Equality in the Informed Consent Process: Competence to Consent, Substitute Decision-Making, and Discrimination of Persons with Mental Disorders
Matthé Scholten, Jakov Gather, Jochen Vollmann
Journal of Medical Philosophy, 25 January 2021; 46(1) pp 108-136
Open Access
Abstract
According to what we propose to call “the competence model,” competence is a necessary condition for valid informed consent. If a person is not competent to make a treatment decision, the decision must be made by a substitute decision-maker on her behalf. Recent reports of various United Nations human rights bodies claim that article 12 of the Convention on the Rights of Persons with Disabilities involves a wholesale rejection of this model, regardless of whether the model is based on a status, outcome, or functional approach to competence. The alleged rationale of this rejection is that denying persons the right to make their own treatment decisions based on an assessment of competence necessarily discriminates against persons with mental disorders. Based on a philosophical account of the nature of discrimination, we argue that a version of the competence model that combines supported decision-making with a functional approach to competence does not discriminate against persons with mental disorders. Furthermore, we argue that status- and outcome-based versions of the competence model are discriminatory.

Implementing Electric Consent Aimed at People Living with Dementia and Their Caregivers: Did We Forget Those Who Forget?
Yvonne O’ Connor, Ian Twohig, Leona O’ Brien
Proceedings of the 54th Hawaii International Conference on System Sciences, 2021
Open Access
Abstract
As policy flows down from law and/or regulation (e.g. GDPR) our individual privacy concerns give rise to demands on improving accessibility, awareness and comprehension, the topic of eConsent is becoming more prevalent. We provide a critical voice by considering, but also challenging, the underlying assumptions that the status quo of eConsent design and implementation is appropriate for all people in society. By answering “what eConsent characteristics are prevalent in the context of dementia applications?”, this paper identifies that the “one size fits all” ethos for eConsent is not applicable in every context. As a result, a taxonomy that depicts the multifaceted concept of eConsent is proposed. It makes us aware of the different ethical, legal, social and technical implications of ICT use and provides an opportunity to create discourse in this area. It argues that future research examining the effectiveness of innovative ICTs must take the eConsent process into account.

How should the ‘privilege’ in therapeutic privilege be conceived when considering the decision-making process for patients with borderline capacity?
Original Research
Sumytra Menon, Vikki Entwistle, Alastair Vincent Campbell, Johannes J M van Delden
BMJ Medical Ethics, 22 December 2020
Open Access
Abstract
Therapeutic privilege (TP) is a defence that may be available to doctors who fail to disclose to the patient relevant information when seeking informed consent for treatment if they have a reasonable belief that providing that information would likely cause the patient concerned serious physical or mental harm. In a landmark judgement, the Singapore Court of Appeal introduced a novel interpretation of TP, identifying circumstances in which it might be used with patients who did not strictly lack capacity but might be inclined to refuse recommended treatments. In this paper, we explore the conceptual and practical challenges of this novel interpretation of TP. We propose that more emphasis should be placed on forms of shared and supported decision-making that foster the autonomy of patients with compromised mental capacity while being mindful of the need to safeguard their well-being. The kind of privilege that doctors might need to invoke is one of time and supportive expertise to ensure a flexible, responsive approach calibrated to the individual patients’ needs. The provision of such service would extinguish the need for the novel TP proposed by the Singapore Court of Appeal.

[Capacity to consent of people with dementia : Insights into the S2k AWMF guidelines 108-001]
J Haberstroh, VA Tesky, J Pantel
Journal of Gerontology and Geriatrics, 7 December 2020
Abstract
People with dementia often require medical and nursing care and are regularly confronted with the need to make decisions in this respect; however, in practice uncertainty often exists as to whether a person with dementia is capable of providing consent, what procedures should be used to obtain informed consent, how to provide the necessary information and how capacity to consent can be assured. By providing structured practical recommendations, the S2k guidelines “Consent of persons with dementia to medical treatment” (coordinated by the Association of the Scientific Medical Societies of Germany, AWMF, registration number 108-001) provide a first attempt to summarize and update the relevant medical, legal, ethical and psychological requirements that should be satisfied in this respect. This article enables insights into the guidelines and an overview of the most important recommendations.

Editor’s note: This is a German Language Publication

Ethics of Informed Consent, Coercive and Preventive Medication
Hanfried Helmchen
NeuroPsychopharmacotherapy, 5 December 2020; pp 1-16
Abstract
Acknowledgement of human rights and its translation into psychiatric action is an increasingly extensive achievement of the past decades. Orientation towards the individual patient means to recognize both his/her right and capacity of self-determination as well as to consider his/her preferences. This is particularly valid in the use of psychotropic medication in problematic situations such as in coercive and in preventive medication. In view of coercive medication in life-threatening psychiatric emergencies, psychiatrists must convert a seemingly antagonism between respecting the autonomy of the mentally ill and their obligation to care into an ethically acceptable complementary solution. Medication for primary prevention confronts the psychiatrist with difficulties of informing an (almost) healthy individual in view of uncertainties of conversion rates in schizophrenia as well as of lacking drugs with satisfying efficacy in dementia. The application of psychotropic drugs in such cases is often only the last choice due to their questionable or low efficiency, unwanted effects, and other preferences of the comprehensively informed patient.

Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke
Personal View
Erwin J O Kompanje, Jeroen T J M van Dijck, Vicky Chalos, Sophie A van den Berg, Paula M Janssen, Paul J Nederkoorn, Mathie uvan der Jagt, Giuseppe Citerio, Nino Stocchetti, Diederik W J Dippel, Wilco C Peul
The Lancet Neurology, 21 October 2020
Summary
Health-care professionals and researchers have a legal and ethical responsibility to inform patients before carrying out diagnostic tests or treatment interventions as part of a clinical study. Interventional research in emergency situations can involve patients with some degree of acute cognitive impairment, as is regularly the case in traumatic brain injury and ischaemic stroke. These patients or their proxies are often unable to provide informed consent within narrow therapeutic time windows. International regulations and national laws are criticised for being inconclusive or restrictive in providing solutions. Currently accepted consent alternatives are deferred consent, exception from consent, or waiver of consent. However, these alternatives appear under-utilised despite being ethically permissible, socially acceptable, and regulatorily compliant. We anticipate that, when the requirements for medical urgency are properly balanced with legal and ethical conduct, the increased use of these alternatives has the potential to improve the efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent.

The Attitudes of Relatives of ICU Patients toward Informed Consent for Clinical Research
Research Article
Rania Mahafzah, Karem H. Alzoubi, Omar F. Khabour
Critical Care Research and Practice, 9 October 2020
Open Access
Abstract
Background
Informed consent is a key ethical requirement for biomedical research that is implemented to ensure autonomy and voluntary participation. However, patients in the intensive care unit (ICU) may be unconscious or severely ill and thus lack the capacity for decisions about research participation. Thus, relatives or guardians are usually asked to provide informed consent prior to the inclusion of ICU patients in research.
Aims
This study aimed to assess the attitudes and preferences of relatives of ICU patients toward informed consent in biomedical research in Jordan.
Subjects and Methods
A sample of 184 relatives with a critically ill next of kin in the ICU was anonymously surveyed regarding their attitudes and preferences toward giving informed consent for biomedical research on behalf of their patients.
Results
The study showed that the majority of relatives had a positive attitude toward the informed consent process on behalf of their patients in the ICU (72.3%). The perception that participation in research would be directly beneficial to their patient was the most significant reason to provide informed consent among relatives. The degree of relatedness to the patient was significantly associated with the decision to provide informed consent on behalf of the patients in the ICU. Additionally, more than 70% of the relatives strongly agreed to take part in clinical research if they were to be unconscious patients in the ICU. Moreover, the majority of the respondents agreed that their first-degree relatives would give consent on their behalf.
Conclusion
Relatives with a critically ill next of kin in the ICU had positive attitudes toward providing informed consent on behalf of their patients. This was motivated by the direct benefit from the research to their patient.

Family perceptions of clinical research and the informed consent process in the ICU
Short Communication
Marie Labruyère, Nicolas Meunier-Beillard, Fiona Ecarnot, Audrey Large, François Aptel, Jean-Baptiste Roudaut, Pascal Andreu, Auguste Dargent, Jean-Philippe Rigaud, Jean-Pierre Quenot
Journal of Critical Care, 28 September 2020
Abstract
Purpose
We investigated experiences of families who provide consent for research on behalf of a loved-one hospitalized in intensive care (ICU).
Methods
Multicentre, qualitative, descriptive study using semi-directive interviews in 3 ICUs. Eligible relatives were aged >18 years, and had provided informed consent for a clinical trial on behalf of a patient hospitalized in ICU. Interviews were conducted from 06/2018 to 06/2019 by a qualified sociologist, recorded and transcribed.
Results
Fifteen relatives were interviewed; average age 50.3 ± 15 years. All emphasized their interest in clinical research, seeing it as a duty. Involving their loved-one in research allowed them to find meaning in the events. Participants underlined that trust in caregivers and communication are determinant. The strict regulation of research was perceived as a guarantee of safety. Participants felt they lacked the intellectual capacity and knowledge to question explanations. The greatest fear was not that they might incur a risk for the patient, but rather, that they might deprive the patient of a chance at a cure.
Conclusion
Acceptance of research opportunities by relatives on behalf of decisionally-incapacitated patients is underpinned by trust in the physicians and the legislative framework. Communication and the quality of information provided by the caregivers are key.

How do dementia researchers view support tools for informed consent procedures of persons with dementia?
Original Contributions
Theresa S. Wied, Aoife Poth, Johannes Pantel, Frank Oswald, Julia Haberstroh
Zeitschrift für Gerontologie und Geriatrie, 19 September 2020
Open Access
Abstract
The study aimed to assess how dementia researchers view eight support tools that have been defined to enhance informed consent (IC) procedures for people with dementia (PwD). In an online survey, 19 dementia researchers from Germany and Portugal evaluated the tools in terms of 4 implementation criteria. Overall, they all had a very positive attitude towards the support tools, whereby the tools person-centered attitude of the researcher and elaborated plain language were the most highly rated of the eight tools. Our findings also indicated that familiar support tools were assessed more favorably than those that were previously unknown. Overall, the results of this study showed that the participating dementia researchers were open to the use of decision support measures in PwD and were willing to apply the support tools in practice.

Awareness and Understanding of Decision-Making Capacity and Its Relationship to Legally Valid Consent for Older Patients in Dentistry
Research Article
Amardeep Singh Dhadwal, Lwazi Sibanda, Igor R. Blum
Primary Dental Journal, 17 September 2020
Abstract
With a growing ageing population and increased life expectancy in the UK, oral healthcare professionals will be exposed to a greater number of patients with health conditions which may affect cognitive function, communication and capacity to consent to treatment. This often gives rise to a conundrum which clinicians may face when considering capacity, consent and the legal implications and frameworks surrounding this. Assessing patient capacity is encountered routinely in dental practice and so oral healthcare professionals should be well informed of their responsibilities in this context. This article summarises and introduces readers to key concepts regarding consent and capacity with reference to relevant cross-jurisdictional legislation.