IRB: Ethics & Human Research

No Girls Allowed: A Sponsor’s Rejection of One IRB’s Contraception Policy

Institutional review boards (IRBs) are repeatedly faced with the ethical dilemma of how to balance the inclusion of women of childbearing potential in clinical studies with protecting potential offspring from risk of harm from the study intervention. This paper discusses a recent IRB review of a clinical drug trial in which the sponsors wished to exclude all women of childbearing potential from participating. We summarize the deliberations of the IRB, including the IRB’s policy on the inclusion of women in clinical trials and acceptable options for a contraception requirement as a condition of participating. When the IRB declined to approve the study as proposed, with its exclusion of women of childbearing potential, the sponsors withdrew the application from the site.

Brown JS, Schonfeld TL, Amoura NJ, Gordon B. No girls allowed: A sponsor’s rejection of one IRB’s contraception policy. IRB: Ethics & Human Research 2014;36(6):13-15.