El aborto eugenésico: entre el diagnóstico prenatal y el consentimiento desinformado / Eugenic abortion: between prenatal diagnosis and uninformed consent

El denominado aborto “eugenésico” tiene un extraordinario matiz diferencial frente a las otras moda lidades de aborto legalmente establecidas, que se concreta en el modo en que llega a formarse la decisión de la mujer, que no es previa, sino consecuencia de una información médica recibida sobre el feto; decisión, además, en la que late una clara componente ‘discriminatoria’, puesto que el aborto se produce exclusiva mente por la discapacidad del feto. Esa singularidad exige prestar atención al contexto en que se plantean las decisiones eugenésicas, porque en ellas inciden tres elementos fundamentales que, según se planteen, pueden conducir o no al aborto: en primer lugar, la oportunidad de realizar determinadas pruebas pre natales sin existir factores de riesgo. En segundo lugar, la enorme responsabilidad de los profesionales sanitarios a la hora de informar a los padres sobre el resultado de una prueba prenatal. En tercer lugar, el punto de vista de los futuros padres, que deberían evitar una concepción eugenésica de la paternidad/ maternidad, siendo conscientes de que lo que se está desarrollando en el útero de la mujer es su hijo o hija, no un embrión genérico afectado por anomalías; y que un hijo o hija es una realidad personal, más allá de sus capacidades. El artículo aborda estas tres cuestiones, que convierten al aborto eugenésico en una práctica discriminatoria y evitable, puesto que no se trata de impedir la decisión abortiva de la mujer, sino de refrendar su decisión primaria de continuar con el embarazo a partir de una visión positiva y no eugenésica de la discapacidad (AU)

The so-called “eugenic” abortion has an extraordinary differential nuance compared to the other le gally established modalities of abortion, which is specified in the way the woman’s decision is formed, which is not prior, but a consequence of medical information received about the foetus; a decision, more over, in which there is a clear “discriminatory” component, since the abortion is produced exclusively because of the disability of the foetus. This uniqueness requires attention to the context in which eugenic decisions are made, because they involve three fundamental elements which, depending on how they are made, may or may not lead to abortion: firstly, the opportunity to carry out certain prenatal tests in the absence of risk factors. Secondly, the enormous responsibility of health professionals in informing parents about the results of a prenatal test. Thirdly, the point of view of future parents, who should avoid a eu genic conception of parenthood, being aware that what is developing in the woman’s womb is their son or daughter, not a generic embryo affected by anomalies; and that a son or daughter is a personal reality, beyond his o her capabilities. The paper addresses these three issues, which make eugenic abortion a dis criminatory and avoidable practice, since the aim is not to prevent the woman’s decision to abort, but to endorse her primary decision to continue with the pregnancy on the basis of a positive, non-eugenic view of disability (AU)

A response to Al et al. Trials 2023;24:233.

In their recent paper, Al and colleagues (Trials 2023;24:233) argue that manipulation of the methods of recruitment using well-known techniques in order to increase enrollment can be ethically acceptable. This brief response challenges that notion as an affront to voluntariness and a devolution of the ethics of human subjects research to the "ethics" of the marketplace.

A Stakeholder-Informed Ethical Framework to Guide Implementation of Suicide Risk Prediction Models Derived from Electronic Health Records.

OBJECTIVE: Develop a stakeholder-informed ethical framework to provide practical guidance to health systems considering implementation of suicide risk prediction models. METHODS: In this multi-method study, patients and family members participating in formative focus groups (n = 4 focus groups, 23 participants), patient advisors, and a bioethics consultant collectively informed the development of a web-based survey; survey results (n = 1,357 respondents) and themes from interviews with stakeholders (patients, health system administrators, clinicians, suicide risk model developers, and a bioethicist) were used to draft the ethical framework. RESULTS: Clinical, ethical, operational, and technical issues reiterated by multiple stakeholder groups and corresponding questions for risk prediction model adopters to consider prior to and during suicide risk model implementation are organized within six ethical principles in the resulting stakeholder-informed framework. Key themes include: patients' rights to informed consent and choice to conceal or reveal risk (autonomy); appropriate application of risk models, data and model limitations and consequences including ambiguous risk predictors in opaque models (explainability); selecting actionable risk thresholds (beneficence, distributive justice); access to risk information and stigma (privacy); unanticipated harms (non-maleficence); and planning for expertise and resources to continuously audit models, monitor harms, and redress grievances (stewardship). CONCLUSIONS: Enthusiasm for risk prediction in the context of suicide is understandable given the escalating suicide rate in the U.S. Attention to ethical and practical concerns in advance of automated suicide risk prediction model implementation may help avoid unnecessary harms that could thwart the promise of this innovation in suicide prevention. HIGHLIGHTSPatients' desire to consent/opt out of suicide risk prediction models.Recursive ethical questioning should occur throughout risk model implementation.Risk modeling resources are needed to continuously audit models and monitor harms.

