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There have been significant advances in the medical and surgical options available for contraception and management of menses for individuals, including those with intellectual developmental disorder. This new statement frames the ethical, legal, and medical issues of permanent contraception in children, adolescents, and young adults with intellectual developmental disorder, emphasizing the importance of utilizing long-acting reversible and minimally invasive treatments, whenever possible. The historical use and abuse of permanent contraception is briefly reviewed, providing the foundation for ongoing ethical and legal considerations, including issues of informed consent. The authors then discuss medical decision-making and patient preferences that should be considered and make recommendations to providers who are contemplating permanent contraception therapies in this population., (Copyright © 2024 by the American Academy of Pediatrics.)

Clinical imaging uses a variety of medical imaging techniques to diagnose and monitor diseases, injuries and other health conditions. These include X‑ray images, computed tomography (CT), magnetic resonance imaging (MRI) and ultrasound. These procedures are used to make accurate diagnoses and plan the best possible treatment for patients. Forensic imaging, in contrast, is used in both living and deceased persons in the context of criminal investigations. Postmortem forensic imaging techniques, such as postmortem CT (PMCT) and postmortem CT angiography (PMCTA), include some of the same procedures used in clinical imaging. An important difference between clinical and forensic imaging is the purpose and context in which the imaging studies are used. In addition, radiological procedures, such as angiography, need to be adapted and modified in the post-mortem setting. From a legal perspective clinical and forensic imaging must strictly adhere to privacy and procedural guidelines. Forensic images often need to be admissible as evidence in court, which places specific requirements on the quality, authenticity and documentation of images. In the case of living individuals, there must be a valid indication and consent from the patient. Consent must also fundamentally be obtained for post-mortem examinations, e.g. from the public prosecutor's office., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Summary: Informed consent is the principal tool that bridges the gap between clinical practice and our society's ethical ideals. The intricacies of informed consent, however, are frequently misunderstood, and its effective implementation can be challenging in practice. The continuous stream of innovations, wide array of procedures, and other characteristics inherent to the practice of plastic surgery compound the challenges of implementing informed consent. Unfortunately, there remains a dearth of literature to provide a comprehensive overview of informed consent as it relates to plastic surgery. In this article, the authors highlight the history, legal components, and challenges of informed consent within plastic surgery and offer recommendations on how to approach them. A deeper understanding of informed consent helps enhance patient care, mitigates unnecessary malpractice risk, and leads to better physician-patient relationships., (Copyright © 2024 by the American Society of Plastic Surgeons.)

The working group set up by the SEAP-IAP addresses in this Part II some general considerations and five particular considerations to be taken into account when a biological sample of human origin, coming from our archives, acquires a different destination from the usual one, in this case for research. From this moment on, we must follow mandatory legal and ethical rules, and the different recitals provide us with guidelines to ensure good practice, both for biological material and its associated data. The traditional task of custody given to the Pathological Anatomy is approached, as always, from the point of view of responsibility and, in this article, adjusted to its time., (Copyright © 2024 Sociedad Española de Anatomía Patológica. All rights reserved.)

Plain Language Summary Title: An Ontario review of legal cases which have considered patients' ability to consent to substance use treatments., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Dentists providing implant dental treatment need to fully appreciate the legal and clinical issues that are relevant to implant dentistry. The legal aspects of implant dentistry, according to UK law, are described in this article. Suggestions for how the risks of implant treatment might be mitigated, with tips and examples are provided.

Background: Since the creation of legal requirements for advance directives by the legislator in 2009, special aspects of their application in the treatment of people with mental illnesses have been discussed., Goal of the Paper: Important questions on dealing with advance directives in everyday life will be answered in a practice-oriented manner., Results: Among other things, this document answers the question of the conditions under which a patient can refuse or consent to hospitalization and treatment in advance, and in particular how to deal with advance directives whose implementation would also affect the rights of third parties. The German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) has addressed these and other questions in the present document and added practical advice on how to formulate advance directives for people with mental illnesses and how to deal with psychiatric advance directives., Discussion: The DGPPN has developed an advance directive for the area of mental health and published it on its website together with detailed explanations. With the help of this advance directive, people can decide on their treatment in phases of incapacity to consent in the context of a mental crisis or illness., (© 2024. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Many important questions in health professions education require datasets that are built from several sources, in some cases using data collected for a different purpose. In building and maintaining these datasets, project leaders will need to make decisions about the data. While such decisions are often construed as technical, there are several normative concerns, such as who should have access, how the data will be used, how products resulting from the data will be shared, and how to ensure privacy of the individuals the data is about is respected, etc. Establishing a framework for data governance can help project leaders in avoiding problems, related to such matters, that could limit what can be learned from the data or that might put the project (or future projects) at risk. In this paper, we highlight several normative challenges to be addressed when determining a data governance framework. Drawing from lessons in global health, we illustrate three kinds of normative challenges for projects that rely on data from multiple sources or involved partnerships across institutions or jurisdictions: (1) legal and regulatory requirements, (2) consent, and (3) equitable sharing and fair distribution., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

