Physicians who wish to use radioactive materials in human subjects, including materials licensed under the U.S. Nuclear Regulatory Commission license issued to the NIH, must usually be specifically authorized to do so by the NIH's Radiation Safety Committee. This requirement applies to physicians who wish to use radioactive materials in humans for routine medical uses as well as in research involving human subjects must be specifically Authorized to do so by the Radiation Safety Committee. Applicants must be a licensed physicians and meet training and experience requirements related to the use of radioactive materials in humans. This requirement is separate and distinct from gaining approval from the Radiation Safety Committee for individual studies (protocols) for research uses of radioactive materials in human subjects, application for which is made on form NIH 88-23(a).

Applications are to be submitted form NIH 88-24, "Application for Authorization for Clinical Use of Radiation Sources;" with attached "Supplements" are also to be filled out. These forms are used both to document the training and experience necessary to satisfy regulations of the U.S. Nuclear Regulatory Commission and to indicate the type of Authorization that is being applied for. Reference should be made to Title 10 Code of Federal Regulations, Part 35, "Medical Use of Byproduct Material".

Applications should be submitted under cover of a memorandum addressed to the Chairman of the Radiation Safety Committee. Applicants should clearly indicate in the memorandum the type(s) of Authorization for which they wish to apply; consult form 88-24 for a list of types.

Physicians who wish to qualify on the basis of board certification need only complete Items 1, 2, and 3 on Supplement A. Other applicants should submit Supplements A and B with all items completed. A separate Supplement B should be completed and signed by each preceptor who provided training or supervised experience. Care should also be taken to show enough information to enable a determination that training and experience are current, i.e., within the past seven years to enable compliance with 10 CFR 35, §35.972.

Note that most investigators applying for Authorization for clinical use of radioactive materials also apply to be an Authorized User for Laboratory Use (if such Authorization has not already been granted). However, the Committee will approve an Authorization limited to clinical use only. In such cases, the clinician may not order and receive radioactive materials; this must be done by another Authorized User who has such authority, or through the radiopharmacy. Information about applying for Authorization for lab use of radioactive materials is available from the Radiation Safety Office, by calling 496-2254.

Physicians who do not have sufficient training and experience to qualify for Authorization in one of the categories listed in 10 CFR 35, Subpart J may apply for Authorization with a narrower scope. In such cases, applicants should contact the Executive Secretary in advance regarding application procedures. The Radiation Safety Committee will evaluate such applications on a case-by-case basis to assure compliance with conditions imposed in the NIH's NRC license and 10 CFR 35.
Please fell free to contact Lisa Coronado by calling 496-2253, or via Email at "coronado@mail.nih.gov" if you have any questions about the authorization procedure; contact Radiation Safety Branch's Training Officer at 496-2255 for a schedule of training courses or if you need other radiation safety training information.