Prevention of infective endocarditis in at-risk patients: how should dentists proceed in 2024?

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.

Informed consent of the patient for medical intervention for conducting biomedical research.

OBJECTIVE: Aim: is to find out the peculiarities of informed consent of the patient for medical intervention during biomedical research. PATIENTS AND METHODS: Materials and Methods: The dialectical method was used as a universal and general scientific method, which made it possible to consider the peculiarities of the content of the patient's informed consent. Using the logico-semantic method, the essence and features of biomedical research with the patient's participation were determined. The formal-legal method is used to analyze adaptation processes of biomedical research. System-structural method were applied when comparing the content of the patient's informed consent in separate legislation. The work also used such methods of cognition as comparative-legal, systemic-logical, and logical-legal. CONCLUSION: Conclusions: "Informed consent" includes not only the concept of consent itself, i.e. the free decision of a person, but also an explanation of a specific case or research procedure. And it largely depends on the specialist. Will he be able to convey and explain the patient's problem, illness, actions correctly, fully and in an accessible form? Yes, free consent is given by a person, but the doctor also influences this decision to some extent. Patients' freedom in choosing medical care methods is somewhat limited.

A comparative ethical analysis of the Egyptian clinical research law.

BACKGROUND: In this study, we examined the ethical implications of Egypt's new clinical trial law, employing the ethical framework proposed by Emanuel et al. and comparing it to various national and supranational laws. This analysis is crucial as Egypt, considered a high-growth pharmaceutical market, has become an attractive location for clinical trials, offering insights into the ethical implementation of bioethical regulations in a large population country with a robust healthcare infrastructure and predominantly treatment-naïve patients. METHODS: We conducted a comparative analysis of Egyptian law with regulations from Sweden and France, including the EU Clinical Trials Regulation, considering ethical human subject research criteria, and used a directed approach to qualitative content analysis to examine the laws and regulations. This study involved extensive peer scrutiny, frequent debriefing sessions, and collaboration with legal experts with relevant international legal expertise to ensure rigorous analysis and interpretation of the laws. RESULTS: On the rating of the seven different principles (social and scientific values, scientific validity, fair selection of participants, risk-benefit ratio, independent review, informed consent and respect for participants) Egypt, France, and EU regulations had comparable scores. Specific principles (Social Value, Scientific Value, and Fair selection of participants) were challenging to directly identify due to certain regulations embodying 'implicit' principles more than explicitly stated ones. CONCLUSION: The analysis underscores Egypt's alignment with internationally recognized ethical principles, as outlined by Emanuel et al., through its comparison with French, Swedish, and EU regulations, emphasizing the critical need for Egypt to continuously refine its ethical regulations to safeguard participant protection and research integrity. Key issues identified include the necessity to clarify and standardize the concept of social value in research, alongside concerns regarding the expertise and impartiality of ethical review boards, pointing towards a broader agenda for enhancing research ethics in Egypt and beyond.

Comparative study on informed consent regulation in health care among Italy, France, United Kingdom, Nordic Countries, Germany, and Spain.

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.

Determining the state of guidance on pediatric biobanking for researchers, HRECS, and families: Regulatory mapping of international guidance.

Biobanking-the storage of human biological samples, including tissue, blood, urine, and genetic data-raises many ethical, legal, and social issues, including confidentiality and privacy. Pediatric biobanking is more complicated, with difficulties arising because children lack capacity to consent and acquire this capacity upon maturity when the research is still ongoing. Yet given the limited availability of pediatric samples, the translational nature of biobanking presents a unique opportunity to share samples and produce clinically necessary information about pediatric development and diseases. Guidance on navigating these legal and ethical difficulties is needed for those involved in pediatric biobanking-including researchers, participants, and families, and those involved in biobank governance. This paper seeks to map the current regulatory framework governing pediatric biobanking to determine what guidance is currently offered. Regulatory mapping of current international and national guidelines on pediatric biobanking addressing the ethical, legal, and social nuances of pediatric biobanking was undertaken. This paper finds that international guidelines around biobanking are mostly for adults, and even when pediatric-specific, documents are non-binding, inconsistent, or only limited guidance is offered on a range of important issues specific to pediatric biobanks.   Conclusion: This paper shows a need for consistent, comprehensive, and clear regulation on pediatric biobanking so that research can more quickly, efficiently, and ethically be translated to useful information and treatment in pediatric care. What is Known: • Pediatric biobanking presents new opportunities to conduct valuable translational research to benefit pediatric populations. However, the storage of pediatric biological samples raises many ethical, legal and social issues-in part because child participants may be considered to lack capacity to consent but can acquire this capacity upon maturity when the research is still ongoing. Pediatric biobanks must grapple with issues of consent, confidentiality and privacy, and long-term participation regarding child participants. What is New: • Regulatory guidance on these ethical, legal, and social issues is needed for researchers, participants, and families and those involved in biobank governance. This paper identifies nationally specific and international guidance on biobanking and summarizes the guidance provided in relation to these pediatric specific issues. It finds that most guidance is non-binding and inconsistent between guidance documents and may offer only limited guidance to stakeholders. A need for consistent, comprehensive, and clear regulation on pediatric biobanking is needed at an international level to enable research.

