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J Med Ethics. 2017 Oct;43(10):657-663. doi: 10.1136/medethics-2016-103955. Epub 2017 Jul 17.

Vulnerability of pregnant women in clinical research.

Author information

1
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Utrecht, Netherlands.
2
Department of Obstetrics and Gynaecology, Amsterdam Medical Centre, Amsterdam, North Holland, Netherlands.

Abstract

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 of vulnerability. Consequently, we argue that pregnant women are vulnerable if they encounter an identifiably increased likelihood of incurring additional or greater wrong. According to the literature, this increased likelihood could exist of four alleged features for pregnant women's vulnerability: (i) informed consent, (ii) susceptibility to coercion, (iii) higher exposure to risk due to lack of knowledge, (iv) vulnerability of the fetus.

DISCUSSION:

Testing the features against Hurst's definition demonstrates that they all concern the same issue: pregnant women are only vulnerable because a higher exposure to risk due to lack of scientific knowledge comprises an increased wrong. Research Ethics Committees have a responsibility to protect the vulnerable, but a higher exposure to risk due to lack of scientific knowledge is a much broader issue and also needs to be addressed by other stakeholders.

CONCLUSIONS:

The only reason why pregnant women are potentially vulnerable is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge. Accordingly, the discussion can advance to the development of practical strategies to promote fair inclusion of pregnant women in clinical research.

KEYWORDS:

Obstetrics and Gynaecology; Research Ethics; Research on Special Populations; Women

PMID:
28716977
DOI:
10.1136/medethics-2016-103955
[Indexed for MEDLINE]

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