Lack of assent to dental examination in children with intellectual disabilities: Dentists’ practices in Europe and ethical issues
Original Article
Ariane Camoin, Isabelle Blanchet, Lionel Dany, Pierr Le Coz, Bérengère Saliba-Serre, Corinne Tardieu
Special Care in Dentistry, 19 March 2024
Abstract
Aim
(1) To determine the repartition of criteria which can be considered as marks of lack of assent by the child with
intellectual disabilities from the dentist’s point of view and whether that influences the decision to examine the patient or not. (2) To explain the decision of practitioners and determine the ethical implications of these practices.
Methods
An anonymous and structured questionnaire was distributed online using the scenario of a 9-year-old child with moderate cognitive impairment with eight different oppositional behaviours. The practitioners were asked about their perception of the patient’s lack of assent and about their decision to perform the dental examination or not.
Results
The proportion of them who performed a dental examination despite the patient’s refusal represented between 13% and 28.8% of the population of respondents.
Conclusion
There was an ambivalence among the practitioners who carried out a dental consultation when children were uncooperative. They adopted a teleological point of view. It calls for us to reflect on the ethical principles of autonomy and beneficence.
Month: April 2024
Reliability of clinical judgment for evaluation of informed consent in mental health settings and the validation of the Evaluation of Informed Consent to Treatment (EICT) scale
Reliability of clinical judgment for evaluation of informed consent in mental health settings and the validation of the Evaluation of Informed Consent to Treatment (EICT) scale
Original Research
Nicola Di Fazio, Donato Morena, Federica Piras, Fabrizio Piras, Nerisa Banaj, Giuseppe Delogu, Felice Damato, Paola Frati, Vittorio Fineschi, Stefano Ferracuti, Gabriele Sani, Claudia Dacquino
Frontiers of Psychology – Quantitative Psychology and Measurement, 26 February 2024
Excerpt
The competence assessment to give informed consent in the legal and healthcare settings is often performed merely through clinical judgment. In the present pilot study, we evaluated the reliability of clinical judgment in the mental health field, with a focus on assessing the general competence of outpatients with schizophrenia. Moreover, we tested a new scale (“Evaluation of Informed Consent to Treatment” -“EICT” Scale) suitable as a standardized assessment tool. The scale assesses four dimensions of competence, Understanding, Evaluating. Reasoning and Expressing a choice. Thirty-four outpatients with schizophrenia were evaluated for their competence to consent by five referring clinicians with different backgrounds (psychiatrist, forensic psychiatrist, geriatrician, anesthetist, and medico-legal doctor). Correlation analyses were conducted between the scores obtained by the clinicians on a modified version of the Global Assessment of Functioning scale (GAF) designed specifically to subjectively assess functioning in each of the four competence dimensions. Moreover, two validated competence scales (Mac-CAT-T, SICIATRI-R), and a neuropsychological battery were administered along with scales for evaluating neuropsychiatric symptoms severity and side effects of medication…
Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study
Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study
Research
Masunga K. Iseselo, Edith A. M. Tarimo
BMC Medical Ethics, 13 March 2024; 25(29)
Open Access
Abstract
Background
Informed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers’ comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort.
Methods
We conducted a qualitative study among volunteers who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants.
Results
Volunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers’ decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study.
Conclusion
Engagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials.
The informed consent process: An evaluation of the challenges and adherence of Ghanaian researchers
The informed consent process: An evaluation of the challenges and adherence of Ghanaian researchers
Paa-Kwesi Blankson, Florence Akumiah, Amos Laar, Lisa Kearns, Samuel Asiedu Owusu
Developing World Bioethics, 13 March 2024
Abstract
This study assessed challenges faced by researchers with the informed consent process (ICP). In-depth interviews were used to explore challenges encountered by Investigators, Research assistants, Institutional Review Board members and other stakeholders. An electronic questionnaire was also distributed, consisting of Likert-scale responses to questions on adherence to the ICP, which were derived from the Helsinki Declaration and an informed consent checklist of the US Department of Health and Human Research (HSS). Responses were weighted numerically and scores calculated for each participant. The median score of the level of adherence to the informed consent process was 93%. Most of the respondents (60%) cited the lack of time for the ICP to be a challenge, with 65% indicating a lengthy consent document to be the main challenge with the informed consent document. Challenges with language and communication were the dominant theme among informants. Despite the high adherence of Ghanaian researchers and research assistants to the ICP, challenges are still prevalent, requiring diligent and continuous efforts in research implementation.
