Withholding consent to participate in clinical trials: decisions of pregnant women

Objective To identify factors affecting the decision of pregnant women to w ithhold their consent to participate in a clinical trial. Design A qualitative, cross-sectional, retrospective study using semi-struc tured interviews with thematic content analysis. Setting Patients' homes. Participants Eighteen women who had been invited previously to participate in a clinical trial in pregnancy, but who had declined. Results The invitation to participate in a clinical trial when pregnant has different implications for different women, and the meanings they ascribe to the invitation to participate will affect the likelihood of them partici pating. A pregnant woman may feel the pressure of conflicting duties: a pro tective duty to the fetus and to be a 'good citizen' when asked to particip ate in research. The sharing of information during the recruitment phase ha s a crucial bearing on how the invitation will be received. The design of t he trial, the type and style of information available, the manner in which it is conveyed, the timing and process of the invitation and by whom it is made all affect the likelihood of a woman agreeing to take part. Conclusion By asking for the contribution of these women, this study identi fied factors that can influence the chances of an individual entering a tri al or not. Contextualising and personalising risk is important in the conse nt process as recruiting women when pregnant can be difficult and hinder re search. From these comments recommendations for future research involving p regnant women have been drawn up.