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.
- Question 1: Are you currently pregnant?
- Question 2: Are you planning on becoming pregnant [insert the timeframe for the study duration, such as “Are you planning on becoming pregnant in the next month”]?
Suggested language to include in consent documents
As an added safeguard, research teams should remind female subjects of the unknown risks to the fetus from an MRI scan in the consent document by including the language below.
Pregnancy Status – Female Subjects Only
is no evidence that MRI scans can cause harm to a fetus, there may be risks to
a fetus that are not known at this time.
For these reasons, this study is not approved for the enrollment of
pregnant women. You should only take
part in this study only if you are certain you are not pregnant.