The Food and Drug Administration (FDA) mandates that all research studies that involves the use of radioactive material in or on humans, be reviewed and approved by the RDRC.  The RDRC will review all research protocols that involve the use of radioactive material in or on human subjects regardless of the amount of radioactivity. The RDRC only approves research studies that are intended to obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of radioactive labeled drugs or regarding human physiology, pathophysiology, or biochemistry. The RDRC would not review and approve studies that are intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety and effectiveness of the drug in humans for such purposes (i.e., to carry out a clinical trial). Approval of the RDRC, the RSC and the Institutional Review Board (IRB) are required prior to initiation of any research on human by the use of radioactive drugs.

The RDRC will review and approve a research protocol, if it considers that the scientific knowledge and benefits are likely to result from such study. Therefore, a protocol should be based upon a sound rationale derived from appropriate animal studies or published literature and must be designed such that the information of scientific value may result. The radiation dose should be minimized and should be no greater than is necessary to obtain valid measurement. The projected number of human subjects should be sufficient but no greater than is necessary for the purpose of the study.

The RDRC submits an annual report on or before January 31 of each year to the FDA. The annual report s includes the names and qualifications of the members of, and of any consultants used by, the RDRC, and, for each study conducted during the preceding year.  The RDRC activities are monitored and reviewed periodically by the FDA. The FDA may monitor by reviewing the RDRC annual reports, or by reviewing full protocols for certain studies, and/or by on-site inspections.

The complete description of the RDRC can found in this document.