Voluntariness of consent in paediatric HIV clinical trials: a mixed-methods, cross-sectional study of participants in the CHAPAS-4 and ODYSSEY trials in Uganda
Voluntariness of consent in paediatric HIV clinical trials: a mixed-methods, cross-sectional study of participants in the CHAPAS-4 and ODYSSEY trials in Uganda
Original Research
Shafic Makumbi, Francis Bajunirwe, Deborah Ford, Anna Turkova, Annabelle South, Abbas Lugemwa, Victor Musiime, Diana Gibb, Imelda K Tamwesigire
BMJ Open, 1 March 2024
Open Access
Abstract
Objectives
To examine the voluntariness of consent in paediatric HIV clinical trials and the associated factors.
Design
Mixed-methods, cross-sectional study combining a quantitative survey conducted concurrently with in-depth interviews.
Setting and participants
From January 2021 to April 2021, we interviewed parents of children on first-line or second-line Anti-retroviral therapy (ART) in two ongoing paediatric HIV clinical trials [CHAPAS-4 (ISRCTN22964075) and ODYSSEY (ISRCTN91737921)] at the Joint Clinical Research Centre Mbarara, Uganda.
Outcome measures
The outcome measures were the proportion of parents with voluntary consent, factors affecting voluntariness and the sources of external influence. Parents rated the voluntariness of their consent on a voluntariness ladder. Indepth interviews described participants’ lived experiences and were aimed at adding context.
Results
All 151 parents randomly sampled for the survey participated (84% female, median age 40 years). Most (67%) gave a fully voluntary decision, with a score of 10 on the voluntariness ladder, whereas 8% scored 9, 9% scored 8, 6% scored 7, 8% scored 6 and 2.7% scored 4. Trust in medical researchers (adjusted OR 9.90, 95% CI 1.01 to 97.20, p=0.049) and male sex of the parent (adjusted OR 3.66, 95% CI 1.00 to 13.38, p=0.05) were positively associated with voluntariness of consent. Prior research experience (adjusted OR 0.31, 95% CI 0.12 to 0.78, p=0.014) and consulting (adjusted OR 0.25. 95% CI 0.10 to 0.60, p=0.002) were negatively associated with voluntariness. Consultation and advice came from referring health workers (36%), spouses (29%), other family members (27%), friends (15%) and researchers (7%). The indepth interviews (n=14) identified the health condition of the child, advice from referring health workers and the opportunity to access better care as factors affecting the voluntariness of consent.
Conclusions
This study demonstrated a high voluntariness of consent, which was enhanced among male parents and by parents’ trust in medical researchers. Prior research experience of the child and advice from health workers and spouses were negatively associated with the voluntariness of parents’ consent. Female parents and parents of children with prior research experience may benefit from additional interventions to support voluntary participation.
Biomedical research on autism in low- and middle-income countries: Considerations from the South African context
Biomedical research on autism in low- and middle-income countries: Considerations from the South African context
Siobhan de Lange, Dee Muller, Chloe Dafkin
Developing World Bioethics, 26 February 2024
Abstract
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by social/communicative difficulties and perseverative behaviours. While research on autism has flourished recently, few studies have been conducted on the disorder in non-Western contexts. In low- and middle-income countries (LMICs), biomedical research on autism is required to better understand the needs of the population and to develop contextually appropriate interventions. However, autistic individuals are a vulnerable study population and LMICs present with various considerations. While the presentation of autism is heterogeneous, stigma is a common social consequence affecting research. Drawing specifically on the South African context, the ethical intersections of these issues are discussed, along with the limitations of the current informed consent process. Community engagement is recommended as an adjunct to informed consent to ensure that biomedical research is conducted in a more inclusive way. Practical pointers are provided for implementing systematic support for conducting community engagement alongside biomedical research.
