[The provision of assisted death in the context of the desire to anticipate death]. / La prestación de ayuda a morir en el contexto del deseo de anticipar la muerte.

The entry into force of the Organic Law on the Regulation of Euthanasia in June 2021 obliges clinicians to reconsider their professional work, in the face of a new service that expands the limits of what was considered correct until then. This new service affects the entire healthcare system, but especially primary care professionals. Beyond the procedural and moral aspects, it is necessary to rethink the assessment of the patient who expresses a wish to die. In this review, we start with the relatively recent definition of the wish to hasten death (WTHD), its causes, epidemiology and differential diagnosis. Then, we examine the different mental frameworks found in the process of dying and the concept of a «good death¼. Finally, we analyse the paths that can lead to the provision of aid in dying within the framework of current legislation. The WTHD is specific to requests in case of «serious and advanced illness¼, not in other cases contemplated by the Law. When faced with a request to activate the Aid in Dying Prestation in the context of WTHD (that is, in the proximity of death), it becomes necessary to increase the patient's sense of control and begin to work on grief. Besides, in the face of an administrative process that will necessarily be long, adapting the therapeutic efforts and sedation should be considered as possible options. We understand that it is essential not to create false expectations for patients/families and not to overload healthcare professionals with administrative tasks that will be futile. It is difficult to balance these in the face of a request for a right to which the patient should always have access.

[Analysis of the challenges and dilemmas that bioethics of the 21st century will face in the digital health era]. / Análisis de retos y dilemas que deberá afrontar la bioética del siglo xxi, en la era de la salud digital.

The medical history underscores the significance of ethics in each advancement, with bioethics playing a pivotal role in addressing emerging ethical challenges in digital health (DH). This article examines the ethical dilemmas of innovations in DH, focusing on the healthcare system, professionals, and patients. Artificial Intelligence (AI) raises concerns such as confidentiality and algorithmic biases. Mobile applications (Apps) empower but pose challenges of access and digital literacy. Telemedicine (TM) democratizes and reduces healthcare costs but requires addressing the digital divide and interconsultation dilemmas; it necessitates high-quality standards with patient information protection and attention to equity in access. Wearables and the Internet of Things (IoT) transform healthcare but face ethical challenges like privacy and equity. 21st-century bioethics must be adaptable as DH tools demand constant review and consensus, necessitating health science faculties' preparedness for the forthcoming changes.

[[Translated article]]Bioethical Conflicts in Current Dermatology: A Narrative Review. / Conflictos bioéticos en la dermatología actual: una revisión narrativa.

Both the functions and equipment of dermatologists have increased over the past few years, some examples being cosmetic dermatology, artificial intelligence, tele-dermatology, and social media, which added to the pharmaceutical industry and cosmetic selling has become a source of bioethical conflicts. The objective of this narrative review is to identify the bioethical conflicts of everyday dermatology practice and highlight the proposed solutions. Therefore, we conducted searches across PubMed, Web of Science and Scopus databases. Also, the main Spanish and American deontological codes of physicians and dermatologists have been revised. The authors recommend declaring all conflicts of interest while respecting the patients' autonomy, confidentiality, and privacy. Cosmetic dermatology, cosmetic selling, artificial intelligence, tele-dermatology, and social media are feasible as long as the same standards of conventional dermatology are applied. Nonetheless, the deontological codes associated with these innovations need to be refurbished.

Bioethical Conflicts in Current Dermatology: A Narrative Review. / Conflictos bioéticos en la dermatología actual: una revisión narrativa.

Both the functions and equipment of dermatologists have increased over the past few years, some examples being cosmetic dermatology, artificial intelligence, tele-dermatology, and social media, which added to the pharmaceutical industry and cosmetic selling has become a source of bioethical conflicts. The objective of this narrative review is to identify the bioethical conflicts of everyday dermatology practice and highlight the proposed solutions. Therefore, we conducted searches across PubMed, Web of Science and Scopus databases. Also, the main Spanish and American deontological codes of physicians and dermatologists have been revised. The authors recommend declaring all conflicts of interest while respecting the patients' autonomy, confidentiality, and privacy. Cosmetic dermatology, cosmetic selling, artificial intelligence, tele-dermatology, and social media are feasible as long as the same standards of conventional dermatology are applied. Nonetheless, the deontological codes associated with these innovations need to be refurbished.