[Psychiatry without coercion-Exclude the coercion or the patients?] / Psychiatrie ohne Zwang ­ den Zwang ausschließen oder Patient:innen?

BACKGROUND: With reference to the United Nations Convention on the Rights of Persons with Disabilities (UN CRPD), a fundamental change in psychiatric care in Germany was proposed in 2019 by Zinkler and von Peter, supported by a legal perspective from Kammeier, which has since led to controversial debates. Essentially, the aim is not only to reduce coercion in psychiatry to a minimum, but also to fundamentally exclude it in a psychiatry that only provides care. The function as an agent of social control is to be returned from psychiatry to state institutions. Psychiatric hospitals will only admit patients with their consent; patients who refuse therapy will not be admitted regardless of their capacity for self-determination and will remain untreated or, if they have committed a criminal offence or threaten to commit a criminal offence, they will be taken into custody or imprisoned in accordance with the legal regulations applicable to all people. There they will receive psychiatric care if they so wish. AIM OF THE PAPER: The paper outlines the background of this concept, including international sources, traces the discussion in German specialist literature and takes a critical look at it. RESULTS: The criticism is primarily directed against the fact that responsibility for a relevant proportion of psychiatric patients would be handed over to the police and judiciary and that, as a result, two realities of care would be established that would considerably differ in terms of quality. CONCLUSION: Arguments are put forward in favor of retaining the function of social control and considerations are suggested as to how caring coercion can be largely minimized.

Consentimiento informado y directivas anticipadas: análisis comparado de la legislación en América Latina / Consentiment informat i directives anticipades: anàlisi comparada de la legislació a Amèrica Llatina / Informed consent and living wills: comparative analysis of the legislation in Latin America

Objetivos: Describir la forma en que se establecen normativamente el consentimiento informado (CI) y las directivas anticipadas (DA) en países latinoamericanos en relación a la asistencia en salud y la investigación, y su análisis desde la bioética. Métodos: Se realizó un análisis comparativo de las normativas vigentes de los 21 países latinoamericanos respecto al CI y las DA. Se confeccionaron reportes de extracción de datos que fueron diseñados antes de iniciar el proceso de investigación para cada país. Se analizaron cualitativamente similitudes y diferencias respecto a variables predefinidas. Se realizaron tablas para sintetizar la información donde fue posible.Resultados:Dieciocho países latinoamericanos prevén una norma específica para el uso del CI en el ámbito clínico. Seis países han incorporado normativas respecto al uso del CI en la virtualidad. Respecto al uso del CI en investigación, 20 países latinoamericanos prevén una norma específica para este ámbito. En el caso de la exposición académica, son 6 países los que nombran esta situación en la normativa. Siete países latinoamericanos cuentan con normativa para establecer DA.Conclusiones:América Latina ha presentado una notable evolución en torno a normar dos de los más importantes instrumentos del ejercicio de la autonomía, como los son el CI y las DA. La legislación sobre ambos instrumentos no garantiza mayor autonomía en salud, pero su existencia como reguladora de acciones para la toma de decisiones constituye el primer paso para su ejercicio.(AU)

Objectius: Descriure la manera com s'estableixen normativament el consentiment informat (CI) i les directives anticipades (DA) en països llatinoamericans en relació amb l'assistència en salut i la investigació, i la seva anàlisi des de la bioètica. Mètodes: Es va realitzar una anàlisi comparativa de les normatives vigents dels 21 països llatinoamericans respecte al CI i les DA. Es van confeccionar reports d’extracció de dades que van ser dissenyats abans d’iniciar el procés de recerca per a cada país. Es van analitzar qualitativament similituds i diferències respecte de variables predefinides. Es van fer taules per sintetitzar la informació on va ser possible.Resultats:Divuit països llatinoamericans preveuen una norma específica per a l'ús del CI a l'àmbit clínic. Sis països han incorporat normatives respecte a l'ús del CI a la virtualitat. Pel que fa a l'ús del CI eninvestigació, 20 països llatinoamericans preveuen una norma específica per a aquest àmbit. En el cas de l'exposició acadèmica, són 6 països els que nomenen aquesta situació a la normativa. Set països llatinoamericans tenen normativa per establir DA.Conclusions:Amèrica Llatina ha presentat una notable evolució al voltant de normar dos dels instruments més importants de l'exercici de l'autonomia, com els són el CI i les DA. La legislació sobre tots dos instruments no garanteix més autonomia en salut, però la seva existència com a reguladora d'accions per a la presa de decisions constitueix el primer pas per al seu exercici.(AU)

