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.
Consent in pregnancy: A qualitative study of the experiences of ethnic minority women
Consent in pregnancy: A qualitative study of the experiences of ethnic minority women
Zahra Khan, Anne Lanceley, Katherine Maslowski, Lily Hutton, Jacqueline Nicholls
Patient Education and Counseling, June 2024
Open Access
Abstract
Objective
Consent in ante-natal and birthing contexts is often challenging, controversial and poorly understood. Increasing evidence indicates that ethnic minority women’s overall experiences of ante-natal care are unsatisfactory, but little is known about their involvement in the consent process. This study aims to explore the views and experiences of ethnic minority women when making decisions requiring their consent.
Design
Qualitative interview study
Setting
A national study conducted in the UK
Sample
Seventeen self-selecting ethnic minority women who had given birth in a UK hospital in the previous 12 months.
Methods
In-depth telephone interviews with seventeen women. A thematic analysis was conducted with a focus on women’s experiences of the consent process.
Results
Three themes were identified. 1. Compromised choice: women experienced limited choice; some women were not asked for their consent at all, or consent was presumed. 2. Pressured consent and silencing: women reported feeling undermined and ‘othered’ based on their ethnicity. 3. Impersonal consent: discussions were impersonal and not tailored to women as individuals; some women suggested that healthcare professionals ignored cultural concerns which were important to them.
Practice Implications
There is an urgent need for healthcare professionals to be supported in actively facilitating consent consultations which enable women from ethnic minority backgrounds to freely voice their concerns and priorities without censure.
Conclusions
This exploratory study is a first step towards understanding how consent is experienced by ethnic minority women. Many women’s experiences reflected failure of healthcare professionals to support genuine choice-making which was perceived to be further undermined by negativity related to women’s ethnicity and cultural identity. There is a need for further research focusing on the consent experiences of specific ethnic minority groups.
Are we gaining valid consent for dental extractions? A retrospective audit on restorability assessment at one dental institution
Are we gaining valid consent for dental extractions? A retrospective audit on restorability assessment at one dental institution
Research
Melody Shirazi, Jasleen Batra, Maria Devine
British Dental Journal, 15 March 2024
Abstract
Introduction
This paper explores the widely relevant topic of obtaining valid consent in dental practice, focusing on assessing restorability of teeth planned for extraction. The General Dental Council stresses discussing treatment options, benefits and risks for informed decision-making. The study evaluates if pertinent factors, including tooth structure, endodontic status, periodontal health and patient considerations, are considered before consent.
Aim
To ensure restorability has been assessed and all options communicated with patients for completeness of the consent process before tooth extraction.
Objective
To assist clinicians in their systematic assessment of a tooth’s restorability and provide a framework for contemporaneous documentation.
Materials and methods
A two-week retrospective audit of oral surgery outpatients at a dental hospital in London was conducted, analysing the frequency of restorability discussions and patient involvement in decision-making. A simplified restorability guide and educational interventions were introduced to target the set standard of 100% of consenting clinicians to discuss restorability with patients.
Results
Results from two audit cycles show a significant increase in documented restorability discussions and consideration of patient factors.
Discussion
The study recognised restorability assessment subjectivity, thus creating a simplified tool for clinicians. Patients may lack awareness of restorability options, consequences of edentulism, future costs and tooth replacement considerations, emphasising the importance of documented discussions.
Conclusion
Educational interventions and a simplified restorability guide proved beneficial and showed significant improvement in communication with patients regarding restorability and gaining valid consent. Further consideration should be given to barriers patients face when opting for tooth extraction of their restorable teeth, including discussions regarding long-term consequences.
