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Impact Ethics

Research with Pregnant Women

SELECT MEDIA ARTICLES

  •  Baylis, F. (14 Feb 2012). . Science in the City, Bourns Lecture in Bioethics. Hamilton, ON: McMaster University.

SELECT IIMPACT ETHICS BLOGS

  • Ethics Working Group on ZIKV Research & Pregnancy. (18 Jul 2017). . Impact Ethics.

  • Caluwaerts, S., & Baylis, F. (25 Nov 2016). . Impact Ethics.

  • MacQuarrie, R. (29 Jul 2014). Impact Ethics.

  • Dreger, A., & Feder, E.K. (17 Apr 2014). .Impact Ethics.

SELECT PUBLICATIONS

  • Baylis, F., & Halperin, S. (2012). .Clinical Investigation, 2(2), 139-146.

  • Baylis, F., & Kaposy, C. .Journal of Obstetrics and Gynaecology Canada, 32(5), 473-476.

SELECT POLICY CONTRIBUTIONS

  • Baylis, F. (1 Mar 2016). [PDF - 394 KB].
     
  • Baylis, F., & MacQuarrie, R. (25 May 2015). [PDF - 816 KB]

Recent News

Revised CIOMS guidelines were recently published (update from 2002 version). NTE members contributed (see above) as part of the open call for recommendations in the lead up to

Overview

While great strides have been made in recent history with respect to the inclusion of women and children in clinical trials, pregnant women are often routinely excluded. Pregnant women and their fetuses require safe, effective, evidence-based treatment. Excluding them from clinical trials forces their physicians to either withhold treatment or prescribe drugs 鈥渙ff-label鈥�, without the benefit of clinical data to verify safe, effective and appropriate dosages for pregnant women and their fetuses.

This occurs despite guidelines promulgated by the Council for International Organizations of Medical Sciences (CIOMS) which clearly state that pregnant women should be included in research. [PDF - 1.7 MB] also states that women should not be excluded from research simply because they are pregnant or breastfeeding.

Fran莽oise Baylis argued before the [PDF - 106 KB], "pregnant women get sick and sick women get pregnant", and they should be entitled to the same level of evidence-based healthcare as other individuals. Her concerns were noted in (page 16) [PDF - 1.5 MB], and also in (page 23) [PDF - 4.4 MB].

Fran莽oise Baylis is co-editor with Angela Ballantyne of (Springer, 2016).

The debate has been heard in conference presentations, the media and academic journals:

  • Pregnant Women and Health Research: An Ethical Imperative [PDF - 2.8 MB]
    Fran莽oise Baylis, presentation at Queen's University, May 7, 2013.

  • Anne Kingston, Macleans, April 29, 2013.
  • [PDF - 1.8 MB]
    Fran莽oise Baylis and Scott Halperin, Clinical Investigation, 2012, 2(2),139-146.

  • Chris Kaposy and Fran莽oise Baylis, The American Journal of Bioethics, 2011, 11(5): 60-62.

  • Melinda Wenner Moyer, Body Politic, January 6, 2011.

Last updated September 2017.