Communication in Psychiatric Coercive Treatment and Patients’ Decisional Capacity to Consent [BOOK CHAPTER]
Gabriele Mandarelli, Giovanna Parmigiani
Springer – Empathy, Normalization and De-escalation, 29 January 2021; pp 113-132
Abstract
Effective communication and the acquisition of a valid consent are central to a good doctor-patient relationship and a clinician’s ethical obligation in order to respect patients’ autonomy, as well as their right to be involved in treatment decisions. However, often clinicians face several issues in performing this task, among which the most frequently reported are the fear of hurting the patient by communicating a bad diagnosis or not knowing how to manage the patient’s emotional reactions. In addition, there are vulnerable populations, such as those represented by psychiatric patients, who are at higher risk of decisional incapacity. Especially for those patients, it is in fact particularly difficult for clinicians to find the proper balance between respecting the right of capable patients to make choices about their treatment and the right of incapable patients to be protected from the possible harmful consequences of their improper decisions. However, nor the presence of a severe psychiatric disorder nor a status of “involuntary hospitalized patient” has been reported to be a label for incapacity. Several tools have been developed to assist clinicians in patients’ decisional capacity evaluations, together with interventions aimed at enhancing informed consent acquisition in order to achieve shared decision-making and lead the patient to become actively involved in his/her treatment decisions. Such an approach would lead to a decrease in the perceived coercion, often reported in mental healthcare settings and also from patients who are not involuntarily hospitalized, and to an increase in patients’ adherence to treatment.
Month: February 2021
Equality in the Informed Consent Process: Competence to Consent, Substitute Decision-Making, and Discrimination of Persons with Mental Disorders
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.
The importance of consent in case reports
The importance of consent in case reports
Ross J Thomson, C Fielder Camm
European Heart Journal – Case Reports, 4 January 2021
Open Access
Excerpt
…The Committee on Publication Ethics and the International Committee of Medical Journal Editors have issued guidelines on the publication of case reports. These state that, with limited exceptions, consent from the patient should be obtained prior to publication of a case report. When obtaining informed consent authors must advise their patients not only that their case will be placed in the public domain but that despite every effort at anonymisation there exists a possibility that they may be identified, and that their consent is irrevocable after (but not before) publication. As part of the consent process, the patient should have the opportunity to read the manuscript and view any images accompanying it…
The patient’s right to informed consent in the US Legal System. Genesis, development, foundations and brief questioning comparison with the Spanish model
The patient’s right to informed consent in the US Legal System. Genesis, development, foundations and brief questioning comparison with the Spanish model
Noelia Martinez-Doallo
Derecho y Salud, 2020; 30(2) pp 57-83
Abstract
A legal analysis on the informed consent of the patient primarily requires considering the common law, regardless of solutions provided by the malpractice statutes and a promising constitutional protection route, despite the ascertainment of some preventable shortcomings. This paper aims to offer a comprehensive review on the genesis, advancement and basis of the U.S. legal protection of the informed consent in the healthcare extent, to afterwards carry out a brief comparative study with the Spanish regulation.
Indigenous Peoples’ Free, Prior and Informed Consent (FPIC) and the World Bank Safeguards: Between Norm Emergence and Concept Appropriation
Indigenous Peoples’ Free, Prior and Informed Consent (FPIC) and the World Bank Safeguards: Between Norm Emergence and Concept Appropriation
Stéphanie de Moerloose
World Comparative Law, 2020; 53(3) pp 223-244
Abstract
The question of the consent of indigenous peoples is at least as old as colonization. Indeed, the consent of indigenous peoples was already an issue at the heart of treaty-making between colonial settlers and indigenous peoples. The issue of indigenous peoples’ consent, understood as their Free, Prior and Informed Consent (FPIC), has been re-emerging and gaining acceptance internationally in international Human Rights law over the last 30 years. When the new World Bank safeguards were adopted in 2016, one of the most discussed topics during the consultation rounds had been the integration in the safeguards of the concept of the FPIC of indigenous peoples, as it had been notoriously absent from the previous safeguards. Finally, FPIC was made part of the new safeguards. This paper first maps the concept of FPIC under international law from a postcolonial perspective. Then, it attempts to analyze the processes of operationalization of the concept by the World Bank in the new safeguards, drawing on Human Rights and on law and development literature. The paper argues that there is a tension between the re-emergence of FPIC as a customary norm and the fragmentation of the interpretations of the concept of consent by different actors. The operationalization of the concept of FPIC, understood as a negotiated process rather than a process of self-determination, may in fact limit its remedial objective and diminish its quality as a resistance tool.
Ethical Dimensions in Research – Informed Consent and Female Gender in Nigeria [BOOK CHAPTER]
Ethical Dimensions in Research – Informed Consent and Female Gender in Nigeria [BOOK CHAPTER]
Olufunke Olufunsho Adegoke
Africa’s Radicalisms and Conservatisms; Brill, 15 January 2021; Chapter 17 pp 321-340
Abstract
Women in any society are germane to its continual existence and development. Their contribution to development cannot be neglected and undermined. However, there is the persistence of gender inequality in many places in Africa (carried over perhaps from traditional African societies). Such inequality marginalizes the societies from the gains of development. The inequality manifests itself in many areas including in research. This chapter postulates that there has to be a re-evaluation of female gender status quo on informed consent in research. There are issues of contention which arises in the context of the local environment, spousal consent and of importance is the level of education with the contextual understanding of the informed consent in any research. It is a system of social stratification and differentiation on the basis of sex, which provides material advantages to men while simultaneously placing severe constraints on the roles and activities of women. Evidence based researches have disclosed that women are not well informed and this over shadows their judgment on appropriate decision making. This observation calls for the need of culturally competent and sensitive approaches that addresses identity specific barriers in research when designing consent forms. There is the need for gender mainstreaming in research implementation and ethical process especially informed consent. The attainment of gender equality is not only seen as an end itself and human right issues, but as a prerequisite for the achievement of sustainable development.
