Aspectos éticos y recomendaciones para investigación en seres humanos en la era genómica / Ethical aspects and recommendations for human research in the genomic age

Este artículo revisa los principales desafíos éticos que plantea la investigación vinculada al genoma humano a la luz de la bibliografía internacional y entrega recomendaciones sobre su abordaje basada en nuestra experiencia en el Comité de Ética para la Investigación en Seres Humanos de la Facultad de Medicina, Universidad de Chile, incluyendo las regulaciones legales nacionales. Los estándares éticos de la investigación en seres humanos deben extremarse para proteger adecuadamente a los participantes en estudios involucrados con la genómica. Especialmente relevantes en este contexto son: la protección de la confidencialidad y anonimato; la política de entrega de resultados y la posibilidad de retirarse del estudio. Compartir datos resultantes de investigaciones genéticas permite optimizar recursos, otorga mayor transparencia y replicabilidad de los análisis y permite descubrir alteraciones genéticas responsables de enfermedades raras y genes involucrados en enfermedades hereditarias multifactoriales, además de contribuir al diseño de medicina de precisión y de nuevas estrategias terapéuticas. Sin embargo, plantea grandes desafíos: proteger la privacidad y evitar la re-identificación de los voluntarios, la entrega de resultados con asesoría pre y post estudio. Estos aspectos requieren la elaboración de un cuidadoso proceso de consentimiento informado para investigaciones genómicas cuyos componentes principales se analizan en este artículo.

This article reviews the main ethical challenges posed by human genome research in the light of the international literature and provides recommendations on how to approach them based on our experience in the Ethics Committee for Research on Human Subjects of the Faculty of Medicine, University of Chile, including national legal regulations. Ethical standards in human research must be extreme, in order to adequately protect participants in studies involving genomics. Particularly relevant in this context are the protection of confidentiality and anonymity; the policy of delivery of results and the possibility of withdrawing from the study. Sharing data resulting from genetic research optimizes resources, provides greater transparency, and replicability of the analyses and makes it possible to discover genetic alterations responsible for rare diseases and genes involved in multi-factorial hereditary diseases, as well as contributing to the design of precision medicine and new therapeutic strategies. However, it poses great challenges: protecting privacy and avoiding re-identification of volunteers, delivery of results with pre- and post-study counseling. These aspects require the elaboration of a careful informed consent process for genomic research, the main components of which are discussed in this article.

Renegar del agujero en el caldero: defensas inconsistentes sobre el experimento de gemelos de Neubauer / To deny the hole in the cauldron Inconsistent defenses over Neubauer's twin experiment

El documental Three Identical Strangers, de Tim Waldle (2018) revela una investigación secreta sobre el desarrollo de hermanos genéticamente idénticos separados de manera deliberada para ser criados en circunstancias diferentes. Desde su estreno el experimento expuesto ha provocado una serie de rechazos en la opinión pública y entre los profesionales de la salud mental. El presente trabajo analiza los argumentos de los psiquiatras y psicoanalistas Leon Hoffman y Lois Oppenheim, que han cuestionado el documental y defendido el experimento, para analizar sus argumentos y evaluar si los mismos son consistentes o, por el contrario, pretenden legitimar una investigación éticamente inaceptable

Tim Waldle documentary film Three Identical Strangers (2018), reveals a secret investigation on the development of genetically identical siblings who were separated on purpose so as to be raised in different social contexts. Since it´s premiere, the exposed experiment has caused a series of rejections among public opinion and mental health professionals. This paper focuses in the arguments of psychiatrists Leon Hoffman and Lois Oppenheim in defense of the experiment and against the film, so as to analyzse if their arguments are consistent, or on the contrary, they pretend to legitimate an ethically unacceptable investigation.

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.

Prison research: a bioethics or an ethics issue? / Investigación en prisión: ¿una cuestión de bioética o de ética? / Investigação em contexto prisional: Um questão de bioética ou de ética?

