El Foro Global de Bioética en Investigación (GFBR por sus siglas en inglés) se reunió el 3 y 4 de noviembre en Buenos Aires, Argentina, con el objetivo de discutir la ética de la investigación con mujeres embarazadas. El GFBR es una plataforma mundial que congrega a actores clave con el objetivo de promover la investigación realizada de manera ética, fortalecer la ética de la investigación en salud, particularmente en países de ingresos bajos y medios, y promover colaboración entre países (...) del norte y del sur.a Los participantes en el GFBR provenientes de Latinoamérica incluyeron a eticistas, investigadores, miembros de comités de ética y representantes de autoridades sanitarias provenientes de Argentina, Brasil, Chile, Colombia, Ecuador, El Salvador, Guatemala, Honduras, Panamá, Perú, Nicaragua y la República Dominicana. Una legítima preocupación por la protección de las mujeres embarazadas y sus embriones o fetos ha llevado a la mayoría de los países de la Región de las Américas a limitar la realización de estudios con mujeres embarazadas exclusivamente a aquellos estudios específicos sobre el embarazo, y a requerir la exclusión sistemática de las mujeres embarazadas o de las mujeres que quedan embarazadas en el curso del estudio. Ciertamente, a lo largo de la historia de la ética de la investigación, se ha creído erróneamente que proteger a una población es sinónimo de excluirla de los estudios. Se sabe ahora que proceder así implica exponer a riesgos mucho mayores a la población que se busca proteger. El embarazo implica cambios fisiológicos sustantivos e impacta profundamente la manera como el cuerpo metaboliza los medicamentos. Sin embargo, por evitar hacer investigación con mujeres embarazadas, no se ha producido la evidencia científica necesaria para tomar decisiones sobre tratamientos e intervenciones preventivas con dosis eficaces y seguras para ellas y sus embriones o fetos. A manera de ilustración, en el 2001 había en los Estados Unidos apenas más de una docena de medicamentos aprobados para uso en el embarazo (1) y en el 2011 la Food and Drug Administration (FDA) aprobó por primera vez en 15 años un medicamento para su uso en el embarazo (2). Como consecuencia de no haber producido la evidencia necesaria, se pone en riesgo la salud de las mujeres embarazadas cada vez que se les da atención médica. Las mujeres embarazadas se enferman y las mujeres enfermas se embarazan, y no se sabe si los medicamentos que se les da son eficaces o siquiera seguros para ellas y sus embriones o fetos. (shrink)

ABSTRACT This study is an ethical reflection on the formulation and application of public policies regarding reproductive health in Brazil. The Integral Assistance Program for Women's Health (PAISM) can be considered advanced for a country in development. Universal access for family planning is foreseen in the Brazilian legislation, but the services do not offer contraceptive methods for the population in a regular and consistent manner. Abortion is restricted by law to two cases: risk to the woman's life and rape. This (...) reality favors the practice of unsafe abortion, which is the third largest cause of maternal death in Brazil. Legal abortion is regulated by the State and the procedure is performed in public health centers. However, there is resistance on the part of professionals to attend these women. Prenatal care is a priority strategy for promoting the quality of life of these women and of future generations. Nonetheless, it is still difficult for these women to access the prenatal care services and to have the required number of consultations. Moreover, managers and health professionals need to be made aware of the importance of implementing the actions indicated by the public policies in the area of sexual and reproductive health, favoring respect for autonomy in a context of personal freedom. (shrink)

This paper focuses on the debate about the utilization of new reproductive technologies in Brazil, and the paths taken in the Brazilian National Congress in an attempt to draw up legislation to regulate the clinical practice of human assisted reproduction. British documents, such as the Warnock Report and Human Fertilization and Embriology Authority (HFEA) are used for thorough reference. The analysis of the Law Projects in the National Congress, the Resolution by the Federal Medicine Council, Resolution 196/96 and documents by (...) the Ministério Público (Public Prosecution Office), suppled the bases for the discussion. The principal question involved is the observation of different technical and moral prientations that influence the conduct of the issue in the legislative process. It is possible to observe that the main focus of the projects relates to the rights and interests of the children, to those possibly benefited by the technique and to embryo reduction. Very little attention has been directed to the issues of sexual and reproductive rights and to the health of the women submitted to the new reproductive techologies. (shrink)

Neste livro, novos desafios da ética em pesquisa com seres humanos são explorados pelos autores - da pesquisa com populações vulneráveis às pesquisas em Ciências Sociais. Dentre os destaques da obra está o caso do Sangue Yanomami e a pesquisa antropológica e genética conduzida nos anos 1970.

Introduction The Brazilian national curriculum guidelines for undergraduate medicine courses inspired and influenced the groundwork for knowledge acquisition, skills development and the perception of ethical values in the context of professional conduct. Objective The evaluation of ethics education in research involving human beings in undergraduate medicine curriculum in Brazil, both in courses with active learning processes and in those with traditional lecture learning methodologies. Methods Curricula and teaching projects of 175 Brazilian medical schools were analyzed using a retrospective historical and (...) descriptive exploratory cohort study. Thirty one medical schools were excluded from the study because of incomplete information or a refusal to participate. Active research for information from institutional sites and documents was guided by terms based on 69 DeCS/MeSH descriptors. Curriculum information was correlated with educational models of learning such as active learning methodologies, tutorial discussions with integrated curriculum into core modules, and traditional lecture learning methodologies for large classes organized by disciplines and reviewed by occurrence frequency of ethical themes and average hourly load per semester. Results Ninety-five medical schools used traditional learning methodologies. The ten most frequent ethical themes were: 1 – ethics in research (26); 2 – ethical procedures and advanced technology (46); 3 – ethic-professional conduct (413). Over 80% of schools using active learning methodologies had between 50 and 100 hours of scheduled curriculum time devoted to ethical themes whereas more than 60% of traditional learning methodology schools devoted less than 50 hours in curriculum time to ethical themes. Conclusion The data indicates that medical schools that employ more active learning methodologies provide more attention and time to ethical themes than schools with traditional discipline-based methodologies. Given the importance of ethical issues in contemporary medical education, these findings are significant for curriculum change and modification plans in the future of Brazilian medical education. (shrink)

Ethics in research became a central theme regarding globalization of the scientific development, particularly when related to the socioeconomic conditions of the countries involved as partners in research protocols, production of inputs and of knowledge. The objective of this paper is to analyze the sources of information about ethics in research present at Scientific Electronic Library Online. Methodologically, this is an exploratory study was carried out by the systematic analysis of the literature available. The search engines retrieved 885 summaries, from (...) which 170 were analyzed. The first publication was dated from 1996 and it could be identified the mention to international documents about research in humans. Since 2002 there has been an increase of publications related to the gain of legitimacy of the topic in academy. As a conclusion, although the amount is not huge, the manuscripts presented great impact as they stimulated debates and produced scientific knowledge on the topic. It can be observed that ethics in research has outcome the biomedical field, being inserted in other fields of knowledge. (shrink)