Fair inclusion of pregnant women in clinical research : a systematic review of reported reasons for exclusion

This empirical chapter provides a systematic review of literature relevant to the inclusion of pregnant women in clinical trials. In particular, it addresses barriers to fair inclusion identified within the literature. The 31 articles reviewed discuss the exclusion of pregnant women from clinical trials. Reasons given for such exclusion were grouped under several themes, including: foetal safety, collective memory or social controversies, liability, regulations, research ethics committee interpretations, research design, willingness to participate and consent. The discussion reviews arguments in the literature for how many of these barriers to fair inclusion can be surmounted. The authors find that barriers to fair inclusion of pregnant women in clinical research interact. While there are practical solutions for surmounting some barriers, others require further discussion