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Radiation – Human Use Research

Research involving human participants is under the oversight of the University of Utah (U of U) Institutional Review Board (IRB). Such studies that also utilize ionizing radiation require ancillary review by either the Human Use Sub-committee of the Radiation Safety Committee (HUS-RSC), or the Radioactive Drug Research Committee (RDRC). HUS-RSC review is used for most research studies involving ionizing radiation and human use, where RDRC review is only used when the study is for basic research of a radioactive drug in humans, without a Food and Drug Administration-Investigational New Drug (FDA-IND) approval. Applications for these studies are submitted through the IRB Electronic Research Integrity & Compliance Administration database (ERICA).

Things to Consider

University Radiation Safety

The Radiation Safety Committee (RSC) oversees the safe use of radiation sources at the U of U. They establish policies, procedures, and rules to ensure compliance. This includes oversight and review of the Radiation Safety Officer (RSO), Radiation Safety Office, and anyone using radiation sources or machines on campus.

 

Human Subjects and Radiation

All research studies of ionizing radiation associated with human participants are evaluated by the HUS-RSC or the RDRC. This radiation can come from machines or radioactive materials approved by the US Food and Drug Administration (FDA) for human use. The HUS-RSC categorizes the use of radiation in the study as either:

  • Standard of Care (SOC): The participant would receive this scan/procedure even if not in the study; or
  • Research-Related (not SOC): The radiation exposure is specific to the research question.

A study may involve both SOC and research-related radiation use.

The HUS-RSC does not review studies involving:

  • Non-ionizing radiation: MRI, ultrasound, etc.
  • Data analysis from other studies: No new radiation exposure occurs.
  • Studies outside the U of U Covered or Affiliated Entities: as defined by the IRB.
  • Those studies which require RDRC review.

 

A Responsible User (RU), an authorized individual with radiation expertise, oversees studies with radiation exceeding SOC, and is included in the review process. RU approval is mandatory for such studies.

 

Contact Information

For any questions about:

  • ERICA or the IRB, please visit the IRB Website.
  • radiation safety, please contact the Environmental Health & Safety (EHS) office at (801) 581-6590 or email questions@ehs.utah.edu.

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