La relevancia moral del dolor de animales de experimentación y de producción / The moral relevance of pain in experimental and production animals

RESUMEN: El aspecto emocional del dolor no solo es controvertido en aves, peces y roedores, sino también en los seres humanos autoconscientes. Cuando el dolor emocional, o la insatisfacción, es vista como un mal intrínseco, evitarla o, al menos, minimizarla es un deber moral directo. El objetivo de este artículo es mostrar que no solo los modelos animales mamíferos que se utilizan en experimentación -rata (Rattus norvegicus) y ratón (Mus musculus)- sienten dolor, como reconocen universalmente las instituciones que se ocupan del bienestar animal, sino también los peces de laboratorio (Danio rerio) y los de producción (Salmo salar), y que este hecho es moralmente relevante desde el punto de vista de todas las concepciones de la moral que suelen enfrentarse en los debates morales públicos y académicos. En consecuencia, también en el caso de los peces habría que tener en cuenta indicadores de bienestar animal.

SUMMARY: The emotional aspect of pain is not only controversial in fish and rodents, but also in self-conscious humans. When pain or dissatisfaction is seen as an intrinsic evil, avoiding it or at least minimizing it is a moral duty direct. The objective of this article is to refer to pain, stress and the most widely used indices of animal welfare both in laboratory fish (Danio rerio) and production fish (Salmo salar) as well as in rat experimental animal models (Rattus norvegicus) and mouse (Mus musculus).

Ética y jurisprudencia administrativa de los derechos de los sujetos de investigación en pandemia (COVID-19): función de los comités éticos científicos: Chile / Ethics and administrative jurisprudence of the rights of subjects of research in pandemic (COVID-19): role of the scientific ethics committees: Chile

RESUMEN: Todo gobierno debe reaccionar rápida y efectivamente ante cualquier pandemia, Chile no es la excepción y apoyado en el estado de Excepción Constitucional, ha tenido que implementar medidas que podrían involucrar poca información sobre las percepciones de las personas y las reacciones durante la implementación de las restricciones. Las instituciones internacionales de salud han determinado que es un deber moral realizar investigaciones que generen evidencia que promuevan y mejoren la atención de la salud y la mitigación de la pandemia, instando a reducir los "obstáculos" prácticos de la revisión ética. Los objetivos de este trabajo fueron analizar desde las perspectivas de las consideraciones éticas y jurídicas, el rol que cumplen los Comités Éticos Científicos en el manejo y la protección de las personas durante la pandemia de la COVID-19. La metodología de trabajo se basó en la recolección de la información de Instituciones nacionales e internacionales de Salud y luego analizarla según la jurisprudencia administrativa del gobierno de Chile. Se concluye que los cambios de criterios que deben observar los CECs en el proceso de revisión de los protocolos de los proyectos de investigación científica, deben velar por proteger los derechos de los pacientes y sujetos de investigación en cuanto puede involucrar información sensible, más aún, si se consideran las graves consecuencias de su transgresión, dar un sentido distinto al que corresponda a las normas sobre derechos de pacientes, puede resultar en "falta de servicio" y eventual vulneración en los derechos del sujeto de investigación. La labor de los CEC, debe realizarse siempre desde una interpretación restrictiva, reconociendo la función pública que cumplen como parte integrante de la labor ética encomendada por el legislador al efecto.

SUMMARY: Every government must react quickly and effectively to any pandemic, Chile is no exception and supported by the state of Constitutional Exception, it has had to implement measures that could involve little information about people's perceptions and reactions during the implementation of the restrictions. International health institutions have determined that it is a moral duty to carry out research that generates evidence that promotes and improves health care and the mitigation of the pandemic, urging to reduce the practical "obstacles" to ethical review. The objective of this study was to analyze from the perspectives of ethical and legal considerations, the role that Scientific Ethics Committees play in the management and protection of people during the COVID-19 pandemic. The methodology used was based on collecting information from national and international Health Institutions and then analyzing it according to the administrative jurisprudence of the Chilean government. It is concluded that the changes in criteria that the CECs must observe in the process of reviewing the protocols of scientific research projects, must ensure the protection of the rights of patients and research subjects insofar as it may involve sensitive information, even more if the serious consequences of its transgression are considered. Giving a different meaning to the one that corresponds may result in "lack of service" and eventual violation of the rights of the research subject. The task of the CEC, must always be carried out from a restrictive interpretation, recognizing the public function that they fulfill as an integral part of the ethical work entrusted by the legislators to that effect.