Genetic counselors’ and community clinicians’ implementation and perceived barriers to informed consent during pre-test counseling for hereditary cancer risk
Genetic counselors’ and community clinicians’ implementation and perceived barriers to informed consent during pre-test counseling for hereditary cancer risk
Alexandra Capasso, Bita Nehoray, Nicholas Gorman, Emily A Quinn, Daiana Bucio, Kathleen R Blazer
Journal of Genetic Counselling, 13 March 2024
Abstract
As demand for genetic cancer risk assessment (GCRA) continues to increase, so does the sense of urgency to scale up efforts to triage patients, facilitate informed consent, and order genetic testing for cancer risk. The National Society of Genetic Counselors outlines the elements of informed consent that should be addressed in a GCRA session. While this practice resource aims to improve health equity, research on how well the elements of informed consent are implemented in practice is lacking. This retrospective and prospective mixed-methods study assessed how adequately the elements of informed consent are addressed during pre-test GCRA among 307 community clinicians (CC) and 129 cancer genetic counselors (GC), and barriers they face to addressing these elements. Results revealed that more than 90% of both cohorts consistently addressed components of at least 5 of the 10 elements of informed consent during a pre-test consultation. Technical aspects and accuracy of the test and utilization of test results were the most similarly addressed elements. Notably, GCs more often review the purpose of the test and who to test, general information about the gene(s), and economic considerations whereas CCs more often review alternatives to testing. Both cohorts reported psychosocial aspects of the informed consent process as the least adequately addressed element. Time constraints and patient-related concerns were most often cited by both cohorts as barriers to optimal facilitation of informed consent. Additional barriers reported by CCs included provider lack of awareness, experience, or education, and availability of resources and institutional support. Findings from this study may contribute to the development of alternative delivery models that incorporate supplementary educational tools to enhance patient understanding about the utility of genetic testing, while helping to mitigate the barrier of time constraints. Equally important is the use of this information to develop continuing education tools for providers.
Current Status of Informed Consent Form for Acupotomy in Korean Medicine Hospitals and Development of a Standard Informed Consent Form Using Delphi Method
Current Status of Informed Consent Form for Acupotomy in Korean Medicine Hospitals and Development of a Standard Informed Consent Form Using Delphi Method
Original Article
Jihun Kim, Bonhyuk Goo, Hyongjun Kim, Kyoungsuk Seo, Myungjin Oh, Myungseok Ryu, Sang-Hoon Yoon, Kwang Ho Lee, Hyun-Jong Lee, Jungtae Leem, Hyungsun Jun, Jeong Ihn Sook, Sung Woon Choi, Tae Wook Lee, Yeonhak Kim, Yoona Oh, Kunhyung Kim, Gi Young Yang, Eunseok Kim
The Journal of Korean Medicine, 1 March 2024; 45(1) pp 180-199
Abstract
Objectives
This study was conducted to develop a standard acupotomy consent form that takes into account the unique characteristics of Korean Medicine. The study was motivated by the increasing importance of patient autonomy and the growing number of legal disputes related to medical malpractice in the clinical field of Korean Medicine.
Methods
The analysis phase of the study involved a survey of the current status of acupotomy consent forms in Korean Medicine hospitals nationwide. The items of each form were analyzed based on the contents of the Medical law and the standard contract for medical procedures of the Fair Trade Commission (FTC). In the development and evaluation phase, the items and contents of the acupotomy consent form were evaluated using a 5-point Likert scale and content validity was assessed through two rounds of Delphi surveys. In the improvement phase, the contents of the consent form were revised based on the results of a survey of inpatient and outpatient patients in the Department of Acupuncture and Moxibustion at Pusan National University Korean Medicine Hospital, and real-time online meeting. The final version of the standard acupotomy consent form was completed after undergoing proofreading and corrections by a linguistics expert.
Results
Only 30% of Korean Medicine hospitals have implemented acupotomy consent forms. The items of the consent forms did not fully include the items presented in the Medical act and the standard contract for medical procedures of the FTC. To address this issue, two rounds of Delphi surveys and a real-time discussion were conducted with a panel of 12 experts on 27 preliminary items of consent forms. The items and contents that met the criteria for content validity ratio, convergence, and consensus were derived. Based on the derived items and content, a standard acupotomy consent form was developed.
Conclusions
The standard consent form for acupotomy is anticipated to ensure patient autonomy and enhance transparency and liability in acupotomy. Furthermore, it is expected to serve as evidence in case of medical disputes related to acupotomy and contribute as a reference document for the development of standard consents forms for various procedures of Korean Medicine. However, the limitations of the study include that the survey of consent forms was limited to only training hospitals of Korean Medicine, and the standard consent form is only applicable to adults in Korea. Future studies are needed to address these limitations.
Center for Informed Consent Integrity 