All new submissions are initially screened by the RDRC administrator to determine whether all required documents have been submitted. Each protocol requiring full review by the RDRC is reviewed prior to a Committee meeting by at least three Committee members; one physician, a radiation dosimetry reviewer, and a radiochemistry/radiopharmacy reviewer. Protocols subject to the requirements of 21 CFR 361.1 that involve administration of radioactive drugs to research subjects under 18 years of age are also reviewed by one or more ad hoc pediatric consultants to the Committee, who report their assessment of the protocol in writing.
All investigators who submit research applications to the RDRC must be qualified by training and experience to conduct the proposed research. At Washington University, this is accomplished by authorization application to the Radiation Safety Committee to use radioactive materials for human-use research purposes.
All applications submitted to the Committee should contain complete answers to all of the questions in the application. A detailed protocol that outlines the entire research procedure, as well as pertinent portions of grant applications, if applicable, should be submitted. All applications must also be accompanied by a completed application to the IRB. The IRB will not grant final approval to a study involving the use of radioactive drugs until the RDRC has either confirmed that the study is exempt from RDRC review/approval or reviewed the formal RDRC application and found it to be approvable. Any actions taken by the IRB regarding investigations that involve radioactive drugs are reported to the RDRC and the IRB correspondence is filed in the permanent file of the RDRC.
There are two different RDRC application forms to be completed based on the type of protocol that is being submitted.
Please submit electronic copies of the application documents to rdrc@wustl.edu. To keep file sizes manageable, please send individual documents, in their original formats (Word, Excel, pdf files, etc.) instead of scanning the whole application as one file. If the signed RDRC application form is submitted as a pdf file, the original Word document also should be submitted.