The specificity of the involvement of pregnant women in clinical studies: medical and bioethical approach

Abstract

Introduction: Clinical trials are a type of research based on new drug and interventional treatment with the analysis of their effects on human health. Clinical trials that include pregnant women have an outstanding interest in the medical and bioethical field. Purpose: To highlight the medical and bioethical aspects of clinical trials involving pregnant women. Material and methods: The results of scientific, ethical and bioethical investigations, articles on clinical trials involving pregnant women. The analytical, bioethical and sociological method was applied. Results: Pregnancy is not an exclusion criterion from clinical trials unless there is a convincing scientific or ethical reason for it. Research is needed to provide women with effective, safe treatment for the fetus that would not be possible outside of the study.Ethical complexity is reflected in the need to balance the interests of the pregnant woman and the fetus. Conclusions: The inclusion of pregnant women is guided by the protection of the human being.If the clinical study offers the potential clinical benefit to the pregnant woman, for the fetus the risk must be more than minimal.