroin Trials were approved in Europe, they probably would not be approved in Canada or the United States under existing regulations. Interested readers might want to consider the wide variety of reactions to my paper, published in the same issue [5]. Unfortunately, the editorial by Hall et al . does little to advance this debate. (shrink)

The revision of the Council of International Organizations of Medical Sciences (CIOMS) International ethical guidelines for health‐related research (2016) heralds a paradigm shift from the ‘protectionist’ policies that emerged following historical research atrocities of the 20th century, towards a more nuanced and inclusive approach to research participation. Adopting this modified approach will enable countries to secure the benefits of research for individuals and for society as a whole, while at the same time minimizing the potential for exploitation and research‐related harms. (...) This article considers the potential impact of Guideline 16 of the CIOMS 2016 from a New Zealand perspective, with respect to research involving adults with impaired capacity and who are incapable of giving informed consent. While the CIOMS 2016 apply a ‘minimal risk’ threshold to guide research involving adults who lack capacity to consent, New Zealand law currently adopts a ‘best interests’ standard which significantly restricts the scope of permissible research that may be performed in this context. This article argues that the CIOMS 2016 should influence change to New Zealand’s legal framework for ethical review of research. CIOMS 2016 provides useful guidance for the necessary standards and processes to enable the responsible and ethical inclusion of adults with impaired capacity in research. (shrink)

This article presents an overview for clinician investigators on the concepts of decision-making capacity and vulnerability as related to human subjects research. Tools for capacity assessment and unacknowledged sources of vulnerability are discussed, and the practical gaps in current informed consent requirements related to impaired capacity and potential vulnerability are described. Options are suggested for research discussions when full regulatory consent is not possible and an exception from informed consent does not apply.