IV. AUTHORIZATION TO USE RADIOACTIVE MATERIAL AND RADIATION SOURCES

  1. TYPES Of AUTHORIZATIONS

    2. The two types of Authorizations to use radioactive material and radiation sources at Duke University and the Medical Center are:

    1. Authorization for use in scientific research or other applications that do not involve human subjects; and
    2. Authorization for clinical or research use in humans.

    In addition, shipboard use associated with the Duke University Marine Laboratory must be covered under either the Duke University license or a license issued by the United States Nuclear Regulatory Commission, an Agreement State, or other recognized licensing agency.

  2. STATUS OF AUTHORIZATIONS

    3. The "status" of each Authorization (and Authorized User) falls into one of following three categories:

    1. Active: The user is authorized by the Committees to use, purchase and possess radioactive material including equipment containing sealed sources, irradiators, or radiation producing machines. This person purchases or performs experiments with radioactive material or radiation sources at least once in a year. A person must remain classified as "active" if they possess any amount of usable unencapsulated radioactive material or if they are using equipment containing sealed sources, irradiators, or radiation producing machines.
    2. Inactive: The user is authorized to use, purchase and possess radioactive material including equipment containing sealed sources, irradiators, or radiation producing machines. An inactive user has chosen not to perform experiments utilizing unencapsulated radioisotope or use radiation equipment for an extended period of time exceeding one year. A user who wishes to change to inactive status must notify the Radiation Safety Officer in writing of this decision. An inactive user shall have no usable unencapsulated radioactive material (including radioactive waste) in their possession. Inactive users who have equipment containing sealed sources, irradiators, or radiation producing machines must not use them and must declare this information to the Radiation Safety Officer, in writing, at the same time as they request "inactive" status. If an inactive user desires to reinstate their "active" status, they must notify the Radiation Safety Officer in writing and fulfill "Active" status training requirements.
    3. Terminated: The Authorized User is no longer employed by Duke University; is deceased; or has terminated, by their own choice or by the direction of the Committees, their Authorization to use, order or possess radioactive material including equipment containing sealed sources, irradiators, or radiation producing machines. This person has no radioactive material, equipment containing radioactive material, or radiation producing equipment. A "terminated status" Authorized User shall have a completed (either prior to termination or in absentia) a "close-out" procedure, in which the inventory of radioactive material under the Authorization has been disposed or transferred, radioactive waste has been removed, and rooms and facilities have been surveyed and determined to be free of radioactive contamination. Documentation of the "close-out" will be maintained by the Radiation Safety Division.

  3. NON-HUMAN RESEARCH USE OF RADIOACTIVE MATERIAL

    1. QUALIFICATIONS

      2. An applicant for non-human radioisotope use shall be a full-time member of the faculty and have both training and experience commensurate with the types and quantities of radioactive material for which application is being made.

    2. DEVELOPMENT OF WRITTEN STANDARD OPERATING PROCEDURES

      3. Recognizing that the types of clinical and laboratory operations encompassed by the programs at Duke vary greatly, the Committees require that each Authorized User develop a set of written procedures that are specific to his/her laboratory. Laboratory-specific Standard Operating Procedures give the individual Authorized Users autonomy in determining the day-to-day conduct of radiation protection procedures in their laboratories, based on the nature of their use of radioactive material and/or radiation-producing devices.

      Each Authorized User's written procedures should contain the following information, based upon the general requirements of the Duke Radiation Safety Program:

      1. The types of radioactive material and/or radiation-producing devices present in the laboratory.
      2. General safety issues that address the proper handling of radioactive material, use of fume hoods, wearing of personal protective equipment, etc.
      3. Laboratory-specific procedures for ordering, receiving, storing and disposing of radioactive material.
      4. Laboratory-specific procedures for conducting surveys for detection of contamination (wipe test locations, frequencies, etc.).
      5. Description of laboratory-specific record-keeping procedures. As an aid to formulating these laboratory-specific written procedures, the Radiation Safety Division will supply any current or prospective Authorized User with a template electronic document that is based on the radionuclides included in the User's authorization. The User may modify this template as required.

    3. AMENDING THE AUTHORIZATION

      4. If the Authorized User wishes to alter the conditions of the authorization (such as by adding or deleting permitted radionuclides or devices, changing locations of use or changing possession limits), he/she may contact the Radiation Safety Officer directly to obtain approval to amend the authorization. All such amendments are subject to review and approval by the appropriate Committee.

    4. PRECEPTORS

      5. The following requirements shall apply to an individual acting as a preceptor for the radioisotope program when the applicant does not meet the requirements stipulated above:

      1. The preceptor shall be an Authorized User.
      2. The preceptor shall have such professional relationships with the applicant as would permit real knowledge of the day-to-day course of the use of radioisotopes. The preceptor shall have a relationship with the applicant which would give him/her veto power over the applicant's use of radioisotopes. Having this power, the preceptor must be willing to accept accountability for proper radioactive material usage.

  4. AUTHORIZATION FOR MEDICAL USE OF RADIOACTIVE MATERIAL IN HUMANS

    5. The administration of radioactive material to patients or research subjects is regulated by the Food and Drug Administration (FDA), the State of North Carolina and the Medical Center Radiation Control and Radioactive Drug Research Committee. Requests for the human use of radionuclides must be sufficiently detailed to enable a determination of compliance with current regulations and procedures. In order to participate in the human use of radioactive material at Duke University Medical Center, the applicant must provide evidence of possession of a medical license issued by the North Carolina Medical Board and current registration by the Board and possess credentials that reflect those set forth in Title 10, Part 35 of the Code of Federal Regulations (10 CFR 35). These requirements generally involve (1) training in basic radioisotope handling techniques, (2) supervised clinical training in an institutional nuclear medicine or radiation oncology program, and (3) relevant experience. The clinical training should cover all appropriate types of diagnostic procedures. The specific recommended training requirements are outlined in Appendix A: Training Requirements for Human Use of Radioactive Material. Each human use shall be determined to fall into one of the following categories.