Informed consent in anesthesiology: An exploratory study / El consentimiento informado en anestesiología: un estudio exploratorio / Consentimento informado em anestesiologia: um estudo exploratório

Abstract: In the literature Informed consent (IC) assumptions is well established. However, the different stages and the conditions under which the IC for anesthetic practices is obtained, is scarce. The aim of the present study is to explore the phases and conditions of IC in anesthesiology. Anonymized clinical records of 325 patients submitted to anesthetic procedures at the Institute of Oncology of Porto were analyzed. A total agreement between the anesthetic techniques established in the IC and those performed, was reach with 270 patients. The importance of IC in clinical practice is discussed and an ideal process for IC is argued.

Resumen: El consentimiento informado (CI) está bien establecido en la literatura. Sin embargo, la información sobre las diferentes fases y condiciones en las que se obtiene el CI para las prácticas anestésicas es escasa. El objetivo del presente estudio es explorar las fases y condiciones de obtención de la CI en anestesiología. Se analizaron las historias clínicas anónimas de 325 pacientes sometidos a procedimientos anestésicos en el Instituto de Oncología de Oporto. Se alcanzó una concordancia total entre las técnicas de anestesia establecidas en el CI y las realizadas con 270 pacientes. Se defiende la importancia del CI en la práctica clínica y se discute un proceso ideal para obtenerlo.

Resumo: Na literatura o Consentimento Informado (CI) é bem estabelecido. Contudo, a informação sobre as diferentes fases e as condições em que o CI para práticas anestésicas é obtido, é escassa. O objetivo do presente estudo é explorar as fases e condições da obtenção do CI em anestesiologia. Foram analisados os registos clínicos anónimos de 325 pacientes submetidos a procedimentos anestésicos no Instituto de Oncologia do Porto. Foi alcançado um acordo total entre as técnicas anestésicas estabelecidas no CI e as realizadas, com 270 pacientes. A importância do CI na prática clínica é defendida e discute-se um processo ideal para a obtenção do CI.

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials.

We sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tissue plasminogen activator (tPA) in order to identify the approaches and challenges in obtaining informed consent. Out of 401 articles evaluated, 14 trials met inclusion criteria. Trial representatives were contacted to complete a survey concerning the consent process. None of the 14 trials published materials related to the informed consent process. Trials with 75% to 100% of patients directly consented had shorter door-to-treatment (DTT) times than trials that directly consented less than 50% of patients. Trials that had translators available (for recruiting participants who were not native speakers in the local language) and translated consent documents had longer DTT times. The study findings suggest that differences in the standards of informed consent internationally may allow more patients with moderate strokes to provide direct consent without delaying DTT time. Future trials should emphasize transparency to the public and scientific community in the informed consent process.

Obtaining informed consent: psychiatric nurses' knowledge and practice at federal neuropsychiatric hospital Enugu, Nigeria / Obtención de consentimiento informado: conocimiento y práctica de enfermeras de psiquiatría En El Hospital Federal de Neuropsiquiatría Enugu, Nigeria / Obtendo consentimento informado: conhecimento e prática de enfermeiras psiquiátricas no Hospital Federal Neuro-Psiquiátrico Enugu, Nigéria

Abstract: Background: Within a psychiatric care setting, informed consent is the voluntary acceptance of a plan for medical care by a competent patient after full disclosure of the care plan, its risks, benefits, and alternative approaches. This implies that the patient must have full information about any treatment options and must be competent to make the needed decisions. Objective: To assess psychiatric nurses' knowledge and practices of obtaining informed consent. Research Method: The study used a quantitative, descriptive cross-sectional survey design. Data were collected from a random sample of 99 nurses selected from a total of 131 nurses of different professional cadres working in the hospital, by means of a structured questionnaire constructed by the researchers. Data were analyzed using descriptive statistics. Results: Respondents' score on Knowledge of Informed Consent was above average (15.06 ± 2.671 out of a possible total score of 25). Likewise, their score on the disclosure of full information to psychiatric patients before treatment was well above average (6.01 ± 2.198 out of a maximum possible score of 8). However, respondents' score on the practice of obtaining Informed Consent was below average (2.41 ± 0.940 out of a maximum possible score of 5). Conclusion: Though a majority of the participants indicated good knowledge of informed consent, there was no corresponding correct practice of obtaining informed consent from patients in the hospital.