Abstract: The hypothesis of reducing aggressiveness through transcranial direct current stimulation was recently tested on a cohort of inmates in Spain. The experiment, including 1.5 mA electric shocks, was an external research initiative that received the initial acquiescence of the carceral system. An alarm was raised at the time the research was published, encouraging the directorate of prisons to stop the ongoing replication of the experiment. Nevertheless, no (bio)ethics committee, in the universities or among bioethics experts, has questioned the research. In this think piece, we aim to again discuss some ethical approaches to these clinical interventions on crime. After its positivistic period, the field of criminology has been questioning the simple psychobiological approach to crime because of the reductionistic view of this phenomenon and its harmful consequences. Thus, we address academic experimentation under prison governance and the "re" roles of prisons. We argue that the minor disadvantages of such research, if performed with consent, could be positive if the research can minimize the harmfulness of prison itself; thus, penitentiary treatment and science should go together. Prison administrations, in addition to their duty to protect the individuals under their control from ethically biased research, must promote reintegration. We conclude that human rights are over criminal policy and science and that ethics are over narrower bioethics.

Resumen: La hipótesis de la reducción de la agresividad por medio de estimulaciones transcraneales ha sido recientemente testada sobre encarcelados en España. El experimento, que incluyó descargas eléctricas de 1.5mA, fue una iniciativa de investigadores externos que encontró la aquiescencia inicial del sistema carcelario. La alarma surgió en el momento en que se publicó la investigación, alentando a la dirección de las prisiones a detener la replicación del experimento. Sin embargo, hasta entonces, ningún comité encontró ningún inconveniente, ni en las universidades ni entre expertos en bioética. En este artículo de reflexión pretendemos argumentar algunos enfoques éticos de estas intervenciones clínicas sobre la delincuencia. De nuevo, ya que la criminología, después de su periodo positivista, ha venido cuestionado el mero enfoque psicobiológico de la delincuencia. Así, abordamos el experimento académico dentro de la gobernanza penitenciaria y los roles "re" de las prisiones. Argumentamos que no es tanto que no se pueda investigar con internos, sino que posibles inconvenientes de tales investigaciones puedan servir, bajo consentimiento, para minimizar los inconvenientes de la misma pena de prisión. La administración, además del deber de proteger a sus individuos de investigaciones éticamente sesgadas ha de fomentar la reintegración. Concluimos que los derechos humanos han de estar por encima de la política criminal y de la ciencia, y la ética por encima de una más limitada bioética.

Resumo: A hipótese de diminuir a agressividade através da estimulação elétrica transcraniana foi recentemente testada num grupo de reclusos em Espanha. A experiência, que incluiu choques elétricos de 1,5mA, partiu de uma iniciativa de investigadores externos que encontraram a aquiescência no sistema prisional. O alarme surgiu no momento em que a investigação foi publicada, o que levou a direção administrativa das prisões a interromper a replicação do estudo. No entanto, até ao momento, nenhuma comissão de (bio)ética encontrou qualquer inconveniente, nem nas universidades, nem entre os especialistas em bioética. Com este artigo, pretendemos discutir algumas abordagens éticas dessas intervenções clínicas no crime. A criminologia tem vindo a questionar, após o seu período de investigação positivista, a abordagem psicobiológica do crime, devido à visão redutora desse fenómeno e das suas consequências nefastas. Assim, neste artigo, abordamos a experiência académica dentro da governança prisional e os fins da prisão. Concluímos que as pequenas desvantagens da investigação seriam positivas se pudessem, sob consentimento, minimizar os malefícios da própria prisão, o que significa que o tratamento penitenciário e a ciência deveriam andar 'de mãos dadas'. A administração das prisões, para além do dever de proteger os indivíduos de estudos que acarretem problemas éticos, deve promover a reintegração. Concluímos, assim, que os direitos humanos estão acima da política e da ciência criminais, e a ética acima da bioética mais restrita.

