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
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…

Emergency research without prior consent in the United States, Canada, European Union and United Kingdom: How regulatory differences affect study design and implementation in cardiac arrest trials
Review
Catherine E. Ross, Melissa J. Parker, Spyros D. Mentzelopoulos, Barnaby R. Scholefield, Robert A. Berg
Resuscitation Plus, March 2024
Abstract
Aim
A major barrier to performing cardiac arrest trials is the requirement for prospective informed consent, which is often infeasible during individual medical emergencies. In an effort to improve outcomes, some governments have adopted legislation permitting research without prior consent (RWPC) in these circumstances. We aimed to outline key differences between legislation in four Western locations and explore the effects of these differences on trial design and implementation in cardiac arrest research.
Data sources
We performed a narrative review of RWPC legislation in the United States (US), Canada, the European Union (EU) and the United Kingdom (UK).
Results
The primary criteria required to perform RWPC was similar across locations: the study must involve an individual medical emergency during which neither the prospective subject nor their authorized representative can provide informed consent. The US regulations were unique in their requirements for performing Community Consultation and Public Disclosure in the communities in which the research takes place. Another major difference was the requirement for consent for ongoing participation in Canada, the EU and the UK, while only notification of enrollment and the opportunity to discontinue participation are required in the US. Additionally, only Canada and the EU explicitly state that the subject or their representative may request withdrawal of their data.
Conclusion
Regulations governing RWPC in the US, Canada, the EU and the UK have similar goals and protections for vulnerable populations during medical emergencies. Differences in the qualifying criteria and implementation procedures exist across locations and may affect study design.

Ethical challenges in organ transplants for refugees in a healthcare system
Research Article
Deniz Birtan, Aslihan Akpinar
Nursing Ethics, 7 February 2024
Abstract
Background
Several ethical issues are associated with providing living organ transplantation services, and there is limited information on these issues faced by the teams providing service to refugees or asylum seekers.
Aim
To determine the challenges healthcare professionals face in organ transplant centers providing services to Syrians under temporary protection status and discern whether these difficulties align with ethical issues in living organ transplantation.
Research design
This study employed a qualitative design and conducted individual semi-structured, in-depth interviews with 18 transplant team members in Istanbul between September and November 2022. Data analysis was based on Braun and Clarke’s thematic analysis.
Participants and research context
The participants comprised 18 healthcare professionals, including 6 physicians and 12 nurses working in organ transplant teams in Istanbul.
Ethical considerations
The University’s Ethics Committee provided approval. Participants were informed regarding confidentiality and signed an informed consent form.
Results
Three themes emerged from the data on ethical issues faced by organ transplantation services to Syrians: (a) beneficence or double equipoise, (b) autonomy, and (c) justice. Transplant teams experience problems related to preserving double equipoise in the provision of living donor organ transplantation because of language barriers, poor socioeconomic conditions, and cultural factors, which increases transplant teams’ individual and indirect social burden. Although problems arise from the language barrier when obtaining informed consent in the autonomy theme, institutional and national policies in preventing donor abuse have a comforting effect. Health workers had the least problems with the justice theme, wherein national health policies are determined.
Conclusion
Fewer issues related to autonomy and justice were reported in providing organ transplantation services to Syrians, with the most intense reported issues being maintaining double equipoise. The results revealed the need to develop institutional, national, and international policies with individual solutions to prevent difficulties healthcare professionals face in this process.