Bibliometría o altimetría: desde las métricas tradicionales a las actuales. Revisión bibliográfica / Bibliometry or altimetry: from traditional metrics to present. A review

Introducción:La forma en la que se mide la difusión de la información en la comunidad científica ha sufrido cambios en la última década. Objetivo:Esta revisión tiene como objetivo contextualizar al lector sobre las diferentes formas de medir el impacto de un artículo, tomando en cuenta el "sistema de medición tradicional" y el de "métricas alternativas". Metodología de búsqueda:Se realizó una búsqueda en las bases de datos "PubMed/MEDLINE", "Dialnet", "Scielo" y "ScienceDirect", utilizando las palabras clave: Bibliometría, alt métricas, métricas alternativas y factor de impacto. Conclusiones:El "sistema de medición tradicional", basado en el factor de impacto y que se apoya esencialmente en la opinión de expertos, con el fin asegurar la calidad de las investigaciones, es una herramienta aún vigente que en conjunto con las métricas alternativas o altmétricas, favorecen la difusión del conocimiento, sin que necesariamente midan de manera precisa la calidad del artículo y su impacto...(AU)

Cómo leer y generar publicaciones científicas: aspectos éticos de la investigación clínica en niños y adolescentes / Ethical aspect in clinical research in children and adolescent

Clinical research obtains new knowledge for well-being of people and is ethically is justified for the common good. The objective of this article is to describe some of aspects of an ethical research, that must be valuable, valid, independently evaluated and must consider risks and benefits of participants. The respect of participants is an informed consent, autonomous, beneficiary, protective and with equitable access to the study, considering children and adolescents biologically and socially vulnerable.

La investigación clínica obtiene nuevos conocimientos necesarios para el bienestar de las personas y éticamente se justifica por el bien común. El objetivo de este artículo es describir algunos aspectos de una investigación ética, la que debe ser valiosa, válida, evaluada independientemente, considerando riesgos y beneficios de las personas participantes. El respeto por los participantes es un consentimiento informado, autónomo, beneficiario, protector y con acceso equitativo al estudio, considerando que los niños/as y adolescentes son vulnerables biológica y socialmente.

Análisis comparativo de las pautas del consejo de organizaciones internacionales de ciencias médicas (CIOMS) 2016. (Parte 1 de 3) / Comparative analysis of the standards of the council of international organizations of medical sciences (CIOMS) 2016. (Part 1 of 3)

Para la realización de investigaciones científicas en seres humanos es fundamental el cumplimiento de la Declaración de Helsinki, cuya última actualización se publicó en el 2013. Para los países de América Latina esta declaración se adaptó como las Pautas CIOMS, por lo que también fue necesario actualizar y su publicación ocurrió en el 2016. Como parte de la evaluación de la asignatura Bioética e Investigación, se solicitó a los estudiantes de la VI Cohorte de la Maestría en Bioética de la Facultad de Medicina, UCV, que realizarán un análisis comparativo de éstas con las pautas contempladas en la edición anterior del 2002 a fin de proporcionar a los investigadores un aporte en su formación y una rápida adaptación a la nueva propuesta. Para el desarrollo de estos trabajos se agruparon las pautas en grandes temas afines y se presentan en tres entregas(AU)

To carry out scientific research on human beings, compliance with the Declaration of Helsinki, whose last update was published in 2013, is essential. For Latin American countries, this statement was adopted as the CIOMS Guidelines, which were last updated and published in 2016. As part of the evaluation of the subject Bioethics and Research, students of the VI Cohort of the Master in Bioethics of the Faculty of Medicine, UCV, were asked to perform a comparative analysis of these with the guidelines contemplated in the previous edition of 2002 to provide researchers with a contribution in their training and a rapid adaptation to the new proposal. For the development of these works, the guidelines were grouped into large related topics and presented in three installments(AU)

