Abstract

MONTENEGRO SURIS, Alexander  and  MONREAL AGUERO, Magda Elaine. Revision of the procedure of informed consent by the ethical committees of clinical research. Rev Cubana Invest Bioméd [online]. 2007, vol.26, n.2, pp. 0-0. ISSN 1561-3011.

Good Clinical Practice Standards of the International Conference of Harmonization and scientific articles related to the topic were consulted in order to define the general forms that should be followed by the Ethical Committees for revision of the procedure of informed consent. The fundamental information to be provided to the potential participants in the research is the differences between the procedures of the routine medical practice and those of the clinical assay. The monitoring of the procedure of informed consent should verify that subjects are given the approved model; each included subject must have a duly signed model containing all appropriate information and relevant changes up to the time of the assay. The researchers must know and fulfil their obligations, and also consents will be well documented in medical histories.   The Ethical Committees must prepare and fulfil a training program to perform these functions.

Keywords : Ethical committees; informed consent; clinical assays.