Adherence to General Medical Council guidance regarding disclosure of alternative treatments during the consent process
Conference Presentation
George S Bethell, Robert A Wheeler, Nigel J Hall
69th British Association of Paediatric Surgeons Annual Congress, 21-23 June 2023; Bruges
Abstract
Introduction
General Medical Council (GMC) guidelines dictate that reasonable alternatives to treatment should be disclosed during the consent process. We aimed to determine if GMC guidelines on disclosure of alternatives during consent are being followed in a real world example which is disclosure of non-operative management as an alternative to appendicectomy in uncomplicated paediatric appendicitis.
Methods
Retrospective single centre observational study and national consultant specialist paediatric surgeon survey. Two groups of 50 consecutively treated children (< 16 years) with acute uncomplicated appendicitis were included in the observational study during two time periods. UK based consultant surgeons that treat appendicitis were included in the national survey. The main outcomes were disclosure and use of NOM as an alternative to appendicectomy.
Results
Overall, in the observational study, NOM was disclosed in 30(30%) children and 77%(23/30) opted for this treatment method when it was disclosed. There were 83 survey respondents representing all 25 eligible specialist pediatric surgery centres. Ten(12%) consultants reported routinely offering NOM, 39(47%) offer it in select circumstances, and 34(41%) never offer NOM. Only 25(30%) respondents always disclose NOM as an alternative to appendicectomy, whilst 22(27%) never do. Consultants who never disclose NOM are more likely to prefer appendicectomy over NOM compared to those always disclose it(p<0.001).
Conclusion
In this illustrative clinical scenario, observed and reported practice regarding disclosure of alternative treatments during the consent process do not meet GMC guidance. This risks depriving children and caregivers of a choice that they are entitled to.

Clinical Informed Consent and ABA
Abraham Graber, Allison Maguire
Behavior Analysis in Practice, 8 January 2024
Open Access
Abstract
The practice of clinical informed consent in America is governed by over 100 years of case law. Although predominant ethics resources for behavior analysts offer some guidance regarding the provision of clinical informed consent, such guidance remains limited. The goal of this article is thus to expand the contemporary literature on clinical informed consent in behavior analysis by providing a historical and contemporary guide to relevant case law. The article will highlight seminal moments in the history of case law regarding clinical informed consent, discuss their applicability to the process of clinical informed consent in behavior analysis, and provide an enhanced understanding of the ethical and legal obligations related to informed consent in the therapeutic context.

Editor’s note: ABA stands for applied behavior analysis.

Towards the implementation of law n. 219/2017 on informed consent and advance directives for patients with psychiatric disorders and dementia. Physicians’ knowledge, attitudes and practices in four northern Italian health care facilities
Research
Corinna Porteri, Giulia Ienco, Mariassunta Piccinni, Patrizio Pasqualetti
BMC Medical Ethics, 6 January 2024
Open Access
Abstract
Background
On December 2017 the Italian Parliament approved law n. 219/2017 “Provisions for informed consent and advance directives” regarding challenging legal and bioethical issues related to healthcare decisions and end-of life choices. The law promotes the person’s autonomy as a right and provides for the centrality of the individual in every scenario of health care by mean of three tools: informed consent, shared care planning and advance directives. Few years after the approval of the law, we conducted a survey among physicians working in four health care facilities specific for the care of people suffering from psychiatric disorders, cognitive disorders and dementia located in the North of Italy aiming to investigate their perceived knowledge and training need, attitudes regarding law n. 219/2017 provisions, and practices of implementation of the law.
Methods
A semi-structured questionnaire was developed on an online platform. The invitation to participate in the survey was sent by email to the potential participants. Information was collected by means of the online platform (Google Forms) which allows to export data in a spreadsheet (Windows Excel) to perform basic statistical analysis (frequency distributions, bar chart representation).
Results
Twenty-five out of sixty physicians participated in the survey. None of the respondents value their knowledge of the law as very good, 10 good, 13 neither poor nor good, 1 poor and 1 very poor. All the respondents want to learn more about the law (21 yes and 4 absolutely yes). The majority of respondents agrees with the content of the law as a whole (3 absolutely agree, 13 agree), and on each provision. The question on the clarity of the concept of capacity in the law received mixed answers and this impacted on the physicians’ opinion regarding the legitimacy in principle for our groups of patients to realize shared care planning and write advance directives. Thirteen physicians neither introduced the theme of shared care planning nor arranged for shared care planning and the main reason for this was that no patient was in a clinical situation to require it. When shared care planning is realized, a variability in terms of type and number of meetings, mode of tracking and communication is registered.
Conclusions
Our survey results indicate a need for more clarity regarding the interpretation and implementation of the law in the patient groups under study. There are in particular two related areas that deserve further discussion: (1) the question of whether these patient groups are in principle legitimized by the law to realize shared care planning or write advance directives; (2) the notion of capacity required by the law and how this notion can be declined in real-life situations.

