Protocols proposing the use of ionizing radiation (either machine-generated or by radioactive materials), other than standard radiologic procedures required for clinical care by the subject’s condition, must be evaluated and approved by the Medical Radiation Safety Committee. Explanation of Risk Categories of ApplicationsEach human-use research shall be determined to fall into one of the following categories: 1. Basic Research (Human Use Form A) The use of radioactive drugs to obtain basic research information but not intended for immediate therapeutic, diagnostic, or similar purposes. 2. Well-Established Medical Use (Human Use Form B) The investigation will utilize radioactive drugs which through previous use have been proven to be safe and effective in diagnosis and/or therapy. 3. Non-Routine Medical Use (Human Use Form C) The proposed human use of any radioactive drug, which is not identified in categories 1 or 2. 4. The Use of Machine Generated Radiations (Human Use Form D) Investigations in which generated radiations (such as X-rays, etc.) are used for other than standard radiological procedures required by the subject’s condition. Specific questions about completing these forms should be directed to EH&S Radiation Safety at 716-1201. Completed application should be sent to the EH&S Radiation Safety Office. |