Approvals
Approval of proposed research may be granted when the RDRC has determined, in accord with the standards set forth in 21 CFR 361.1, that:
The pharmacological dose is within the limits set forth in the standard.
The radiation dose from the radioactive drug and other x-ray or radiation procedures that are part of the research study is within the limits set forth in the standard.
The radiation exposure is justified by the quality of the study being undertaken and the importance of the information it seeks to obtain.
The study meets the other requirements set forth in the standard regarding qualifications of the investigator, proper authorization for handling radioactive materials, selection and consent of research subjects, quality of radioactive drugs used, research protocol design, reporting of adverse reactions, and approval by an appropriate Institutional Review Board (IRB).
The RDRC meets at least once each quarter in which research activity has been authorized or conducted to review committee activities.
