Vulnerability, therapeutic misconception and informed consent: is there a need for special treatment of pregnant women in fetus-regarding clinical trials?

Abstract

Historically, pregnant women have generally been excluded from clinical trials. One of the reasons for this exclusion has been the belief that pregnant women are vulnerable as research participants. Although this view has now largely fallen into disfavour, this article argues that in the situation where the pregnant woman is newly diagnosed with a fetal condition for which the only option, other than watchful waiting, is enrolment in a clinical trial, she should be considered a cognitively and medically vulnerable research participant. This is because she is in a highly stressed emotional state and so less able to decide completely freely whether or not to participate in the clinical trial. In other words, she is under a higher risk of therapeutic misconception and of not understanding what she is consenting to. This article suggests that in order for the consent of these women to be given freely and without emotional pressure, it has to be ensured that strategies are developed to ensure they are fully informed and actually understand the information. This surpasses the requirements of the English law of informed consent and also of General Medical Council (GMC) guidance on consent to research but such an approach would help safeguard that, despite these women's poor bargaining position, their trial participation is really free, voluntary and informed.