If your study involves a radioligand that is not commercially available, the Principal Investigator will need to submit an IND application to the FDA. The Columbia Clinical Trials Office provides assistance regarding IND and IDE applications.
JRSC has provide updated consent form language:
The procedures involving radiation in this research study will expose you to a very small amount (xx mSv) of radiation in addition to the amount that you might receive from your normal medical care. There may be an increase in the chances of your developing cancer many years after this study. The additional risk from this research study is less than X%. At this very low level, scientists are uncertain as to the actual risk from research and there may be no risk at all.