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.
- Research Ethics
- Research on Special Populations
- Obstetrics and Gynaecology
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Contributors IZ and RG designed the study and IZ drafted the manuscript. MO and JD made critical revisions to the paper. IZ, RG, MO and JD contributed equally to the final version of the manuscript submitted for publication.
Funding Funding was provided by the Dutch grant supplier the Netherlands Organisation for Health Research and Development (ZonMw), grant number: 11310500.
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.
Read the full text or download the PDF:
Other content recommended for you
- Facilitating participation in clinical trials during pregnancy
- Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’
- Vulnerability, therapeutic misconception and informed consent: is there a need for special treatment of pregnant women in fetus-regarding clinical trials?
- Insight into the process of postpartum care utilisation and in-home support among vulnerable women in the Netherlands: an in-depth qualitative exploration
- Projected cost-savings with herpes simplex virus screening in pregnancy: towards a new screening paradigm
- Targeted social care for highly vulnerable pregnant women: protocol of the Mothers of Rotterdam cohort study
- HIV-1 infection and pregnancy in young women in Brazil: socioeconomic and drug resistance profiles in a cross-sectional study
- Inability to control gestational weight gain: an interpretive content analysis of pregnant Chinese women
- Critical COVID-19 in a 24-week pregnant woman with 32 days of invasive mechanical ventilation before delivery of fetus: a case of successful collaborative multidisciplinary care
- Association between family functions and antenatal depression symptoms: a cross-sectional study among pregnant women in urban communities of Hengyang city, China