Section 2: Obtaining Authorization to Use Radioactive Materials

A. Application Procedure

Application forms may be obtained from VEHS or downloaded from the VEHS website www.safety.vanderbilt.edu . Criteria, guidelines, and instructions are included with the forms. Applications are initially reviewed by VEHS staff and then submitted to the RSC for review.

B. Qualifications

1. Principal Investigator
   1. The Principal Investigator must normally be a full-time faculty member.
   2. The Principal Investigator must have a college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering
   3. The Principal Investigator must have training and experience in the safe handling of radioactive materials, and in the characteristics of ionization radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive materials to be used.
   4. The Principal Investigator cannot be visiting faculty, residents, or fellows.
2. Authorized User Physicians
   The physician must meet the following criteria:
   1. The Authorized User must be a physician, dentist, or podiatrist licensed to practice medicine in the State of Tennessee.
   2. Authorized Users who use radioactive materials for human use must meet the training requirements outlined in Appendix A "Acceptable Training and Experience for Medical Uses of Radioactive Material".
   3. Each Authorized Users Physician who administers or supervises the administration of radioactive materials or ionizing radiation from radioactive materials to humans must be approved by the RSC.
3. Authorized Nuclear Pharmacist
   The pharmacist must meet the following criteria:
   1. The Authorized User Pharmacist must be a pharmacist licensed to practice pharmacy in the State of Tennessee.
   2. Authorized User Pharmacists must meet the training requirements outlined in Appendix A "Acceptable Training and Experience for Medical Uses of Radioactive Material".
   3. Each Authorized Users Pharmacist must be approved by the RSC.

C. Additional Requirements for Human Use

Authorized User Physicians wanting to perform research must also obtain approval from the HSRC/RDRC subcommittees of the IRB for each protocol. Research includes phase I, II, or III clinical trails, off label use of FDA approved radiopharmaceuticals, research protocol in which normals are exposed to radiation sources, human subjects receiving radiation from a procedure that is not part of standard care.

D. Renewal

All radioactive material approvals must be renewed and updated annually. VEHS will mail a renewal to each PI in January of each year.

E. Amendments

1. Significant changes (i.e. increases in possession limits, addition/deletion of radionuclides) to the radioactive materials authorizations must be approved by the RSC. When amending an application that is more than 5 years old, the PI is required to submit a complete updated application that includes all previously approved radioisotopes and usages.
2. Minor amendments that meet the following criteria can be administratively approved by the RSO:
   1. Possession limit increase less than or equal to 20% of the current possession limit or one exempt quantity, which ever is greater.
   2. The addition of a radionuclide with a possession limit not exceeding one exempt quantity.
   3. Substitution of 33P for 32P or 35S. The 33P possession limit cannot exceed the current possession limit for 32P or 35S.

F. Leave of Absence

In the event that a PI takes a leave of absence, the authorization will remain in effect provided the PI appoints a suitably qualified individual to supervise operations during the PI's absence. This individual should be approved by the RSC before the leave of absence.