Orientación para la supervisión ética de las investigaciones sobre COVID-19 ante la generación de nueva evidencia / Guidance for ethics oversight of COVID-19 research in response to emerging evidence

La investigación relacionada con la salud con seres humanos es un componente esencial de la respuesta a la pandemia de COVID-19. Este documento tiene como objetivo orientar el análisis ético y los procedimientos que se deben seguir para llevar a cabo la supervisión de las investigaciones relacionadas con la COVID-19 ante la producción rápida de evidencia durante la pandemia.

Health-related research with human subjects is an essential component of the response to the COVID-19 pandemic. This document aims to guide the ethics analysis and procedures for the oversight of COVID-19-related research in light of the rapid production of evidence during the pandemic.

The Northwestern Abdominoplasty Scar Model: A Tool for High-Throughput Assessment of Scar Therapeutics.

Significance: Scar management is an important concern in plastic surgery. Scar models that best mimic in vivo human scarring are essential for understanding scar development and progression, assessing the efficacy of therapeutics, and providing reliable and valid research outcomes. Recent Advances: In 2016, Lanier et al. proposed a new in vivo patient model, the Northwestern Abdominoplasty Scar Model, that overcomes the prior limitations of both animal and human models, with greater representativeness of the human scarring process, expedited recruitment, smaller sample requirements, and greater flexibility in the types and number of interventions that can be studied simultaneously. Critical Issues: Existing animal models suffer from limitations that impede generalization to human scars. Human scar studies are difficult to conduct and rarely used due to recruitment difficulties, ethical concerns regarding purposeful wounding, and inherent variability based on location, type of scar, and the heterogeneity of the host response between humans. Although overcoming many of these hurdles, the Northwestern Abdominoplasty Scar Model still has a few limitations. In addition, there remains a need for further study of and comparison between the Northwestern Abdominoplasty Scar Model and existing human and animal models, to inspire more widespread acceptance of a standardized human scar model. Future Directions: The Northwestern Abdominoplasty Scar Model is a critical stepping stone toward better human scar models. This model hopefully will inspire other in vivo patient models utilizing elective surgery to overcome recruitment and ethical concerns.

The New 2019 Institutional Review Board Common Rule Update: Implications for Plastic Surgery Research.

Clinical research remains at the forefront of academic practice and evidence-based medicine. Unfortunately, history has shown that human subjects are vulnerable to experimentation without regard for their own dignity and informed decision-making. Subsequently, it is vital for research institutes to uphold safeguards and ethical conscientiousness toward human subjects. The establishment of federal regulations and the development of institutional review boards have set guidance on these processes. On January 21, 2019, final revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule") went into effect. The purpose of this article is to review changes to the Common Rule and discuss their impact on plastic surgery research.

Ethics and Policy for Bioprinting.

3D bioprinting involves engineering live cells into a 3D structure, using a 3D printer to print cells, often together with a compatible 3D scaffold. 3D-printed cells and tissues may be used for a range of purposes including medical research, in vitro drug testing, and in vivo transplantation. The inclusion of living cells and biomaterials in the 3D printing process raises ethical, policy, and regulatory issues at each stage of the bioprinting process that include the source of cells and materials, stability and biocompatibility of cells and materials, disposal of 3D-printed materials, intended use, and long-term effects. This chapter focuses on the ethical issues that arise from 3D bioprinting in the lab-from consideration of the source of cells and materials, ensuring their quality and safety, through to testing of bioprinted materials in animal and human trials. It also provides guidance on where to seek information concerning appropriate regulatory frameworks and guidelines, including on classification and patenting of 3D-bioprinted materials, and identifies regulatory gaps that deserve attention.

