No recognised ethical standards, no broad consent: navigating the quandary in computational social science research
Research Article
Seliem El-Sayed, Filip Paspalj
Research Ethics, 19 April 2024
Open Access
Abstract
Recital 33 GDPR has often been interpreted as referring to ‘broad consent’. This version of informed consent was intended to allow data subjects to provide their consent for certain areas of research, or parts of research projects, conditional to the research being in line with ‘recognised ethical standards’. In this article, we argue that broad consent is applicable in the emerging field of Computational Social Science (CSS), which lies at the intersection of data science and social science. However, the lack of recognised ethical standards specific to CSS poses a practical barrier to the use of broad consent in this field and other fields that lack recognised ethical standards. Upon examining existing research ethics standards in social science and data science, we argue that they are insufficient for CSS. We further contend that the fragmentation of European Union (EU) law and research ethics sources makes it challenging to establish universally recognised ethical standards for scientific research. As a result, CSS researchers and other researchers in emerging fields that lack recognised ethical standards are left without sufficient guidance on the use of broad consent as provided for in the GDPR. We conclude that responsible EU bodies should provide additional guidance to facilitate the use of broad consent in CSS research.

Presumed Consent To High-Risk Medical Actions In Emergencies: Perspective Of Law Number 17 Of 2023
Irsyam Risdawati
Law Synergy Conference (LSC), 2024
Abstract
Patients must provide informed consent before medical procedures are carried out in ordinary situations, but this does not apply in emergency situations and presumed consent is used instead. Doctors are often faced with situations that require high-risk medical procedures for emergency patients. The concept of presumed consent for this action is not recognized under Law Number 17 of 2023 concerning Health. The aim of the research is to analyze the role of presumed consent in the perspective of this law for high-risk medical procedures in emergency cases emergency. This research uses a normative juridical legal research type, namely library legal research, with a statutory approach and a conceptual approach. The results of the analysis show that presumed consent for high-risk medical procedures in emergency situations is not clearly regulated in Law Number 17 of 2023. However, doctors can still rely on several other articles in this law, including Article 293 paragraph (10) which emphasizes the best interests of patients, Article 275 paragraph (1) which requires doctors to provide assistance in emergency cases, and Article 273 paragraph (1) which provides legal protection to doctors who act according to standards. Apart from that, Article 275 paragraph (1) also exempts doctors from claims for compensation in emergency cases, providing legal security for doctors to act quickly to save the patient’s life without any doubt.

Editor’s note: Law 17 of 2023 is part of the Indonesian Health Transformation Plan.

Anatomical Human Body Donation In South Africa: Inconsistencies of Informed Consent
Keegan O. Meiring, Victoria E. Gibbon, Amanda Alblas
Annals of Anatomy, 19 June 2024
Abstract
Introduction
Informed consent is critical for maintaining the ethical standards associated with the utilization of human donor bodies by tertiary education institutions. Body donation programs undertake the responsibility for procuring human donor bodies for didactic and research purposes. However, its processes require scrutiny regarding best practice guidelines and the South African National Health Act (SA-NHA) (2013). Moreover, acknowledging and addressing the current perceptions of human body donation are indispensable in bridging the gap between academia and society. This study aimed to compare informed consent documentation and procedures across South African tertiary education institutions and their affiliated human body donation programs (HBDP) in accordance with international guidelines. The findings were used to create a human body donation form template aligned to current international best practices for consideration by the South African HBDP.
Methodology
A review of information and consent forms collected from South Africa’s eight HBDP was conducted. The analyses consisted of a broad evaluation of information provided, ranging from the terms of use of bodies to the commitments made by HBDP to donors. The results were considered in conjunction with the International Federation of Associations of Anatomists and other recent publications on informed consent in HBDP.
Results
Only two of the eight HBDP provided information and consent forms in more than one language. Most allowed donors to select how their bodies will be utilized – education, training and/or research. Some (6/8) made provisions for the next-of-kin to receive the cremains. Only one tertiary educational institution mentioned the occurrence of a memorial service in its documentation. An HBDF template was created aligned to current international best practices for presentation and possible adaption by SA HBDP.
Discussion & Conclusions
Human body donation forms (HBDF) requires thorough examination for the promotion and sustainability of HBDP. Effective communication by employing standardized non-technical terminology conveyed in language that is understandable and native to potential donors facilitates the deliverance of informed consent. Inconsistencies regarding the use and management of bodies catalyze the weakening perception of human body donation. Thus, this process of securing informed consent for body donation should be conducted in conjunction with public awareness campaigns and underpinned by the necessary policy and legislative reform.

Pre-Mortem Interventions for the Purpose of Organ Donation: Legal Approaches to Consent
Renée Taillieu, Matthew J. Weiss, Dan Harvey, Nicholas Murphy, Charles Weijer, Jennifer A Chandler
Journal of Law, Medicine & Ethics, 31 May 2024
Abstract
The administration of Pre-Mortem Interventions (PMIs) to preserve the opportunity to donate, to assess the eligibility to donate, or to optimize the outcomes of donation and transplantation are controversial as they offer no direct medical benefit and include at least the possibility of harm to the still-living patient. In this article, we describe the legal analysis surrounding consent to PMIs, drawing on existing legal commentary and identifying key legal problems. We provide an overview of the approaches in several jurisdictions that have chosen to explicitly address PMIs within codified law. We then provide, as an example, a detailed exploration of how PMIs are likely to be addressed in one jurisdiction where general medical consent law applies because there is no specific legislation addressing PMIs — the province of Ontario in Canada.

