HUS and RDRC

 

The Human Use Subcommittee (HUS) and Radioactive Drug Research Committee (RDRC) are separate entities with similar but overlapping membership and purpose.

RPR 48-1 HUS:
As required by the Utah Division of Radiation Control, the Human Use Subcommittee (HUS) evaluates and approves or disapproves all proposed uses of ionizing radiation sources on or in human subjects for investigational or non-routine clinical procedures. Review of an application for the use of ionizing radiation sources on or in human subjects are conducted by the HUS only after the adequacy of the facilities and qualifications of the investigator have been verified by the Radiation Safety Officer (RSO). Applications for the use of ionizing radiation sources in human re¬search studies from the Veterans Affairs Medical Center (VAMC), Shriners Hospitals for Children and Primary Children’s Medical Center in support of the University of Utah Institutional Review Board (IRB) which provides reviews for these entities also are reviewed by the University's HUS.


The HUS is responsible for the evaluation and approval or disapproval of applications involving investigational or non-routine clinical uses of FDA-approved radioactive drugs, radioactive drugs with IND numbers issued by the FDA, or any other ionizing radiation sources (x-ray, brachytherapy, etc.).

RPR 48-2 RDRC:
In accordance with the Food and Drug Administration (FDA) regulations, the Radioactive Drug Research Committee (RDRC) is empowered and required to evaluate and to approve or disapprove all research and developmental uses of radioisotopes on or in human subjects. The members of the RDRC also serve on the Human Use Subcommittee of the Radiation Safety Committee (HUS). Reviews of applications for the use of ionizing radiation sources on or in human subjects are conducted by the RDRC only after the adequacy of the facilities and qualifications of the investigator have been verified by the Radiation Safety Officer (RSO). Applications for the use of ionizing radiation sources in human re¬search studies which require an RDRC review from the Veterans Affairs Medical Center (VAMC), Shriners Hospitals for Children and Primary Children’s Medical Center in support of the University of Utah Institutional Review Board (IRB) which provides reviews for these entities are also reviewed by the University's RDRC.

The RDRC is responsible for the evaluation and approval or disapproval of applications involving investigational or non-routine clinical uses of radioactive drugs without New Drug Applications (NDA) filed with the FDA or without Investigational New Drug (IND) numbers issued by the FDA.