[The informed consent in the mature minor: Understanding and decision-making capacity]

[The informed consent in the mature minor: Understanding and decision-making capacity]
R Boceta, O Martínez-Casares, M Albert
Anales de Pediatria, 29 November 2020
Abstract
Introduction
The informed consent of the minor is a fundamental requirement of paediatric research. There is a lack of harmonisation as regards the age of the mature minor to consent, and there are no systematic tools available to assess competence in decision-making capacity. The objective of this work is to analyse the ethical and legal situation of consent by minors, as well as studies that use an objective assessment tool in the mature minor.
Material and methods
Systematic review of scientific articles in PubMed, Embase and the Grey Literature, published with keywords “informed consent minors”, without date restriction until March 2019. Abstracts and a selection of complete articles were reviewed following a protocol including identification, screening, eligibility, and inclusion.
Results
Of the 260 records identified, 139 were excluded. After categorising the resulting 121 publications, 13 were finally selected following the eligibility criteria, including 7 articles on international ethical and legal regulations and 6 on understanding and decision- making capacity assessment. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) semi-structured interview was used in 4 studies, including different age ranges (6-21 years) in healthy and sick children.
Conclusions
The semi-structured MacArthur interview adapted to adolescents could be an appropriate tool with robust psychometric measures for assessing competence for the informed consent of minors between 9 and 12 years of age. The regulation of informed consent in paediatric research should consider this evidence.

Editor’s note: This is a Spanish Language Publication.

Implementing Electric Consent Aimed at People Living with Dementia and Their Caregivers: Did We Forget Those Who Forget?

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?

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]

[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

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.

When patients behave badly: Consent, breach of the duty of care and the law

When patients behave badly: Consent, breach of the duty of care and the law
Perspective
Anne‐Maree Kelly, Tina Cockburn, Bill Madden
Emergency Medicine Australasia, 2 December 2020
Abstract
Patients who are abusive or aggressive in ED raise special clinical and legal challenges. These include what steps clinicians should take to exclude serious illness/injury as the cause of the behaviour and when investigations or treatments can be imposed on these patients without their consent. Using a case illustration, this paper discusses legal issues which arise in this context, including how the standard of care owed by clinicians is determined and what may constitute a breach of duty; such patients’ right to consent to (or decline) tests and treatment; and when clinicians may lawfully act without consent and/or control the patient’s behaviour.

Informed Consent in Right-to Try – A Dubious Assumption

Informed Consent in Right-to Try – A Dubious Assumption
Rebecca Dresser
Wake Forest Journal of Law & Policy, 2020; 11(1)
Open Access
Excerpt
In the debate over right-to-try, everyone agrees that the patient’s informed consent is essential. If individual autonomy is the justification for giving patients access to experimental interventions, then adequate understanding must be part of the process. To make autonomous choices, patients must compare the potential harms and benefits of investigational drugs to their other medical options.
Is it possible for patients to make informed decisions in the right-to-try context? Will patients make autonomous decisions about trying investigational drugs when expert oversight is absent? Much of the critical commentary on right-to-try laws focuses on the damage the laws could do to other patients in need of safe and effective treatments.1 But these laws also present dangers to the patients who are their purported beneficiaries.2 Right-to-try supporters claim that patient autonomy underlies their crusade, but they have done little to ensure that patients actually understand the choices these laws allow them to make.
This article examines the deficiencies in right-to-try requirements for informed consent. Part I reviews right-to-try statutes, focusing on the federal right-to-try law that was adopted in 2018. This part also compares the informed consent provisions in right-to-try laws with informed consent provisions in two other laws authorizing patient access to experimental interventions: federal law governing participation in human subject research and the Food and Drug Administration’s (“FDA”) Expanded Access Program…

Clinicians’ consent law knowledge: The case for education

Clinicians’ consent law knowledge: The case for education
Denise Patricia Craig, Fintan Thompson
Focus on Health Professional Education, 2020; 21(3)
Abstract
Introduction
The short-term objectives of this study were to investigate clinicians’ confidence with, and knowledge of, consent laws, their behaviour regarding familiarisation with patients’ advance care plans and the potential benefit of brief education. Education covered patients’ rights to refuse treatment, including via advance directive, and the legislated hierarchy of decision-making authority.
Methods
Throughout 2018, all clinicians at one Queensland Hospital and Health Service were invited to attend a 1-hour legal education session. The study used a crosssectional survey to measure clinicians’ knowledge before and after education. Responses from 316 pre- and 319 post-education questionnaires were analysed.
Results
A 1-hour legal education session improved clinicians’ understanding of legislated consent hierarchy and patients’ rights. Pre education, 4.1% of participants correctly identified the lawful consent hierarchy, rising to 65.5% after education. Accuracy increased significantly after education; however, substantial errors persisted.
Conclusions
The potential benefit of education to increase multidisciplinary clinicians’ legal knowledge was supported. Education can ensure that clinicians are made aware of patients’ rights and the potential complexity of lawful substitute decision making.       

