Terms of clinical research consent’s validity

The object of this paper is to define terms that have to be fulfilled under Serbian regulations in order to have duly valid subject’s consent to participate in a clinical research. Authors highlight and analyze three of those terms indicating how imprecisely those are regulated, possible disputable situations in practice, but also way to overcome those. The topic itself is important to be elaborated for the fact that in Serbia these terms are not gathered and regulated in one document but within even five laws, as well ratified international conventions – this makes the task very complex for a researcher, who usually is personally in charge of getting the consent. On the other hand, fulfillment of terms for consent's validity is of crucial relevance both for protection of research subject's personality and for protection of researchers from possible responsibility – authors elaborate this issue in the last segment of the paper.