Controlled Substances in Research

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Research involving the use of controlled substances at the University of Michigan (U-M) is strictly regulated. U-M faculty who obtain, store, and utilize controlled substances in their research must:

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  • Obtain, as applicable, a State of Michigan (SOM) license and a U.S. Department of Justice – Drug Enforcement Administration (DEA) registration
  • Record their approved license/registration in the U-M CSIR database
  • Follow proper procedures when purchasing controlled substances
  • Ensure proper security, storage, and disposal of controlled substances
  • Adhere to federal, state and U-M policies, guidelines, and procedures regarding the use of controlled substances in research

* Provided by the U-M Medical School

Controlled Substance Schedules

The license and registration processes, as well as purchasing and storage guidelines, are determined by the controlled substance’s schedule.  Drugs and other substances considered controlled substances per the federal Controlled Substance Act are classified into five (5) schedules (I – V) according to their potential for abuse and addiction.

  • Schedule I:  illicit drugs, compounds, and their chemical precursors that have a high potential for abuse, no accepted medical use, and that lack of accepted safety protocols for medical use.  These drugs and substances are typically used for drug abuse/addiction research or for analytical research.
  • Schedules II-V:  drugs, compounds, and their chemical precursors that have accepted medical uses and a decreasing potential for abuse.

Schedule I substances require a separate license and registration and additional controls on purchasing and storage than Schedules II – V.

Schedule Lists & Definitions

Controlled substance drugs are labeled with a and the corresponding schedule number.

Image of controlled substance drug label

Controlled Substances Research Review Committee (CSRRC)

The Controlled Substances Research Review Committee (CSRRC) provides guidance for conducting research with drugs or other substances that have potential for abuse which are subject to state and federal regulations. This guidance is reflected in U-M’s controlled substance research policy and procedures.  The committee reviews any incidents involving controlled substances in research in order to assist the investigator in identifying and implementing corrective actions.

The committee meets monthly and consists of faculty from major units in which controlled substance are used in research and also key U-M administrators from across campus.

Roles & Responsibilities

To conduct research at U-M involving controlled substances, you must:

  • Have your own active controlled substance SOM license and DEA registration, or
  • Be approved as authorized personnel or an authorized agent under the license and registration of another U-M researcher
  • List that licensee/registrant as a member of the study team on your animal and/or human subject research protocol

As an active SOM licensee/DEA registrant, you must:

  • Properly store controlled substances per schedule requirements
  • Properly screen and document as authorized personnel or authorized agent the U-M investigators and laboratory staff who will use the controlled substances for research under your license and registration
  • Maintain at all times accurate and complete records per compliance regulations
  • Immediately report any diversions of the controlled substances under your supervision

Best Practice:

If you have a controlled substance practitioners license/registration, it is strongly recommended that you obtain a separate research license/registration to conduct research activity using controlled substances. This reduces risk to your medical or dental practice in cases of non-compliance with research per SOM or DEA policies.

Tools & Resources

CSIR Database

You must record your State of Michigan license and DEA registration in the Controlled Substances In Research (CSIR) database for regulatory oversight at U-M.  Once recorded, CSIR sends you automated email reminders when it’s time to renew your license and registration.  Email CSIR-Help@umich.edu to request access to CSIR.

Education & Training

See Controlled Substances in Research Procedures to download procedures and obtain templates for usage logs, etc.