Ethics & Human Research
Should More Pregnant Women Be Included in Research Studies?
Doctors often prescribe medications to pregnant women without good evidence that they are safe or effective during pregnancy. This is largely because pregnant women are routinely left out of medical research. Although this exclusion is meant to protect fetuses, it has created serious gaps in knowledge that can put both pregnant women and fetuses (and future children) at risk, concludes an international study published in Ethics & Human Research.
The study found that most national and U.S. research policies technically allow pregnant women to join studies, but that, in practice, the policies make it easy to exclude them. Most rules focus narrowly on avoiding risk and still mistakenly label pregnant women as “vulnerable,” an outdated designation in international research ethics.
After reviewing policies from 59 countries and major U.S. research institutions, the authors find that very few actively encourage including pregnant women in research, and even fewer mention fairness or equal access to research benefits. The article concludes that changing policy language—by removing the “vulnerable” label and requiring clear justification for excluding pregnant women—could help close dangerous evidence gaps and lead to safer, better medical care during pregnancy.
