In an effort to further strengthen, safeguard, and support research at the University of Michigan, the U-M Controlled Substances in Research Monitoring Program has introduced a revised escalation plan (available via PDF download) for all individuals who use controlled substances in research.
Central to the plan is an institutional commitment to increased transparency through more clearly defined roles/responsibilities for research personnel to remain in compliance, as well as the development of a corrective action process that outlines the steps that may be taken in instances of continued and/or serious non-compliance with U-M, state, and federal policies and regulations.
Plan Structure
The plan places registrants (individuals with an active State of Michigan license/DEA registration to use controlled substances in research) and their staff (individual study team members who have been approved as authorized personnel/authorized agents under the license and registration of another U-M researcher) into one of four categories based on their overall compliance with applicable research controlled substances policies.
Placement into corrective action categories is based on:
- The number of non-compliant findings that occur during a controlled substance monitoring visit
- The seriousness of the non-compliance(s)
- Repeated non-compliance(s)
- Professional opinion of the Controlled Substances Monitor (i.e., the ability of research personnel/lab staff to adhere to regulations)
Questions or Concerns?
If you have any questions or concerns about the revised escalation plan, or about the use of controlled substances in research, please contact Kelli Christman, Controlled Substance Monitoring Program Manager, at cs-monitors@med.umich.edu.