II. The research ethics involving vulnerable groups

Abstract Vulnerability in research occurs when the participant is incapable of protecting his or her interests and therefore, has an increased probability of being intentionally or unintentionally harmed. This manuscript aims to discuss the conditions that make a group vulnerable and the tools and requirements that can be used to reduce the ethical breaches when including them in research protocols. The vulnerability can be due either to an inability to understand and give informed consent or to unequal power relationships that hinder basic rights. Excluding subjects from research for the only reason of belonging to a vulnerable group is unethical and will bias the results of the investigation. To consider a subject or group as vulnerable depends on the context, and the investigator should evaluate each case individually.

Los comités de investigación en salud: su autoridad, responsabilidad fundamental y necesidad de que se sometan a auditorías periódicas / Health research committees: their authority, fundamental responsibility and the need for them to undergo periodic audits

Resumen 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.

Abstract 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.

Integridad y conductas inapropiadas en investigación biomédica / Integrity and misconduct in biomedical research

Resumen: Los Comités Editoriales de revistas de corriente principal se ven enfrentados ocasionalmente a con ductas éticas inapropiadas en los manuscritos recibidos. El Comité de Ética en las publicaciones (COPE) ofrece recomendaciones para los editores respecto a cómo actuar frente a la sospecha de falta de ética en los manuscritos, ya sea recibidos o publicados. Cuando se pesquisa una mala práctica durante el proceso de revisión por pares, el manuscrito es rechazado, no obstante, si la conducta ina propiada es detectada después de la publicación de manuscrito, se procede a retractar la publicación. Revista Chilena de Pediatría no ha sido exenta a este tipo de conflictos. En este artículo analizamos los distintos aspectos relacionados con la falta de integridad de las publicaciones, como son las autorías, el plagio y el conflicto de intereses. Podemos concluir que las malas prácticas ocurren principalmente por desconocimiento de los autores, más que por intención de fraude. Se espera que el presente ma nuscrito logre instruir y sensibilizar a nuestros investigadores, respecto a las buenas prácticas en la investigación y publicación, y, contribuir, en lo posible, a prevenir que estas acciones ocurran en los manuscritos enviados a nuestra Revista.

Abstract: Editorial Boards of mainstream journals occasionally face ethical misconducts in received manus cripts. The Committee on Publication Ethics (COPE) provides recommendations for editors on how to deal with suspected ethical misconduct in either received or published manuscripts. The manus cript is rejected when malpractice is observed during the peer review process, however, if the mis conduct is detected after the publication, the publication will be retracted. The Revista Chilena de Pediatría (Chilean Journal of Pediatrics) has not been exempt from these type of conflicts. In this article, we analyze different aspects regarding the lack of integrity in publications, such as authorship, plagiarism, and conflict of interest. We can conclude that malpractices take place mainly due to the lack of knowledge of the authors rather than intent to defraud. It is expected that this article will suc ceed in instructing and sensitizing our researchers on good practices in research and publication, and contribute, as far as possible, to prevent this actions in the manuscripts sent to our Journal.

Ética em pesquisa no sistema CEP-CONEP brasileiro: reflexões necessárias / Research ethics in the Brazilian CEP-CONEP system: necessary reflections

Resumo O Brasil conta com um reconhecido sistema de avaliação ética das pesquisas envolvendo seres humanos - Sistema CEP-CONEP, em funcionamento há 20 anos. Entretanto, observa-se que as suas eficácia e efetividade, nestes últimos anos, vêm sendo questionadas, criticadas e colocadas em xeque. Trata-se de um ensaio, com base em vivências da autora enquanto docente na área de bioética, pesquisadora e ex-coordenadora de CEP, com o objetivo de refletir, de forma crítica, a respeito do papel da ética como fio condutor de todas as etapas do processo de pesquisa e discutir alguns impasses, lacunas e questões desafiadoras que deverão ser considerados e enfrentados com urgência pelo Sistema CEP-CONEP. Discutem-se questões que merecem ser reavaliadas permanentemente para se enfrentar os inúmeros desafios, propiciando um real avanço científico aliado ao avanço ético-social, por exemplo: a questão da importância social do estudo e seu retorno e/ou contribuição à sociedade; os aspectos éticos e políticos envolvidos nas prioridades de pesquisas; o avanço da básica apreciação inicial da pesquisa e da simples avaliação normativa; a necessidade de valorização e reconhecimento do trabalho dos Comitês; o descrédito do Sistema por precariedade de infraestrutura, os cuidados pós-estudo, dentre outros.

