ABSTRACT
Pregnant women with substance use disorders face many obstacles, including obtaining evidence-based treatment and care. This article (1) briefly reviews the history of pregnant women in clinical trials and substance use disorders treatment research; (2) identifies current ethical issues facing researchers studying pregnant women with substance use disorders; (3) presents and describes an ethical framework to utilize; and (4) identifies future directions needed to develop appropriate research and treatment policies and practices. Current research is not providing enough information to clinicians, policy-makers, and the public about maternal and child health and substance use disorders, and the data will not be sufficient to offer maximum benefit until protocols are changed.