Rethinking with Onora O’Neill the Kantian Concept of Autonomy in Biolaw
Book Chapter
María Jesús Vázquez Lobeiras
The Discourse of Biorights, 1 October 2024; Chapter 6 [Springer]
Abstract
The concept of autonomy plays a significant role in Bioethics as well as in Biolaw, the Kantian conception of autonomy being an unavoidable element in the debate. Some of the most relevant contributions in this discussion stem from Onora O’Neill’s work. Prof. O’Neill promotes an anti-individualist interpretation of autonomy and, in order to increase its ethical efficiency, suggests reconsidering the meaning of autonomy as closely linked to trust. This chapter tries to show how intertwined information, autonomy and trust are at a time when medical technologies and care need to be interpreted and disclosed in order to be properly understood.
Introduction
…Informed consent and the ethical and legal principle of autonomy are closely linked, since the former is usually considered a genuine expression of the latter…Considering informed consent to be one of the main expressions of autonomy, although not the only one, in what follows we will analyse it from the perspective of Onora O’Neill. Kant’s texts will be consulted once again in order to clarify what the eminent thinker of Königsberg understands by autonomy and to what extent his concept of application can be applied in the field of biolaw.

Unraveling a Political Technology: Free, Prior, and Informed Consent in Peruvian Oil and Mining Sectors
Research Article
Roger Merino
Journal of Politics in Latin America, 27 September 2024
Open Access
Abstract
The worldwide dissemination of the right to free, prior, and informed consent (FPIC) has fostered discussions about its significance for removing the social exclusion of indigenous peoples. Most studies address problems in the regulation and implementation of FPIC, but less attention is paid to how the strengths and weaknesses of indigenous organizations and their different political engagements influence FPIC processes and outcomes. Based on the analysis of consultation agreements in the mining and oil sectors in Peru (2011–2022) and the evaluation of two case studies, this article explains how FPIC might be a tool for indigenous politics and state governance.

Ethical, Psychological and Social Un/certainties in the Face of Deemed Consent for Organ Donation in England
Original Article
Laura L. Machin, Elizabeth Wrench, Jessie Cooper, Heather Dixon, Mark Wilkinson
Health Care Analysis, 24 September 2024
Open access
Abstract
Deemed consent legislation for deceased organ donation was introduced in England in 2020, and is considered a vital part of the new UK NHS Blood and Transplant’s 10-year strategy to increase consent for organ donation. Despite the legislation containing safeguards to protect the public, the introduction of deemed consent creates ethical, psychological and social un/certainties for healthcare professionals in their practice. In this paper, we offer insights into healthcare professionals’ perspectives on deemed consent, drawn from interview data with 24 healthcare professionals in an NHS Trust in England, prior to the introduction of the legislation. Whilst participants supported deemed consent in principle, they were concerned that it would present a threat to the nature of donation as a ‘gift’; the notion of informed consent (or non-consent); and the autonomy of donors, their relatives, and their own roles as health professionals, posing dilemmas for practice. We argue that healthcare professionals present themselves as guardians of potential (non)donors and thus as having ethics and integrity in their own practice. We draw conclusions around the values and principles that matter to healthcare professionals when contemplating consent in deceased donation which will be useful for organ donation committees and ethics forums.

The requirement to obtain the consent of a legal guardian for the provision of reproductive health pharmacist services to minors under the pilot program
Marek Tomków, Radosław Balwierz, Opole University, Adam Majewski,Aleksandra Szopa
Polish Journal of Public Health, September 2024
Abstract
Emergency contraception in Poland is often referred to as the “morning-after pill”. Its legal status has changed many times. In Poland, it has only been available on prescription since 2017. Attempts have been made to change the legal status in 2024. A draft amendment to the Pharmaceutical Act was then submitted to Parliament. However, the bill was vetoed by the President of the Republic of Poland. In response to the veto, the Minister of Health issued a decree on a pilot programme in the field of pharmacists’ services related to reproductive health. In connection with this regulation, a question arose for pharmacists: whether it is necessary to obtain the consent of the legal guardian of minors who want to use the programme. Therefore, the aim of the work was a legal-comparative and dogmatic-legal analysis of legal acts in the field of reproductive health. A review of the data shows that while the pharmacist carries out the activities indicated in the pilot programme for pharmacist services about reproductive health, health services are provided to patients. Therefore, in the case of minor patients under 16 years of age, or who are over 16 but under 18 years of age, the consent of their legal representatives is required. It should also be noted that the term “pharmacist service” used in the title is not defined in any way in the law (unlike the term “pharmaceutical service”) and does not constitute a definition that would allow the statement to be made that it is another unlisted activity that exempts the pharmacist from the obligation to obtain the consent of the legal guardian. It should therefore be assumed that this consent is necessary to provide the service.

