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Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’
  1. Carleigh B Krubiner,
  2. Ruth R Faden
  1. Johns Hopkins University, Berman Institute of Bioethics, Baltimore, Maryland, USA
  1. Correspondence to Dr Carleigh B Krubiner, Johns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA; ckrubiner{at}jhu.edu

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A new study published in Journal of Medical Ethics by van der Zande et al 1 further highlights why classifying pregnant women as a ‘vulnerable population’ in the context of research is deeply problematic. Because the designation of ‘vulnerable’ is otherwise applied to populations whose decision-making capacity about research participation is somehow compromised—such as children and adults of limited cognitive ability—many of us have been arguing for some time that using this designation for pregnant women is inappropriate and disrespectful.2–4 There is nothing about the state of pregnancy that renders pregnant women incapable of offering valid research consents or refusals. Moreover, rather than protecting the health interests of pregnant women and their offspring, this designation has had the opposite effect. It has contributed to the widespread exclusion of pregnant women from research activities, which is itself pernicious to the health of pregnant women.5

We know that pregnant women encounter a range of health needs across their pregnancies. In the USA, for example, approximately 9 out of every 10 women use some kind of medication during pregnancy to manage health conditions.6 Yet because pregnant women have largely been …

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Footnotes

  • Contributors CBK drafted the commentary with substantive input and edits from RRF.

  • Funding The work referenced in this commentary was supported by the Wellcome Trust (grant number: 203160/Z/16/Z) and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (award number: R01 AI108368-01A1). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Wellcome Trust.

  • Competing interests None declared.

  • Provenance and peer review Commissioned; internally peer reviewed.

  • Correction notice This article has been corrected since it was published Online First. Funding information have been added.

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