At Stanford the oversight of human subject research involving radiology devices and radioactive materials is a function of the Clinical Radiation Safety Committee (CRSCo) which is chartered by the Food and Drug Administration. At SHS, SCH and VAPAHCS, all uses of radionuclides in humans regardless of quantity or purpose must be approved by CRSCo.  Research protocols involving human subjects must also be approved by Stanford’s Institutional Review Board (IRB).  Reviews may be conducted concurrently. In most cases, according to IRB procedures, only medical faculty and VA staff physicians may apply.

Safety policies and instructions for clinical use of radiation sources at SHS, SCH and VAPAHCS are available from Health Physics. Additionally, section 12.4 Guidance for Preparing Research Proposals Involving Ionizing Radiation in Human Use Research provides information on administrative procedures and informed consent language.  Health Physics is available to assist protocol directors designing studies with radiation. Early consultation will help assure that the proposal will be approved on the first review.

The Committee meets at least once during each calendar quarter, or more frequently, at the discretion of the Chair. A quorum consists of more than fifty percent of its then current membership, and must include the Chair, the RSO, and the Management representative.