Resumen: Antecedentes: En un establecimiento de cuidado de la salud mental, el consentimiento informado es la aceptación voluntaria de un plan de cuidado médico de un paciente competente después de haber recibido información completa del plan, sus riesgos, beneficios y alternativas posibles. Esto implica que el paciente debe tener información completa acerca de las opciones de tratamiento y debe ser competente para realizar las decisiones necesarias. Objetivo: Evaluar el conocimiento y la práctica de obtención de consentimiento informado de enfermeras de psiquiatría. Método de investigación: El estudio usó un diseño de encuesta transversal cuantitativo y descriptivo. Los datos fueron recolectados de una muestra al azar de 99 enfermeras seleccionadas de un total de 131 de diferentes grupos profesionales que trabajan en el hospital, mediante un cuestionario estructurado desarrollado por los investigadores. Los datos se analizaron mediante estadística descriptiva. Resultados: El puntaje de los encuestados sobre el conocimiento de consentimiento informado fue mayor del promedio (15.06 ± 2.671 de un posible puntaje total de 25). De la misma forma, su puntaje sobre la entrega de información completa a los pacientes de psiquiatría antes del tratamiento fue bastante mayor que el promedio (6.01 ± 2.198 de un máximo posible de 8). Sin embargo, los puntajes de los encuestados sobre la práctica de obtención de consentimiento informado fue por debajo del promedio (2.41 ± 0.940 de un máximo posible de 5). Conclusión: Aunque una mayoría de los participantes indicó un buen conocimiento del consentimiento informado, no hubo en correspondencia una práctica correcta de obtención de consentimiento informado de pacientes en el Hospital.

Resumo: Background: Em um ambiente de cuidados psiquiátricos o consentimento informado é a aceitação voluntária de um plano para cuidado médico, por um paciente competente, depois da apresentação integral do plano de tratamento, seus riscos, benefícios e abordagens alternativas. Isso implica que o paciente deve ter informação completa sobre quaisquer opções de tratamento e deve ser competente para tomar as decisões necessárias. Objetivo: Avaliar conhecimento e práticas de enfermeiras psiquiátricas ao obter consentimento informado. Método de Pesquisa: O estudo utilizou um desenho de levantamento transversal descritivo, quantitativo. Os dados foram coletados de uma amostragem aleatória de 99 enfermeiras selecionadas de um total de 131 enfermeiras de diferente quadros profissionais trabalhando no hospital, por meio de um questionário estruturado construído pelos pesquisadores. Os dados foram analisados usando estatística descritiva. Resultados: O escore dos respondentes no Conhecimento do Consentimento Informado esteve acima da média (15.06 ± 2.671 de um escore total possível de 25). Da mesma forma, seus escores na apresentação de informação completa para pacientes psiquiátricos antes do tratamento esteve bem acima da média (6.01 ± 2.198 de um escore máximo possível de 8). Entretanto, o escore dos respondentes na prática de obter Consentimento Informado esteva abaixo da média (2.41 ± 0.940 de um escore máximo possível de out 5). Conclusão: Embora a maioria dos participantes indicou bom conhecimento do consentimento informado, não houve prática correta correspondente em obter o consentimento informado dos pacientes no hospital.

Tele-consent using mixed reality glasses (NREAL) in pediatric inguinal herniorrhaphy: a preliminary study.

There is an increasing demand and need for patients and caregivers to actively participate in the treatment process. However, when there are unexpected findings during pediatrics surgery, access restrictions in the operating room may lead to a lack of understanding of the medical condition, as the caregivers are forced to indirectly hear about it. To overcome this, we designed a tele-consent system that operates through a specially constructed mixed reality (MR) environment during surgery. We enrolled 11 patients with unilateral inguinal hernia and their caregivers among the patients undergoing laparoscopic inguinal herniorrhaphy between January through February 2021. The caregivers were informed of the intraoperative findings in real-time through MR glasses outside the operating room. After surgery, we conducted questionnaire surveys to evaluate the satisfaction and usefulness of tele-consent. We identified contralateral patent processus vaginalis in seven out of 11 patients, and then additionally performed surgery on the contralateral side with tele-consent from their caregivers. Most caregivers and surgeons answered positively about the satisfaction and usefulness of tele-consent. This study found that tele-consent with caregivers using MR glasses not only increased the satisfaction of caregivers and surgeons, but also helped to accommodate real-time findings by adapting surgical plan through the tele-consent.

Data sharing and privacy issues in neuroimaging research: Opportunities, obstacles, challenges, and monsters under the bed.

