Guidance

The IRB is responsible for considering the risks of radiation exposure for women who are pregnant and participate in research. The IRB may choose to allow a research study to follow standard of care practices for pregnancy testing when performing medical scans.

University of Utah Department of Radiology Standard of Care for All Scans (including MRI, MR with contrast, CT scans, etc.):

If the female is of reproductive age, the patient is asked to self-report whether she might be pregnant.

1. If the woman states she cannot be pregnant, the scan is scheduled and performed.
2. If the woman indicates there is doubt regarding her pregnancy status, two options are offered:
   1. The woman may take a pregnancy test. If positive, she is referred to her primary care physician. If negative, the scan is scheduled and performed.
   2. The woman may elect to have the scan re-scheduled until after she has a period.

While the University of Utah IRB may require any level of testing deemed reasonable in each case to protect the welfare of participants, we encourage board members to use these guidelines whenever applicable when reviewing research.

Ancillary Approvals Tab

The Human Use Subcommittee of the Radiation Safety Committee (HUS-RSC) must approve the use of radiation in the study. Typically, this is completed prior to the IRB review of the study. You may view the approval under the Ancillary Approvals Tab in the study workspace.

Scroll down to see the approvals for the Radioactive Drug Research Committee (RDRC). The HUS-RSC approval will display as in this example below.

Points to Consider