[Knowledge, use and opinion about written informed consent in primary healthcare nurses: CONOSER pilot project]. / Conocimiento, implementación y opinión acerca del consentimiento informado por escrito de las enfermeras de atención primaria: proyecto piloto CONOSER.

OBJECTIVE: To know the knowledge, implementation and opinion on informed consent of generalist nurses, specialists and primary care residents. DESIGN: Descriptive cross-sectional study using an online self-administered 'ad hoc' questionnaire. SETTING: Primary care nurses in Madrid, from November 2020 to March 2021. PARTICIPANTS: Sample of 114 nurses: 91 generalist, 20 specialists and 3 residents. MAIN MEASUREMENTS: Sociodemographics, knowledge, implementation and opinion. RESULTS: The response rate was 27.7%. As a general rule, 48.2% indicated that informed consent was collected verbally, as established by law, with differences being found between categories, this percentage being higher in specialists and residents (P=0.004), and within specialists in those who had obtained their speciality by internal resident nurse (IRN) (P<0.0001). In addition, specialists and residents were those who most identified the legal norm regulating informed consent (P<0.0001). In terms of implementation and opinion, all groups obtained similar results. DISCUSSION: There are no previous studies that have analysed these aspects of informed consent comparing the different categories. Studies from other healthcare and geographical areas show that nurses have greater knowledge, although the demand for specific training in bioethics and biolaw is greater in the nurses participating in this study. CONCLUSIONS: Nurses have adequate knowledge about informed consent, use it in clinical practice and have an appropriate conception of it, being higher in some items in specialist nurses IRN and in residents.

Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension.

BACKGROUND: The experience on informed consent form (ICF) readability at the Research Ethics Committee of the National Institute of Cancerology of Mexico (INCan) is described. OBJECTIVE: To evaluate the readability of a randomly-selected sample of ICFs submitted for review between March 1, 2022 and March 31, 2023. The number of pages, the time the reader takes to read the text and the level of education necessary to understand it were determined. RESULTS: More than half the ICFs from internal investigations were shown to be somewhat or very difficult to read; the level of education required to understand them was up to 9.9 years, and the reading time was short. The ICF texts from international multicenter investigations were aimed at an average education level of 5.5 years and had normal readability. Most ICFs from external trials require a reading time of more than 60 minutes per ICF. CONCLUSION: It is necessary to have tools that provide objectivity to the evaluation of ICFs under investigation by ethics committees, which should be indicators of their comprehension, such as readability of the documents.

ANTECEDENTES: Se describe la experiencia sobre la legibilidad de los formatos de consentimiento informado (FCI) del Comité de Ética en Investigación del Instituto Nacional de Cancerología de México. OBJETIVO: Evaluar la legibilidad de una muestra seleccionada aleatoriamente de FCI sometidos para revisión entre el 1 de marzo de 2022 y el 31 de marzo de 2023. Se determinó el número de páginas, el tiempo que el lector invierte para leer el texto y el grado de escolaridad necesario para comprenderlo. RESULTADOS: Más de la mitad de FCI de investigaciones internas mostraron ser algo o muy difíciles de leer, la escolaridad necesaria para comprenderlos fue hasta de 9.9 años y el tiempo de lectura fue corto. Los textos de los FCI de investigaciones internacionales multicéntricas estuvieron dirigidos a un nivel escolar promedio de 5.5 años y tuvieron una legibilidad normal. La mayor parte de los ensayos externos requiere un tiempo de lectura superior a los 60 minutos por FCI. CONCLUSIÓN: Es necesario disponer de herramientas que den objetividad a la evaluación de los FCI en investigación por parte de los comités de ética y sean indicadores de su comprensión, tales como la legibilidad de los documentos.

Bioethics and public health policies in Mexico.

