A survey of national ethics and bioethics committees.

OBJECTIVE: To assess the current state of national ethics committees and the challenges they face. METHODS: We surveyed national ethics committees between 30 January and 21 February 2018. FINDINGS: In total, representatives of 87 of 146 national ethics committees (59.6%) participated. The 84 countries covered were in all World Bank income categories and all World Health Organization regions. Many national ethics committees lack resources and face challenges in several domains, like independence, funding or efficacy. Only 40.2% (35/87) of committees expressed no concerns about independence. Almost a quarter (21/87) of committees did not make any ethics recommendations to their governments in 2017, and the median number of reports, opinions or recommendations issued was only two per committee Seventy-two (82.7%) national ethics committees included a philosopher or a bioethicist. CONCLUSION: National ethics (or bioethics) committees provide recommendations and guidance to governments and the public, thereby ensuring that public policies are informed by ethical concerns. Although the task is seemingly straightforward, implementation reveals numerous difficulties. Particularly in times of great uncertainty, such as during the current coronavirus disease 2019 pandemic, governments would be well advised to base their actions not only on technical considerations but also on the ethical guidance provided by a national ethics committee. We found that, if the advice of national ethics committees is to matter, they must be legally mandated, independent, diverse in membership, transparent and sufficiently funded to be effective and visible.

Declaración de conflictos de interés y revisión por comités de ética en publicaciones con sede en el norte de Perú / No disponible

No disponible

Will medically-assisted suicide mean the rebirth of (clinical) ethics committees in Italy?

The Italian Constitutional Court has held that, in certain specific circumstances, prosecution for assisted suicide, regulated by Article 580 of the Criminal Code, is not compatible with the Constitution. The circumstances in question relate to individuals who are being kept alive by life-sustaining treatments, who are fully capable of taking free, informed decisions and are suffering from irreversible conditions that are a source of intolerable physical or mental suffering. The Court has held that the Ethics Committees must assess a request for assisted suicide made by an individual meeting these conditions. The decision requires the identification of the Ethics Committee authorised to issue authorisation in such cases and a guarantee that these Ethics Committees are able to deal with this type of issue. The Court's decision is an important opportunity to establish and promote clinical Ethics Committees, which are not nationally regulated in Italy and exist in very small numbers in only a few parts of the country.

Clinical ethics consultation among Italian ethics committee: A mixed method study.

OBJECTIVE: The general purpose for ethics consultations is to deliberate on issues on medical and scientific research and act towards the safeguard of the patient's rights and dignity. With the implementation of European Union (EU) Regulation 536/2014 on clinical trials and cost and time-optimization, the nature of consultations and the bodies they are carried out might be to some extent affected. Accordingly, we sought to gain an updated perspective on the current role and current practices of ethics consultations nationwide in both clinical and research settings. METHODS: The study was carried forth by a three-step mixed-method approach: i) review of policies/regulations for ethics committee (EC) nationwide; ii) a structured survey on ethics consultation activity completed by each EC during 2016; iii) incorporated into the third part, a qualitative assessment with a selected sample of 8 key-informants for a semi-structured interview, discussing EC history, the ethics consultation function, and the professional experience of consultants. RESULTS: Review of the policies/regulations promoted by ECs showed that 72,6% (n = 69) of all the ECs (N = 95) being actually capable of providing ethics consultation service by policy. 71 ECs (74.7%) responded to the survey on ethics consultation requests; among them, 48 (67.6%) provided ethics consultations of which 23 (23/48) actually received requests for this service in the year 2016. Many ECs did not have a structured database in place to provide precise figures of requests received in the last year nor of their contents. CONCLUSION: To date, ethics consultation in clinical and research practice is largely underappreciated and not well understood by users. The consultants themselves lack a comprehensive vision of work carried out in their field, and bioethics training programs to keep them updated. Despite clinical ethics consultation services should not necessarily be mandatory, following the recent EU Regulation on clinical trials, institutional ethics consultation bodies should be re-evaluated.

