Creighton University

Creighton University is guided by federal regulations governing administration of radioactive drugs to human subjects in research. The Radioactive Drug Research Committee (RDRC) reviews and approves protocols that involve administration of radioactive drugs to human subjects. The RDRC approves only those radioactive drugs that are generally considered safe for human research. Radioactive drugs that have not been shown in the literature to be safe cannot be approved by the RDRC. An investigator who wishes to use such a drug will need to submit an Investigational New Drug Application to the U.S. Food and Drug Administration (FDA).

The RDRC reviews protocols to ensure the following:

• The pharmacological dose is within the limits set forth by the U.S. Food and Drug Administration (FDA) in Title 21 CFR Part 361.
• The radiation dose is within the limits set forth by the FDA.
• 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 other requirements set forth by the FDA regarding qualifications of the investigator, proper licensure 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 the Institutional Review Board.