INTRODUCTION: Bioethics, as a reference framework for collective decision-making in plural societies, represents a valuable tool for the development, implementation and evaluation of public policies in order to address structural deficiencies and contexts of vulnerability that disproportionately affect certain sectors of the population. OBJECTIVE: To provide guidelines for the strengthening of actions, programs and public policies aimed at addressing the ethical dilemmas and challenges faced by health personnel. METHODS: A documentary research process was carried out on the moral context faced by health personnel at the federal level. RESULTS: Health budget programs show important gaps in their design, implementation or evaluation, which give rise to various ethical and human rights problems. CONCLUSIONS: Given the difficulty for reaching agreements or generating common understanding with regard to public health problems, bioethics contributes to a systematic approach to the challenges of the National Health System, for the safeguarding of the human rights of users, as well as of the integrity of its institutions.

INTRODUCCIÓN: La bioética como marco referencial para la toma de decisiones colectivas en sociedades plurales representa una valiosa herramienta para el desarrollo, implementación y evaluación de las políticas públicas a fin de abordar deficiencias estructurales y contextos de vulnerabilidad que afectan desproporcionalmente a ciertos sectores de la población. OBJETIVO: Brindar pautas para el fortalecimiento de las acciones, programas y políticas públicas orientadas al abordaje de los dilemas y desafíos éticos que enfrenta el personal de salud. MÉTODOS: Se llevó a cabo un proceso de investigación documental sobre el contexto moral que enfrenta el personal de salud a nivel federal. RESULTADOS: Los programas presupuestarios en salud presentan lagunas importantes en su diseño, implementación o evaluación, que dan lugar a diversos problemas éticos y de derechos humanos. CONCLUSIONES: Ante la dificultad de alcanzar acuerdos o generar entendimiento común en relación con problemas públicos en salud, la bioética contribuye al abordamiento sistemático de los desafíos del Sistema Nacional de Salud, para la salvaguarda de los derechos humanos de los usuarios, como también de la integridad de sus instituciones.

[Euthanasia: is this the law we need?] / Eutanasia: ¿es esta la ley que necesitamos?

The Spanish Euthanasia Law introduces a new right that is added to the portfolio of services provided by the Spanish health system and whose application is guaranteed within a period of 40 days. From the perspective of clinical experience, it is argued that without the effective right to quality palliative care and given the current shortcomings in dependant care, this law may send a threatening message to particularly fragile and dependant individuals that will lead to them feeling like a burden to their families and society. It is reasoned that basing the right to die on the dignity of the individual may have unexpected social repercussions. The text of the law presents the flaws of having been written hastily and without the support of advisory entities. There are issues that require clarification with regard to the application of euthanasia within the context of general practice. The conclusion is that this new law will pose more problems of the type it aims to resolve.

Reflections around ethics, human intelligence and artificial intelligence.

On the internet, artificial intelligence has grown to become a program with codes and algorithms that learn and reprogram themselves to carry out pre-established tasks with greater efficiency; although this translates into improvements, the scope of the results and reprogramming are unknown to the programmer. Given the risk of deviation from pre-established objectives and ethical regulations, filters must be installed at the beginning, during and at the end of the process, as alarms for detecting deviations with bioethical implications. The interaction of human intelligence with artificial intelligence has had negative and positive disagreements. Initially, adapting regulations, labor laws and human rights was enough; now it is necessary for ethical standards to be established, such as those formulated in the Barcelona Declaration for the Proper Development and Usage of Artificial Intelligence in Europe.

En internet ha crecido la inteligencia artificial hasta convertirse en un programa con códigos y algoritmos que aprenden y se reprograman para efectuar tareas preestablecidas con mayor eficiencia; si bien lo anterior se traduce en mejoría, el programador desconoce los alcances de los resultados y de la reprogramación. Ante el riesgo de desviación de los objetivos preestablecidos y de los reglamentos éticos, se tienen que implementar filtros al inicio, durante y al final del proceso, como alarmas cuando existan desviaciones con implicación bioética. La interacción de la inteligencia humana con la inteligencia artificial ha tenido desencuentros negativos y positivos. Al principio, bastó con adecuar normas, leyes laborales y derechos humanos; ahora se requiere establecer normas éticas, como las formuladas en la Declaración de Barcelona para el Adecuado Desarrollo y Uso de la Inteligencia Artificial en Europa.

