Conclusion
The Belmont Report originally published in 1979 enforces the adherence to the basic ethical principles in research including beneficence, justice, and respect to persons. We need a call to action by all stakeholders (i.e. legislative agencies, pharmaceutical companies, funders and academic researchers) to prioritize including pregnant women in clinical trials. It helps not only make a better risk-benefit assessment, but also help prevent adverse effects in the fetus or the pregnant woman when it is medically needed to give medications. We should strengthen the pregnant woman’s autonomy to be able to participate in clinical trials if she wishes and that this should not be a predicament; at the same time monitoring for fetotoxicity should be standardized and required in clinical research. If pregnant women are not included in future drug research studies, they will lag behind in terms of receiving benefits of therapeutic advancement compared to the general population. Learning from pediatric drug advances, clinical research involving pregnant women has a promising road ahead.