Radiological Drug Research Committee & Human Use Subcommittee (RDRC-HUS)
The Radioactive Drug Research Committee (RDRC) is required to evaluate and to approve or disapprove all research and developmental uses of radioisotopes on or in humans. The RDRC also serves as the Human Use Subcommittee of the Radiation Safety Committee (HUS). As required by Utah Division of Radiation Control, the HUS evaluates and approves or disapproves all proposed uses of ionizing radiation sources on or in humans for investigational or non-routine clinical procedures.
Studies involving the use of ionizing radiation - if the study involves the use of radioactive isotopes, or x-rays (i.e., oncology, radiology, CT, bone densitometry) that are in any way a result of participation in the study - must be approved by the Radioactive Drug Research Committee - Human Use Subcommittee of the Radiation Safety Committee (RDRC-HUS), as well as the IRB.
Note that a quantitative statement regarding the risk relative to exposure to ionizing radiation must be included in the consent form. Applications for the use of ionizing radiation sources in human research studies from the Veterans' Administration Medical Center (VAMC) also are reviewed by the University's RDRC-HUS.
Approval from RDRC-HUS must be received before the IRB will give final approval for a study.
Application forms are submitted to the RDRC-HUS for use of radioactive drugs, diagnostic external radiation, and therapeutic ionizing radiation in human research studies via the ERICA system. The RDRC-HUS application is incorporated into the IRB New Study Application and users are prompted to complete the RDRC-HUS application when the completed IRB application indicates that the study involves exposure to radioisotopes or ionizing radiation.
This feature allows the RDRC-HUS application to be submitted with the IRB application when the PI clicks "Submit to the IRB", eliminating the need to submit applications separately. Please note that these are still two different applications that require two separate reviews. RDRC-HUS reviews the study first and must approve it before it will move on to the IRB for review.
What should I submit? On the "HIPAA and the Covered Entity" Page of the IRB application, indicate that your study involves radiation. This action will automatically prompt ERICA to generate the RDRC review pages as you click "Continue" through the application.