Objectives: To describe how informed consent (IC) and living wills (LW) are legally established in Latin American countries in relation to health care and research, and to analyse that from bioethics. Methods: A comparative analysis of the current regulations of the 21 Latin American countries regarding CI and LW was carried out. Data extraction reports were prepared before starting the research process for each country. Similarities and differences were qualitatively analyzed according to predefined variables. Tables were made to synthesize the information where possible.Results:Eighteen Latin American countries provide a specific criteria for IC use in clinical setting. Six countries have incorporated regulations regarding the use of ICin virtually environment. Regarding the use of IC in research, 20 Latin American countries provide a specific regulation. In the case of the academic exposure, 6 countries name this situation in their regulations. Seven Latin American countries have regulations to establish LW.Conclusions:Latin America has presented a notable evolution around regulating two of the most important instruments of the exercise of autonomy, such as the CI and the DA. The legislation on both instruments does not guarantee that there is greater autonomy in health, but its existence as a regulator of actions for decision-making constitutes the first step for its exercise.(AU)

The Politics of Informed Consent and the Limits of the First Amendment.

This Viewpoint discusses the expansion of politically motivated informed consent laws and identifies opportunities for the medical profession to challenge them.

[Organ donation after determination of brain death : Legal aspects and practical approach]. / Organspende nach irreversiblem Hirnfunktionsausfall : Rechtliche Aspekte und praktisches Vorgehen.

The prerequisites for post-mortem organ donation in Germany include the determination of irreversible loss of brain function, consent to organ donation, and the exclusion of medical contraindications. In addition, mainly because of the shortage of donor organs in Germany and the sometimes controversial social and media discussions on the topic of organ donation, all physicians involved in the donation process must be familiar with the relevant laws, guidelines, and procedural instructions. This applies especially to those who are to carry out the verification of irreversible brain death. Only then, can they act safely in this challenging situation and serve as competent consultants for all involved.

[Improper informed consent of the patient: legal and expert assessment]. / Nenadlezhashchee informirovannoe soglasie patsienta: pravovaya i ekspertnaya otsenka.

The purpose of the study is to draw the attention of the legal and medical community to the problem of insufficient awareness of the patient about the upcoming medical intervention; to identify the scope of interaction between the court and the expert in relation to disputes related to improper information. Despite the fact that the conclusion about improper informing of the patient implies a legal assessment of the circumstances, special medical knowledge is needed to identify some defects of voluntary informed consent. The expert, in particular, can answer the questions of the court about what risks are characteristic of a certain type of medical intervention (perforations, bleeding, etc.) and how high their probability was in relation to a particular patient (taking into account his state of health, anatomical features); whether there were alternative treatment options. Based on the explanations received, the court will be able to assess whether the patient's attention was focused on the relevant circumstances, whether his consent was conscious, and the complications that occurred were foreseeable.

[Clinical and regulatory challenges of forced hospitalization in Chile under the new Mental Health Law]. / Desafíos clínicos y normativos de la internación forzada en Chile, en virtud de la nueva Ley de Salud Mental.

Forced hospitalization is a common practice in psychiatry. It involves limiting the patient's freedom of movement in a clinical context without expressing informed consent, causing stress to the family and support network. Thus, forced hospitalization may cause violations, disturbances, or threats to the human rights of a vulnerable population. Considering this clinical reality, the present study seeks to analyze the current law on this subject in Chile compared to the international human rights guidelines. The analysis included a review of legal documents and referenced scientific articles. The new law No. 21,331 establishes a more demanding standard for the origin of forced internment, shortening the distance concerning the human rights guidelines regarding intellectual disability. The incoming development of the regulations mandated by the law could fill in the gaps in several situations that may arise and clarify fuzzy points. The key stakeholders' participation level will be critical in this matter.

