Research Diversion Prevention Committee Policies

Roswell Park expects that all faculty, staff and students who may come in contact with controlled substances during the conduct of research or instruction to comply with federal, NYDOH BNE regulations, and Roswell Park policy. These policies are listed below.

Exclusions

This Roswell Park research policy does not apply to controlled substances dispensed to a patient by a licensed practitioner in the course of professional medical or dental practice.

Monitoring & inspection

As part of federal and state regulations, and Roswell Park controlled substance requirements, storage locations and laboratories are subject to external and internal inspections to verify compliance, safety, and security.

External

The U.S. Drug Enforcement Administration (DEA) conducts announced and unannounced inspections of the locations registered to store and use controlled substances. The licensee/registrant, authorized investigators, and Roswell Park laboratory staff should be prepared at all times for such inspections by maintaining proper storage, security, and records.

Internal

The following Roswell Park departments guide, provide, or participate in internal monitoring and inspection activity for the controlled substance research compliance program:

1. The Research Diversion Prevention Committee works closely with researchers, units and other Roswell Park research compliance programs, e.g., Institutional Animal Care & Use Committee (IACUC), Legal and Occupational and Environmental Safety (OES) to ensure that:
   • All research involving controlled substances meets the NYS and the DEA regulations
   • Roswell Park controlled substance policies and procedures are developed and maintained per state and federal regulations
     The Biosafety and Diversion Committee makes laboratory visits to verify that Roswell Park researchers are properly handling, storing, disposing of, and documenting controlled substances. The Research Diversion Prevention Committee is your first point of contact for questions or concerns.
2. IACUC – as part of the post-approval monitoring for a protocol, when applicable
3. Roswell Park Waste Disposal (Pathological, Biological, Hazardous Drug, Chemical and Pharmaceutical) -  for disposal of controlled substances

References and resources

• Roswell Park Policy on Use of Controlled Substances in Research - Outlines the investigator and/or department roles and responsibilities when utilizing controlled substances in research at Roswell Park. (must be on Roswell Park network to view)
• Title 21 United States Code (USC) Controlled Substance Act - U.S. Department of Justice - Drug Enforcement Administration (DEA) outline of the federal Controlled Substance Act
• Title 21 Code of Federal Regulations, Part 1300-End - Index listing the links to the sections of DEA policy for controlled substance registration
• Part 80: Rules and Regulations on Controlled Substances in NYS
• R3CR Home Page - variety of resources related to conducting research with cannabis or cannabinoid- containing products.
• Office of Cannabis Management - NYS OCM cannabis research requirements.
• FDA Regulation of Cannabis and Cannabis-Derived Products- FDA specific guidance on cannabis and cannabinoid research
• Frequently Asked Questions about Conducting Research with Cannabis (Marijuana and Hemp) | National Institute on Drug Abuse (NIDA) - Containing helpful information from NIH on conducting plant touching studies
• NIH-Supported Research on Cannabis, Cannabinoids, and Related Compounds - NIH sponsored information on conducting research involving cannabis
• Diversion Control Division: Registration - DEA page for registration

Questions?

Email

Jillianna Wasiura
Director, Diversion Prevention
Phone: 716-845-3425
Email: Jillianna.Wasiura@RoswellPark.org

Ericka Bennett
Vice President for Corporate Ethics, Research Integrity & Research Subject Protection
Phone: 716-845-8132
Email: Ericka.Bennett@RoswellPark.org