Pautas éticas y operativas para la evaluación ética acelerada de investigaciones en seres humanos relacionadas con el COVID-19 / Ethical and operational guidelines for the accelerated ethical evaluation of human research related to COVID-19

Ante la pandemia de COVID-19 la primera obligación es responder a las necesidades de atención de salud de las personas y comunidades afectadas. Al mismo tiempo, resulta un deber realizar investigaciones que generen evidencia para mantener, promover y mejorar la atención de la salud, la toma de decisiones y la definición de políticas en salud para el tratamiento y mitigación de la pandemia. La conducción de investigación durante la emergencia sanitaria conlleva mayores desafíos que los habituales. Demanda generar conocimiento rápidamente para dar respuesta a la pandemia, asegurar la validez científica de las investigaciones, respetar los principios éticos en su realización y mantener la confianza de la comunidad. Esta tarea requiere de la colaboración y solidaridad de la comunidad científica, investigadores, patrocinadores, comités evaluadores, personal de salud, autoridades sanitarias y la sociedad, para encontrar el mejor modo de evitar retrasos en la realización de las investigaciones. En este contexto, los comités de ética en investigación (CEI) deberían formular procedimientos para una evaluación ética rigurosa de las investigaciones en seres humanos que, a su vez, aseguren la existencia de mecanismos rápidos y flexibles para dar una respuesta eficiente a los tiempos y necesidades de una emergencia sanitaria. Estas recomendaciones buscan orientar a los CEI en el desarrollo de procedimientos operativos para una evaluación acelerada de proyectos de investigación relacionados con el COVID-19.

Illegitimate authorship and flawed procedures: Fundamental, formal criticisms of the Declaration of Helsinki.

Some of the recent criticisms published during and after the last revision process of the Declaration of Helsinki are directed at its basic legitimacy. In this article we want to have a closer look at the two criticisms we consider to be the most fundamental. The first criticism questions the legitimate authorship of the World Medical Association to publish a document such as the Declaration. The second fundamental criticism we want to examine argues that the last revision process failed to meet the standards for fair, democratic procedures. Although both criticisms deny the formal legitimacy of the Declaration in the most fundamental way, they have never been addressed in detail in a single article. We refute most of the related arguments. However, acknowledging some of the points made, improvements for future revision processes and versions of the Declaration of Helsinki are outlined.

A conformação protetiva dos direitos fundamentais em pesquisas científicas com seres humanos: um olhar face aos fundamentos autonomia e vulnerabilidade / The protective conformation of fundamental rights in scientific research with humans: a look at the fundamentals autonomy and vulnerability

Busca-se identificar os direitos fundamentais dos participantes da pesquisa que devem ser resguardados no curso dos experimentos. Pretende-se, ainda, tratar da autonomia e da vulnerabilidade, como pressupostos ínsitos à situação de pesquisa, esclarecendo a sua relevância para a maximização da tutela. Metodologia: A pesquisa tem natureza bibliográfica, em livros e artigos da área jurídica, em legislações ordinárias e resoluções relacionadas, bem como em artigos publicados em periódicos da área de Saúde. Resultados: A realização de pesquisas científicas com pessoas deve ter como pressuposto primordial a observância adequada e eficaz dos seus direitos fundamentais inerentes, considerando que, nesta relação, não se deve afastar o exercício da autonomia, revelada pela obtenção do consentimento, e a condição de vulnerabilidade. Conclusão: A preservação dos direitos fundamentais dos participantes da pesquisa deve pugnar pela captação da exteriorização de uma vontade verdadeiramente esclarecida, considerando, inclusive condições de vulnerabilidade que se concretizam a partir de circunstâncias distintas e de aspectos sociais e econômicos diferentes. Tal garantia depende da coleta de um consentimento adequado e eficaz por parte do pesquisador responsável, resguardando de forma mais ampla a dignidade e os direitos daqueles sujeitos que participam da pesquisa. (AU)