Abstract Brazil counts with a well-known human research ethics evaluation system - the CEP-CONEP System, which has been in operation for 20 years. However, its efficacy and effectiveness have been questioned, criticized and put in check, especially in recent years. This work is based on the author's experiences as faculty member in the field of bioethics, researcher and former coordinator of a CEP and aims to critically reflect on the role of ethics as a driving force of all the steps of the research process, and discuss some deadlocks, gaps, and challenging issues which must be urgently considered and addressed by the CEP-CONEP System. Issues that deserve to be permanently and critically reevaluated are discussed to cope with several challenges, providing a real scientific advance, linked to the social and ethical advance of science, such as the issue of social relevance of the study and its yield/contribution to society; the ethical and political aspects involved in research priorities; the advance of the basic initial appreciation and of the simple normative evaluation; the need for the valorization and recognition of the Ethics Committees' work; the System's discredit due to poor infrastructure, post-study care, among others.

Experiencia en el Foro Global de Bioética en Investigación: desafíos para la revisión ética en Chile / Experience in the global forum of bioethics in research: challenges for the ethical review in Chile

The Global Forum on Bioethics in Research annually convenes a number of researchers, bioethicists and stakeholders with a shared interest in the ethics of conducting research in low and middle-income countries (LMIC). It provides a useful platform to discuss ethical issues that affect research practice in different scenarios, promoting ethically conducted research, global development for health research ethics and partnerships between the global north and south. As participant of the last three meetings, in this article the author analyzes the main ethical issues that were discussed in this forum, namely "Emerging epidemic infections and experimental medical treatments" (Annecy, France, 2015); "Ethics of research in pregnancy" (Buenos Aires, Argentina, 2016), and "The ethics of alternative clinical trial designs and methods in LMIC research" (Bangkok, Thailand, 2017). Local research ethics committees are not well prepared to face the new ethical challenges associated with research conducted in emergency situations or in pregnant women, or to evaluate new methods, such as alternative clinical trial designs (cluster randomized trials, adaptive platforms, or controlled human infection models, among others). According to this scenario, research ethics committees should be trained to carefully assess the risks and benefits of approving this type of research. In this context, it is necessary to harmonize local regulations with the new international standards in research ethics.

Problemas éticos en las publicaciones científicas / Ethical problems in scientific publications

Ethical problems have always been present in scientific publications. Since the founding of medical journals, in the XIX Century, until today they are a source of concern because one main purpose of medical scientific publications is to add new, reliable information that could guide or modify medical decisions and public health policies. Since 1997, Revista Médica de Chile has published several articles clarifying this situation and emphasizing the need to avoid ethical misbehavior. The present review reminds that the main sources of information dealing with publication ethics appear in the web sites of ICMJE, COPE and WAME. Misconduct have been detected in Revista Médica de Chile in a few cases of redundant publications, plagiarism, lack of recognition of conflicts of interest mainly with pharmaceutical companies, and one attempt of forging the publication of an article that had been previously rejected. In handling situations identified as ethical misbehavior, the editors of this journal have successfully followed rules established by COPE. This article reviews and reinforces recommendations to avoid ethical misbehavior in biomedical research and in manuscripts submitted for publication.

