Reconsidering research exclusion for serious mental illness: Ethical principles, current status, and recommendations
Irene Harris, Devin Hanson, Jennie Leskela, John Billig, Viviana Padilla-Martinez, Jennifer Boyd, Tasha Nienow
Journal of Psychiatric Research, November 2021; 143 pp 138-143
Historically, individuals managing serious mental illness (SMI) have often been excluded from research, typically because of concern that these individuals may not be able to understand and provide truly informed consent. As treatment has improved, the assumption that individuals managing SMI may not be capable of consent needs to be re-examined. Systematic exclusion from research may limit empirically tested treatments available for people managing SMI, and may contribute to the health care disparities seen in this population.
This article examines this issue by documenting current rates of research exclusion for high disease burden conditions, based on empirical review of studies in ClinicalTrials.gov.
Current rates of exclusion from studies for psychiatric conditions were assessed through systematic review of relevant clinical trials on ClinicalTrials.gov.
Subjects in this inquiry are either articles accessed in the literature reviews, or descriptions of studies in public data on ClinicalTrials.gov.
The primary measure was a previously published coding system to document the extent and types of research exclusion related to psychiatric status.
Among studies of interventions for substance use disorders and chronic pain, individuals managing SMI were more likely to be excluded than those with other psychiatric disorders at statistically significant levels. This was not the case among studies of interventions for ischemic heart disease. In studies of substance use disorders, 9% explicitly excluded SMI and 83% could exclude people with SMI based on broader exclusion criteria. In studies of chronic pain these two categories of exclusion were 16% and 55%, and in studies of ischemic heart disease, these two categories of exclusion were 1% and 20%.
Evidence indicates that it is ethically and scientifically more appropriate to exclude based on capacity to consent than membership in the group of individuals managing SMI. The discussion outlines techniques researchers can use for more equitable and generalizable sampling.
‘Surrogate decision-making’ in India for women competent to consent and choose during childbirth
Kaveri Mayra, Zoë Matthews, Jane Sandall
Agenda: Empowering women for gender equity, 1 September 2021
In a postcolonial, deeply patriarchal culture, decisions are often made for Indian women about every aspect of their life – beginning with whether they will be allowed to be born. This is followed by every life decision, including education and marriage. A ‘surrogate decision-maker’ is a guardian who decides for an adult incapable of making their own decisions due to a mental health condition, or as a substitute based on a patient’s stated or predicted wishes. However, the majority of Indian women are ‘controlled’ and ‘allowed’ or otherwise regarding everything. No choice in women’s life is women’s own, including decisions about deeply personal experiences such as giving birth.
Our article is embedded in feminist epistemology and uses voice-centred relational analysis of interviews with four women from impoverished backgrounds in Bihar, India, to explore decision making around childbirth and throughout their lives. The surrogate decision-makers in the birth environment are: 1) healthcare and non-healthcare providers, and/or 2) family members (who play the dominant role in every other decision about women’s lives). They communicate amongst themselves about a woman’s active bodily experience. Through I-poems we present women’s varied levels of resistance and non-resistance to obstetric violence, which can be looked at as an extension of their response to violence in their routine lives. We find similarities in women’s conditioning to endure, and argue that women should be the key stakeholders of their decisions about themselves and their bodies, which includes decisions about birth.
Dental informed consent challenges and considerations for cognitively impaired patients
Ahmed Alsaleh, Anjuli Kapila, Iftee Shahriar, Yvonne L. Kapila,
Periodontology, 31 August 2021
Because the US population is living to an older age, the number of individuals with cognitive impairment and periodontitis is increasing, as both conditions/diseases increase with age. Dental informed consent best practices for dental/periodontal treatment of individuals with cognitive impairment have not been explored, yet warrant consideration, because complex dental treatments to address periodontal needs/edentulism raise challenges for informed consent in the elderly with cognitive impairment. The purpose of this review is to help practitioners better understand this topic and develop best practices in dentistry for informed consent of patients with cognitive impairment that need extensive dental treatment, including surgical and implant therapy.
