Pregnancy, Vulnerability, and the Risk of Exploitation in Clinical Research

Abstract

Pregnant women and their foetuses have long been regarded as vulnerable, where being vulnerable indicates a likelihood of suffering harm. This perception has led to the widespread exclusion of pregnant women from clinical research, in order to protect foetuses and the women who carry them from any dangers associated with exposure to experimental therapeutic products or interventions. This chapter explores the ways in which pregnant women are vulnerable, and the potential risk of exploitation if pregnant women are enrolled in clinical research. There are three overlapping sources of vulnerability: inherent, situational, and pathogenic, and each of these may be dispositional (i.e. potential) or occurrent (i.e. requiring immediate action to limit harm). We argue that while pregnant women may experience one or more forms of vulnerability, in general they are not at risk of exploitation during research because they do not provide researchers with the opportunity to conduct more efficient research. We conclude with policy suggestions for conducting research with pregnant women that responds to vulnerability, promotes autonomy, and supports fair access to research participation. We focus on pregnancy registries, parental consent, and minimal risk research limits.