A didactic approach to presenting verbal and visual information to children participating in research protocols: the comic book informed assent

OBJECTIVE: When children participate in research protocols, consent (by a parent or legal guardian) and assent (by the children) must be given. Understanding research protocols can be challenging for an adult and even more difficult for a child. The aim of this study was to describe the development of a comic book created to facilitate children's understanding of informed assent with clear and simple language. METHODS: Five researchers with scores above seven according to the Fehring criteria developed the comic book, avoiding the use of technical terminology. Twenty children between 7 and 12 years old, and enrolled in a larger study, responded using a Likert scale and questions about the clarity of texts and illustrations. The final version met National Health System Resolutions (Resoluções do Conselho Nacional da Saúde - CNS n° 196/1996 and 466/2012). RESULTS: The comic book assent presents a short story containing information about a real study: the invitation to participate, objectives, methods, instruments, procedures, risks, benefits, and the researchers' contact information. Most of the participants answered that they perceived the content of the text to be "Excellent" (40%) and "Very good" (40%), and the illustrations were perceived as "Excellent" (45%) and "Very good" (55%). CONCLUSION: The construction of a simple and clear model of informed assent is possible, and this model should be used in experiments with children.

Pautas Éticas del Consejo de Organizaciones Internacionales de las Ciencias Médicas: avances y temáticas no resueltas en la actualización 2016 / Council for International Organizations of Medical Sciences (CIOMS) Ethical Guidelines: advancements and unsolved topics in 2016 upgrade

A fines del año 2016 se publicó la nueva edición de las Pautas Éticas Internacionales para la Investigación Relacionada con la Salud con Seres Humanos del Consejo de Organizaciones Internacionales de las Ciencias Médicas (CIOMS, por sus siglas en inglés Council for International Organizations of Medical Sciences), estándares universalmente reconocidos en la investigación biomédica. En este artículo se realiza un análisis crítico de las potencialidades y falencias de las nuevas pautas del CIOMS 2016. Algunos avances alcanzados consideran la importancia asignada al valor social de la investigación y su repercusión en la toma de decisiones y la creación de políticas públicas, el desarrollo de investigación en escenarios de bajos recursos, la participación de las comunidades en el proceso investigativo, la determinación de la vulnerabilidad de los participantes de una investigación y los cambios en los procedimientos de consentimiento informado. Esta actualización es una gran herramienta para investigadores y miembros de los comités de ética científica. Asimismo, aunque constituye una adaptación a los rápidos cambios científicos, tecnológicos y sociales; permanecen aspectos no resueltos, principalmente en torno al manejo del riesgo mínimo de los participantes y de los conflictos de interés involucrados en una investigación, además del desarrollo de ésta en escenarios de bajos recursos. No obstante, se hace un positivo progreso en cuanto al contexto y las necesidades de las poblaciones en las que se desarrollarán las investigaciones y la participación comunitaria en las distintas fases del proyecto, accediendo a sus potenciales beneficios. El impacto de las pautas del CIOMS 2016, deberá evaluarse en el tiempo, en particular en escenarios de inequidades socio-sanitarias y de intereses comerciales de la industria en la investigación biomédica.

In 2016, the new edition of the Council for International Organizations of Medical Sciences (CIOMS) Ethical Guidelines was released, which are universally acknowledged as ethical standards in biomedical research. In this article, we critically analyze the improvements and shortcomings of the CIOMS Ethical Guidelines 2016. Among the improvements are the relevance assigned to the social value of research and its effects on decision-making and the creation of public policies; the research development in low-resources scenarios; the communities' involvement in the research process; the determination of participants' vulnerability and changes on informed consent related proceedings. Despite the improved harmonization with scientific, technologic and social changes, and that the guidelines provide a tool for researchers and members of research ethics committees alike, some topics remain unsolved, namely the management of participants' minimal risk and conflicts of interest involved in research, and the development of research in low-incomes scenarios. Nonetheless, we recognize that these new guidelines constitute a progress regarding the context and needs of populations in which research will be conducted, with greater community involvement in the different phases of the investigation project, thus allowing them to access the potential benefits. The impact of the CIOMS Ethical Guidelines 2016, should be appraised over time, particularly in socio-sanitary inequities scenarios and in the context of commercial interests of industry on biomedical research.