Objectives: To identify the frequency of which a legal guardian is at the bedside of children admitted to the PICU that are eligible for research studies., Design: A prospective, observational study., Setting: Three tertiary Canadian PICUs., Patients: Two hundred one patients were admitted to the PICU between September 2021 and March 2023 (site 1), from March 2019 to March 2020 and March 2022 to March 2023 (site 2), and from March 2019 to March 2020 and July 2020 to November 2021 (site 3)., Interventions: None., Measurements and Main Results: At each center, the duration of consent encounters was recorded for patients eligible for research by documenting the length of each attempt (min). The frequency of parental presence at bedside and the ability for a guardian to make a decision were also recorded. Thirty-five percent of patients eligible for research did not have a legal guardian at the bedside on the first attempted consent encounter. Twenty-three percent of approached patients were not enrolled due to an inability for a consent decision to be made by the child's legal guardian or an inability to contact the guardian before discharge., Conclusions: The absence of legal guardians in the PICU poses a barrier to the enrollment of critically ill children in pertinent research studies and suggests that a model of deferred consent or implied consent would aid in the future of critical care research., Competing Interests: Ms. Assaf disclosed she is a research coordinator with Children’s Hospital of Eastern Ontario. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)

Aim: To give an insight into areas for future development and suggestions in the complexities of incorporation of AI into human colorectal cancer (CRC) care while bringing into focus the importance of clinicians' roles in patient care., Methods: Existing literature around AI use in CRC care is reviewed and potential regulatory issues and medicolegal implications around its implementation in CRC multidisciplinary team meetings (MDTs) are identified., Results: Challenges with patient privacy and confidentiality, patient consent, inequity and bias, patient autonomy, as well as AI system transparency and the liability and accountability issues arising from complications that arise from AI-aided clinical decisions are important focusses associated with the use of AI in CRC MDTs., Conclusion: Consideration of various medicolegal aspects of the use of AI in CRC MDTs is warranted to ensure its safe and smooth incorporation into CRC MDTs. AI function as a clinical decision support system and does not replace professional expertise., (© 2024 Association of Coloproctology of Great Britain and Ireland.)

This paper analyses the information disclosures in two biobank consent documents used by biobanks operating under the General Data Protection Regulation (GDPR). The aim of the analysis is to investigate how these documents inform potential sample donors about possible future uses of biobank data. The findings suggest that the consent documents provide potentially misleading information regarding the range of possible future uses of biobank data. Based on these information disclosures, potential sample donors may reasonably believe that the data can only be used for a narrowly defined range of research purposes. However, the range of lawful uses of the data is much broader and less clearly defined. Consent provided based on misleading information is not morally transformative, even if it were legally valid. To facilitate morally transformative biobank consent, this paper provides two recommendations for information disclosure to potential sample donors regarding future uses of biobank data: first, potential sample donors should be informed about the legal scope of consent; and second, they should be informed about the full range of lawful uses of biobank data., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

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., (© 2024. The Author(s).)

In the well-known case of Henrietta Lacks, cells from her tumor were taken without consent and used more than 70 years ago to create the first immortal human cell line ("HeLa" cells). That event led to many scientific breakthroughs and to the debate about the ethics of consent and requirements for compensation. May 2024 saw two decisions by US federal courts-one related to Lacks-that could narrow the scope of research allowed on tissues obtained without consent and on nonidentified tissues, with implications for biomedicine.

Background: In Europe, within the scope of the General Data Protection Regulation, more and more digital infrastructures are created to allow for large-scale access to patients' health data and their use for research. When the research is performed on the basis of patient consent, traditional study-specific consent appears too cumbersome for many researchers. Alternative models of consent are currently being discussed and introduced in different contexts., Objective: This study explores stakeholder perspectives on ethical, legal, and practical concerns regarding models of consent for health data research at German university medical centers., Methods: Semistructured focus group interviews were conducted with medical researchers at German university medical centers, health IT specialists, data protection officers, and patient representatives. The interviews were analyzed using a software-supported structuring qualitative content analysis., Results: Stakeholders regarded broad consent to be only marginally less laborious to implement and manage than tiered consent. Patient representatives favored specific consent, with tiered consent as a possible alternative. All stakeholders lamented that information material was difficult to understand. Oral information and videos were mentioned as a means of improvement. Patient representatives doubted that researchers had a sufficient degree of data security expertise to act as sole information providers. They were afraid of undue pressure if obtaining health data research consent were part of medical appointments. IT specialists and other stakeholders regarded the withdrawal of consent to be a major challenge and called for digital consent management solutions. On the one hand, the transfer of health data to non-European countries and for-profit organizations is seen as a necessity for research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legally possible under certain conditions but deemed problematic by all stakeholder groups, albeit for differing reasons and to different degrees., Conclusions: More efforts should be made to determine which options of choice should be included in health data research consent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation for research without consent is required at the national and European Union level. Obtaining consent for health data research should be independent of medical appointments, and additional personnel should be trained in data security to provide information on health data research., (©Svenja Wiertz, Joachim Boldt. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 07.08.2024.)

