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

Although there 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. 

I confirm that I am not pregnant and am not planning on becoming pregnant during this study. 



Signature of subject and date signed

See Also:

Keywords:women of child bearing potential, female, pregnancy, pregnant, MRI, pregnancy status   Doc ID:18878
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-06-16 19:00 CDTUpdated:2015-10-13 15:15 CDT
Sites:Health Sciences IRBs
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