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How the CIOMS guidelines contribute to fair inclusion of pregnant women in research

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 eligibilit...

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Autores principales: van der Graaf, Rieke, van der Zande, Indira S. E., van Delden, Johannes J. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6587561/
https://www.ncbi.nlm.nih.gov/pubmed/30341918
http://dx.doi.org/10.1111/bioe.12520
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author van der Graaf, Rieke
van der Zande, Indira S. E.
van Delden, Johannes J. M.
author_facet van der Graaf, Rieke
van der Zande, Indira S. E.
van Delden, Johannes J. M.
author_sort van der Graaf, Rieke
collection PubMed
description 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 vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change.
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spelling pubmed-65875612019-07-02 How the CIOMS guidelines contribute to fair inclusion of pregnant women in research van der Graaf, Rieke van der Zande, Indira S. E. van Delden, Johannes J. M. Bioethics Special Issue: Research Ethics Revised 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 vulnerability. However, close reading of the guidelines reveals morally relevant different approaches to fair inclusion of pregnant women and other under‐represented groups, such as children and incompetents. Where CIOMS sets out that children and adolescents must be included unless a good scientific reason justifies their exclusion, no such claim of having to justify exclusion appears in the guideline on pregnant women. Instead, CIOMS claims that research relevant to pregnant women’s health needs must be promoted. This paper analyses how and to what extent the guideline on pregnant women differs from other guidance on fair inclusion in the document. Accordingly, the paper evaluates to what extent the current phrasing may contribute to fair inclusion of pregnant women in research. We will conclude that a system change towards a learning health system is essential to break down the status quo of knowledge generation in the field of medication use during pregnancy and argue that the CIOMS guidelines allow for this system change. John Wiley and Sons Inc. 2018-10-20 2019-03 /pmc/articles/PMC6587561/ /pubmed/30341918 http://dx.doi.org/10.1111/bioe.12520 Text en © 2018 The Authors Bioethics Published by John Wiley & Sons Ltd This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Special Issue: Research Ethics Revised
van der Graaf, Rieke
van der Zande, Indira S. E.
van Delden, Johannes J. M.
How the CIOMS guidelines contribute to fair inclusion of pregnant women in research
title How the CIOMS guidelines contribute to fair inclusion of pregnant women in research
title_full How the CIOMS guidelines contribute to fair inclusion of pregnant women in research
title_fullStr How the CIOMS guidelines contribute to fair inclusion of pregnant women in research
title_full_unstemmed How the CIOMS guidelines contribute to fair inclusion of pregnant women in research
title_short How the CIOMS guidelines contribute to fair inclusion of pregnant women in research
title_sort how the cioms guidelines contribute to fair inclusion of pregnant women in research
topic Special Issue: Research Ethics Revised
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6587561/
https://www.ncbi.nlm.nih.gov/pubmed/30341918
http://dx.doi.org/10.1111/bioe.12520
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