Background: Aesthetics medicine, a controversial branch of clinical medicine known for its high degree of commercialization, faces numerous conflicts, particularly in some developing countries. The global aesthetics medicine industry requires enhancements of its legal and supervision framework and risk management systems., Aims: This paper aimed to provide a comprehensive visual analysis of academic achievements related to regulatory and legal issues in the field of aesthetic medicine and to identify its development trends and research hotspots., Methods: The Web of Science Core Collection was employed to retrieve relevant studies, resulting in a total of 602 research articles after selection. Utilizing bibliometric methods and CiteSpace, this study analyzed the primary countries, institutions, authors, journals, hotspots, frontiers, and trends in this domain., Results: The findings indicated rapid increases in the number of published papers. The United States emerged as the leading contributor with 131 research papers and the highest intermediate centrality. Eleven keyword clusters were identified, with "adolescence" and "office-based surgery" being the most recent topics. We also analyzed the trends and frontiers of legal research in medical aesthetics., Conclusion: The importance of informed consent has been increasingly emphasized, and research in the field of medical aesthetics has been gradually expanding beyond individual cosmetic procedures. The management system has become more comprehensive, moreover, guidelines and medical laws have been continually published, with research shifting toward a holistic perspective that encompasses patients, medical aesthetic providers, and regulatory authorities in the study of medical aesthetics regulation and legislation. This paper also proposes some innovative directions for future research and applications., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

There is little guidance concerning biomedical research using tissues from deceased individuals. Unique ethical and legal challenges gained visibility during the coronavirus disease 2019 (COVID-19) pandemic, when important studies using genome sequencing required access to biological materials from deceased individuals. These studies proposed to determine whether specific genomic profiles were associated with important disease outcomes. Such research has previously required consent from next-of-kin or other surrogate decision makers. Ethics waivers for such consent vary within Canada. In Ontario, research ethics boards can grant waivers of consent if the Tri-Council Policy Statement-2 conditions are met. These include that the individual is not harmed, that the materials are essential to the research, and that privacy will be protected. Conversely, in Quebec, Civil Code article 22 imposes an obligation on researchers to seek consent from next-of-kin or another surrogate decision maker with no option for waivers. It became evident to researchers that these standards can sometimes impose an impracticable balance of risks and benefits, especially in public health emergencies. We seek to establish why and when consent requirements should be waived for public health and research involving the tissues of deceased individuals.

In the legal context of Chinese law, genetic data are an object of complex rights. At the level of private law, genetic data contain personal information, thus being protected by the Civil Code and the Personal Information Protection Law. At the level of public law, genetic data are important genetic resource that embody both public and national interests, which should also be regulated by public laws such as the Biosecurity Law and the Data Security Law. The recently issued Regulation on the Administration of Human Genetic Resources have refined the approval and record procedure, in order to promote the utilization of genetic data in China. At present, China still lacks sufficient protection for genetic data privacy, and the "informed consent" and "anonymization" system cannot work effectively. On the path of improvement, we should break constraints of individualism and start from the following three levels to strengthen genetic data privacy protection: formulating specialized legislation and leveraging the functions of group organizations and public interest litigation systems.

Background: In May 2020, England implemented soft 'opt-out' or 'deemed consent' for deceased donation with the intention of raising consent rates. However, this coincided with the COVID-19 pandemic, making it difficult to assess the early impact of the law change. Wales and Scotland changed their organ donation legislation to implement soft opt-out systems in 2015 and 2021 respectively. This study provides a descriptive analysis of changes in consent and transplant rates for deceased organ donation in England, Scotland and Wales., Methods: Logistic regression and descriptive trend analysis were employed to assess the probability of a patient who died in critical care becoming a donor, and to report consent rates using data, respectively, from the Intensive Care National Audit and Research Centre (ICNARC) in England from 1 April 2014 to 30 September 2021, and from the Potential Donor Audit for England, Scotland and Wales from April 2010 to June 2023., Results: The number of eligible donors in April-June 2020 were 56.5%, 59.3% and 57.6% lower in England, Scotland and Wales relative to April-June 2019 (pre-pandemic). By April-June 2023, the number of eligible donors had recovered to 87.4%, 64.2% and 110.3%, respectively, of their levels in 2019. The consent rate in England, Scotland and Wales reduced from 68.3%, 63.0% and 63.6% in April-June 2019 to 63.2%, 60.5% and 56.3% in April-June 2023., Conclusions: While the UK organ donation system shows signs of recovery from the COVID-19 pandemic, the number of eligible potential donors and consent rates remain below their pre-pandemic levels., Competing Interests: NO authors have competing interests., (Copyright: © 2024 O'Neill et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Although biobanks have become fundamental to many research centers and contribute to medical development, they generate many ethical and legal issues that may discourage patients from donating., Materials and Methods: To understand patients' perception of ethical and legal issues related to biobanks we conducted a survey among 548 Polish patients with cancer., Results: While 93.1% of patients with cancer declared themselves willing to donate biospecimens left over after a medical procedure to a biobank, most opted for one-time consent or study-specific consent, blanket consent being less frequently preferred. Many patients believed that future use of previously collected tissues require second contact. Most patients preferred pseudonymization over anonymization of the data, and supported donors' right to withdraw informed consent at any given moment. Finally, while personal health information was the most expected form of compensation for donation, most patients suggested that all parties, including the biobank concerned, the sponsors of the research, and the donors, should own the rights to cancer tissues donated and profit from the biobank research. Patients' opinions on the ethical and legal issues related to biobank research were associated with age, sex, religiosity, education level, and place of residence., Conclusions: Since biobanks generate ethical and legal issues related to informed consent, data protection and storage, as well as the sharing of biosamples, tissue ownership, and profit sharing, that may discourage patients from donation, when asking a patient for a donation, healthcare professionals should communicate in a donor-centered manner and address patients' ethical and moral concerns related to donation and offer resources to help manage these concerns., (© The Author(s) 2024. Published by Oxford University Press.)

