For all (Hu)mankind? The intersection of mental capacity, informed consent and contract law with U.K. space law
Alexander Ian Simmonds
International Journal of Discrimination and the Law, May 2023
Abstract
The UK Space Industry Act 2018 has now been supplemented with the new Space Industry Regulations. While examples of Space Tourism grace our screens and newsfeeds on an increasingly regular basis such as William Shatner’s recent voyage (Luscombe, 2021) the UK Regulations also pave the way for ‘human occupants’ (UK Space Industry Regulations, Regulation 2) to experience such a flight (UK Space Agency, 2020). A key part of the regulations pertaining to human occupants is that they must provide ‘informed consent’ before embarking on such a flight. If, as is likely to be the case, future courts are to draw analogies with the current state of medical law in this area, spaceflight operators will have to tread carefully if they are to avoid vitiating any informed consent by ‘bombarding’ any willing human occupant with technical detail prior to their flight (Simmonds, 2020). Whilst this could prove legally problematic for ‘capacitous’ individuals within the meaning of the Mental Capacity Act 2005, it is likely to be even more so for those who could be deemed, in some aspects of their cognitive ability, to lack capacity. UK Space Legislation as it presently stands faces three problems: 1) There is presently no legal mechanism under UK Space Law to determine capacity. 2) As examples from the Court of Protection indicate, ‘capacity’ is a very nuanced legal concept and individuals who, on the fact of things, may appear to lack capacity as regards potentially risky activities, have been regarded by the Courts as, at least, partially capacitous in respect of certain decisions. Operators may find themselves having to tread a fine line to avoid claims of discrimination. 3) because of point 1) and the state of the Law of Contract as regards contractual relationships entered into by potentially incapacitous individuals, further significant legal problems may present themselves. This paper will focus primarily on the Law in England and Wales but some of the overarching conclusions will be of relevance to all UK jurisdictions.

Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian study
Federica Del Signore, Alessia Rosi, Rocco Palumbo, Nicola Allegri, Alfredo Costa, Stefano Govoni, Elena Cavallini
Mediterranean Journal of Clinical Psychology, January 2023
Abstract
Background
A specific evaluation of the capacity to consent to research in older adults with cognitive decline is often not included routinely in research practice. However, there is a need to evaluate this competence adopting brief standardized instruments to guarantee their ethical rights. The present study evaluated in older adults with normal cognitive functioning, and major and mild neurocognitive disorders whether the Mini-Mental State Examination (MMSE) and a brief battery of neuropsychological tests are sensitive and specific to discriminate subjects able to provide consent to research.
Methods
54 participants with Major Neurocognitive Disorder (MajorNCD), 22 with Mild Neurocognitive Disorder (MildNCD), and 37 Normal Cognitive Functioning individuals (NCF). The capacity to provide consent was assessed using the MacArthur Competence Assessment Tool for Clinical Research. Cognitive functioning was assessed using the MMSE, Verbal Fluency Tests, Trail Making Test (TMT-A), Immediate and Delayed Recall Test.
Results
In the MildNCD and NCF groups, the aggregate score of neuropsychological tests showed high sensitivity and specificity in classifying subjects able to provide consent to research. In the MajorNCD group, MMSE, Recall test, and TMT-A performed better than the aggregate score in classifying subjects as able of consenting to the hypothetical research.
Conclusion
The choice of the best tool to assess the ability to provide consent to research may depend on the degree of cognitive impairment. MMSE is a good tool for subjects with MajorNCD. A more comprehensive battery of neuropsychological tests would represent a better tool in NCF and MildNCD individuals.

Assent and vulnerability in patients who lack capacity
Commentary
Christopher A Riddle
Journal of Medical Ethics, 17 April 2023
Excerpt
Smajdor’s Reification and Assent in Research Involving Those Who lack Capacity claims, among other things, that ‘adults who cannot give informed consent may nevertheless have the ability to assent and dissent, and that these capacities are morally important in the context of research’. More pointedly, she suggests we can rely upon Gillick competence, or that ‘it is worth thinking about why the same trajectory [as children] has not been evident in the context of [adults with impairments of capacity to give informed consent (AWIC)]’. I argue that her likening assent in AWIC to assent in children is problematic for at least two related reasons. First, direct comparisons between AWIC and children run the risk of perpetuating or reinforcing infantilising stereotypes against people with disabilities. Second, I argue that people with disabilities are vulnerable in ways that most children are not, and thus, are dissimilar in a morally relevant manner…

Editor’s note: The article which is referenced in this commentary was featured in the February edition of this digest.

