Ethical implications of women’s underrepresentation in clinical trials

Abstract

Excluding women from participating in clinical drug trials might seem like a good thing. It may seem like a good way to protect women from the risks of being a research subject and a way to prevent fetal harm. However, the exclusion or inadequate representation of women in clinical trials may actually cause harm. Excluding women from clinical trials does not rule out the possibility of damage to offspring. Nor does it guarantee researchers or institutions freedom from legal liability. The issue of women’s exclusion has received substantial attention in the USA but very little in Australia.