Divergent Human Rights Approaches to Capacity and Consent [BOOK CHAPTER]
Mental Health, Legal Capacity, and Human Rights, 2021 [Cambridge University Press]
The institutional dialogue among the Committee on the Rights of Persons with Disabilities and other human rights tribunals has led to greater protection of rights. But not all courts and treaty bodies have accepted the Committee’s absolutist position on legal capacity. The chapter illustrates the multiple human rights-based approaches to capacity and decision-making, and describes how the Committee’s absolutism endangers many of the people living with moderate or severe dementia whom it supposedly benefits.
An Ageing Population Creates New Challenges Around Consent to Medical Treatment
Alice L. Holmes, Joseph E. Ibrahim
Journal of Bioethical Inquiry, 5 July 2021
Obtaining consent for medical treatment in older adults raises a number of complex challenges. Despite being required by ethics and the law, consent for medical treatment is not always validly sought in this population. The dynamic nature of capacity, particularly in individuals who have dementia or other cognitive impairments, adds complexity to obtaining consent. Further challenges arise in ensuring that older people comprehend the medical treatment information provided and that consent is not vitiated by coercion or undue influence. Existing mechanisms to address issues surrounding consent for older adults only address incapacity and raise further challenges. As the ageing population increases, these issues are likely to become more profound, thus action is required to address these challenges. Raising awareness, more education, engaging with people with dementia, and conducting further research would assist in beginning to overcome these challenges.
Uninformed consent: Who knows what Ivan Ilyich would have thought?
A D’Imperio, M Ienca, A Maiese, V Fazio, R La Russa
La Clinica Terapeutica, 1 July 2021, 172(4) pp 264-267
In the modern era, when prolonging life is not an option, the end-of-life discussions are unavoidably influenced by Neuroethics. Despite this, it is interestingly evident how the sentiments of a terminal patient of 1885 and a physician of 2020, are still comparable. This paper presents the arguments behind the so-called “Therapeutic Misconception” and the aim of palliative care to provide dying patients support. It is essential to address priorities of informed consent, signed before any remedy is provided. A key component of the newest Neuroscience research is the analysis of motivation and free will. So, it is necessary to comprehend if the patient struggles to feel at peace with these aspects of his “right to die”: Is he free to choose or is he influenced by the doctors? Is this confusion an example of “Therapeutic Misconception”? Is his Informed Consent totally “Informed”? In order to broaden our understanding, we account for many critical situations, such as the mentally impaired Psychiatric patients or the famous Italian case of Eluana Englaro. In addition, we suggested some current approaches such as Artificial Intelligence, useful in preserving some cognitive functions the patient may have lost. Furthermore, research in this field is very critical and in some Catholic countries like Italy, people faced difficulties accepting the idea of the “Anticipated directives”. In general, whatever the mental status and whatever the terminal state, the patients seem still far from handling their own auto-determination and their Consent, even if the ultimate goal is to die with dignity.
Ethical Aspects of Informed Consent in Dementia
Ethical Viewpoint Paper
Global Bioethics Enquiry, 2021; 9(1)
Informed Consent is an ethical and legal obligation that a medical practitioner or researcher must take in order to explain the treatment plan or enrol a participant in a research trial. In this process the participant or patient is informed about all the aspects of the treatment or trial in detail, which are important for the participant or patient to decide after studying these aspects in detail whether they want to voluntarily confirm their participation in the trial or is willing to undergo the said procedure or treatment. The concept is based on the principle of the Nuremberg Code, The Declaration of Helsinki, and the Belmont Report.
The informed consent is described in ethical codes and regulations for human subject’s research. The goal of the informed consent process is to provide sufficient information to a potential participant, in a language which is easily understood by him/her, so that he/she can make the voluntary decision regarding “to” or “not to” participate in the research study. The same is applicable when an Individual undergoes a medical procedure, surgery or takes certain medications. No individual has the right to infringe a person’s fundamental right, thus “Informed Consent” is an important and ethical tool…
How to deal with the consent of adults with cognitive impairment involved in European geriatric living labs?