Objective: It seeks to identify the fundamental rights of research participants that should be protected in the course of experiments. It is also intended to address autonomy and vulnerability, as inherent assumptions to the research situation, clarifying its relevance for the maximization of guardianship. Methodology: The research has a bibliographic nature, in books and articles of the legal area, in ordinary legislations and related resolutions, as well as in articles published in periodicals in the area of Health. Results: Scientific research with people must have as a primary presupposition adequate and effective observance of their inherent fundamental rights, considering that in this relationship, the exercise of autonomy, revealed by obtaining consent, and the condition of vulnerability should not be ruled out. Conclusion: The preservation of the fundamental rights of the research participants should strive to capture the externalization of a truly enlightened will, considering, including conditions of vulnerability that are materialized from different circumstances and from different social and economic aspects. Such a guarantee depends on the collection of an adequate and effective consent from the researcher in charge, protecting more broadly the dignity and the rights of those subjects who participate in the research. (AU)

Objetivo: Se busca identificar los derechos fundamentales de los participantes de la investigación que deben ser resguardados en el curso de los experimentos. Se pretende, además, tratar de la autonomía y de la vulnerabilidad, como presupuestos íntimos a la situación de investigación, aclarando su relevancia para la maximización de la tutela. Metodología: La investigación tiene naturaleza bibliográfica, en libros y artículos del área jurídica, en legislaciones ordinarias y resoluciones relacionadas, así como en artículos publicados en periódicos del área de Salud. Resultados: La realización de investigaciones científicas con personas debe tener como presupuesto primordial la observancia adecuada y eficaz de sus derechos fundamentales inherentes, considerando que, en esta relación, no se debe apartar el ejercicio de la autonomía, revelada por la obtención del consentimiento, y la condición de vulnerabilidad. Conclusión: La preservación de los derechos fundamentales de los participantes de la investigación debe pugnar por la captación de la exteriorización de una voluntad verdaderamente esclarecida, considerando, incluso condiciones de vulnerabilidad que se concretan a partir de circunstancias distintas y de aspectos sociales y económicos diferentes. Esta garantía depende de la recolección de un consentimiento adecuado y eficaz por parte del investigador responsable, resguardando de forma más amplia la dignidad y los derechos de aquellos sujetos que participan en la investigación. (AU)

Saúde e pesquisa científica com seres humanos: a conformação dos danos decorrentes e o modelo brasileiro de fiscalização / Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection / Salud e investigación científica con seres humanos: la conformación de los daños resultantes y el modelo brasileño de fiscalización

Objetivo: Este artigo objetiva analisar o ordenamento jurídico brasileiro às pesquisas envolvendo seres humanos no tocante aos danos à saúde decorrentes dos experimentos, com fundamento na Resolução nº 466/2012 do Conselho Nacional de Saúde. Metodologia: Realizou-se pesquisa de natureza bibliográfica, em livros e artigos da área jurídica, em legislações ordinárias e resoluções relacionadas, bem como em artigos publicados em periódicos da área de Saúde. Resultados: Os danos decorrentes dos experimentos devem ser cuidadosamente evitados e, se ocorrerem, deve o participante da pesquisa ser indenizado. Conclusão: Eventuais danos decorrentes dos experimentos devem ser evitados e observados durante todo o curso da pesquisa, iniciando-se com a assinatura do Termo de Consentimento Livre e Esclarecido pelo participante e perpassando pela fiscalização pelo Comitê Nacional de Ética e Pesquisa e pelas Comissões de Ética em Pesquisa. É essencial que o acompanhamento e a fiscalização sejam feito de forma mais próxima, obstando e ressarcindo a ocorrência de eventuais danos, além de garantir a regularidade do processo de consentimento realizado no projeto

Objective: This article objectives to analyze the legal treatment and the procedure adopted by Brazil on clinical research with basis on the Resolution nº 466/2012 from National Health Council towards the occurrence of damages due to the project. Methodology: The research was carried out in nature bibliographical references, in books and articles of the legal area, in ordinary legislations and related resolutions, as well as in articles published in periodicals of the Health area. Results: Damages must be avoided and, when occurring, must provide also an compensation to those who were harmed. Conclusion: Any damages resulting from the experiments should be avoid and noted during the curse of the project, since the moment of the informed consent's signature to the stage of inspection from the National Ethics and Research Committee and Research Ethics Committees. The completion of a closest monitoring is essential to prevent this damages and to indemnify the participant. Furthermore, it guarantees that the process of consent is being held on a satisfactory form

