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

Abstract

OBJECTIVE: To identify factors affecting the decision of pregnant women to withhold their consent to participate in a clinical trial. DESIGN: A qualitative, cross-sectional, retrospective study using semi-structured 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 participating. A pregnant woman may feel the pressure of conflicting duties: a protective duty to the fetus and to be a 'good citizen' when asked to participate in research. The sharing of information during the recruitment phase has a crucial bearing on how the invitation will be received. The design of the 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 identified factors that can influence the chances of an individual entering a trial or not. Contextualising and personalising risk is important in the consent process as recruiting women when pregnant can be difficult and hinder research. From these comments recommendations for future research involving pregnant women have been drawn up.