England switched to an opt-out system of consent in 2020 aiming to increase the number of organs available. Spain also operates an opt-out system yet has almost twice the organ donations per million population compared with England. We aimed to identify both differences and similarities in the consent policies, documents and procedures in deceased donation between the two countries using comparative qualitative content and discourse analysis. Spain had simpler, locally tailored documents, the time taken for families to review and process information may be shorter, there were more pathways leading to organ donation in Spain, and more robust legal protections for the decisions individuals made in life. The language in the Spanish documents was one of support and reassurance. Documents in England by comparison appeared confusing, since additions were designed to protect the NHS against risk and made to previous document versions to reflect the law change rather than being entirely recast. If England's ambition is to achieve consent rates similar to Spain this analysis has highlighted opportunities that could strengthen the English system-by giving individuals' decisions recorded on the organ donor register legal weight, alongside unifying and simplifying consent policies and procedures to support families and healthcare professionals., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Rees, Mclaughlin, Paredes-Zapata, Miller, Mays and Noyes.)

Richard Griffith , Senior Lecturer in Health Law at Swansea University, discusses the importance of consent in nursing and outlines the key elements for ensuring the patient has given valid consent before providing treatment.

Consent is an essential part of healthcare practice, allowing patients to make autonomous decisions. However, this changes when a patient has mental incapacity or is unable to make decisions for themselves for a duration of time. This month's Policy column looks at some of the key principles of the Mental Capacity Act 2005, and how this can be applied in community nursing practice.

Background: In Italy, the law n. 219/2017 regarding informed consent states that "Communication time between doctor and patient constitutes treatment time". Legal guardian is designated as a proxy to consent on the child's behalf. The issue of proxy informed consent should be approached with a model for parent-child decision-making that is participatory, collaborative, respects and supports the autonomy of child by recognizing their evolving capacities. We aim to assess the informed consent related to healthcare decisions for medically fragile child, using the MacArthur Competence Assessment Tool for Treatment (MacCAT-T)., Materials and Methods: An observational study has been conducted at a Child Neuropsychiatry Service, administering a semi-structured interview with customized questionnaire to examine their capacities in four areas of the MacCAT-T. Results were evaluated with the Pearson correlation coefficient for the cognitive and adaptive levels of the Wechsler-Intelligence-Scale-for-Children (WISC-IV) and the Vineland-Adaptive-Behavior-Scales-II (VABS-II)., Conclusions: The MacCAT-T domains Understanding, Appreciation, Reasoning, Expressing a Choice were correlated with the cognitive and adaptive levels of the WISC-IV and the VABS-II. Understanding, Appreciation and Expressing a choice have positive correlation with the Communication and Socialization scores of VABS-II; Reasoning has positive correlation with the Working-Memory-Index scores of the WISC-IV. The study enabled to assess the informed consent processes in vulnerable children and although demonstrating how they participate in their care process in a mostly unconscious way, making the frail children more involved in their own care process was possible. Future studies should assess the impact of incorporating MacCAT-T into standard informed consent in other settings.

Assisted reproductive technology (ART) has emerged in recent years as a point of significant innovation in the medical field but is also controversial from a bioethical and legal standpoint. In the Italian context, this matter is regulated by Law 40/2004, which specifically requires that informed consent should be obtained from both members of a couple before proceeding with any ART procedure. This consent is deemed irrevocable at the moment of egg fertilization. Recently, a ruling by the Italian Constitutional Court on this matter elicited controversy. The decision permitted embryo transfer even in a case of parental separation, notwithstanding the father's explicit opposition. The Court emphasized the priority of the woman's psychophysical health over the man's, highlighting the traumatic consequences of interrupting the undertaken path. As a result, both the man's right to self-determination regarding the decision to become a father and the need for informed consent at every stage of medical procedures have been downplayed. Moreover, the extensive utilization of procedures like embryo cryopreservation, with associated parental implications, particularly concerning the time frame and the actuality of informed consent, is posing challenges to the initial application framework of Law 40/2004. The objective of this Commentary is to scrutinize and discuss the issues mentioned above., (Copyright © 2024 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