. Objetivos: Trabajo destinado al análisis jurídico de la protección conferida por el ordenamiento brasileño a las investigaciones involucrando a seres humanos en lo que se refiere a los daños a la salud derivados de los experimentos, con base en la Resolución 466/2012 del Consejo Nacional de Salud. Metodología: Se realizó investigación de naturaleza bibliográfica, en libros y artículos del área jurídica, en legislaciones ordinarias y resoluciones relacionadas, así como en artículos publicados en periódicos del área de Salud. Resultados: Los daños resultantes de los experimentos deben ser cuidadosamente evitados y, si ocurren, el participante de la investigación debe ser indemnizado. Conclusión: Eventuales daños resultantes de los experimentos deben ser evitados y observados durante todo el curso de la investigación, iniciándose con la firma del Término de Consentimiento Libre y Esclarecido por el participante y pasando por la fiscalización por el Comité Nacional de Ética e Investigación y por las Comisiones de Ética en Investigación. Es esencial que el seguimiento y la fiscalización se haga de forma más cercana, obstaculizando y resarciendo la ocurrencia de eventuales daños, además de garantizar la regularidad del proceso de consentimiento realizado en el proyecto

Neurosurgical Patients as Human Research Subjects: Ethical Considerations in Intracranial Electrophysiology Research.

Intracranial electrical recordings and stimulation of neurosurgical patients have been central to the advancement of human neuroscience. The use of these methods has rapidly expanded over the last decade due to theoretical and technical advances, as well as the growing number of neurosurgical patients undergoing functional procedures for indications such as epilepsy, tumor resection, and movement disorders. These methods pose the potential for ethical conflict, as they involve basic neuroscientific research utilizing invasive procedures in human patients undergoing treatment for neurological illnesses. This review addresses technical aspects, clinical contexts, and issues of ethical concern, utilizing a framework that is informed by, but also departs from, existing bioethical literature on matters in clinical research. We conclude with proposals for improving informed consent processes to address potential problems specific to intracranial electrophysiology research, a general schema for scrutinizing research-related risk associated with different methods, and a call for the development of consensus to ensure continuing scientific progress alongside crucial patient protections in this promising area of human neuroscience.

Revisión comentada de la legislación colombiana en ética de la investigación en salud / Commented review of the Colombian legislation regarding the ethics of health research

Resumen La ética de la investigación en salud no se agota en el marco normativo y trasciende la Resolución 8430 de 1993. Las normas constituyen una herramienta fundamental que determina los estándares mínimos de protección de los sujetos de investigación y, por lo tanto, su conocimiento y aplicación, así como la reflexión sobre ellas, son deberes de todos los investigadores en salud. En este texto se presentan y discuten desde un punto de vista analítico las normas para el ejercicio de la investigación en salud, entendiendo por salud un proceso multidimensional y por investigación en salud, un proceso multidisciplinario que trasciende este campo y abarca la investigación básica, la clínica y de salud pública, la colectiva y la de ciencias afines. Las principales categorías analíticas que se presentan se relacionan con los principios y los participantes en la investigación, las entidades reguladoras, los comités de ética y los sujetos y poblaciones especiales o vulnerables, y con los códigos de ética profesional, el consentimiento informado y el tratamiento de los datos. A pesar de los aportes de las normas éticas a la cualificación del ejercicio investigativo en salud, se concluyó que la normatividad vigente en Colombia debe actualizarse con respecto a los desarrollos técnicos y científicos y las especificidades de los diversos tipos de investigación en salud.

