RDRC/SHUR Committees
The Radioactive Drug Research Committee (RDRC) and the Subcommittee on the Human Use of Radioisotopes (SHUR) are subcommittees under the U-M Radiation Policy Committee (RPC) and are Ancillary Committees to the IRBMED. These subcommittees review uses of radioactive material in/on humans, including radiopharmaceuticals administered to human subjects for the purpose of research. RDRC or SHUR approval is required for Institutional Review Board (IRBMED) approval.
RDRC & SHUR Committees
The RDRC and SHUR are joint but distinct committees. While the same members serve on both subcommittees, their respective functions, regulatory requirements, and review criteria are distinct:
RDRC
The RDRC reviews the use of radiopharmaceuticals in humans for the purpose of basic science research, not intended for therapeutic or diagnostic purposes.
- The research must not propose to determine the safety or effectiveness of the radiopharmaceutical.
- Protocols approved by the RDRC are not clinical trials.
- Research conducted through the RDRC approval pathway does not require an Investigational New Drug application (IND) but the RDRC pathway does introduce significant restrictions for research design.
To understand these limitations, review the FDA guidance document The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application and explore the Q&A pages.
RDRC Program Reference Materials
Link to FDA guidance document: RDRC Final Guidance: Human Research without an Investigational Drug Application
Additionally, the regulations of RDRC research can be viewed at 21 CFR 361.1.
SHUR
The SHUR reviews the administration of all radioactive materials to humans. This includes clinical uses and research studies that don’t fall under RDRC purview. SHUR review applies when the radiopharmaceutical is FDA approved or is being administered under an existing Investigational New Drug Application (IND).