Do internists know what limitation of therapeutic effort means? / ¿Saben los internistas qué es la limitación del esfuerzo terapéutico?

OBJECTIVES: To ascertain whether internists know what limitation of therapeutic effort (LTE) means and whether training in palliative care affects this understanding. METHODS: A survey was administered to Spanish internists on their knowledge of LTE and the training in palliative care. RESULTS: A total of 273 respondents completed the survey (mean age, 42±12 years), 80.2% of whom were associates. Some 23.8% of the respondents identified the complete definition of LTE. The most often chosen responses were «not starting an active treatment¼(85.0%) and «withdrawing an active treatment¼ (65.9%). Forty-three percent of the respondents lacked training in palliative care, 73.3% considered their level of understanding to be good or very good, 62.3% stated that they became anxious when addressing the planning for end-of-life care with the patient, and 81.3% stated that they had had some conflict with their LTE decisions. CONCLUSIONS: Only 1 of every 4 internists knew the proper definition for LTE, with no association with the level of training in palliative care.

Which are the most prevalent ethical conflicts for Spanish internists? / ¿Cuáles son los conflictos éticos más frecuentes para los internistas españoles?

BACKGROUND AND OBJECTIVE: Clinicians face a multitude of ethical conflicts in their daily practice. There have been no studies on the types of ethical conflicts encountered most frequently and that are of most concern to clinicians in Spain. The aim of this study is to report the most common ethical conflicts faced by Spanish internists, as well as the importance that the practitioners attribute to each conflict. MATERIALS AND METHODS: Our observational cross-sectional study employed a voluntary and anonymous survey aimed at Spanish medical internists and distributed through an ad hoc platform of the Spanish Society of Internal Medicine. RESULTS: The most common and relevant ethical issues for Spanish internists are related to patients' end of life (decisions limiting therapeutic effort, use of palliative treatments, the establishment of do-not-resuscitate orders), the conflicts arising within the doctor-patient/family relationship, and making decisions with noncompetent patients. These results are similar to those of other English and European series. The ethical problems further complicate the healthcare activity of clinicians who more often notice these problems (50.3%) than those who do not notice them (16%). CONCLUSIONS: The most common and relevant ethical conflicts among Spanish internists are related to managing patients' end of life, followed by those related to the doctor-patient relationship and the management of noncompetent patients. It is essential that training programs be designed to better address and recognise these problems.

Considerations on genetic engineering: regarding the birth of twins subjected to gene edition.

In this essay, the bioethical implications of the recent genetic manipulation in human embryos with CRISPR-Cas9 to eliminate the CCR5 gene and the birth of a pair of discordant twin girls are analyzed. The experiment was disseminated via social media. The main bioethical flaws identified include the justification of the model, the informed consent process and the lack of disclosure of evident conflicts of interest. The consequences of the experiment on the life of the twins that were born were not properly evaluated, such as the impact on their autonomy, the alleged benefits to be received and the future risks of harm during their lifetime. Having manipulated the germ cell line, the effects on their future offspring were not considered. This type of actions negatively affects the way society conceives science. Genetic engineering should be reserved to the basic experimental context or as clinical research for the correction of known serious diseases of genetic origin under strict regulatory and bioethical supervision and using a gradualist approach in accordance with the advances of gene editing techniques.

En este ensayo se analizan las implicaciones bioéticas de la reciente manipulación genética en embriones humanos con CRISPR-Cas9 para eliminar el gen CCR5 y el nacimiento de dos gemelas discordantes. El experimento se divulgó en medios sociales. Los principales problemas bioéticos identificados son la justificación del modelo, el proceso de consentimiento informado y la falta de declaración de evidentes conflictos de interés. No se evaluaron apropiadamente las consecuencias del experimento sobre la vida de las gemelas nacidas como la afectación a su autonomía, los supuestos beneficios por recibir y los riesgos futuros de daño durante su vida. Habiendo manipulado la línea celular germinal, no se consideraron los efectos sobre su descendencia futura. Este tipo de acciones tiene un impacto negativo en la forma como la sociedad concibe la ciencia. La ingeniería genética debe reservarse al contexto experimental básico o bien como investigación cínica para la corrección de enfermedades conocidas graves de origen genético, bajo estricta supervisión regulatoria y bioética y de manera gradualista de acuerdo con el progreso de las técnicas de edición genética.