    1. Well-established Medical Use: those radioactive drugs which through previous use, (primarily in Nuclear Medicine) have proven to be safe and effective in diagnosis and/or therapy.
    2. Non-Routine Medical Use: the proposed human use of any radioactive drug which is not identified as a well-established use.
    3. Basic Human Research: the use of radioactive drugs to obtain basic research information; but not intended for immediate therapeutic, diagnostic, or similar purpose.

    The specific requirements for authorization for each type of human use are summarized below.

    1. WELL-ESTABLISHED MEDICAL USE

      2. For well-established medical uses, the applicant must provide evidence of medical licensing in the State of North Carolina and credentials as described above. The applicant's Department Chair shall directly contact the Radiation Safety Officer with the request for authorization and supply the appropriate documentation. The Radiation Safety Officer will review the documentation and consult the Medical Center Committee for final approval.

    2. NON-ROUTINE MEDICAL USE AND THE INSTITUTIONAL REVIEW BOARD

      3. Non-routine medical use is the use of radioactive material in humans, which is neither a recognized, well-established medical use, nor meets the definition for Basic Human Research. Non-routine medical uses of radioactive material may be classified into one of two phases of development:

      1. Clinical research which applies to a new use in humans. In this case, there is limited experience with the new use or procedure, and limited published precedent regarding it. The basis for proceeding with the new use in humans is derived from the knowledge obtained from animal studies. This phase of development includes the initial introduction into humans and initial trials on a limited number of patients. Investigators shall contact the Radiation Safety Officer for evaluation and submission of proposals to the Duke University Medical Center Radioactive Drug Research Committee (RDRC). The investigator must also submit an appropriate protocol to the Duke University Institutional Review Board (IRB). The Institutional Review Board approves basic and clinical human research protocols involving investigational drugs and ionizing radiation. The investigator shall fulfill all the relevant requirements of the IRB with regards to submission and approval of the clinical protocol. General information to be supplied is outlined in Appendix B: Information to be Supplied For New Medical Use of Ionizing Radiation. The requirements for radiation dose limits to research subjects, and other requirements of the RDRC, are described in the Federal Regulations under 21 CFR 361.1.
      2. Clinical evaluation which applies to the planned testing of a new diagnostic or therapeutic procedure in a clinical trial. The procedure and results of clinical research will ordinarily be reported in the literature or at meetings. If adequate information has not been published, the applicant shall obtain sufficient information from the investigators who developed the test to be thoroughly familiar with the details. The investigator must fulfill all appropriate FDA requirements for an Investigational New Drug (IND). These requirements are described in the Federal regulations under 21 CFR 312; additional information to be supplied is outlined in Appendix C: Information To Be Submitted For Basic Human Research Use Of Ionizing Radiation Investigators shall contact the Radiation Safety Officer for evaluation and submission of proposals to the Duke University Medical Center Radioactive Drug Research Committee. The investigator must also submit an appropriate protocol to the Duke University IRB.

    3. BASIC HUMAN RESEARCH AND THE INSTITUTIONAL REVIEW BOARD

      4. Basic human research includes projects intended to obtain basic research information regarding the metabolism (including kinetics, distribution and localization) of a radioactively labeled drug or regarding human physiology, pathophysiology or biochemistry; but not intended for immediate therapeutic, diagnostic or similar benefit. For these studies:

      1. the amount of active pharmaceutical ingredient or combination of pharmaceutical ingredients to be administered shall be known not to cause any clinically detectable pharmacological effect in human beings, and
      2. the radiation dose shall be the smallest practical to perform the study. Under no circumstances shall the whole body effective dose equivalent exceed a yearly cumulative value of 5 rem, or a single-exposure value of 3 rem. The total critical organ dose shall not exceed 15 rem annually. For research subjects who have not reached 18 years of age, the maximum permissible whole body and critical organ exposure limitations are 10 percent of the foregoing. A female research subject of childbearing potential shall state in writing that she is not pregnant, or shall be given a pregnancy test before participating in any study.

      Investigators shall contact the Radiation Safety Officer for evaluation and submission of proposals to the Duke University Medical Center Radioactive Drug Research Committee. In addition, the investigator shall meet all the relevant requirements of the IRB.

    4. INFORMED CONSENT FOR PROCEDURES INVOLVING IONIZING RADIATION IN CLINICAL INVESTIGATIONS

      5. The Medical Center Radiation Control and Radioactive Drug Research Committee has adopted the following requirements relative to expressing radiation dosage to patients or research subjects who are participating in clinical or basic human research.

      1. The investigator shall calculate the anticipated radiation dosage as effective dose equivalent and the dose to the critical organ (where appropriate). Calculation should include the dose from the initial administration and, if applicable, quarterly and yearly cumulative exposures due to subsequent procedures.
      2. The calculated dose should be expressed both as an absolute quantity (mrem) and as a fraction or multiple of the natural background radiation, or a fraction or multiple of the applicable FDA limits for investigational radioactive drugs or the United States Nuclear Regulatory Commission (NRC) occupational dose limits, whichever is most appropriate to the circumstances of the study population and the study characteristics. The expression of dosage is not restricted to the preceding suggested formats. However, any expression of radiation dose must assist the subject in making an informed value judgment as to the magnitude of the component of risk attributable to ionizing radiation. Investigators may contact the Radiation Safety Division for assistance in supplying the appropriate dose information and for templates of the appropriate wording for subject consent forms for a variety of diagnostic procedures.

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