¿Modificar o no modificar el genoma de nuestra descendencia? Algunos comentarios a raiz de la Declaración del Comité de Bioética de España sobre la edición genómica en humanos / To modify or not to modify the genome of our offspring? Some comments following the Declaration of the Spanish Bioethics Committee on genomic editing in humans / Modificar o no modificar el genoma de la nostra descendència?. Alguns comentaris arran de la Declaració del Comitè de Bioètica d'Espanya sobre l'edició genòmica en humans

La modificación genética de la línea germinal humana presenta grandes problemas de carácter ético y jurídico. El Comité de Bioética de España ha publicado una Declaración ofreciendo una respuesta a estos retos. Este artículo analiza críticamente su postura, subrayando la escasa consistencia de cualquier argumento que pretenda censurar cualquier forma de mejora en la salud humana. Con tal fin, se exponen cuestiones como la relación entre dignidad humana y modificación genética o la inconsistencia de la apelación al argumento de la pendiente resbaladiza en este contexto. Asimismo, se afirma la necesidad de trazar distinciones entre las intervenciones que afectan a bienes absolutos, como la salud, y los que no lo son

Genetic modification of the human germline presents major ethical and legal problems. The Spanish Bioethics Committee has published a Declaration offering a response to these challenges. This article critically analyzes its position, underlining the scarce consistency of any argument that attempts to censor any form of improvement in human health. To this end, questions such as the relationship between human dignity and genetic modification or the inconsistency of the appeal to the argument of the slippery slope in this context are raised. At the same time, this paper highlights the need to draw distinctions between interventions that affect absolute goods, such as health, and those that are not

La modificació genètica de la línia germinal humana presenta enormes problemes de caràcter ètic i jurídic. El Comitè de Bioètica d'Espanya ha publicat una Declaració oferint una resposta a aquests reptes. Aquest article analitza críticament la seva postura, subratllant l'escassa consistència de qualsevol argument que pretengui censurar qualsevol forma de millora en la salut humana. Amb tal fi, s'exposen qüestions com la relació entre dignitat humana i modificació genètica o la inconsistència de l'apel·lació a l'argument del pendent relliscós en aquest context. Així mateix, s'afirma la necessitat de traçar distincions entre les intervencions que afecten béns absoluts, com la salut, i els que no ho són

["The ethical risks associated with artificial intelligence must be identified and regulated"]. / « Les risques éthiques associés à l'intelligence artificielle doivent être identifiés et régulés ¼.

Artificial intelligence and its applications in healthcare inevitably raise ethical questions. The 'human guarantee' is at the heart of the discussions. Interview with Cynthia Fleury-Perkins, member of the French national advisory ethics committee and holder of the Humanities and Health Chair of the Conservatoire national des arts et métiers.

German Ethics Council's Opinion: intervening in the human germline

No disponible

Dealing with Ethical Concerns in Suicide Research: A Survey of Australian Researchers.

Given the increasing trend in suicide mortality and its burden on individuals, families and communities, ethically sound research is crucial to improve the prevention of suicidal behaviour. However, few studies have looked at the experiences of researchers in obtaining ethics approval for their studies. This study addressed this gap by investigating researchers' experiences in obtaining ethics approval and how they dealt with the concerns raised by ethics committees. Respondents were recruited from September to November 2018 through the Australian Suicide Prevention Research Leaders Network, and 33 respondents (35%) completed the study survey, comprising forced-choice and open-ended questions. Respondents most commonly reported concerns from ethics committees regarding potential harm to participants and researchers' responsibilities to participants within the context of intervention and evaluation studies. Most researchers modified their ethics application and/or consulted with their ethics committee to reply to the concerns raised. Most respondents perceived the impact of the modification as positive or neutral. The study concludes that researchers may anticipate potential concerns of ethics committees. Improved understanding of how ethics committees work and dialogue between researchers and ethics committees should sustain the quality in suicide-related research.

