At Stanford the oversight of human subject research involving radiology devices and radioactive materials is a function of the Clinical Radiation Safety Committee (CRSCo) LCC which is chartered by the Food and Drug Administration. At SHS 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.

Consultation

Safety policies and instructions for clinical use of radiation sources at SHS and VAPAHCS are available from Health Physics. Additionally, Guidance for Preparing Research Proposals Involving Ionizing Radiation in Human Use Research, provides information on administrative procedures and informed consent language. The Health Physics Medical Group 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.

Application

All protocols involving both “research” or “clinical investigations” and “human subjects” must be submitted by the electronic Human Subjects “eProtocol” system and be reviewed and approved by the IRB before recruitment and data collection may start. Applications for Human Subjects which include the use of radiation are forwarded to the Health Physics Medical Group for review. Human subject protocols are then approved by the Stanford Clinical Radiation Safety Committee (CRSCo). If the research requires Radioactive Drug Research Committee (RDRC) review as specified by FDA RDRC regulations 21 CFR 361.1, an additional application from Health Physics must be completed.

Review and approval

Your application must be reviewed by the Health Physics Medical Group and may need to be circulated to individual members of the CRSCo/RDRC committee for evaluation and approval. Consult with the Health Physics Medical Group if you have a time‐sensitive need.

Human use research approvals are contingent on contemporaneous approval by the Stanford University Research Compliance Office on Human Subject Research.

Renewal

Most human use approvals are for one year.

Amendments

The project director is responsible for informing Health Physics of changes in procedures, personnel, or modifications that might affect radiation safety.