[Ethical problems in the biomedical research projects, presented to the Ethical Committee of the Medical School at the Pontificia Universidad Católica of Chile].
BACKGROUND
The higher methodological complexity of either diagnostic or therapeutic procedures has raised concern about the ethical principles that should underlie the conduct of biomedical research involving humans.


OBJECTIVE
To evaluate ethical problems of research proposals submitted to an ethics committee.


METHODS
All research proposals involving humans, submitted within a two years period to the ethics committee 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.


RESULTS
In 20 of 44 reviewed projects, an ethical problem was identified. The most common 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.


CONCLUSIONS
According to the Nüremberg code, the Helsinki declaration and the International Principle of Ethics in Biomedical Research, we analyse ethical problems and suggest judgement elements for them.
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Departamento de Neurología, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago de Chile. zunino@med.puc.cl
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D002677:Chile; D017041:Ethics Committees; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D010919:Placebos / Q000627:therapeutic use; D012107:Research Design; D012189:Retrospective Studies
D010919:Placebos
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.