Mechanical ventilator as a shared resource for the COVID-19 pandemic.

COVID-19, the causative agent of which is a new type of coronavirus called SARS-CoV-2, has caused the most severe pandemic in the last 100 years. The condition is mainly respiratory, and up to 5% of patients develop critical illness, a situation that has put enormous pressure on the health systems of affected countries. A high demand for care has mainly been observed in intensive care units and critical care resources, which is why the need to redistribute resources in critical medicine emerged, with an emphasis on distributive justice, which establishes the provision of care to the largest number of people and saving the largest number of lives. One principle lies in allocating resources to patients with higher life expectancy. Mechanical ventilator has been assumed to be an indivisible asset; however, simultaneous mechanical ventilation to more than one patient with COVID-19 is technically possible. Ventilator sharing is not without risks, but the principles of beneficence, non-maleficence and justice prevail. According to distributive justice, being a divisible resource, mechanical ventilator can be shared; however, we should ask ourselves if this action is ethically correct.

COVID-19, cuyo agente causal es un nuevo tipo de coronavirus denominado SARS-CoV-2, ha provocado la pandemia más grave en los últimos 100 años. La afección es principalmente respiratoria y hasta 5 % de los pacientes desarrolla enfermedad crítica, lo cual ha producido una enorme presión sobre los sistemas de salud de los países afectados. Principalmente se ha observado alta demanda de atención en las unidades de cuidados intensivos y de recursos de atención vital. De ahí la necesidad de redistribuir los recursos en medicina crítica, con énfasis en la justicia distributiva, la cual establece atender al mayor número de personas y salvar el mayor número de vidas. Un principio estriba en asignar los recursos a pacientes con mayores expectativas de vida. Se ha dado por hecho que el ventilador mecánico es un bien indivisible; sin embargo, técnicamente es posible la ventilación mecánica simultánea a más de un paciente con COVID-19. La acción de compartir el ventilador no está exenta de riesgos, pero prevalecen los principios de beneficencia, no maleficencia y justicia. Conforme la justicia distributiva, al ser un bien divisible, el ventilador mecánico puede ser compartido, sin embargo, cabe preguntarse si esta acción es éticamente correcta.

Towards medicine of excellence in Mexico: the "Código Infarto" protocol, a view from the perspective of translational bioethics.

INTRODUCTION: Mexico is the country with the highest mortality due to ST-elevation acute myocardial infarction (STEMI), and the IMSS has therefore developed the protocol of care for emergency departments called Código Infarto (Infarction Code). In this article, aspects of translational medicine are discussed with a bioethical and comprehensive perspective. OBJECTIVE: To analyze the Código Infarto protocol from the perspective of translational bioethics. METHOD: A problem-centered approach was carried out through reflective equilibrium (or Rawls' method), as well as by applying the integral method for ethical discernment. RESULTS: The protocol of care for emergency services Código Infarto is governed by evidence-based medicine and value-based medicine; it is guided by a principle of integrity that considers six dimensions of quality for the care of patients with STEMI. CONCLUSION: The protocol overcomes some adverse social determinants that affect STEMI medical care, reduces mortality and global economic disease burden, and develops medicine of excellence with high social reach.

