When Hypothetical Vulnerability Becomes Actual: Research Participation and the Autonomy of Pregnant Women

Abstract

Various national and international research guidelines and regulations limit the inclusion of pregnant women in clinical research by classifying them as vulnerable. This exclusion has widely acknowledged negative consequences for the health of women, foetuses, and future children. Another negative consequence is the threat to a pregnant woman’s autonomy and agency when she is treated as a ‘vulnerable’ person without cause. Research guidelines and regulations around the world continue to be overly protectionist. The limitations on autonomy they imply (and create) infantilise pregnant women, treating them ‘as if’ they are vulnerable – as if they, in fact, lack autonomy and the capacity to make informed choices about their own research participation. The hypothetical ‘as if’ becomes actual as research guidelines and regulations effectively reduce the autonomy and agency of pregnant women, making them unable to protect their own interests, including their interests in protecting their future children.