[The informed consent in international clinical trials including developing countries].
BACKGROUND
The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries.


METHODS
We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials.


RESULTS
To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers.


CONCLUSIONS
Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.
Montenegro Surís
Alexander
A
Centro Nacional Coordinador de Ensayos Clínicos. alexander@cencec.sld.cu
Monreal Agüero
Magda Elaine
ME
D002986:Clinical Trials as Topic / Q000592:standards*; D003142:Communication; D003466:Cultural Characteristics; D003906:Developing Countries; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D012959:Socioeconomic Factors; D014175:Translating