Declaración sobre: Ética y Responsabilidad en la Sostenibilidad del Sistema Nacional de Salud / Declaration on ethics and responsibility in the sustainability of the Spanish National Heatlh System

Representantes de Comités de Bioética autonómicos y del Comité de Bioética de España reunidos en Zaragoza con fecha de 16 de noviembre de 2016 elaboraron una declaración para contribuir a la reflexión pública sobre la sostenibilidad del Sistema Nacional de Salud a partir de los valores éticos que deben impulsar la responsabilidad de todos los agentes implicados en su desarrollo. Manteniéndose la vigencia de las circunstancias concurrentes en su redacción inicial, la reunión de la "Red de Consejos, Comisiones y Comités autonómicos de Bioética y del Comité de Bioética de España" (REDECABE) celebrada en Logroño el día 26 de octubre de 2018 ratificó su plena vigencia como herramienta para la sostenibilidad del Sistema Nacional de Salud, instando su máxima difusión tanto en lengua española como inglesa

Representatives from Autonomous Communities' Bioethics Committees and the National Bioethics Committee met in Zaragoza on 16 November 2016 to draft a joint statement to contribute to publicly reflecting upon the sustainable nature of the National Health System, taking into consideration the ethical values that should promote the responsibility of all actors involved in their development. Since circumstances of the first draft remain, the meeting of the Network of Bioethics Councils, Commissions and Committees of Autonomous Regions (REDCABE), held Logroño on 26 October 2018, ratified the full validity of the declaration as a tool for sustainability of the National Health System, aiming for its dissemination in as many fields as possible, both in Spanish and English language

Ethics committee registration and re-registration with the regulatory authority in India.

Background: All ethics committees (ECs) that review and monitor clinical trials in India must be registered with the regulatory authority. We ascertained the status of registration and re-registration of ECs till December 2017. Methods: The ECs registered and re-registered with the Indian regulatory authority till December 2017 were extracted. The status of ECs was analysed according to the state, institute category and registration. Results: A total of 1260 ECs were registered, of which 14% were based in medical colleges, 2% in dental colleges, 61.2% in hospitals other than medical colleges and 8% as independent ECs. Of the recognized medical and dental colleges, only 37.3% and 10.9%, respectively, and 45.9% of ECs from teaching hospitals (other than medical and dental colleges) had registered with the regulatory authority. Of the 911 ECs eligible for re-registration, 516 (56.5%) had reregistered. Conclusion: A low proportion of registrations ofECs from eligible academic health institutions raises concern about adherence to regulatory guidelines and conduct of clinical trials in India. The lower re-registration of ECs helps in the identification of factors which should be addressed to facilitate clinical research in India.

Ethics Committees: Team Perspectives and Organizational Responses.

Healthcare ethics committees can be valuable resources but are largely underutilized by nurses. The purpose of this project was to review ethics concerns and educational needs of nurses in a large, integrated healthcare delivery system. Seven themes were identified: organizational issues, nonbeneficial care, withdrawing life-sustaining therapies, discharge disposition, challenging patients and families, communication with physicians, and capacity versus competence. A process was then developed to better engage nurses in ethical discussions.

Defining and categorizing outcomes of Moral Case Deliberation (MCD): concept mapping with experienced MCD participants.

BACKGROUND: To support healthcare professionals in dealing with ethically difficult situations, Clinical Ethics Support (CES) services like Moral Case Deliberation (MCD) are increasingly implemented. To assess the impact of CES, it is important to evaluate outcomes. Despite general claims about outcomes from MCD experts and some qualitative research, there exists no conceptual analysis of outcomes yet. Therefore, the aim of this study was to systematically define and categorize MCD outcomes. An additional aim was to compare these outcomes with the outcomes in the Euro-MCD Instrument from 2014, to further validate this Instrument. METHODS: The concept mapping method was used and involves qualitative and quantitative steps including brainstorming, individual structuring, computation of concept maps (by principal component analysis and cluster analysis), group interpretation and utilization. In total, 12 experienced MCD participants from a variety of professional backgrounds participated in two sessions. RESULTS: The focus group brainstorm resulted in a list of 85 possible MCD outcomes, of which a point map and concept maps were constructed. After a thorough discussion of each cluster, final consensus was reached on the names and position of 8 clusters of MCD outcomes: 1) Organisation and Policy; 2) Team development; 3) Personal development focused on the Other Person; 4) Personal development as Professional, focused on Skills; 5) Personal development as Professional, focused on Knowledge; 6) Personal development as an Individual; 7) Perception and Connection; and 8) Concrete action. CONCLUSIONS: This study explored and categorized MCD outcomes in a concept mapping focus group. When comparing the results with the Euro-MCD Instrument, our study confirms that outcomes of MCD can be categorized in clusters referring to the organisational level, team development, personal development (both as an individual and a professional) and the concrete case-level. In developing CES evaluation tools, it is important to be explicit if an outcome refers to the individual or the team, to knowledge or skills, to the organisation or the specific case. The findings will be used in the further validation of the Euro-MCD Instrument. The current study further contributes to the field of evaluating CES in general and defining outcomes of MCD in particular.

