A qualitative study on acceptable levels of risk for pregnant women in clinical research

BMC Medical Ethics
Indira S E van der ZandeJohannes J M van Delden

Abstract

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 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. We 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. Three 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 zer...Continue Reading

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Citations

Jul 19, 2017·Journal of Medical Ethics·Indira S E van der ZandeJohannes J M van Delden
Oct 4, 2019·Health Expectations : an International Journal of Public Participation in Health Care and Health Policy·Deirdre Hayes-RyanKeelin O'Donoghue
Feb 13, 2019·BMC Pregnancy and Childbirth·Indira S E van der ZandeJohannes J M van Delden
Oct 2, 2021·The Journal of Medicine and Philosophy·Indira S E van der ZandeJohannes J M van Delden

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Software Mentioned

Nvivo
APOSTEl
RvdG

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