RESUMO
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.
RESUMO
Bad news communication is a frequent and difficult task for health care professionals. There are valuable protocols that systematize this task through a series of steps. However, these protocols have important limitations. The objective of this work is to analyze the main shortcomings of the protocols for CMN, according to the available ethical and clinical evidence. An orientation by objectives is recommended, considering that communication of bad news is a contextual process that involves different actors, and that requires reflection and flexibility to determine the best course of action according to the circumstances of each particular case. The importance of affectionate attention for patients and their relatives is highlighted.
Assuntos
Humanos , Relações Médico-Paciente , Revelação da Verdade , Pessoal de Saúde , ComunicaçãoRESUMO
Organizations develop codes of ethics to give orientations to their members on how to recognize, understand and handle ethical dilemmas in their daily work. In year 2005 a group of faculty members of the Universidad de Chile Faculty of Medicine started an institutional ethics project, acknowledging that all institutional decisions have moral contents. The purpose of this project is to promote an ethical environment in the institution. The first step was to establish a diagnosis by means of the organization of focal groups that collected the perceptions of students, faculty members and non-academic personnel. With a diagnosis in hand, a preliminary document was prepared, the Universidad de Chile Faculty of Medicine declaration of principles and values. Members of all groups that participated in the diagnostic phase had the opportunity to discuss this preliminary document and check if their agreement with its contents. Given the relevance of the ethical aspects of the learning and teaching process for the positive modeling of students from all health-related professions, special emphasis is given to its discussion.