INTRODUCCIÓN: México es el país con mayor mortalidad por infarto agudo de miocardio con elevación del segmento ST (IAM CEST), por lo que el Instituto Mexicano del Seguro Social desarrolló el protocolo de atención para los servicios de urgencias denominado Código Infarto. En este artículo se discuten aspectos de la medicina traslacional con una perspectiva bioética e integral. OBJETIVO: Analizar el protocolo Código Infarto desde la perspectiva de la bioética traslacional. MÉTODO: Se realizó una aproximación centrada en el problema a través del equilibrio reflexivo, así como la aplicación del método integral para el discernimiento ético. RESULTADOS: El protocolo de atención para los servicios de urgencias Código Infarto se rige por la medicina basada en la evidencia y la medicina basada en valores; se orienta por el principio de integridad que considera las seis dimensiones de la calidad para la atención de pacientes con IAM CEST. CONCLUSIÓN: El protocolo supera algunos determinantes sociales adversos que afectan la atención médica del IAM CEST, disminuye la mortalidad, la carga económica global de la enfermedad y desarrolla una medicina de excelencia de alto alcance social.

[Presence of relatives during cardiopulmonary resuscitation: Perspectives of health professionals, patients and family in the Basque Country]. / Presencia de familiares durante la reanimación cardiopulmonar: perspectivas de pacientes, familiares y profesionales de la salud en el País Vasco.

OBJECTIVE: To determine the perception of nurses, doctors, patients and family or relatives being present during cardiopulmonary resuscitation (CPR) in adult patients. DESIGN: A qualitative exploratory study and thematic analysis were developed. SITE: Primary Care, Hospital Care and Emergency Service of the Basque Health Service. PARTICIPANTS: The selection of the participants was made through intentional sampling. Four focus groups were developed: one of patients and family, 2 of nurses, and one of physicians. METHOD: Thematic analysis was performed. Triangulation techniques were used between investigators and investigator-participant member. The Open code 4.1 statistics software was used. RESULTS: Three significant categories were identified: the impact on the family; the weight of ethical and legal responsibility; power, place of death, and cultural assumptions. CONCLUSIONS: CPR is a social construct influenced by values which are situated in specific socio-cultural contexts. In this study, patients and family members describe the fear and resistance to being present during CPR. Health professionals consider that their decision is complex, and each case must be assessed independently, and patients and relatives must be integrated into decision-making. Future research should explore in greater depth the subjective experience of relatives who have witnessed CPR and the impact of contextual and sociocultural elements from the perspectives of relatives.

[Assessing bioethics education: Teaching to be virtuous doctors or just doctors with practical ethical skills]. / Evaluando la enseñanza de la bioética: formando «médicos virtuosos¼ o solamente médicos con habilidades éticas prácticas.

OBJECTIVE: In the last decades, bioethics has been incorporated into the academic training of the Medical Schools. Some studies analyze the ethical-moral development of medical students and the effect of ethical education in other countries. This evaluation is done by measuring Kohlberg's moral reasoning (virtuous doctors), or ethical sensitivity to resolve clinical cases (physicians with ethical skills). The following study is proposed to assess the impact of bioethics training on these two variables, in Spanish medical students. DESIGN: Observational cross-sectional study. SITE: Faculty of Medicine, University of Lleida. PARTICIPANTS: 175 students from third year of medicine (78 before bioethics and 97 after bioethics, in different courses) were conducted. INTERVENTION: Bioethics course. MAIN MEASUREMENTS: A socio-demographic questionnaire, the Rest Defining Issue test scale, and Problem Identification Test with clinical vignettes were administered. RESULTS: A consistent and significant correlation has been found between moral reasoning and ethical sensitivity. Women presented greater post-conventional reasoning. There were no changes in Kohlberg's stage of global moral reasoning with ethical training. There were changes in ethical sensitivity with bioethical training, with a significantly and globally improvement. CONCLUSION: In our study, training in bioethics does not improve moral development but rather the ethical problem solving skills. It is asked if this improvement is enough to train doctors prepared for the new challenges.

Los comités de investigación en salud: su autoridad, responsabilidad fundamental y necesidad de que se sometan a auditorías periódicas.

Research ethics must include theoretical and practical dimensions. The first one is structured by regulations and policies, and the second dimension refers to how the committee interprets and applies those regulations and policies. This article analyses the operation of the committees at a practical level. Given that the evaluation and judgement of research protocols is a process that requires full awareness, its omission entails important implications for health research.

