VA Guidance on Pregnancy in Human Subjects Research

ORD Guidance on Pregnancy in Human Subject Research- June 2009 06/11/09. The VHA Office of Research and Development (ORD) has received questions from drug companies and investigators about collecting information on pregnant women when they are research subjects, research subjects who have withdrawn from the study or who have been terminated from the study, or pregnant partners of male research subjects. Many prescription and over-the-counter drugs used in clinical care are labeled as Pregnancy Category C by the FDA.* When Category C drugs are administered to women enrolled in research studies and these women then become pregnant, any information collection regarding the pregnancy or the outcome of the pregnancy must be included in the study protocol and informed consent, and the women must remain in the study while the information is being collected. VA Office of Research & Development