Guillaume Sacco, Frédéric Noublanche, Frédéric Blazek, Catherine Hue, Loïc Carballido, Marine Asfar, Philippe Allain, Cédric Annweiler
Philosophy, Ethics, and Humanities in Medicine, 16 June 2021; 16(3)
Living labs are realistic environments designed to create links between technology developers and end-users (i.e. mostly older adults). Research in LLH (Living labs in health) covers a wide range of studies from non-interventional studies to CT (clinical trials) and should involve patients with neurocognitive disorders. However, the ethical issues raised by the design, development, and implementation of research and development projects in LLH have been the subject of only little interest thus far.
Our aim was to determine a pragmatic, ethical and regulatory correct approach to seek the informed consent of patients with neurocognitive disorders according to the different types of studies carried out in European LLH, with a focus on the French context.
A narrative review of regulatory texts and clinical articles was conducted, and a pragmatic procedure to determine the decision-making capacity of older adults in LLH was proposed.
Individuals must be adequately informed and freely agree to participate in CT. The capacity to consent should be assessed in CT including cognitively impaired older adults. We propose the following steps: first to assess for delirium using the 4 ‘A’s Test (4AT) or the 3-min Diagnostic interview for Confusion Assessment Method (3D-CAM), second to search for medical history of major neurocognitive disorder, and third to assess the decision capacity using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC).
Including individuals with neurocognitive disorders in research implies using an efficient and pragmatic strategy to inform participants and obtain their consent. The tool we offer here may be useful in the routine operation of LLH but can also be extended to all CT with this population.
The Convention on the Rights of Persons with Disabilities and the challenge to treatment without consent of individuals with psychosocial disabilities [BOOK CHAPTER]
Bernadette McSherry, Lisa Waddington
Routledge, Human Rights Education for Psychologists, 2020
This chapter explores the developing emphasis on human rights in mental health care and treatment and what it means in particular for the compulsory treatment of individuals with psychosocial disabilities. Informed consent to treatment is generally presumed to be central to the provision of good-quality health care. However, many countries have mental health laws that enable the detention and treatment without consent of individuals with “psychosocial disabilities”. Awareness of the need to support people with psychosocial disabilities to make their own decisions is an obvious starting point for promoting human rights in this area. Psychologists and professional associations may have a role in ensuring that mental health care and treatment are provided on a voluntary basis as much as possible. The chapter provides an overview of the conceptual aspects of human rights and compulsory mental health treatment and analyse what the Convention on the Rights of Persons with Disabilities may mean for the practice of human rights-based treatment.
Assessment of capacity to give informed consent for medical assistance in dying: a qualitative study of clinicians’ experience
Ellen Wiebe, Michaela Kelly, Thomas McMorrow, Sabrina Tremblay-Huet, Mirna Hennawy Abstract
Canadian Medical Association Journal, 13 April 2021;9(2) pp E358-E363
Under the Canadian Criminal Code, medical assistance in dying (MAiD) requires that patients give informed consent and that their ability to consent is assessed by 2 clinicians. In this study, we intended to understand how Canadian clinicians assessed capacity in people requesting MAiD.
This qualitative study used interviews conducted between August 2019 and February 2020, by phone, video and email, to explore how clinicians assessed capacity in people requesting MAiD, what challenges they had encountered and what tools they used. The participants were recruited from provider mailing listserves of the Canadian Association of MAiD Assessors and Providers and Aide médicale à mourir. Interviews were audio-recorded and transcribed verbatim. The research team met to review transcripts and explore themes as they emerged in an iterative manner. We used abductive reasoning for thematic analysis and coding, and continued to discuss until we reached consensus.
The 20 participants worked in 5 of 10 provinces across Canada, represented different specialties and had experience assessing a total of 2410 patients requesting MAiD. The main theme was that, for most assessments, the participants used the conversation about how the patient had come to choose MAiD to get the information they needed. When the participants used formal capacity assessment tools, this was mostly for meticulous documentation, and they rarely asked for psychiatric consults. The participants described how they approached assessing cases of nonverbal patients and other challenging cases, using techniques such as ensuring a quiet environment and adequate hearing aids, and using questions requiring only “yes” or “no” as an answer.
The participants were comfortable doing MAiD assessments and used their clinical judgment and experience to assess capacity in ways similar to other clinical practices. The findings of this study suggest that experienced MAiD assessors do not routinely require formal capacity assessments or tools to assess capacity in patients requesting MAiD.