In the Polish legal system, each medical procedure requires patient's consent. Exemptions from the obligation to obtain such a consent are limited by the legislator to exceptional situations, i.e., when the delay caused by the procedure for obtaining consent would pose a threat to patient's life, serious injury, or serious health impairment. Undergoing addiction treatment is also voluntary. Exceptions to this principle are stipulated by a legal act. People who abuse alcohol and therefore break down family life, demoralize minors, avoid the obligation to meet the needs of their families, or systematically disturb peace or public order, may be obliged to undergo addiction treatment in an inpatient or outpatient treatment centre on condition that they are addicted to alcohol. A patient who fails to report to the medical entity designated by the court to execute the decision on the obligation to undertake addiction treatment may be brought to this entity by the police. In the context of the obligation to obtain a consent for treatment by a person against whom a court decision containing an obligation in this respect has been issued, there are discrepancies in the application of law provisions. In some medical entities, this results in the forced continuation of addiction treatment by a given patient in hospital, as discharge from the hospital depends on a court order issued in this regard, not on the consent of the patient himself/herself. In other medical entities, patients are not admitted for treatment due to the lack of such a consent, despite the court's obligation in this respect. The article confirms that a specific practice of applying the law, which downgrades the role of the patient's consent in the therapeutic process, has negative consequences for the effectiveness of the therapy.

Sexual violence constitutes a form of gender-based violence, to the extent that the victims are mainly women. Other groups of vulnerable people are also more affected, in particular gender and sexual diversity persons. Sexual and gender-based violence can also occur in healthcare. To respect the legal framework and people's rights, but also to promote safety and quality in healthcare, it is essential to obtain and respect consent. Consent must be informed, explicit, freely given, and reiterated throughout the consultation. This article reviews the concept of consent and offers practical tools for its application in healthcare., Competing Interests: Les auteures n’ont déclaré aucun conflit d’intérêts en relation avec cet article.

The overwhelming weight of legal authority in the USA and Canada holds that consent is not required for brain death testing. The situation in England and Wales is similar but different. While clinicians in England and Wales may have a prima facie duty to obtain consent, lack of consent has not barred testing. In three recent cases where consent for brain death testing was formally presented to the court, lack of consent was not determinative, and in one case the court questioned whether the clinicians were even required to seek consent from the parents of a child at all., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Canada has recently published a new Clinical Practice Guideline on the diagnosis and management of brain death. It states that consent is not necessary to carry out the interventions required to make the diagnosis. A supporting article not only sets out the arguments for this but also contends that 'UK laws similarly carve out an exception, excusing clinicians from a prima facie duty to get consent'. This is supplemented by the claim that recent court decisions in the UK similarly confirm that consent is not required, referencing two judgements in Battersbee We disagree with the authors' interpretation of the law on consent in the UK and argue that there is nothing in Battersbee to support the conclusion that consent to testing is not necessary. Where there is a disagreement about testing for brain death in the UK, court authorisation is required., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

How could we better use public inquiries to stem the recurrence of healthcare failures? The question seems ever relevant, prompted this time by the inquiry into how former nurse Letby was able to murder newborns under National Health Service care. While criminality, like Letby's, can be readily condemned, other factors like poor leadership and culture seem more often regretted than reformed. I would argue this is where inquiries struggle, in the space between ethics and law-with what is awful but lawful. In response, we should learn from progress with informed consent. Inquiries and civil litigation have seen uninformed 'consent' shift from being undesirable to unlawful. If better leadership and culture were sole drivers here, we would likely be doing far better in many other areas of healthcare too. Instead, one could argue that progress on consent has been made by reducing epistemic injustice -by naming and addressing epistemic issues in ways that enhance social power for patients. If this is an ingredient that transforms clinician-patient working, might it also shift conduct within other key relationships, by showing up what else should become unlawful and why? Naming medical paternalism may have helped with consent reform, so I continue this approach, first naming two areas of epistemic injustice: management feudalism and legal chokeholds Remedies are then considered, including the democratisation of management and reforms to legal ethics, legislation and litigation. In brief, public inquiries may improve if they also target epistemic injustices that should become unlawful. Focus on informed consent and epistemic relationships has improved the medical profession. Likewise, it could help healthcare leaders shift from fiat towards consent, and their lawyers from a stifling professional secrecy towards the kind of candour a prudent public expects., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Cosmetic filler injections have gained popularity in recent years, but the rise in complications has led to an increase in legal disputes. This study analyzes civil court rulings related to cosmetic filler injection lawsuits in South Korea from 2007 to 2023. A retrospective case analysis was performed using a systematic database search, and a mixed-methods approach was employed for data analysis. The study examined 27 cases, revealing a high rate of liability findings against medical practitioners. Skin necrosis and blindness were the most common complications, and intravascular filler injection was recognized as negligence. Violation of informed consent was found in most cases, with mean compensation awards of ￦193,019,107 KRW ($142,831 USD) for first instance cases and ￦81,845,052 KRW ($60,564 USD) for second instance cases. The findings emphasize the importance of practitioner awareness, adherence to precautionary measures, and proactive prevention and management of complications. Collaboration among stakeholders is crucial for developing strategies that prioritize patient safety and minimize legal disputes in the aesthetic medicine industry. This study provides valuable insights for enhancing medical practices and safeguarding patient well-being in the field of cosmetic filler injections., (© 2024. The Author(s).)