The Development and Rationale for CECA's Case-Based Study Guide.

This article discusses the approach of the Clinical Ethics Consultation Advisory Committee (CECA) in developing A Case-Based Study Guide for Addressing Patient-Centered Ethical Issues in Health Care. This article addresses the processes used by the CECA, its use of pivot questions intended to encourage critical reflection, and the target audience of this work. It first considers the salience of case studies in general education and their relevance for training ethics consultants. Second, it discusses the enfolding approach used in presenting the case material designed to engage the trainee in the details of the case while stimulating critical reflection. And, third, this article briefly comments on the target audience with the caveat that even superbly developed cases are prone to misuse, although that prospect should not deter their development.

Health research institutional mapping: an Eastern Mediterranean Regional perspective.

BACKGROUND: Research-conducive environments are mandatory for planning, implementing and translating research findings into evidence-informed health policies. AIM: This study aimed at comprehensive situation analysis of health research institutions in the Region. METHODS: We collected data on: institutional characteristics, research scope, capacity building, ethics, governance and resources. RESULTS: We contacted 575 institutions, of which, 223 (38.8%) responded, indicating that they conducted population research (82%). Reported studies were mostly in medicine, public health and epidemiology, while reported capacity building mainly focused on scientific writing (20.6%), research proposal writing (18%) and quantitative research methods (17%). Most institutions reported having collaborating partners (82%) - predominantly national (77%). Sixty-four percent of institutions received their own funding, with 48% reporting always having access to national databases. CONCLUSION: Governments in the Eastern Mediterranean Region and international funding agencies are called upon to support health research production through increasing allocated support and capacity building in health research.

Ethics Committees and Mental Health. / Comités de ética y salud mental.

Although research processes are covered by the objectivity of science, they are still influenced by the interests of those who conduct them. This is why high level committees have been tasked with defining the scope of the studies and performing a thorough assessment of them, since these imply great dilemmas. This premise leads to the emergence of Ethics Committees, where liaison psychiatry has an important place due to its communication abilities and knowledge of the human behavior. This paper attempts to provide some observations to take into account when discussing the link between ethics and mental health. In this work, the authors approach the question of ethics committees and the importance that psychiatrist performance has within them. This is done through a review of relevant papers on the subject. A detailed description on research ethics is provided in terms of justification, purpose and duties. Likewise, emphasis is placed on each of the areas in which psychiatrists are involved and bear great responsibilities in the medical decision-making process. Similarly, this description also includes the moment in which participants give their informed consent when taking part in medical research. Finally, we conclude that there are several questions regarding the relevance given to these committees in the methodological and ethical assessment of research projects. This in turn implies greater effort in the search for a culture of quality which highlights the emphasis on research subjects.

Health data research in New Zealand: updating the ethical governance framework.

Demand for health data for secondary research is increasing, both in New Zealand and worldwide. The New Zealand government has established a large research database, the Integrated Data Infrastructure (IDI), which facilitates research, and an independent ministerial advisory group, the Data Futures Partnership (DFP), to engage with citizens, the private sector and non-government organisations (NGOs) to facilitate trusted data use and strengthen the data ecosystem in New Zealand. We commend these steps but argue that key strategies for effective health-data governance remain absent in New Zealand. In particular, we argue in favour of the establishment of: (1) a specialist Health and Disability Ethics Committee (HDEC) to review applications for secondary-use data research; (2) a public registry of approved secondary-use research projects (similar to a clinical trials registry); and (3) detailed guidelines for the review and approval of secondary-use data research. We present an ethical framework based on the values of public interest, trust and transparency to justify these innovations.