Autonomy of Individuals with Alcohol-Related Disorders: Informed Consent and Empowerment
João Paulo Barbosa Azevedo
Journal of Addiction & Addictive Disorders, 12 April 2023
Abstract
Informed consent is a central concern in the care practice of individuals with alcohol- related disorders, with research and clinical practice indicating that they often refuse or abandon treatment early. In the relational care encounter it is important not only to recognize the patient as the subject of will and decision-making power, but also to pay attention to the experiences of vulnerability and the importance of promoting autonomy. These issues are particularly relevant when individuals with alcohol-use disorders come to treatment suffering from coercion or disturbed by anxiety and/or depression. A study on informed consent ethical practice was conducted on a sample of 85 professionals from the Addictive Behaviours and Dependencies network of the Regional Health Administration of the North, Portugal. A questionnaire was used to survey ethical attitudes. The results suggest the importance of reinforcing the practice of informed consent of individuals with alcohol-related disorders suffering from coercion, anxiety or depression as a place of a psychological empowerment process.

Informed consent with people judged incapable of legally consenting
Amy Bittick, Ryan Holliman
Advances in Mental Health and Intellectual Disabilities, 6 April 2023
Abstract
Purpose
The purpose of this study is to consider informed consent with those who may be legally judged incapable of consent. Frequently individuals with traumatic brain injuries and intellectual disabilities may fall into this category. This paper seeks to consider aspects of guardianship, moral and legal implications and best practices for mental health professionals.
Design/methodology/approach
This practice piece reviews literature regarding informed consent, as well as pertinent issues in the professional literature regarding types of guardianship as well as the occurrence of “Lucid intervals.” Furthermore, literature from moral philosophy and current legal research was examined to fully provide readers with a grasp of the legal and ethical landscape of this issue.
Findings
The paper finds that treating consent as a one-time binary event is lacking in both practicality and nuance. Moral philosophy and issues regarding paternalism are raised, as well as practice approaches to assessment of capability and how to engage in therapy in meaningful ways.
Originality/value
This paper provides insight into providing dignity-affirming therapy with a population that is often not considered in the literature of mental health ethics. When it is considered, the suggestions are so vague as to be of limited use. This manuscript provides nuance and practical applications to be a therapist that promotes dignity in those who might have varying levels of capacity to consent.

The Role of Different Aspects of Communication Behavior in the Assessment of Capacity to Consent
Luise Badenhoop, Stefanie Baisch, Susanne Penger, Julia Haberstroh
Journal of Gerontopsychology and Geriatric Psychiatry, 5 April 2023
Open Access
Abstract
Any medical treatment that interferes with physical integrity requires the informed consent of a patient capable of such consent. For people with dementia, the capacity to consent is questioned even in the early course of the disease. Particularly diagnostic instruments like the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) often deny people with dementia the capacity to consent because of high confounding of the results with patients’ verbal abilities. To date, it remains unclear whether not only verbal but also nonverbal communication is associated with assessments of capacity to consent. The current study investigates associations between patients’ verbal and nonverbal communication behaviors as assessed by the measure for Communication Behavior in People with Dementia in Ambulant Settings (CODEMamb) and capacity to consent as assessed by the MacCAT-T. We expected the strongest positive associations for verbal communication behaviors compared to nonverbal communication behaviors. Data of N = 43 patients with dementia (n = 8 capable of consent) were collected at two different German psychiatric clinics. The results show small to moderate correlations between the overall scores of CODEMamb and MacCAT-T. As expected, correlations were strongest for the verbal CODEMamb subscale. The results support current findings on the dependency of the MacCAT-T on verbal communication. Based on the findings, the discussion addresses how people with dementia can be enabled to make self-determined medical treatment decisions.