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., Competing Interests: None.

Background: Physician malpractice lawsuits are climbing, and the reasons underlying litigation against dermatologists are unclear., Objective: To determine the reasons patients pursue litigation against dermatologists or dermatology practices., Materials and Methods: A retrospective analysis of all state and federal cases between 2011 and 2022 was performed after a query using "Dermatology" and "dermatologist" as search terms on 2 national legal data repositories., Results: The authors identified a total of 48 (37 state and 11 federal) lawsuits in which a practicing dermatologist or dermatology group practice was the defendant. The most common reason for litigation was unexpected harm (26 cases, 54.2%), followed by diagnostic error (e.g. incorrect or delayed diagnoses) (16 cases, 33.3%). Six cases resulted from the dermatologist failing to communicate important information, such as medication side effects or obtaining informed consent. Male dermatologists were sued at a rate 3.1 times higher than female dermatologists., Conclusion: Although lawsuits from patients against dermatologists largely involve injury from elective procedures, clinicians should practice caution regarding missed diagnoses and ensure critical information is shared with patients to safeguard against easily avoidable litigation., (Copyright © 2024 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

This section explores the challenges involved in translating genomic research into genomic medicine. A number of priorities have been identified in the Australian National Health Genomics Framework for addressing these challenges. Responsible collection, storage, use and management of genomic data is one of these priorities, and is the primary theme of this section. The recent release of Genomical, an Australian data-sharing platform, is used as a case study to illustrate the type of assistance that can be provided to the health care sector in addressing this priority. The section first describes the National Framework and other drivers involved in the move towards genomic medicine. The section then examines key ethical, legal and social factors at play in genomics, with particular focus on privacy and consent. Finally, the section examines how Genomical is being used to help ensure that the move towards genomic medicine is ethically, legally and socially sound and that it optimises advances in both genomic and information technology., Competing Interests: Nicol and Otlowski are supported by a grant from the Australian Research Council, DP180100269. The Melbourne Genomics Health Alliance is supported are supported by the Victorian Government Department of Health and Human Services (www.dhhs.vic.gov.au/).

Objectives: Electroconvulsive therapy (ECT) can be life-saving in situations where patients are at risk of dying from severe manifestations of psychiatric illness. In some of these cases, patients are unwilling/unable to consent to ECT, and involuntary ECT is required. Such use of involuntary ECT varies substantially across European countries for unclear reasons. The aim of this study was to examine clinical and legal differences in this use of involuntary ECT across European countries., Methods: A questionnaire based on a case vignette (a 55-year-old female inpatient with psychotic depression at imminent risk of dying from metabolic derangement because of refusal to eat and drink) was sent to an ECT practitioner in each of 31 European countries., Results: We received responses from ECT practitioners in 18 countries. In 7 of these countries, involuntary ECT could be carried out without approval from others and/or involvement of the court system in the case described in the vignette. Practitioners in the remaining 11 countries responded that they either could not carry out involuntary ECT or would have to meet certain requirements before initiating involuntary ECT (e.g., approval from medical/ethics committee and second opinion from an independent psychiatrist). Notably, the rules regarding involuntary ECT differed for adults and minors (more restrictive for the latter) in 6 of the 18 countries., Conclusions: In many European countries, legislation precludes or delays the use of involuntary ECT. Harmonization of the legislation on involuntary ECT across European countries to allow for better access to this potentially life-saving treatment seems warranted., Competing Interests: Conflicts of interest: C.H.K. reports personal fees from UpToDate, Cambridge University Press, Northwell Health, and Psychiatric Times. In addition, C.H.K. has a patent for a bite block for protecting the mouth of patients receiving electroconvulsive therapy (US6098627A). S.D.Ø. received the 2020 Lundbeck Foundation Young Investigator Prize. Furthermore, S.D.Ø. owns/has owned units of mutual funds with stock tickers DKIGI, IAIMWC, SPIC25KL, and WEKAFKI, and has owned units of exchange-traded funds with stock tickers BATE, TRET, QDV5, QDVH, QDVE, SADM, IQQH, USPY, EXH2, 2B76, and EUNL., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

