Wanted: inclusive guidelines for research involving pregnant women

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) was first issued in 1998. At that time, the inappropriate exclusion of women from clinical trials was a serious problem. Currently, the TCPS is undergoing a comprehensive review and it is expected that new research guidelines will be issued in 2010. One of the problems with the current draft of the revised TCPS is that it fails to properly address the routine exclusion of pregnant women from research. We illustrate the negative ethical implications of excluding pregnant women from research and argue for changes to the research guidelines that would address these negative implications.