The Civil Law Aspects of Informed Consent to Medical Procedures
Gede Agus Kurniawan, Ade Chandra
SASI, September 2024
Abstract
Introduction
Informed consent is a communication process between healthcare providers and patients regarding the medical procedures to be performed. Its aim is to provide sufficient information so that patients can make informed decisions, and it is regulated by various laws and regulations in Indonesia.
Purpose of the Research
The purpose of this research is to analyze the legal position of informed consent from the perspective of Indonesian civil law and to examine the civil law implications that arise if there is a violation of the informed consent principle in medical procedures.
Method of Research
This research uses normative legal methods with legislative and conceptual approaches, analyzing primary, secondary, and tertiary legal materials through literature study, and applying descriptive qualitative analysis.
Results of Research
Research findings indicate that informed consent holds a strong legal position within the perspective of Indonesian civil law, being viewed as a manifestation of a therapeutic agreement that must meet the valid agreement requirements according to the Civil Code (KUHPerdata) and be supported by various regulations. Violations of the principles of informed consent can lead to significant civil legal implications, including claims for damages on the grounds of breach of contract or unlawful acts, cancellation of the therapeutic agreement, liability for breach of professional standards, and claims based on consumer protection law. These implications can involve healthcare professionals and healthcare institutions, with consequences that include payment of material and immaterial damages, the burden of proof in court, and impacts on reputation and medical practice.

Editor’s note: SASI is a peer-reviewed journal published by the Faculty of Law, Universitas Pattimura, Indonesia.

Pitfalls of the green transition: Towards a genuine understanding of the right to free, prior and informed consent of the Indigenous peoples
Yuko Osakada
Polar Science, 6 September 2024
Abstract
This article examines the changes required to make the green transition more inclusive and sustainable from an international human rights perspective. Indigenous peoples have been challenging the ways in which this transition is taking place, using the phrase “green colonialism.” Although, in many countries, it has become common to consult Indigenous peoples to reach an agreement before licensing the establishment of green energy facilities, previous studies that dealt with the Sámi’s struggle against the green transition have revealed that asymmetric power relationship between Indigenous peoples, sovereign states and business enterprises contributed to disguised dialogues and/or agreements among them. Therefore, this article concludes that a genuine transition from the obligation to consult Indigenous peoples to their right to free, prior, and informed consent (FPIC) is crucial when establishing green energy facilities that might affect them. In doing so, this article emphasizes that the meaning of the right to FPIC for Indigenous peoples should be understood correctly from an international human rights perspective. In particular, it argues that the right to FPIC should be ensured not only before the project affecting Indigenous peoples is licensed, but also at all stages of implementing the project with participatory monitoring.

Informed consent form for platelet rich plasma injections: evidence-based and legally guide for orthopaedic surgeons
Research
Madhan Jeyaraman, Satvik N. Pai, Migliorini Filippo, Naveen Jeyaraman, Ravichandran Venkatasalam, Arulkumar Nallakumarasamy, Manish Khanna, Bishnu Prasad Patro, Shilpa Sharma, Ravi Velamor Rangarajan
European Journal of Medical Research, 17 August 2024
Open Access
Abstract
Regarding medico-legal malpractice suits, lawyers and insurers focus on informed consent documentation. Unfortunately, there is no standard protocol for obtaining informed consent for platelet-rich plasma (PRP) injections. The objective of the present study was to create a pre-designed, evidence-based informed consent form specifically for PRP injections. The current evidence on the medico-legal implications of PRP injections was accessed, as well as informed consent in general and specifically informed consent in PRP injections. Additionally, we interviewed orthopaedic surgeons and patients who had undergone PRP injections in the past year using a semi-structured approach. A legally valid and evidence-based informed consent form for PRP injections ensures rights, encouraging open communication and transparency between the patient and surgeon. Moreover, if a lawsuit arose, informed consent would be a critical document in surgeons’ defence and would withstand scrutiny from lawyers and the judiciary. An evidence-based informed consent form for PRP injections was elaborated and reviewed by a legal expert to ensure adherence to legal proprieties. The final form of the informed consent for PRP injection was administered for one year and validated at our institution.

Shared Decision-Making and Informed Consent Legislation in Clinical Decision Making
Yeoran Yoon, Hyuna Bae
Korean Journal of Medical Ethics, 30 June 2024; 27(2) pp 71-87
Abstract
This article examines shared decision-making, a concept that extends beyond informed consent to safeguard patients’ right to self-determination in medical decision-making, emphasizing mutuality with patients. After reviewing the relevant legislation concerning consent, we argue that there are limitations to using this legislation as a basis for integrating shared decision-making across various medical domains. We assess the applicability, acceptability, and consistency of this legislation within the medico-legal system. In particular, we scrutinize the roles of so-called “participants” in shared decision-making, the content of shared information, and potential legal liabilities stemming from deficiencies in this process. Through this examination, we analyze legal precedents concerning the duty to inform and propose policy adjustments necessary for the institutionalization of shared decision-making within the medico-legal framework.

Editor’s note: This is a Korean language publication.

Informed consent and the duty to warn: More than the mere provision of information
Rajesh Gounder
Journal of Law and Medicine, 1 June 2024
Abstract
Before providing any form of medical treatment, medical practitioners are generally required to discharge their duty to warn. It is argued in this article that the duty to warn, at least as it relates to frail and elderly patients, requires the principles of shared decision-making to be adopted. Doing so will ensure a comprehensive biopsychosocial understanding of the patient and assist in identifying material risks that May not be readily apparent. Such risks include risks that threaten the patient’s values, preferences, treatment aims and long-term outcomes. Once such risks are identified, in discharging the duty to warn, they should be contextualised in a manner that makes clear how that risk will manifest in that particular patient. These risks should then also be synthesised within the context of their other medical issues and longer-term interests. Finally, it is suggested that the traditional consent process may need restructuring.