Ethical framework for observational studies of medicinal drug exposure in pregnancy


  • Gideon Koren

    Corresponding author
    1. Motherisk Program, Hospital for Sick Children and the University of Toronto, Toronto, Ontario M5G 1X8, Canada
    • Division of Clinical Pharmacology/Toxicology, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario M5G 1X8, Canada
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The conduct of human research in the teratogenicity of drugs, chemicals, radiation and infections is needed in order to close critical gaps in knowledge.


We reviewed the various aspects of the ethics of conducting prospective human research in teratogenicity.


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).


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. Teratology 65:191–195, 2002. © 2002 Wiley-Liss, Inc.