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  • IRB: ETHICS & HUMAN RESEARCH

A Pregnancy Testing Policy for Women Enrolled in Clinical Trials

We have developed a Pregnancy Testing Policy for studies involving women of childbearing potential that describe pregnancy as an exclusion criterion. This policy is an effort to standardize pregnancy testing procedures and to correlate these procedures with actual data about the risk of fetal harm.

It is inappropriate to exclude pregnant women from clinical trials based on the potential risk of harm to the fetus and yet not require women to undergo pregnancy testing prior to study onset and to take measures to prevent pregnancy while they are enrolled in a trial. Yet data from protocols our institution’s institutional review board reviewed over a one-year period revealed inconsistencies between protocol requirements that excluded pregnant women and the requiring of women to undergo pregnancy testing. After reviewing these data, we developed a Pregnancy Testing Policy for studies involving women of childbearing potential that describe pregnancy as an exclusion criterion. This policy is an effort to standardize pregnancy testing procedures and to correlate these procedures with actual data about the risk of fetal harm. It describes the acceptable methods and frequency of pregnancy testing, should investigators choose to exclude pregnant women but permit nonpregnant women with childbearing potential to participate in a study.

Toby Schonfeld, Kendra K. Schmid, Joseph S. Brown, N. Jean Amoura, and Bruce Gordon, “A Pregnancy Testing Policy for Women Enrolled in Clinical Trials,” IRB: Ethics & Human Research 35, no. 6 (2013): 9-15.

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The Hastings Center has never shied away from the toughest ethical challenges faced by society.

LET US SHARE OUR EXPERIENCES WITH YOU!

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