Collaborative networks and data sharing initiatives are broadening the opportunities for the advancement of science. These initiatives offer greater transparency in science, with the opportunity for external research groups to reproduce, replicate, and extend research findings. Further, larger datasets offer the opportunity to identify homogeneous patterns within subgroups of individuals, where these patterns may be obscured by the heterogeneity of the neurobiological measure in smaller samples. However, data sharing and data pooling initiatives are not without their challenges, especially with new laws that may at first glance appear quite restrictive for open science initiatives. Interestingly, what is key to some of these new laws (i.e, the European Union's general data protection regulation) is that they provide greater control of data to those who "give" their data for research purposes. Thus, the most important element in data sharing is allowing the participants to make informed decisions about how they want their data to be used, and, within the law of the specific country, to follow the participants' wishes. This framework encompasses obtaining thorough informed consent and allowing the participant to determine the extent that they want their data shared, many of the ethical and legal obstacles are reduced to just monsters under the bed. In this manuscript we discuss the many options and obstacles for data sharing, from fully open, to federated learning, to fully closed. Importantly, we highlight the intersection of data sharing, privacy, and data ownership and highlight specific examples that we believe are informative to the neuroimaging community.

Consentimiento informado, limitación del esfuerzo terapéutico, eutanasia. Una reflexión profesional / Informed consent, limitation of therapeutic effort, euthanasia. A professional reflection

Introducción: en la formación del profesional de las Ciencias Médicas en Cuba, se destaca la formación humanista, no obstante, profundizar en los conceptos consentimiento informado, limitación del esfuerzo terapéutico y la eutanasia, el conocimiento y dominio de estos conceptos fortalecerían la práctica médica. Desarrollo: el conocimiento de la bioética y la ética médica es de suma importancia, pues no solo tiene que ver con los principios de la ética, sino también con los valores humanos, y dentro de ellos la claridad de los conceptos y de la profesionalidad médica, que va desde la constante preocupación y ocupación por la superación profesional, así como los aspectos del comportamiento social, institucional, la autodisciplina, la entrega total, y la forma de presentarse no solo en la sociedad y en la institución, sino frente a cada paciente, siendo sobrios, elegantes, educados, amables, utilizando correctamente la bata sanitaria, conocida como bata médica, haciendo honor al color blanco como expresión de pureza y de guardar el secreto médico. Conclusiones: deberá ampliarse a la población por los diferentes medios de comunicación, y especialmente en los educandos y profesionales no solo en la impartición por parte de profesores universitarios, sino a través del uso de las tecnologías de la información. Es el momento para institucionalizar jurídicamente el consentimiento informado(AU)

Introduction: in the training of the professional of the Medical Sciences in Cuba, the humanist training stands out, however, deepening in the concepts informed consent, limitation of the therapeutic effort and euthanasia, the knowledge and mastery of these concepts would strengthen the medical practice. Development: the knowledge of bioethics and medical ethics is of the utmost importance, because it not only has to do with the principles of ethics, but also with human values, and within them the clarity of concepts and medical professionalism, ranging from the constant concern and occupation for professional improvement, as well as the aspects of social, institutional behavior, self-discipline, total dedication, and the way of presenting oneself not only in society and in the institution, but in front of each patient, being sober, elegant, polite, kind, correctly using the sanitary gown, known as a medical gown, honoring the white color as an expression of purity and keeping the medical secret. Conclusions: it should be extended to the population by the different means of communication, and especially in the learners and professionals not only in the teaching by university professors, but through the use of information technologies. It is time to legally institutionalize informed consent(EU)

Research Involving Participants With Impaired Consent Capacity: An Examination of Methods to Determine Capacity to Consent.

OBJECTIVE: To examine methods of assessing consent capacity in research protocols involving participants with impaired consent capacity, and examine instruments used to evaluate research consent capacity. METHODS: A retrospective review of 330 active research protocols involving participants lacking capacity to consent over a 10-year period (January 1, 2009, through March 1, 2019) was conducted to collect protocol characteristics (medical specialty, level of risk and type of study, consent and assent procedures, and type of vulnerable or protected population). Methods to assess consent capacity are described, and instruments to assess consent capacity are summarized. RESULTS: The specialties most frequently involving participants with impaired consent capacity in research were Neurology (27.3%), Critical Care (16.7%), and Surgery (10%). Type of studies are observational (43.9%), clinical trials (33%), chart review (11.5%), biobank (6.1%), and biomarker (5.5%). Minimal risk (53.3%) outnumbered greater than minimal risk (46.7%) studies. Most obtained written informed consent (77%) and assent (40.9%). The most common method to assess consent capacity was direct assessment by investigators (32.7%). Only 86 (26%) studies used instruments to assess consent capacity. Of the 13 instruments used, the most common was the Evaluation of Decision-Making Capacity for Consent to Act as a Research Subject, and is the only instrument that assesses all four components of decisional capacity: understanding, appreciation, reasoning, and choice. CONCLUSION: Generally, there was lack of uniformity in determining capacity to consent to research participation. Very few studies used instruments to assess consent capacity. Institutional review boards can provide greater guidance for research consent capacity determination.