La ética de la investigación debe incluir las dimensiones teórica y práctica. La primera la conforman regulaciones y directrices y la segunda alude a la forma cómo los comités de ética y ética de la investigación interpretan y aplican esas regulaciones y directrices. En este artículo se analiza la operación de los comités a nivel práctico. Dado que la evaluación y el dictamen de los protocolos de investigación es un proceso que requiere consciencia plena, la omisión de esta conlleva importantes implicaciones para la investigación en salud.

[Core values in family medicine revisited]. / Una vuelta a los valores centrales en medicina de familia.

Family medicine has to continually reinvent itself around a core of values that constitutes its navigation system. But accurate data on its impact on the health of people will account for how far the values are actually being implemented. Thus, we can say that family medicine is a specialty based on values and as well as evidence based. The absence of a clarification system of values or its implementation threatens its very existence. Some of the values that are reviewed have shown great recognition and survival over time. Others are presented because they seem sufficiently significant. These are: people, comprehensiveness, trust relationship, patient-centred method, accessibility, continuity, family unity and the community, teamwork, sustainability of the health system, and continuous improvement.

National survey on the indicators of quality in Bioethics of the SEMICYUC in the departments of Intensive Care Medicine in Spain. / Encuesta nacional sobre los indicadores de calidad en Bioética de la SEMICYUC, en los servicios de Medicina Intensiva en España.

INTRODUCTION: Multiple interventions are performed in critical patients admitted to Intensive Care Units (ICUs). This study explores the presence in the daily practice of ICUs of elements related to the 6 bioethics quality indicators of the Spanish Society of Intensive and Critical Care Medicine and Coronary Units, and the participation of their members in the hospital ethics committees. MATERIALS AND METHODS: A multicenter observational study was carried out, using a survey exploring descriptive aspects of the ICUs, with 25 questions related to bioethics quality indicators, and assessing the participation of ICU members in the hospital ethics committees. The ICUs were classified by size (larger or smaller than 10 beds) and type of hospital (public/private-public concerted center, with/without teaching). RESULTS: The 68 analyzed surveys revealed: daily informing of the family (97%), carried out in the information room (82%); end-of-life care protocols (44%); life support limitation form (48.43%); and physical containment protocol (40%). Compliance with the informed consent process referred to different procedures is: tracheostomy (92%), vascular procedures (76%), and extrarenal clearance (25%). The presence of ICU members in the hospital ethics committee is currently frequent (69%). CONCLUSIONS: Information supplied to relatives is adequate, although there are ICUs without an information room. Compliance with the informed consent requirements of various procedures is insufficient. The participation of ICU members in the hospital ethics committees is frequent. The results obtained suggest a chance for improvement in the bioethical quality of the ICU.

[Informed consent process in clinical trials: Insights of researchers, patients and general practitioners]. / Ensayos clínicos y consentimiento informado: visión de investigadores, pacientes y médicos de familia.

OBJECTIVE: Adequate information for patients and respect for their autonomy are mandatory in research. This article examined insights of researchers, patients and general practitioners (GPs) on the informed consent process in clinical trials, and the role of the GP. DESIGN: A cross-sectional study using three questionnaires, informed consent reviews, medical records, and hospital discharge reports. SETTING: GPs, researchers and patients involved in clinical trials. PARTICIPANTS: Included, 504 GPs, 108 researchers, and 71 patients. RESULTS: Consulting the GP was recommended in 50% of the informed consents. Participation in clinical trials was shown in 33% of the medical records and 3% of the hospital discharge reports. GPs scored 3.54 points (on a 1-10 scale) on the assessment of the information received by the principal investigator. The readability of the informed consent sheet was rated 8.03 points by researchers, and the understanding was rated 7.68 points by patients. Patient satisfaction was positively associated with more time for reflection. CONCLUSIONS: GPs were not satisfied with the information received on the participation of patients under their in clinical trials. Researchers were satisfied with the information they offered to patients, and were aware of the need to improve the information GPs received. Patients collaborated greatly towards biomedical research, expressed satisfaction with the overall process, and minimised the difficulties associated with participation.