Enrolling pregnant women: issues in clinical research.

BACKGROUND Despite the fact that many pregnant women are affected by a range of serious health conditions and take medications for these conditions, there is widespread reticence to include them in clinical intervention research. Hence, their clinical care is typically not informed by evidence derived from pregnant populations. METHOD In October 2010, the National Institutes of Health Office of Research on Women's Health convened a workshop to address ethical, regulatory, and scientific issues raised by the enrollment of pregnant women in clinical research. This report summarizes three areas that emerged from that meeting as important next steps to be taken to promote ethically responsible and scientifically sound research during pregnancy. FINDINGS The three areas are: 1) Reclassify pregnant women from their current status in regulations as a "vulnerable" population to a scientifically "complex" population and change the presumption of exclusion to one of inclusion; 2) examine the institutional review boards' (IRB) gatekeeper role in interpreting regulations governing pregnancy research and identify steps to facilitate IRB approval of ethically informed pregnancy research; and 3) develop a pregnancy-focused research agenda that addresses pressing clinical needs, identifies opportunities to gather information from existing resources and studies, and encourages important new research areas. CONCLUSION Research is needed to address the therapeutic needs of pregnant women and to study pregnancy as it may shed light on a pregnant woman's later health and the health of her child.