Ethical frameworks that support inclusion

While the exclusion of pregnant and lactating women from biomedical research has reduced pregnancy- and breastfeeding-specific risk in research contexts, it has not eliminated risk. Rather, it has shifted the burden of potential risk around drug safety from the clinical trial setting, where safety outcomes are carefully monitored, to the real-world clinical care setting, where safety outcomes are not systemically captured – with the effect of expanding the scope of harms experienced by this population. Harms include potential exposures to unacceptable risks for pregnant and lactating women, fetuses and infants, including incorrect dosing of drugs leading to either underdosing or toxicity, or limited access to indicated, preferred, or optimal treatments and preventives.

Ethical frameworks that attend to these harms support the inclusion of pregnant and lactating women in biomedical research, primarily as a matter of justice. The PHASES Working Group (2021) identified three ethical foundations that underpin the responsibility to address inequities in the evidence base for the use of medication in pregnancy and during the breastfeeding period.

Protection

Pregnant women and the children they will have deserve equitable protection from drug-related risks. Research is essential to ensuring that the drugs taken by women, for example, to prevent or treat conditions that co-occur with pregnancy, meet an acceptable safety standard.

Access

Pregnant and lactating women deserve timely access to the most effective medications to protect their health and that of their future children. Pregnancy- and breastfeeding-specific evidence is needed to avoid delays in access to next-generation treatment and prevention modalities.

Respect

Pregnant and lactating women deserve equitable respect for their own health. While important research has been done to improve fetal and child outcomes, it is crucial to generate data that allows for consideration of the impact of treatment decisions on the health of the woman.