Presumptive Inclusion and Legitimate Exclusion Criteria

Abstract

This chapter presents an ethics framework for decisions about whether to exclude pregnant women from a clinical research trial. It begins by articulating several background assumptions about the care of pregnant women in the clinical setting and the involvement of pregnant women in clinical research. The uncontroversial truth of these background assumptions supports the idea that pregnant women should be presumed to be included in clinical research, and that their exclusion requires justification. After making the case for the presumptive inclusion of pregnant women, I outline the ethics framework for the legitimate exclusion of pregnant women from clinical research. This framework consists of nine factors that researchers and research ethics committees should consider when deciding whether to exclude pregnant women. Details about research ethics committee review, the nature of risks in pregnancy, the balance between risk and potential benefit, and the context of clinical care are addressed by the framework.