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  1.  51
    (1 other version)Vulnerability of pregnant women in clinical research.Indira S. E. Van der Zande, Rieke van der Graaf, Martijn A. Oudijk & Johannes J. M. Van Delden - 2017 - Journal of Medical Ethics 43 (10):657-663.
    Background Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as vulnerable. Our aim was to explore whether and if so to what extent pregnant women are vulnerable as research subjects. Method We performed a conceptual and empirical analysis of vulnerability applied to pregnant women. Analysis A conceptual analysis supports Hurst's definition (...)
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  2.  26
    (1 other version)How the CIOMS guidelines contribute to fair inclusion of pregnant women in research.Rieke van der Graaf, Indira S. E. Van der Zande & Johannes J. M. Van Delden - 2018 - Bioethics 33 (3):377-383.
    As early as 2002, CIOMS stated that pregnant women should be presumed eligible for participation in research. Despite this position and calls of other well‐recognized organizations, the health needs of pregnant women in research remain grossly under‐researched. Although the presumption of eligibility remains unchanged, the revision of the 2002 CIOMS International ethical guidelines for biomedical research involving human subjects involved a substantive rewrite of the guidance on research with pregnant women and related guidelines, such as those on fair inclusion and (...)
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  3.  47
    (1 other version)A qualitative study on acceptable levels of risk for pregnant women in clinical research.Indira S. E. Van der Zande, Rieke van der Graaf, Martijn A. Oudijk & Johannes J. M. van Delden - 2017 - BMC Medical Ethics 18 (1):35.
    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 (...)
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