LEGAL ASPECTS OF CLINICAL TRIALS INVOLVING UNDER-AGE SUBJECTS IN RUSSIA

Abstract

The article focuses on a complicated, no less pressing issue of conducting clinical trials in pediatrics. When vulnerable groups of patients are involved as subjects in clinical trials, specific ethical issues inevitably arise. When conducting clinical trials involving under-age subjects, it is necessary to follow not only international standards, but, quite often, perform an in-depth analysis of national laws, taking into account law enforcement practice.
Key words: clinical trials, Russian Federation laws, children.

(Pediatric Pharmacology. – 2010; 7(2):25-31)