Purpose
To ensure all departments working with cannabis and controlled substance do so in a safe and compliant manner that conforms to all rules and regulations set out by Health Canada and 黑料不打烊.
Scope
This is applicable to all cannabis and controlled substance research being conducted at 黑料不打烊 University (excluding affiliated hospitals or institutions or to 黑料不打烊 University-affiliated research institutes and centers. These affiliated institutes are managed by their internal department compliance).
Approach/Protocol
The cannabis and controlled substance compliance program was implemented to maintain compliance with federal regulation and to help facilitate the application process for the required license. The program also aims to protect the University and its researchers from any noncompliance infractions that may otherwise not be known by the research community. For this reason, a mandatory training is required prior to acquiring, using, and disposing these products. This can be done while any permit acquisition requests are being processed.
Internal Cannabis Research Application
Application to use cannabis 鈥� cannabis materials or their derivatives in research.
*The turnaround time for the processing of this application is 7 working days
The generic application form to use cannabis in research at 黑料不打烊 is here:
EHS-Form-110 v.1 Cannabis Research Permit Application Form
N.B. For research requiring the use or administration of cannabis to human participants, an amendment to the present cannabis research licence will be required from Health Canada. Please, reach out to the henry.ngu [at] mcgill.ca (Cannabis and Controlled Substances Officer) for assistance.
The generic application captures and documents all required documents in compliance with the Cannabis Act.
The internal cannabis research application should be initiated and carried out by the Principal Investigator (PI) or by someone designated by them.
The completed application Form and all other associated documentation is then to be forwarded to the EHS for its review and approbation.
Any requests for modifications must be submitted through an amendment/modification process by completing the appropriate Form. (to be established). Examples of these modifications may include;
- Changes to personnel
- Permit extensions
- Modifications in physical security framework, etc
Application for a Controlled Substance Exemption
Controlled Substances, the generic application form can be downloaded here:
Scientific Exemption Application Form EN-v1
A researcher requiring a controlled substance for research purposes at the University must, whenever necessary, such as in the context of sponsored research, notify OSR through the OSR Checklist, and must always contact and consult EHS to apply for, obtain, maintain and renew a Controlled Substance Exemption.
In completing the application form, the researcher will be asked to provide, among other information:
i. License number issued by provincial licensing body (if applicable)
ii. Project or Study Description
iii. Details of Administration
iv. The current year鈥檚 approval of the protocol from the local Animal Care Committee
(if applicable)
v. Supplier of the Controlled Substances
vi. Description of Storage and Security
Researchers are advised to contact EHS with inquiries or for any assistance in completing this form.
Once completed, EHS must submit the application form to Health Canada on behalf of the researcher.
Upon receipt of approval of the researcher鈥檚 exemption application, EHS must inform the researcher, copying OSR, in the context of sponsored research, and other interested parties.
In addition, EHS must: - provide the appropriate training and orientation to the researcher and, at the request of the researcher, to individuals participating in the same project, under the researcher鈥檚 direction and control, including but not limited to colleagues, assistants and technicians; and create or update the researcher鈥檚 user profiles on MyLab and in 黑料不打烊 Market Place (鈥淢MP).