Informed consent and Montgomery implications for clinical practice
Healthcare ethics and communication
Chantal Patel
Medicine, 28 May 2024
Abstract
Consent is central to the delivery of healthcare, and all healthcare professionals must obtain consent before proceeding with any interventions. The nature of informed consent allows the patient to fully participate in any proposed healthcare interventions. Informed consent requires high-quality information to be given that enables the patient to fully understand all the benefits as well as the risks associated with proposed interventions. This approach respects the right of the patient to self-determine what happens to their body provided they have the relevant capacity to understand the nature of the proposed intervention. Although consent may be seen as a procedural ‘must’, the importance of the dialogue that takes place between the patient and the clinician is what determines the validity of the consent as advocated by the Supreme Court ruling in Montgomery v Lanarkshire Health Board (Scotland) [2015]. It is noted that the number of legal cases related to consent has risen since the Montgomery decision.

Criminal Liability For Analysing Genomic Data Without Owner’s Consent: A Comparative Study
Research Article
Fatiha Mohammed Gourari, Mohammad Amin Alkrisheh
Access to Justice in Eastern Europe, 2024
Abstract
Background
In the rapidly evolving landscape of genomics and biotechnology, the United Arab Emirates (UAE) has launched the Emirates Genome Program to harness the potential of genomic technologies for advancing healthcare services. Central to this initiative is the informed and voluntary participation of citizens in genetic research aimed at contributing to national health objectives through genetic data utilisation. Notably, the enactment of UAE Decree-Law No. (49) of 2023 underscores the importance of safeguarding genomic privacy as a foundational element for data security and individual rights. This study addresses the challenge of striking a delicate balance between individual genetic rights and the pressing scientific and medical needs of genomic research. It aims to analyse the right to genomic privacy and examine crimes associated with the unauthorised analysis of biological samples.
Methods
This research employed an analytical legal methodology and a comparative approach to explore the crime of disclosing genomic data. By analysing Decree-Law No. (49) of 2023 and other relevant Emirati legislation, we examined the legal framework governing genomic research and data protection in the UAE. Comparative legal analysis was then conducted between Emirati and French laws to identify similarities and differences in approaches to genomic data disclosure crimes. The study also considered international standards and ethical principles to provide a comprehensive, multidisciplinary understanding of the intersection of law, ethics, and science in genomic privacy.
Results and conclusions
This study’s findings underscore the necessity of establishing a robust legal framework that safeguards individual rights and ensures the confidentiality of genetic data. Such measures are crucial for fostering public trust in genomic research and aligning the UAE’s genomic endeavours with rigorous ethical and legal standards. Ultimately, Decree-Law No. (49) of 2023 exemplifies the state’s commitment to promoting ethical and legal practices in genomic research, thereby facilitating sustainable advancements in medical science.

Clinical Teaching and Consent: An Analysis of New Zealand’s Legal Requirements for Obtaining Consent to Clinical Teaching Involving Consumers of Health and Disability Services
Lydia Wadsworth
Journal Of Law and Medicine, May 2024
Abstract
Student involvement in patient care without consent has attracted recent attention in New Zealand. New Zealand’s Code of Health and Disability Services Consumers’ Rights (Code) gives patients the right to give or refuse consent to participate in clinical teaching, but its practical application to clinical teaching, particularly postgraduate, is unclear. This article explores the history and precedent of the Code and ethical considerations, to inform where amendment to the Code is desirable in the interests of clarity, pragmatism, and to reflect better the legislature’s intent.

The Law On Informed Consent In Medical Procedures In Nigeria: Organ And Tissue Transplant In Focus
Ikenga K. E. Oraegbunam, Eyiuche Stella Ifediora
International Review of Law and Jurisprudence, January 2024
Abstract
During medical procedures, the law, generally, mandate medical personnel to seek and get the consent of patients before proceeding with any medical treatment. The rule on informed consent, simply put, entails health professionals properly informing patients, to their understanding, about any medical treatment to be administered to such patient and getting approval before proceeding with such treatment. This basically aligns with the medical and legal positions that recognize the autonomy of a patient and recognizes such patient’s right to either accept or reject any medical treatment and also the right to participate in every decision regarding the patient’s medical treatment. The informed consent rule allows some exceptions which include emergency cases where it would be fatal to insist on seeking and getting a patient’s consent to a lifesaving medical intervention. The present research is focused reviewing the current state of the law with respect to informed consent in transplant procedures in Nigeria to determine its adequacy. It is recommended inter alia that the National Health Act be amended to specifically mandate health personnel to seek and get the informed consent of parties to transplant procedures – where possible – to prevent the legal implications of doing otherwise. Also, medical personnel should be trained continually to practice informed consent when handling patients that come to them for any form of medical treatment.

Michigan: Parental Consent Law for Abortion Harms Young People – New Report Examines Law and Calls for Repeal
Human Rights Watch, 28 March 2024
Summary

• A Michigan law that requires a young person to obtain parental consent to have an abortion threatens the health and safety of youth in the state and violates their human rights.
• In some cases, disclosing a pregnancy to a parent will result in abuse or being forced to leave home or continue the pregnancy, and judicial bypass can be subjective and cause delays.
• Michigan’s forced parental consent for abortion law should be immediately repealed to ensure young people’s safety and dignity.

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.