Abstract The scope of ethics in health research transcends its legal framework and the regulations established in Resolution 8430 of 1993. These norms represent a fundamental tool to determine the minimum protection standards for research subjects, and, therefore, they should be known, applied properly, and reflect upon by all researchers in the field. Here I present and discuss from an analytical point of view the regulations that guide research in health. In this framework, health is understood as a multidimensional process, and research in health as a multidisciplinary exercise involving basic, clinical and public health research, collective health, and other related sciences. The main analytical categories are related to the principles and actors involved in research (regulatory authorities, ethical committees, and special or vulnerable subjects and populations), and to professional ethics codes, in addition to informed consents and data management. Despite the contribution of this legislation to the qualification of health research, my conclusion is that the national legislation in ethics for health research requires updating regarding technological and scientific developments, as well as specifications from the multiple types of health studies.

Exploring the risk/benefit balance in biomedical research: some considerations / Explorando el balance riesgos/beneficios en la investigación biomédica: algunas consideraciones / Explorando o balanceamento entre riscos e benefícios em pesquisa biomédica: algumas considerações

Abstract Risk and benefit assessment is one of the fundamental requirements in the ethical review of research involving human participants. As a result, researchers should evaluate and seek to minimize all foreseeable risks involved in their proposed research and members of research ethics committees should evaluate and balance the risks and potential benefits involved in each research proposal as a part of their ethical obligations regarding research protocols. However, current literature provides little detailed guidance on the specifics of how this balancing process should occur. Consequently, this article provides some details of the process to balance risks and benefits in biomedical research and reminds members of research ethics committees of their responsibility to protect those who are vulnerable from exploitation in research projects.

Resumen La evaluación de riesgos y beneficios es uno de los requisitos fundamentales en la revisión ética de la investigación con participantes humanos. Como resultado, los investigadores deben evaluar e intentar minimizar todos los riesgos previsibles involucrados en la investigación propuesta, y los miembros de los comités de ética en investigación deben evaluar y hacer un balance de los riesgos y beneficios potenciales implicados en cada propuesta de investigación como parte de sus obligaciones éticas respecto de los protocolos de investigación. Sin embargo, la literatura actual proporciona escasas guías sobre los detalles específicos de cómo debe ocurrir este proceso de equilibrio. En consecuencia, este artículo ofrece algunos detalles del proceso para equilibrar los riesgos y beneficios en la investigación biomédica y les recuerda a los miembros de los comités de ética de investigación su responsabilidad de proteger a aquellos que son vulnerables a la explotación en proyectos de investigación.

Resumo A avaliação de riscos e benefícios é um dos requisitos fundamentais na revisão ética da pesquisa envolvendo participantes humanos. Consequentemente, os pesquisadores devem avaliar e procurar minimizar todos os riscos previsíveis envolvidos nas pesquisas propostas e os membros dos comitês de ética em pesquisa devem avaliar e balancear os possíveis riscos e benefícios envolvidos em cada proposta de pesquisa como parte de suas obrigações éticas em relação aos protocolos de pesquisa. No entanto, a literatura atual fornece poucas orientações detalhadas sobre como especificamente esse processo de balanceamento deve ocorrer. Consequentemente, este artigo fornece alguns detalhes do processo de balanceamento de riscos e benefícios na pesquisa biomédica e lembra aos membros dos comitês de ética de pesquisa de sua responsabilidade de proteger os vulneráveis da exploração em projetos de pesquisa.

From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies.

Our goals are to (1) set forth and defend a multiprinciple system for selecting individuals who meet trial eligibility criteria to participate in early phase clinical trials testing chimeric antigen receptor (CAR T-cell) for acute lymphoblastic leukaemia when demand for participation exceeds spaces available in a trial; (2) show the relevance of these selection criteria to other breakthrough experimental therapies; (3) argue that distinct distributive justice criteria apply to breakthrough experimental therapies, standard research and healthcare and (4) argue that as evidence of benefit increases, the emphasis of justice in research shifts from protecting subjects from harm to ensuring fair access to benefits.