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5.1 Authorized User Human Use:
The internal or external administration of radioactive material or the
radiation there from to human beings
5.2 University faculty and staff members who
are engaged as a principal investigator and/or have significant
responsibility for administrative, medical, academic, or experimental
functions involving radioisotopes, and can demonstrate an acceptable level
of competence in the safe handling of radioisotopes may apply to be
Authorized Users.
5.3 Approval to use radioisotopes will be based upon the hazards involved with the type and activity of radioisotope requested, the training and experience of the applicant, and with the user's acknowledgment of his/her responsibility for: insuring the safety of employees and the public; minimizing exposures to employees, students, and the general public, both inside and outside the controlled area; and avoiding significant releases of radioactive material to the environment. The applicant must insure that the application correctly and adequately describes the procedures and safety precautions to be followed. These procedures should be evaluated in light of the following philosophy:
Failure to do so may result in delay of application approval or rejection of the application. 5.4 RESPONSIBILITIES OF THE AUTHORIZED USER The Authorized User has direct responsibility for all aspects of radiation safety associated with his/her possession and use of radioisotopes. Specifically, this responsibility includes but is not limited to the following:
5.5 APPLICATION FOR LABORATORY USE OF RADIOACTIVE MATERIALS Each prospective Authorized User shall submit an "Application for Authorization to Use Radionuclides" (Form RSO 313) to the Radiation Safety Office. All items on the application form should be completed in sufficient detail for the Radiation Safety Executive Committee to determine that the applicant's radiation protection program, equipment, and facilities are adequate to minimize health risks, adverse effects on other research, and property loss. The applicant is urged to be realistic with regard to the categories and quantities of radionuclides for which authorization is requested. The application should be completed and sent to: Radiation Safety Office, G-7 Parran Hall, GSPH. Upon approval, a copy of the original application with all attachments will be returned to the applicant. Approval requires, as a condition, that the user follow all statements and representations set forth in the application and any supplements to it. 5.6 APPLICATION FOR THE USE OF RADIOACTIVE MATERIALS IN HUMANS All human use of radioactive material must be carried out by or under the supervision of a licensed physician who has been approved for such use by the Subcommittee on Human Use of Radioisotopes. This requirement applies to both routine diagnostic and therapeutic uses, and to human use research. (See Section 6.4 for additional information.) To obtain authorization for the "human use" of radioactive materials, the applicant shall file RSO Form 313HU with the Radiation Safety Office. Any physician requesting authorization for "human use", at a minimum, must meet the training and experience requirements specified in NRC regulations (10CFR35.900 to 35.981). Details may be found in NRC publication NUREG 1556 Vol. 9. Additional forms, such as preceptor forms NRC 313A and 313B, are available from the Radiation Safety Office. Reapplication or the submission of an amendment is necessary when a nuclide, radiopharmaceutical or compound not previously applied for is desired, or if conditions of use change. Approval to administer radioactive material to humans does not constitute implicit or explicit authorization to use the same or other radioactive material for other purposes, such as non-human, research, or animal use. If the use is experimental, approval of the IRB is required prior to initiation of the use of the material. Following evaluation by the Subcommittee, the applicant will be notified as to the approval or disapproval of the request. Use of experimental radiopharmaceuticals in humans may require animal studies to establish toxicity, biological half-life, distribution and efficacy prior to authorization. Also conformance with applicable FDA(NDA/IND) requirements must be assured. By-product materials not approved under the IND/NDA process shall not be used in humans until their pharmaceutical quality and assay have been established. A Drug Master File (DMF) must be submitted to and be approved by the RDRC prior to the use of such materials in humans. The DMF must address issues related to assay, labeling, identity, quality, purity, sterility, non-pyrogenicity, etc. 5.7 PERIOD OF AUTHORIZATION Much information supplied in the initial application changes over time; therefore, applications must be reviewed and updated periodically to insure that the information on file is current. Authorization to use radionuclides will be granted for intervals not to exceed two years. At the time of expiration a renewal of authorization will be required. A reminder for such purpose will be initiated by the Radiation Safety Office. The Authorized User, however, may submit an amendment application at any time prior to the expiration of his/her authorization if the type of radionuclide, activity limits, or experimental protocol changes significantly. For timely processing, amendment requests should be submitted several weeks before the changes are to be implemented. The Radiation Safety Office is available to assist in the preparation of the application. |
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Radiation Safety Office Webmaster Revised February 9, 2001 |
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