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.

[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.

[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.

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.

Malpractice allegations against vascular surgeons: Prevalence, risk factors, and impact on surgeon wellness.

OBJECTIVE: The contemporary medicolegal environment has been linked to procedure overuse, health care variation, and higher costs. For physicians accused of malpractice, there is also a personal toll. The objective of this study was to evaluate the prevalence of and risk factors for involvement in medical malpractice lawsuits among United States vascular surgeons, and to examine the association between these allegations with surgeon wellness. METHODS: In 2018, the Society of Vascular Surgery (SVS) Wellness Task Force conducted a confidential survey of active members using a validated burnout assessment (Maslach Burnout Index) embedded into a questionnaire. This survey included questions related to medical errors and malpractice litigation. De-identified demographic, personal, and practice-related characteristics were assessed in respondents who reported malpractice allegations in the preceding 2 years, then compared with those without recent medicolegal litigation. Risk factors for malpractice allegations were identified (χ2, Kruskal-Wallis tests), and the association between malpractice allegations with wellness was examined. Multivariate logistic regression models were developed to identify independent risk factors for malpractice accusations. RESULTS: Of 2905 active SVS members, 871 responses from practicing vascular surgeons were analyzed. A total of 161 (18.5%) were named in a malpractice lawsuit within 2 years. Malpractice allegations were significantly associated with surgeon burnout (odds ratio, 1.47; 95% confidence interval, 1.01-2.15; P = .041), but not with self-reported depression or suicidal ideation. The nature of malpractice claims included procedural errors (23.1%), failure to treat (18.8%), and error/delay in diagnosis (16.9%). Twenty percent of claims were settled prior to trial, and 19% were dismissed. Defendant vascular surgeons reported a "fair" resolution in 26.4% of closed cases. By unadjusted analysis, factors significantly associated with recent malpractice claims included mean age (51.7 ± 10.0 vs 49.3 ± 11.2 years; P = .0044) and mean years in practice (18.0 ± 10.7 vs 15.2 ± 11.8; P = .0007). Multivariate analysis revealed independent variables associated with malpractice allegations, including on-call frequency (P = .0178), recent medical errors (P = .0189), and male surgeons (P = .045). CONCLUSIONS: Malpractice allegations are common for vascular surgeons and are significantly associated with surgeon burnout. Nearly 20% of survey respondents reported being named in a lawsuit within the preceding 2 years. Our findings underscore the need for SVS initiatives to provide counseling and peer support for vascular surgeons facing litigation.

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.

A Normative Framework for the Reconciliation of EU Data Protection Law and Medical Research Ethics.

EU data protection law and medical research ethics overlap in scope and content in numerous instances in which personal data are processed in medical research. It is not always the case, however, that the conditions outlined by the two rule-sets precisely coincide. In the past few years, this lack of confluence has led to confusion as to how the two rule-sets should best relate to one another. This confusion has led to different approaches to the relationship being taken, on occasion leading to counter-intuitive conclusions. Unfortunately, there has hitherto been little effort to provide clarity to this confusion. In this regard, this article attempts to provide a general normative framework aimed at facilitating optimally cogent and just reconciliations of EU data protection law and medical research ethics.

Admission of a minor to a psychiatric hospital under Polish law. Part I. / Przyjecie maloletniego do szpitala psychiatrycznego w mysl polskiego prawa. Czesc I.

Within the scope of mental health protection, numerous practical problems arise concerning the issue of providing health services to a minor. Admission of a minor to a psychiatric hospital is associated in practice with numerous doubts. This part of the article describes the conditions of admission to hospital with the consent of the patient. It distinguishes and accurately describes situations where a minor is under or over 16 years of age. In addition, it explains situations where there is a contradiction of declarations of will by legal guardians in relation to admission, their inability to perform legal acts, or a contradiction of the statements of the minor and guardian. It also addresses the aspect of receiving written consent during the COVID-19 epidemic.