drug control / diversion review

IRB

The IRB reviews procedures for ensuring medications are appropriately tracked and tracks violations such as drug loss or diversion closely; the IRB would be the first to be aware of such an issue in a study. Drug loss or diversion, especially in medical research using products containing controlled substances, is understood as a major protocol violation and would invoke intensive audits of all documents for the study and possible study termination. 

IACUC

Provides same function as IRB for animal research involving medications. 

DEA

The Drug Enforcement Administration regulates any studies involving controlled substances (while the RAPC also regulates addiction treatment trials that don’t involve controlled substances, the DEA would not regulate such a study as no controlled substances are involved). For a study involving CS I/II agents, the DEA requires special licenses for on-site maintenance of drugs, requires locked and alarmed sites for drug storage, and requires close record-keeping of products. The DEA does on-site inspections to approve of sites that maintain these agents. Any changes require reporting to the DEA (e.g., if drugs are moved from one room to another, a new license must be issued). 

Controlled substances are extraordinarily tightly regulated by both regulatory authorities and by researchers and their institutions. We are not aware of research CSs ever being diverted (in contrast to clinically-used CSs).