Abstract
BackgroundThere is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study.MethodsWe conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands.ResultsThree themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment.ConclusionsHealthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.
Highlights
There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks
The first three themes concern observations based on the views of all respondents, while the theme relative to the APOSTEL VI study is based on the views of healthcare professionals and pregnant women
Our qualitative study shows that among stakeholders who are actively involved in the conduct of clinical research in pregnant women in the Netherlands, riskadversity is the main characteristic dominating the discourse on acceptable levels of risks
Summary
There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. Various stakeholders have taken up the challenge of inclusion, for example by endorsing the view that pregnant women are presumed to be eligible for participation in clinical research [5, 9, 11] Another (indirect) example can be found in the US Food and Drug Administration (FDA). It used the five pregnancy categories for drug-use in pregnant women, but after much critique that the categorisation was both over-simplistic and ambiguous [12, 13], it has been replaced by the Pregnancy and Lactation Labelling Rule (PLLR), designed to improve risk versus benefit assessment of drugs used in pregnant and nursing mothers. Some have articulated the hope that the new labelling will provide added incentives for the development and conduction of more clinical research in pregnant women [14]
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