Applications for human use research, which are intended to obtain basic information regarding metabolism of a radioactive drug (including kinetics, distribution, and localization) or regarding human physiology, pathophysiology, or biochemistry, but not intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety and effectiveness of a drug in humans (i.e., to carry out a clinical trial), are reviewed and approved by the RDRC. The following information is required for all PHs requesting approval from the RDRC:

• documentation that the PH is a licensed physician in the State of Indiana
• documentation regarding certifications, training, and experience which qualifies the PH for the intended use
• submission of an A-1a, Application to Use Radioactive Materials in Humans for Research Purposes, form or equivalent

Note: Individuals independently administering radioactive material to humans for research under existing permits or diagnostic nuclear medicine procedures carried out independently by the PH must provide the same information, except for submission of the A-1a form.

Certain types of human research may involve the use of an approved diagnostic nuclear medicine procedure with the result being utilized in a research protocol. There is also research involving the use of a radiolabeled drug to carry out a clinical trial (i.e., to determine the safety and to get the desired effect of that drug with such drugs being utilized under an Investigational New Drug (IND) application which has been submitted to the FDA). For these uses, the applicant must provide the same information as above.

Once all necessary information has been received and reviewed by the RSO, a copy of the application and supplementary information is forwarded to each member of either the RRSC or RDRC for comment.

For human use applications which are reviewed by the RRSC, the Chairman of the RRSC may issue preliminary approval which incorporates any comments or restrictions specified by the RSO and/or RRSC member. Final approval will be granted by the RRSC at the next quarterly meeting. Human use applications which are reviewed by the RDRC cannot be preliminarily approved. A formal meeting of the RDRC is required for such applications. Following formal review and approval, a permit is prepared by the RSO and forwarded to the PH.