The Italian law 217/2019 on "Informed consent and advance directives" is an important step forward in the redefinition of patient-doctor relationships. The law points out the principles of the decisional autonomy and freedom of the patient to choose the treatment options. However, it is underestimated and largely unapplied by the Italian cardiologists. The main elements of patient-doctor communication are present in the law. The most important is the time devoted to the patient-doctor relationship, necessary to ease the disease awareness. This time is clearly emphasized in the law, but the healthcare institutions did not arrange for the appropriate organizational procedures. Through the advance directives (ADs) the patients may express their own wishes about healthcare treatments, as well as their consent or refusal regarding the diagnostic or therapeutical doctors' suggestions, allowing their respect in case they become incompetent. This right is supported by the patients' designation of a healthcare proxy, who can interact for them with the healthcare team. However, after 6 years since the law enactment, only 0.4% of the Italian citizens signed ADs, due to insufficient information and organization by the healthcare authorities. In the Law, the advance care planning is closely related to ADs. In this process, the adults can understand and share their personal values, life goals and preferences, in order to define the potential future medical care and to discuss all the issues with family and physicians. These processes can be integrated in a broader shared decision-making, a strong tool of the patient-doctor alliance.

Background: The digitalization in the healthcare sector promises a secondary use of patient data in the sense of a learning healthcare system. For this, the Medical Informatics Initiative's (MII) Consent Working Group has created an ethical and legal basis with standardized consent documents. This paper describes the systematically monitored introduction of these documents at the MII sites., Methods: The monitoring of the introduction included regular online surveys, an in-depth analysis of the introduction processes at selected sites, and an assessment of the documents in use. In addition, inquiries and feedback from a large number of stakeholders were evaluated., Results: The online surveys showed that 27 of the 32 sites have gradually introduced the consent documents productively, with a current total of 173,289 consents. The analysis of the implementation procedures revealed heterogeneous organizational conditions at the sites. The requirements of various stakeholders were met by developing and providing supplementary versions of the consent documents and additional information materials., Discussion: The introduction of the MII consent documents at the university hospitals creates a uniform legal basis for the secondary use of patient data. However, the comprehensive implementation within the sites remains challenging. Therefore, minimum requirements for patient information and supplementary recommendations for best practice must be developed. The further development of the national legal framework for research will not render the participation and transparency mechanisms developed here obsolete., (© 2024. The Author(s).)

Importance: Interest in administering psychedelic agents as mental health treatment is growing rapidly. As drugmakers invest in developing psychedelic medicines for several psychiatric indications, lawmakers are enacting legal reforms to speed access globally, and health agencies are preparing to approve these treatments. Meanwhile, US states, such as Oregon and Colorado, are making psychedelics available for supervised use outside the conventional health care system., Observations: Despite legal change and potentially imminent regulatory approval in some countries, standards for integrating psychedelics into health care have lagged, including norms for designing and implementing informed consent processes. Informed consent is complicated by the unique features of psychedelics and their means of administration. Because no governments have approved any classic psychedelics for general medical or psychiatric use, only clinical researchers have obtained informed consent from trial participants. Accordingly, there is an unmet need for informed consent processes tailored to the challenges of administering psychedelics in nonresearch settings., Conclusions and Relevance: Analysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks of data collection, relevant practitioner disclosures, and interactive patient education and comprehension assessment. Because publicly available informed consent documents for psychedelic clinical trials often overlook or underemphasize these essential elements, sample language and procedures to fill the gap are proposed.

Posthumous conception, the ability to conceive a child after the death of one partner, is increasingly prevalent due to advances in Artificial Reproduction Technology (ART). This paper considers the complexities surrounding the practice in Australia, focusing primarily on the ethical and legal dimensions. It observes that state-based regulations in Australia create disparities in accessibility: some states prohibit the procedure without the deceased's written consent, while others permit it based on guidelines or lack explicit prohibitions. Addressing the juxtaposition of Will Theory and Interest Theory, it emphasises the ongoing debate on whether rights, particularly reproductive autonomy, outlive a person's demise. Finally, the paper highlights an evident inconsistency in Australian legislation and promotes a uniform approach across states., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Informed consent is a fundamental tenet of patient-centred clinical practice as it upholds the ethical principle of patient autonomy and promotes shared decision-making. In the medicolegal realm, failure to meet the accepted standards of consent can be considered as medical negligence which has both legal and professional implications. In general, valid consent requires three core components: (1) the presence of mental capacity - characterised by the patient's ability to comprehend, retain information, weigh options and communicate the decision, (2) adequate information disclosure - based on the 'reasonable physician' or 'reasonable patient' standards and (3) voluntariness in decision-making. Nonetheless, in real-world clinical settings, informed consent is not always optimally achieved, due to various patient, contextual and systemic factors. In this article, I herein discuss three major challenges to informed consent in clinical practice: (1) patient literacy and sociocultural factors, (2) psychiatric illnesses and elderly patients with cognitive impairment and (3) artificial intelligence in clinical care, and sought to offer practical mitigating strategies to address these barriers., Competing Interests: Declaration of conflicting interestsThe author declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

When conducting clinical trials in intensive care and emergency medicine, physicians, ethics committees, and legal experts have differing views regarding the inclusion of patients who are incapable of giving consent. These different views on the participation of patients who are not capable of giving consent also complicate how clinical trials are prepared and conducted. Based on the results of a literature search, a consensus model (Cologne Model) was developed by physicians performing clinical research, ethics committees, and lawyers in order to provide patients, those scientifically responsible for the study, ethics committees, and probate (guardianship) judges with a maximum of patient safety and legal certainty, while simultaneously enabling scientific research., (© 2023. The Author(s).)

