6130.1 Purpose and Scope
The purpose of this policy is to help University students and personnel comply with applicable laws and regulations when conducting research involving Controlled Substances.
This policy does not apply to the bona fide possession or use of any Controlled Substance by an individual for whom the Controlled Substance has been properly prescribed. This policy also does not apply to the clinical prescription, dispensation, or administration of a Controlled Substance, in accordance with the applicable standard of care, by any Ohio-licensed healthcare professional.
The Office of General Counsel is available to answer questions related to this policy and applicable laws and regulations. If there is any irreconcilable conflict between this policy and applicable laws and regulations, such laws and regulations shall supersede this policy. Please alert the Office of General Counsel to any perceived conflicts.
6130.2 Definitions
As used in this policy:
- A "Chief" is an individual Controlled Substance Researcher ("CSR") who is a member of the Controlled Substance Research Team ("CSRT") of a Controlled Substance Research Project ("CSRP") who has been designated to serve as both the Responsible Person (in accordance with Ohio Revised Code and State Board of Pharmacy regulations) and the Principal Investigator (in accordance with U.S. Code and Drug Enforcement Administration Regulations). The Chief bears ultimate legal responsibility for the safe procurement or manufacturer, storage, use, disposal, and recordkeeping of all Controlled Substances obtained using the Chief's license and registration. The Chief may not delegate such responsibility. In the event a CSRP's Chief is no longer willing or capable to serve in such capacity, such Chief shall promptly notify the Workgroup, who will consult with the remainder of the applicable CSRT.
- A "Controlled Substance" is a substance (including its analogues) classified under the U.S. Controlled Substances Act, or the implementing regulations promulgated by the U.S. Drug Enforcement Administration (or "DEA") or the Ohio State Board of Pharmacy (or "OBP"). (See 21 C.F.R. §§ 1308.11 - 1308.15; R.C. §3719.41; OAC § 4729-11-92; OAC § 4729-11-03). Such schedules are amended periodically and this definition shall change accordingly. The Office of General Counsel can provide the most recent state and federal schedules upon request.
- A "Controlled Substance Research Project" (or "CSRP") is any research project that involves the manufacture, procurement, possession, dispensation, or administration of a Controlled Substance.
- A "Controlled Substance Researcher" (or "CSR") is a University student, faculty member, or employee who is engaged, in any capacity, in research involving the manufacture, procurement, possession, dispensation, or administration of a Controlled Substance.
- A "Controlled Substance Research Team" (or "CSRT") is the group consisting of the CSRs involved in a particular research project that involves the manufacture, procurement, possession, dispensation, or administration of a Controlled Substance.
- The "Controlled Substances Workgroup" or "Workgroup" is a committee composed of a representative of the University's: (1) Office of the Provost; (2) Office of General Counsel (or "OGC"); (3) Department of Public Safety (or "DPS"); (4) Department of Environmental Health and Safety (or "EHS"); and (5) Office of Research and Sponsored Programs (or "RSP").
6130.3 Legal Compliance
All CSRs shall comply with all applicable federal, state and local laws and regulations. Applicants shall secure licensing by the OBP and the DEA before engaging in the use of Controlled Substances.
Any incidents involving Controlled Substances shall be promptly reported to the OBP, the DEA and the Workgroup.
6130.4 Approval Process
Any University student, faculty member, or employee seeking to begin a CSRP shall prepare a written proposal and submit it for review and consideration by the Workgroup. The approval process may include but is not limited to: background checks and drug screening, review of security and storage conditions, review of deliveries and transportation, disposal, and others.