HRPP Manual Section 12-6

Pregnancy Testing When Research Involves Non-Contrast MRI of the Head

When an MSU human subject research project involves a Magnetic Resonance Imaging (MRI) procedure, the IRB typically does not require the research protocol include a urine pregnancy test for women who are capable of pregnancy prior to participation if all of the following criteria are met:

  • Women are certain of their pregnancy status

  • MRI scan is limited to the head

  • Contrast agent is not used

  • Research does not involve a legally authorized representative

  • An IRB-approved screening form is used

Research that includes all subjects capable of pregnancy that may meet these conditions will include an IRB-approved screening form to provide a mechanism for education, self-reporting, and the ability to opt-out of pregnancy testing. However, subjects who are unsure of their pregnancy status will be required to undergo a urine pregnancy test prior to participation.

A template “Pregnancy Screening Form for Subjects Undergoing an MRI in Research” is available on the human research website at https://hrpp.msu.edu/templates/index.html

For ongoing research, use of this guidance will require a modification and IRB approval prior to implementation.

This guidance document supersedes those previously drafted.

Version Date: 12/13/2021

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