The Duke University Health System Institutional Review Board (DUHS IRB) has determined that all females and males of reproductive potential being considered for participation in a research study where a possibility of harm to a fetus exists must practice appropriate contraceptive measures before undergoing any study-related activities that might harm a developing fetus. Appropriate contraceptive measures must be maintained until all known risks to the fetus have ended. This policy discusses several reproductive risk considerations in research: contraception, breastfeeding, fertility, and unintended pregnancy.