Not wanted in the study: An ethical, medical and political analysis of the exclusion of pregnant women from clinical research studies

Review and analysis of current clinical research practice suggests a general trend towards excluding pregnant women from clinical research studies. Although exclusionary research practices are premised upon concerns for the well-being of the fetus and the pregnant women, such practices can also produce various inadvertent harms to both parties. In particular, exclusion of pregnant women from clinical research limits the quality of care provided to pregnant women by impeding individual access to innovative research protocols and by limiting data collection applicable to the pregnant population. A review and analysis of relevant historical, legal, ethical, clinical, scientific and political documents suggests that various changes should be made to current clinical practice. To produce many such changes there is a need for a comprehensive, progressive Canadian health policy to be used to guide and direct researchers and research ethics boards in the appropriate inclusion of pregnant women in clinical research studies.