Impact Ethics

Research with Pregnant Women





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 final publication (2016).


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 “off-label”, 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. Article 4.3 of the Tri-Council Policy Statement [PDF - 1.7 MB] also states that women should not be excluded from research simply because they are pregnant or breastfeeding.

Françoise Baylis argued before the Senate Committee in May 2012 [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 Canada's Clinical Trial Infrastructure: A Prescription for Improved Access To New Medicines (page 16) [PDF - 1.5 MB], and also in Prescription Pharmaceuticals in Canada: Post-Approval Monitoring of Safety and Effectiveness (page 23) [PDF - 4.4 MB].

Françoise Baylis is co-editor with Angela Ballantyne of Clinical Research Involving Pregnant Women: Missed Trials (Springer, 2016).

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

Last updated September 2017.