Appropriate professional practice includes the diagnostic and treatment process of urologic pathology, as well as patient information and respect for patient autonomy in decision making. Informed consent is the gradual process of providing information to the patient and their subsequent decision making. The informed consent document (ICD), when required, demonstrates that information has been provided sufficiently in advance to allow for the patient's deliberation. The dual need for simple yet complete documents make the preparation of adequate ICDs extremely difficult. If the information process is not carried out properly, the professional may incur a medical malpractice liability that is treated as a loss of opportunity. To avoid such situations, the work of scientific societies in the preparation, accessibility, and dissemination of ICD models is fundamental., (Copyright © 2024 AEU. Published by Elsevier España, S.L.U. All rights reserved.)

In health care, the provision of pertinent information to patients is not just a moral imperative but also a legal obligation, often articulated through the lens of obtaining informed consent. Codes of medical ethics and many national laws mandate the disclosure of basic information about diagnosis, prognosis, and treatment alternatives. However, within publicly funded health care systems, other kinds of information might also be important to patients, such as insights into the health care priorities that underlie treatment offers made. While conventional perspectives do not take this as an obligatory part of the information to be shared with patients, perhaps through viewing it as clinically "non-actionable," we advocate for a paradigm shift. Our proposition diverges from the traditional emphasis on actionability. We contend that honoring patients as equal moral agents necessitates, among other principles, a commitment to honesty. Withholding specific categories of information pertinent to patients' comprehension of their situation is inherently incompatible with this principle. In this article, we advocate for a recalibration of the burden of proof. Rather than requiring special justifications for adding to the standard set of information items, we suggest that physicians should be able to justify excluding relevant facts about the patient's situation and the underlying considerations shaping health care professionals' choices. This perspective prioritizes transparency and empowers patients with a comprehensive understanding, aligning with the ethos of respect for the patient as person., (© 2023. The Author(s).)

Background: Dentists have a legal and ethical obligation to obtain informed consent from patients before carrying out treatment. In Uganda, the process of obtaining informed consent in dentistry is not well documented. The aim of the present study was to determine dentists' perspectives and practices regarding informed consent to fixed prosthodontic treatment (FPT) in Kampala Metropolitan, Uganda., Methods: A quantitative cross-sectional study was conducted among 153 dentists from July to September 2023. Data were collected using a semi-structured self-administered questionnaire that included both closed- and open-ended questions. The questionnaire included items on participants' sociodemographic information, perspectives, and practices about informed consent for FPT. Perspectives were rated using ten items on a five-point Likert scale. The minimum possible total score was 10, and the maximum possible score was 50. Descriptive statistics and Poisson regression were used to summarize and analyze the quantitative data, and the significance level was set at p < 0.05. Open-ended items were analyzed using content analysis., Results: The majority (83.9%) of the participants were general dentists with working experience ranging from 1 to 38 years and a median of 8 years. The majority were familiar with the concept of informed consent and had positive perspectives regarding its use for FPT. The mean score for perspectives was 39.27 (SD, 5.42). However, there were variations in the practices of the dentists. More than three-quarters (87.6%) reported that they always obtained the patient's informed consent before FPT. Less than a third (29.4%) obtained written consent for FPT. About half of the dentists provided information regarding the procedure, benefits, and risks of treatment during the consent process. Bivariate analysis showed that the use of written consent for FPT was significantly (p < 0.05) associated with having a work experience of more than 10 years and having had training involving informed consent after undergraduate studies., Conclusion: The present study provides baseline data regarding perspectives and practices regarding informed consent for FPT among dentists in Uganda. It is recommended that regular training courses be developed to highlight the importance of improved informed consent practices for patient protection and to instruct dentists about obtaining valid informed consent. There is a need for future research to streamline guidelines for the informed consent process in dental care in Uganda., (© 2024. The Author(s).)

National Institute for Health and Care Excellence (NICE) guidelines are ambiguous over the need for patients at increased risk of infective endocarditis (IE) to receive antibiotic prophylaxis (AP) prior to invasive dental procedures (IDPs), and this has caused confusion for patients and dentists alike. Moreover, the current law on consent requires clinicians to ensure that patients are made aware of any material risk they might be exposed to by any proposed dental treatment and what can be done to ameliorate this risk, so that the patient can decide for themselves how they wish to proceed. The aim of this article is to provide dentists with the latest information on the IE-risk posed by IDPs to different patient populations (the general population and those defined as being at moderate or high risk of IE), and data on the effectiveness of AP in reducing the IE risk in these populations. This provides the information dentists need to facilitate the informed consent discussions they are legally required to have with patients at increased risk of IE about the risks posed by IDPs and how this can be minimised. The article also provides practical information and advice for dentists on how to manage patients at increased IE risk who present for dental treatment., (© 2024. The Author(s).)