Appendix B: Information To Be Supplied For New Medical
Use Of Ionizing Radiation
The following information must be submitted to the Duke University Medical Center
Radioactive Drug Research Committee (RDRC) and the Institutional Review Board (IRB) along with the Protocol Approval form. Please
consult with the IRB for details on submitting protocols for human research.
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Title and purpose of study. Indicate whether the study is to be clinical
research or clinical evaluation and explain why.
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The plan of investigation in sufficient detail to permit a critical evaluation
of the methods for conducting the experiments and the controls
established.
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A statement as to whether any complementary drug or radioisotope
administration is anticipated in conjunction with the study.
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A statement about the expected fate of the isotope administered and if the
procedure is for therapy, a statement about the expected effects.
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If the application is for clinical research, an outline of related work
conducted in laboratory animals and in humans, including data on
localization, effective half-life, and radiation dosage; if no work has been
conducted in animals, explain why. Pertinent reference and a brief abstract
prepared by the applicant of published or unpublished material shall be
submitted.
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If the application is for clinical evaluation, pertinent references and a brief
abstract prepared by the applicant of published or unpublished material,
including information on localization, effective half-life, and radiation
dosage.
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A description of the human subjects to be studied.
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Persons without manifest disease: number, method of selection, age range.
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Persons with manifest disease: number, nature of pathology, method of
selection, age range.
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Pregnant women shall ordinarily be excluded from any test not involving
the condition of the pregnancy itself. Specify whether or not pregnant
women will be tested and if so, explain why.
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The dose range (microcuries or millicuries) to be administered and the
method of administration.
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Calculations of the radiation doses delivered to the whole body and to the
critical organ(s). The calculations shall contain information regarding:
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The expected half-life in various organs.
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The relationship between the retained isotope and permissible
body burden for occupational exposure (except for therapy).
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The rationale for using the dose selected.
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The radiation dose due to other simultaneous or accompanying
radioactive isotope test which may be administered.
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A statement of the institutional resources available to support the study
including:
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Physical facilities and equipment especially suited for the study
under consideration.
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Availability of clinical material.
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Types of consultation or collaboration available including the
name of the study author if other than the applicant.
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Qualifications of the individual physician who will be responsible for the
study, including a summary of research training and experience and
pertinent training or experience in the use of radioisotopes.
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Estimated time needed to complete the study.
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A schedule for reporting results of the study and an outline of the
information to be included in the report. The schedule can be in terms of
time intervals or number of subjects studied. If studies are to be long
range, interim reports shall be provided.
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Copy of consent form.
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Confirmation that adverse reactions associated with the use of the
radioactive material will be immediately reported to the Committee.