The Duke University Health System (DUHS) Institutional Review Board (IRB) has determined that all females who are of child-bearing potential being considered for participation in a research study, in which there is a possibility of harm to a fetus from the study interventions, must have a negative pregnancy test before undergoing any study-related activities with a potential risk to a fetus. This policy describes Duke requirements for pregnancy testing regimens used in research studies. Additionally, the policy presents a definition for the term "child-bearing potential".