Right To Consent In Informed Consent For Medical Treatment For People With Mental Health Disorders
Santi Novia Ayu Kurniawati, Erna Dyah Kusumawati
International Journal of Business, Economics and Law, April 2023; 28(3)
Open Access
Abstract
Based on the philosophy of legal protection, this article seeks to determine the interpretation of the meaning of mental disorders according to the Civil Code and the application of informed consent to medical treatment for people with mental disorders governed by the Civil Code. Based on the principle of legal protection, this article also seeks to determine the implementation of informed consent to medical treatment for people with mental problems. In this study, the normative law method is being employed. The study’s findings reveal that one interpretation of the idea of mental disorder, based on Article 433 of the Civil Code which reads, “Any adult who is constantly dumb, sick of the brain, or dark-eyed should be put under guardianship, even when he is occasionally proficient with his mind.” maintains that mental disorder is a sort of inability to act or incompetence to conduct a legal act. Following the requirements of the Civil Code, even if those under guardianship are adults, they are considered legally incapable. Due to their inability to act for themselves, individuals with mental problems must give informed consent to medical treatment through family members or legal guardians. The application of informed consent to medical treatment for people with mental problems is governed by the Civil Code, which requires physicians to acquire permission from the patient’s family (supporters, according to the Civil Code). Due to their inability to make decisions for themselves, people with mental disorders cannot give informed permission for medical treatment. However, under Law No. 18 of 2014 concerning Mental Health, social services will assume the role of guardian if the patient has no family or relatives.

Editor’s note: The Civil Code referenced in this abstract is present in Indonesia.

Cardiac Interventions In The Absence Of Assent: An Ethical Dilemma
Complex Clinical Cases
Cooper B. Kersey, Beteal Ashinne, Jeffrey Keenan, James N. Kirkpatrick
Journal of the American College of Cardiology, March 2023
Open Access
Abstract
Background
Cardiovascular practitioners increasingly encounter complex treatment decisions, further complicated when patient decisional-capacity is impaired. We present an ethical conundrum of a patient without decision-making capacity who declined a life-saving surgery.
Case
A 63-year-old woman with schizophrenia and a prior history of mitral and aortic valve endocarditis was found to have recurrent endocarditis of her bioprosthetic mitral valve. Surgical management was recommended, but the patient declined. During a formal capacity assessment, the patient was deemed unable to comprehend her medical condition or the consequences of refusing surgery. The patient then developed transient complete heart block. Goals of care discussions revealed that the patient valued life prolongation and amelioration of her symptoms.
Decision-making
The patient’s durable power of attorney gave consent to proceed with the surgery. Surrogate decision-making rests on substituted judgement (based on knowledge of what the patient would have wanted) or best interest standards (based on beneficence or non-maleficence). The hospital ethics team supported the decision to proceed with surgery over the objections of the patient, in light of the prognosis without surgery, the likelihood of surgical benefit, and the values and goals the patient espoused. The ethics consult team also recommended seeking assent for the surgery from the patient. Assent is not required in addition to consent from a surrogate, but it oftentimes facilitates interventions without chemical or physical restraints. Ultimately, the patient provided passive assent and underwent successful re-do mitral and aortic valve replacements and was discharged in stable condition.
Conclusion
We highlight a case in which cardiovascular clinicians encountered a patient without decision-making capacity refusing a life-saving intervention. Cardiovascular clinicians should be familiar with important ethical elements involved in complex decision-making, including autonomy and its limits, substituted judgement and best interests standards, and standards and laws pertaining to surrogate decision-makers.

Informed consent in psychotic decompensation
Matea Podgornjak, Lea Hrvat Matić, Anita Stanišić, Ena Gutić, Igor Salopek
European Journal of Bioethics, 20 February 2023
Abstract
The consent of an informed patient is not merely a signature on a legally binding document,  but rather a process in which the patient is empowered and becomes an active ally in a treatment. Valid informed consent includes adequate information that is given to the patient in an appropriate manner, the voluntariness of consent, and the patient’s ability to make a decision regarding treatment. Meeting these conditions when treating patients with mental health disorders can be challenging. Mental disorders can compromise a person’s ability to understand relevant information about the nature of their illness as well as their ability to make decisions regarding treatment. However, a psychiatric diagnosis does not imply that a person is unable to make a decision regarding their treatment, nor does it exclude them as an equal partner in the therapeutic process. By reviewing the case of a 39-year-old patient who developed an acute psychotic disorder during the treatment of COVID pneumonia, we dive into the ethical dilemmas that arise when approaching a patient who is experiencing psychotic decompensation.