Policies for the Inclusion of Pregnant Women in Research: Results from an International and a US Study

Abstract

Leading medical organizations have called for advancement of pregnancy-specific research to reduce harmful evidence gaps. However, meeting this objective poses ethical, legal, and policy dilemmas for investigators, oversight committees, academic institutions, and sponsors. To better understand the extent to which policies may facilitate or hinder the inclusion of pregnant women in research, we conducted two studies: an international study of laws, regulations, and ethical guidelines from a diverse sample of 59 countries and a study of policies from 84 top-funded US research institutions. We found that most policies use risk-based criteria for determining whether pregnant women should be included in research. Among countries with inclusion policies for pregnant women, 76% had risk-based policies (i.e., inclusion is based on risks and benefits to the pregnant woman and/or fetus), 13% had inclusionary policies (i.e., pregnant women should or must be included in research unless there is a valid scientific or ethical reason for exclusion), and 11% had exclusionary policies (i.e., pregnant women should or must be excluded from research unless there is a valid scientific or ethical reason for inclusion). In the US study, 96% of institutions had risk-based policies, 3% had exclusionary policies, and 1% had inclusionary policies. We also found that many policies referred to pregnant women as vulnerable. To promote fair and responsible inclusion of pregnant women in research, academic institutions, sponsors, and oversight agencies should adopt and implement policies with inclusionary language and refrain from referring to pregnant women as vulnerable.

Keywords: fetus; human subjects research; inclusion in research; policy; pregnancy; reproduction; research ethics; risk; women.