Ethical framework for observational studies of medicinal drug exposure in pregnancy.

BACKGROUND The conduct of human research in the teratogenicity of drugs, chemicals, radiation and infections is needed in order to close critical gaps in knowledge. METHODS We reviewed the various aspects of the ethics of conducting prospective human research in teratogenicity. RESULTS Such research should respect the confidentiality of pregnant women and their families. Because this research is observational, interpretation of results is difficult, and the study design should strive to meet the highest possible scientific standards attainable in the particular research conditions. It should also be acknowledged that confidentiality cannot be always adhered to (e.g., if the interview reveals risks to minors). CONCLUSIONS In general, the benefit risk ratio in this type of research is very favorable, although in specific cases the research follow-up may induce fears (e.g., drugs of abuse) in the woman being interviewed.