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

BMC Medical Ethics

Research Article

Martijn A. Oudijk¹  Johannes J. M. van Delden²  Indira S. E. van der Zande²  Rieke van der Graaf² 

[1]Academic Medical Center, Department of Obstetrics and Gynaecology, Amsterdam, The Netherlands

[2]Julius Center for Health Sciences and Primary Care, Department of Medical Humanities, University Medical Center Utrecht, P.O. box 85500, 3508 GA, Utrecht, The Netherlands

关键词: Risk;    Pregnant women;    Clinical research;    Research ethics;    Qualitative research;   

DOI  :  10.1186/s12910-017-0194-9

 received in 2016-09-30, accepted in 2017-04-27,  发布年份 2017

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2017