Human Use Authorization
In order to obtain the privilege and responsibility of using radioactive materials for human use purposes an individual must first be approved as an Authorized User (AU) by the Radiation Safety Committee.
A prospective AU must submit a completed Human Use of Radionuclides application including all pertinent attachments to the Radiation Safety Department (RSD) to be reviewed by the Radiation Safety Officer (RSO). If the application is approved by the RSO, it will be forwarded to the Human Use of Radiation and Radionuclides Committee (HUC) for review. If the application is denied by the RSO, the applicant will be given an opportunity to edit and re-submit the application to the RSD. If the application is approved by the HUC, it will be recommended for review by the Radiation Safety Committee (RSC) for final approval.
Note: The radiation safety committees meet in January, April, July, and October. For an application to be considered at any of the committee meetings, the prospective AU must submit the application to the Radiation Safety Department before the end of the month prior to the committee meeting month. For example: if the prospective AU is looking for the application to be reviewed during the October meeting, the application must be submitted to RSD by the end of September.
Prospective AUs are encouraged to attend the radiation safety committee meetings at the time their application will be reviewed. Contact RSD for meeting dates and location.
Applying for Human Use of Radionuclides
Individuals applying for human use of radioactive materials must complete and submit the Human Use of Radioactive Material application. See link below:
Applicants for diagnostic or therapeutic use of radionuclides in humans must show that they fulfill the pertinent training and experience requirements in NRC 10 CFR part 35 for the specific authorization the applicant is seeking. These requirements include board certification or specific classroom and laboratory training in relevant radioisotope handling techniques and appropriate clinical experience. The required training and experience, including board certification, described in 10 CFR Part 35 must be obtained within the 7 years preceding the date of the application, or the individual must document having had related continuing education, retraining, and experience since obtaining the required training and experience. Applicants should support their training and experience history with a preceptor attestation from their training institution.
- See below for links to NRC application guidance:
- Applicants who are applying as an AU for use of Yttrium-90 microspheres under 10 CFR 35.1000 can reference the NRC Y-90 Microsphere Brachytherapy Licensing Guidance for training and experience requirements.
The application will need to be approved by both the HUC and the RSC. Applications may be conditionally approved by the committees pending completion of additional requirements (supervised cases, training, etc.) before the applicant will be permitted independent use of radioactive materials.
Note: All applicants, regardless of prior clinical experience will be required to complete additional supervised cases at WVU Medicine before being granted independent Authorized User status. The cases must be supervised by a current Authorized User in that specialty. An applicant who has been in practice and has completed at least 10 cases within the last year in the specialty for which they are applying for AU status, will be required to complete 3 additional supervised cases. All other applicants will be required to complete 10 supervised cases. At the completion of the additional supervised cases, documentation of completion of the cases must be sent to the Radiation Safety Department.
Once applicants have obtained approval as an independent AU, a letter of approval will be sent to the AU, their supervisor and any other individuals if necessary.
Amending Authorization
AUs who wish to amend their current authorization will follow the same application process as described above, however they will submit a modified application. The AU is required to fulfill all training requirements in 10 CFR Part 35 for the specialty in which they are amending their application and will be required to complete supervised cases before the amendment is approved. The application must be approved by the RSO, HUC and RSC.