The Quality of Obtaining Surgical Informed Consent for Cesarean Section in Public Hospitals of Iran

The Quality of Obtaining Surgical Informed Consent for Cesarean Section in Public Hospitals of Iran
Shadi Sabetghadam, Sedighe Rezaie Chamani, Zahra Amirkhanzadeh Barandouzi, Sedigheh Sedigh Mobarakabadi, Yalda Donyaei Mobarrez
Journal of Holistic Nursing and Midwifery, 2021; 31(1) pp 1-7
Abstract
Introduction
Nowadays, about 50-65% of births in Iran occur by Cesarean Section (CS). Informed consent (IC) is one of the most important ethical, legal and professional requirements of a surgical procedure.
Objectives
This study aims to assess the quality of obtaining surgical IC from women underwent CS in public hospitals of Iran.
Materials and Methods
In this analytical study with cross-sectional design, 300 postpartum women who had CS referred to two public hospitals in Rasht, Iran were participated through stratified random sampling method in 2016. Data were collected using a two-part researcher-made questionnaire. Collected data were analyzed by using descriptive statistics, Kruskal-Wallis test, Mann-Whitney U test, and Spearman’s correlation test.
Results
The mean age of participants was 29.84 ± 5.9 years. The majority of them (45.3%) had education lower than high school. The overall mean score for the quality of obtained IC was 62.23±23.38, out of 150 points. Regarding its dimensions, quality of acquiring IC form (20.21±7.12, out of 40 points), provision of CS-related information (15.67±11.10, out of 45 points), voluntariness (7.53±6.95, out of 25), and the physician–patient relationship (18.81±8.87, out of 40 points) were perceived poor. Women’s educational level had a significant correlation with the IC quality dimensions of voluntariness (P=0.0001) and physician–patient relationship (P=0.043). The number of deliveries (P=0.008), live births (P=0.031), and stillbirth (P=0.0001) had a significant correlation with acquiring the IC form. The voluntariness was significantly associated with the number of live births (P=0.023) and stillbirth (P=0.001). The physician-patient relationship dimension was significantly associated with the number of pregnancies (P=0.023) and abortions (P=0.0001). The overall quality of obtained IC was significantly correlated with the women’ age (r= 0.162, P= 0.005).
Conclusion
Most of women in Iran are not informed enough about the CS and its consequences. Health care providers should pay more attention to the women’s characteristics when obtaining IC for the CS.  We recommend essential changes in the process of obtaining surgical IC for the CS in public hospitals of Iran. Obtaining IC during pregnancy may reduce unnecessary CSs.

Power-Laden (Mis)Understandings Surrounding Written Voluntary Informed Consent Procedures in Postcolonial Southern Africa

Power-Laden (Mis)Understandings Surrounding Written Voluntary Informed Consent Procedures in Postcolonial Southern Africa
Michelle R. Brear
The Qualitative Report, 4 December 2020; 25(13) pp 71-89
Abstract
Written voluntary informed consent (VIC) procedures are the standard approach for operationalising the ethical principle of respect for persons’ autonomy in qualitative research. However, achieving fully informed and truly voluntary consent is challenging, particularly in qualitative research and/or postcolonial contexts. Evidence about (mis)understandings (i.e., unintended meanings) surrounding VIC comes primarily from participants in quantitative, biomedical research. I aim to advance knowledge about qualitative research participants’ (mis)understandings of VIC. I used ethnographic methods to document the evolving (mis)understandings participants attached to written VIC procedures in two postcolonial settings, Eswatini and South Africa. All participants provided me consent to document their interactions as co-researchers in participatory research, in which they learned about, designed and implemented VIC procedures. I analysed the data interpretively and abductively, informed by Bourdieu’s theory of practice. Participants valued the opportunity to decide and sign consent to participate but held (mis)understandings of study information and signing, which evolved as they participated. Many (mis)understandings were shaped by what the unfamiliar act of signing symbolised to them (i.e., binding, contractual agreements that protected the researcher/university and through which they relinquished their rights), from their positions of marginalisation amidst economic/material, cultural and social power inequalities. In postcolonial settings, requiring qualitative research participants to sign consent forms likely undermines the ethical principle of respect that VIC is intended to operationalise. Based on these findings I recommend alternative non-written procedures are used to operationalise the principle of respect in postcolonial qualitative research settings.