Challenges of Obtaining Informed Consent in Poorly Coordinated and Funded Healthcare Services: Papua New Guinea Situation
Challenges of Obtaining Informed Consent in Poorly Coordinated and Funded Healthcare Services: Papua New Guinea Situation
Alfred P. Minei, Sam O. Kaipu
Journal of Health Science, July-August 2020; 8(4)
Open Access
Abstract
During a semi-structured interview we ask the participants several questions based on the perceived role of the interviewee within the informed consent process. We asked questions pertaining to how informed consent unravels itself across barriers. Few question topics included how the issue of socio-economic, geography and custom of the people are addressed, and how the medical professionals deal with different groups of people and how the interviewees understood informed consent. Interviews for each group were asked with different sets of questions and were open enough to allow for probing questions in order to gain additional information when the opportunity presented itself. The data were analyzed using interpretative approaches and the various themes and concepts from each question and response qualitatively counted and uncovered patterns in the various group perspectives. We examined the participants’ perspectives and opinions using a visual table for comparing themes and concepts, and we presented the interviewees’ views.
Improving Surgical Informed Consent, Unanswered Questions
Improving Surgical Informed Consent, Unanswered Questions
Review Article
Raper, Steven E., Clapp, Justin T., Lee A.
Annals of Surgery, March 2021; 2(1)
Abstract
Objective
This study reviews randomized clinical trials that have attempted to improve the process of informed consent. Consent should be guided by the ethical imperatives of autonomy, beneficence, and social justice.
Summary Background
Informed consent is constantly evolving. Yet our review of the randomized trials done to improve the surgical informed consent process raises a number of questions: How does one define surgical informed consent? What interventions have been tried to measure and improve informed consent? Have the interventions in informed consent actually led to improvements? What efforts have been made to improve informed consent? And what steps can be taken to improve the process further?
Methods
A literature search for randomized controlled trials (RCTs) on informed consent identified 70 trials. Demographics, interventions, assessments, and a semi-quantitative summary of the findings were tabulated. The assessments done in the RCTs, show the surrogate for patient autonomy was comprehension; for beneficence, satisfaction and mental state (anxiety or depression); and, for social justice, language, literacy, learning needs, and cost.
Results
There were 4 basic categories of interventions: printed matter; non-interactive audiovisual tools; interactive multimedia; and a smaller group defying easy description. Improvement was documented in 46 of the 65 trials that studied comprehension. Thirteen of 33 trials showed improved satisfaction. Three of 30 studies showed an increase in anxiety. Few studies tried to assess primary language or literacy, and none looked at learning needs or cost.
Conclusions
No single study improved all 3 principles of informed consent. Validated interventions and assessments were associated with greater impact on outcomes. All 3 ethical principles should be assessed; autonomy (as comprehension), beneficence (as satisfaction, anxiety), and social justice. Not enough consideration has been given to social justice; appropriate language translation, standardized reading levels, assessment of learning needs, and cost to the individual are all important elements worthy of future study.
Informed Consent to Patients in Root Canal Treatment (Case Study: Melati Dental Clinic Jakarta, Indonesia)
Informed Consent to Patients in Root Canal Treatment (Case Study: Melati Dental Clinic Jakarta, Indonesia)
Pudentiana Rr RE, Tedi Purnama, Syifa Yulia Lestari, Yulianti
Medico-legal Update, January-March 2021, 21(1)
Open Access
Abstract
Teeth with necrosis require root canal treatment. Before taking any action, the treatment plan that will be carried out along with the risks must be explained clearly to the patient and his family, and then must get informed consent for the treatment plan. The purpose of this study was to the description of informed consent in patients with root canal treatment at the Melati Dental Clinic in Jakarta. Method: This research uses descriptive method with research sample using technique total sampling of 50 respondents. The data used are secondary data taken from the patient’s medical record. Results: Respondents 33 people (66%) provided complete informed consent and 17 people (34%) did not give complete informed consent. Respondents doing root canal treatment caused by caries as many as 38 people (76%) and respondent root canal treatment caused not because of caries as many as 12 people (24%). Respondents provided complete informed consent in patients with root canal treatment because of caries by 27 people (71%) and giving complete informed consent not because of caries by 6 people (50%). Whereas giving informed consent was incomplete because of caries as many as 11 people (29%) and incomplete informed consent was not due to caries as many as 6 people (50%). Conclusion: Management of Informed Consent in Root Canal Treatment patients at Melati Dental Clinic in Jakarta has been carried out well.
Is waiver of consent for the use of health information for research acceptable to emergency department patients?
Is waiver of consent for the use of health information for research acceptable to emergency department patients?
Perspective
Chase Schultz‐Swarthfigure, Anne‐Maree Kelly
Emergency Medicine Australasia, 27 January 2021
Abstract
Some emergency medicine research, especially retrospective studies using medical records review, rely on waiver of consent for use of personal health information (PHI) contained in clinical records. This is a secondary use of PHI and waiver of consent raises ethical, legal and practical issues. Granting of a waiver of consent is often (but not always) approved by a human research ethics committee and requires separate but inter‐related consideration of the legal and ethical issues. In part, this involves a balancing of the public interest versus the risk to privacy and an evaluation of whether subjects would, mostly likely, have agreed to the use of their PHI had they been asked. To date, there are no robust data about whether use of PHI without consent for research would be acceptable to people who attend Australasian EDs for care.
Center for Informed Consent Integrity 