Comparative study on informed consent regulation in health care among Italy, France, United Kingdom, Nordic Countries, Germany, and Spain
Comparative study on informed consent regulation in health care among Italy, France, United Kingdom, Nordic Countries, Germany, and Spain
Research Paper
Vittorio Bolcato, Chiara Franzetti, Giovanni Fassina, Giuseppe Basile, Rosa Maria Martinez, Livio Pietro Tronconi
Journal of Forensic and Legal Medicine, 14 March 2024
Open Access
Abstract
The information and subsequent expression of will, so-called informed consent, have become the essential element of health right, understood as the right to autonomous choice in health, based on the fiduciary relationship between physician and patient. This gradually leads European Countries to adopt special legislations and to issue frequent judgments on the subject. However, new challenges in daily clinical practice call for further study of legal solutions. The authors analyse and compare the regulations on informed consent in health care of Italy, France, the United Kingdom, the Nordic Countries, Germany, and Spain. The health and legal contexts, existence of special regulations on informed consent and their characteristics are discussed. Informed consent resulted a mandatory requirement. Clear communication about treatment, therapeutic alternatives, and major risks, discussed in conversation, but preferably documented in writing, are agreed upon. The possibility of dissent and withdrawal of consent are also included. There is a growing interest in involving and regulating the entire health team in information and consent. Lowering the age of consent for minors or analysing the maturity of minors are attempts to increase their participation in health decisions. On another side, the protection of adult incapables persons requires greater involvement of family and fiduciaries to better adapt to changing health needs. Health policy must take responsibility for training health professionals and citizens about the value of health information and communication as a shared choice in care planning, to strengthen the bond of trust with the healthcare system and users.
The Application of the Doctrine of Informed Consent in South African Medical Law: Reflections on Significant Developments in the Case Law
The Application of the Doctrine of Informed Consent in South African Medical Law: Reflections on Significant Developments in the Case Law
Marno Swart, Pieter Carstens
South African Law Journal, 1 March 2023
Abstract
The doctrine of informed consent is the foundation of the physician–patient relationship. This doctrine remains controversial despite its importance, and issues involving consent are frequently litigated. This article examines the application of the doctrine of informed consent in South African medical law as it has developed in South African case law. This examination first sets a normative background for consent as a ground of justification against a wrongful act in either contract or delict (or both) that is significantly influenced by the Constitution of the Republic of South Africa, 1996. Against this normative background, a selected anthology of nine significant judgments by South African courts is analysed, with specific attention paid to the critical shift prompted by the promulgation of the Constitution. Finally, the analyses of the nine judgments are consolidated and collated to draw conclusions about the triumphs and failings of the South African courts, based on the normative background. This analysis reveals which aspects of the doctrine of informed consent have crystallised in South African medical law and which remain unclear.
The new legal requirements of consent in Kuwait
The new legal requirements of consent in Kuwait
Journal Article
Noura Hezam Almutairi
International Data Privacy Law, 28 February 2024
Extract
Introduction
Private and public sector controllers collect and process Internet user data. Consent is a legitimate basis for processing their information. Consent is the legal tool that enables Internet users to control their data to safeguard their right to privacy. Nonetheless, laws governing consent in Kuwait have failed to achieve their objective for three reasons.
First, many Internet users are unwilling to read and understand the content of the privacy notice (of social media sites, smart mobile apps, Internet of Things [IoT] devices such as Fitbit) or cookies (of e-commerce companies such as Amazon and search engines such as Google). The notice may be written in complex and vague language, such as legal jargon, or be overly long. Therefore, Internet users consent to cookies and privacy notices without knowing how their collected data will be used or to whom it will be disclosed.
Secondly, while a user may understand the privacy notice, they only sometimes have an option or right to refuse. This instance is similar to a contract of adhesion, as the individual’s consent is not freely given. Finally, vulnerable Internet users, such as children, may consent to privacy notices without understanding the implications of agreeing to them…
Free, Prior, and Informed Consent, A Norm in Development or a Corporate Obligation?
Free, Prior, and Informed Consent, A Norm in Development or a Corporate Obligation?
Laurence Klein, María Jesús Muñoz-Torres, María Ángeles Fernández-Izquierdo
International Journal on Minority and Group Rights, 27 Feb 2024
Abstract
Free, Prior, and Informed Consent (fpic) is crucial for the exercise of indigenous peoples’ right to self-determination, a binding human rights norm, as it provides them with the opportunity to determine how their lands and resources are developed. While numerous companies have committed to respecting fpic in their corporate policies, there continues to be a huge disconnect between public rhetoric and actions on the ground, and indigenous peoples generally struggle to have a meaningful voice in decision-making processes that concern them. Even if the United Nations Guiding Principles on Business and Human Rights (ungp, 2011) have compelled companies to gain ground with regards to their responsibility to respect human rights, the ‘do-no-harm’ principle does not require them to take positive actions towards fulfilling human rights. This approach is inconsistent with the moral foundation of human rights, which implies duties, and does not account for the substantial economic and political power that increases companies’ potential as guarantors of human rights. Based on the normative and moral legitimacy sustaining the narrative on corporate human rights obligations and the political, moral and legal imperative behind fpic, this article asserts that companies have a normative obligation to observe fpic, which they ought to operationalise in the context of heightened requirements regarding their human rights due diligence.
Center for Informed Consent Integrity 