MRIs and Pregnancy Status Guidance

Version Date: March 20, 2009

The purpose of this document is to present guidelines for the method of determining pregnancy status as part of eligibility screening for studies in which (a) MRIs are performed for research rather than clinical purposes and (b) the study does not propose to enroll pregnant women.  In parallel with clinical practice, pregnancy testing would not be required for these studies.  Instead, research teams should incorporate questions about pregnancy status in their screening procedures. 

Suggested screening questions for research teams

If the potential subject answers “yes” to either of the suggested screening questions below, the research team should not enroll that person in the study.

Please see suggested language to include in consent documents in the Additional Model Language document, under Reproductive Risks.

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