Appendix C: Information To Be Submitted For Basic Human Research Use Of Ionizing Radiation
The following information must be submitted to the Duke University Medical Center
Institutional Review Board (IRB) along with the Protocol Approval form. Please
consult with the IRB for details on submitting protocols for human research.
-
Pharmacological dose calculations based on data available in the
published literature or from other valid studies.
-
Absorbed dose calculations based on biologic distribution data available in
the published literature or from other valid human studies.
-
Investigator's qualifications through training and experience to conduct
the proposed research studies.
-
Copy of consent form and, when applicable, method of pregnancy
determination.
-
Procedure for determining that radioactive material for parenteral
administration is sterile and pyrogen-free.
-
The research protocol must be based upon a sound rationale derived from
appropriate animal studies or published literature and must be of sound
design such that information of scientific value may result.
-
Confirmation that all adverse reactions associated with the use of the
radioactive drug will be immediately reported to the Committee.
-
Types and numbers of research subjects to be employed in the study.