Problemática de los medicamentos empleados fuera de la ficha técnica (uso off-label): Análisis de sus exigencias, con especial consideración a la obligación de información y consentimiento informado / Problems of off-label use of drugs: Analysis of the requirements, with special consideration to the obligation of information and informed consent

El médico siempre debe perseguir el mayor beneficio para su paciente, intentando provocar el mínimo perjuicio a la hora de prescribirle un fármaco. Ante dicha tesitura, cuando no existe una alternativa terapéutica autorizada, es relativamente frecuente administrar medicamentos fuera de la ficha técnica (off-label) en ciertas especialidades. Bajo tales premisas, el objeto de este trabajo es analizar los requisitos legales, la forma de articular la obligación de información y el consentimiento informado del paciente, situación esta última especialmente compleja en el caso de la emisión por parte del menor de edad. (AU)

When prescribing a medication, a physician makes a benefit-risk evaluation based on the drug’s potential benefits outweighing the potential risks. Faced with this situation, when there is no authorized therapeutic alternative, it is relatively common to administer drugs off-label in certain specialties. The aim of this paper is to analyze the legal requirements, the way to articulate the obligation of information and the informed consent of the patient, a particularly complex situation in the case of minors. (AU)

El Proceso de Consentimiento Informado

Este módulo forma parte del Curso "Buenas Prácticas Clínicas en Investigación". La clase, a cargo de Carlos Burger, abogado, doctor en Cs. Jurídicas y Sociales y miembro de la Comisión Conjunta Investigaciones en Salud y el Comité de Ética Central Ministerio de Salud bonaerense, aborda cuestiones generales básicas sobre temas vinculados al proceso de Consentimiento Informado (CI), a saber: ¿De qué se trata? ¿Cuándo solicitarlo? Excepciones. Aplicaciones del nuevo Código Civil y Comercial de la Nación al ámbito de la investigación clínica. Vinculación del Consentimiento Informado con la Bioética y la Autonomía. Regulaciones locales o nacionales respecto del proceso. ¿Qué es una persona autónoma? Modalidad del CI. Obligatoriedad y Excepciones. Régimen Legal aplicable: Ley 11.044 (Provincia de Buenos Aires). Ley 26.529 de Derechos de los Pacientes. Código Civil y Comercial de la Nación. Disposición 6.677 de ANMAT (Investigación farmacológica). Guía de Buenas Prácticas en Investigación (Resolución 1.480/11). Leyes provinciales de investigación según cada jurisdicción. Modalidades del CI de acuerdo al tipo de investigación: escrito, verbal, medios electrónicos a distancia. Importancia de la Ley 26.529 de Derechos de los Pacientes y el Decreto 1.089. Persona Autónoma y Código Civil y Comercial de la Nación (2015): Artículo 26 (Investigaciones de bajo y alto riesgo) y los Artículos 58 y 59 y su posible incongruencia normativa. ¿Qué norma se aplica en grupos vulnerables? Artículo 55: Disposición de Derechos personalísimos.

Patient-centred consent in women's health: does it really work in antenatal and intra-partum care?

BACKGROUND: Legal and social changes mean that information sharing and consent in antenatal and intrapartum settings is contentious, poorly understood and uncertain for healthcare professionals. This study aimed to investigate healthcare professionals' views and experiences of the consent process in antenatal and intrapartum care. METHODS: Qualitative research performed in a large urban teaching hospital in London. Fifteen healthcare professionals (obstetricians and midwives) participated in semi-structured in-depth interviews. Data were collectively analysed to identify themes in the experiences of the consent process. RESULTS: Three themes were identified: (1) Shared decision-making and shared responsibility -engaging women in dialogue is often difficult and, even when achieved, women are not always able or do not wish to share responsibility for decisions (2) Second-guessing women - assessing what is important to a woman is inherently difficult so healthcare professionals sometimes feel forced to anticipate a woman's views (3) Challenging professional contexts - healthcare professionals are disquieted by consent practice in the Labour ward setting which is often at odds with legal and professional guidance. CONCLUSIONS: Results suggest that there is a mismatch between what is required of healthcare professionals to effect an antenatal or intrapartum consent process concordant with current legal and professional guidance and what can be achieved in practice. If consent, as currently articulated, is to remain the barometer for current practice, healthcare professionals need more support in ways of enabling women to make decisions which healthcare professionals feel confident are autonomous whatever the circumstances of the consultation.

Legal and ethical considerations of artificial intelligence in skin cancer diagnosis.

Artificial intelligence (AI) technology is becoming increasingly accurate and prevalent for the diagnosis of skin cancers. Commercially available AI diagnostic software is entering markets across the world posing new legal and ethical challenges for both clinicians and software companies. Australia has the highest rates of skin cancer in the world and is poised to be a significant benefactor and pioneer of the technology. This review describes the legal and ethical considerations raised by the emergence of artificial intelligence in skin cancer diagnosis and proposes recommendations for best practice.