Informed consent – Ethical doctrine and a legal mandate
Review Article
Anjali Gera, Jayashree Sood
Current Medicine Research and Practice, November – December 2023; 13(6) pp 286-291
Open Access
Abstract
Informed consent is not only an ethical doctrine but also a legal mandate in medical practice and clinical research. The concept of consent has changed over the last few decades from doctor-focused to patient-focused. This provides adequate knowledge to the patient about disease and treatment options so that the patient and doctor can make shared decisions. Respecting the patient’s autonomy, disclosure of material risks and solicitation of the patient’s preferences are very important in the process of informed consent. The relationship between doctor and patient should be one of trust and communication. An honest and ethically obtained consent can prevent litigations and medicolegal repercussions.

Consent practices in midwifery: A survey of UK midwives
Rachel Elf, Jacqueline Nicholls, Yanyan Ni, James Harris, Anne Lanceley
Midwifery, February 2024
Abstract
Objective
To explore midwives’ knowledge and understanding of the law and practice of consent in the post-Montgomery world.
Design
Cross-sectional online survey. Descriptive statistical analysis of midwives’ survey responses.
Settings
Social media: Instagram, Facebook and Twitter. Survey distribution was via the UCL Opinio survey platform.
Participants
A total of 402 midwives, surveyed over a four month period between 2nd March and 2nd July 2021.
Measurements
Knowledge of legal consent, ‘sureness’ of meeting current legal requirements and competence to gain consent.
Findings
91% of participants acknowledged correctly that consent must be voluntary. 91% reported that women must be informed of all the risks associated with their care, although 26% reported that women should be informed of some of the risks associated with their care. Most participants were ‘sure’ that their discussions of consent meet current legal requirements (91%). 21% rated their competence to gain consent as ‘excellent’, 71% rated themselves as ‘very good’, whilst 1% rated their competence as ‘poor’. Deficiencies in fundamental knowledge of consent were noted in some participants rating themselves highest in ‘sureness’ of meeting legal requirements and competence to consent.
Key conclusions
Fundamental gaps in midwives’ knowledge of legal consent were identified. Participants demonstrated uncertainty regarding the extent of risk disclosure and discussion of alternative care options. Participants generally rated themselves highly in their consenting practices, despite lacking in basic knowledge of legal consent, revealing a discrepancy between midwives’ self-perceptions and their actual knowledge.
Implications for practice
The overconfidence displayed by some participants is concerning for clinical midwifery practice. Professional education and guidance for midwives on legal consent in keeping with Montgomery is urgently required to ensure that midwives are legally compliant in their consenting practices.

The Role of Informed Consent as Legal Protection for Doctors in Conducting Medical Procedures
Dian Fitriana
Sinergi International Journal of Law, 31 November 2023
Abstract
The field of Health Law recognizes Therapeutic transactions as an agreement between a doctor and a patient, granting authority to the doctor to provide healthcare services to the patient based on their expertise and skills. Therapeutic transactions take the form of informed consent or approval of medical procedures before they are carried out. Informed consent involves the doctor explaining to the patient the condition of their illness and the medical procedures intended to address it, in the doctor’s efforts to achieve recovery. Research findings indicate that informed consent plays a crucial role in the relationship between doctors and patients, serving as written evidence of the agreement between the doctor and the patient before medical procedures are undertaken. Informed consent can serve as the basis for proving whether a patient accepts or refuses a medical procedure, providing protection to the doctor. Legal protection for doctors is obtained as long as they carry out procedures in accordance with professional standards and operational procedures. For doctors, informed consent provides a sense of security when performing medical procedures on patients and can be used as a means of self-defense against potential claims or lawsuits from patients or their families if the medical procedure results in unintended consequences. Legal measures that doctors can take in the event of an undesired outcome related to medical procedures include attempting mediation with the patient first. If mediation fails or lacks good faith, the resolution may proceed through the legal system.

Editor’s note: The Sinergi International Journal of Law is an Indonesian publication by Yayasan Sinergi Kawula Muda.