CLINICAL RESEARCH INVOLVING PREGNANT WOMEN: INTERNATIONAL AND SERBIAN REGULATIONS

Since each clinical research of medicine presents health risks to the persons participating in it, particularly for pregnant women whose bodies develop new lives, the authors think it is surprising that their position is regulated by a small number of national regulations and only one international document in this field - International Ethical Guidelines for Biomedical Research Involving Human Subjects. In the first part of the paper, the authors elaborate and comment on the special terms of the Guidelines regarding the pregnant women participating in clinical trials; and, then, also the concept of pregnant and breastfeeding woman's protection foreseen by the new Medicines and Medical Products Act of the Republic of Serbia. The solutions provided by the Serbian Law are the selected subjects of analysis in the second part of the paper, not only for being one of the rare national regulations dealing with the position of pregnant women in clinical trials, but also for doing that differently from the Guidelines. Based on the analysis and comparison of international and national regulations, the authors conclude the paper by formulating a new regulation model for this issue as they consider it more appropriate, and justify their proposals in details. The essence of this concept is: banning the non-therapeutic research involving pregnant and breastfeeding women; and, the necessity to provide terms additional to those valid for other subjects, when therapeutic researches are conducted on these women.