Problemas éticos en los proyectos de investigación biomédica, presentados al Comité de Etica de la Escuela de Medicina de la Pontificia Universidad Católica de Chile / Ethical problems of research proposals submitted to an ethics committee

RESUMO

All research proposals involving humans, submitted within a two years period to the ethics commitee of the School of Medicine of the Catholic University, were retrospectively reviewed. "Ethical problem" was defined as any explicit disagreement with the ethical principles and guidelines for the protection of human subjects involved in biomedical research, according to the Helsinki declaration. In 20 of 44 reviewed projects, an ethical problem was identified. The most commont problems were the absence or inadequacy of the informed consent, the justification of the use of placebo and problems related to the methodological aspects of the research, particularly the lack of an adequate control group when the potential benefits of a new drug were evaluated. According to the Nuremberg code, the Helsinki declaration and the International Principle of Ethics in Biomedical Research, we analyse ethical problems and suggest judgement elements for them