The Cannabis Control Commission announced in an August bulletin that it will begin reviewing all Marijuana Research Facility license applications previously submitted to the Commission.
A Research Facility license allows licensees to research cannabis and cannabis products for a variety of purposes, including under certain circumstances, studies involving human subjects. Research Facility licenses can be held by any number of different entities, including academic institutions, non-profits, or domestic corporations.
Before conducting any research, licensees must also obtain a Research Permit. This permit signals the Commission’s approval to conduct a specified research project over a specific time period. With its bulletin last month, the Commission also stated it will also begin accepting new permit applications for research studies.
Here are few highlights from the Commission’s regulations and list of FAQ’s that prospective Research Facility licensees should be aware of:
- Research licensees must comply with the same application requirements as other Marijuana Establishments, including but not limited to: providing a Host Community Agreement, identifying a proposed location, and listing all persons/entities with direct or indirect control.
- Licensed Research Facilities are also subject to similar requirements as other Marijuana Establishments, such as: registering individuals engaged in research as Marijuana Establishment Agents, compliance with transportation regulations for Marijuana Establishments (935 CMR 500.105(13), and tracking cannabis in the Commission’s seed-to-sale system.
- A research licensee may acquire its cannabis from a licensed Marijuana Establishment or, with the Commission’s approval, engage in cultivation or product manufacturing for the purpose of conducting research on these products.
- Research facilities may co-locate with Marijuana Establishments, provided they are commonly owned and clearly physically separate.
- Research permits must be renewed every year, or sooner depending on the nature of the research.
- The licensee is restricted to possessing only the amount of cannabis to be used in the research project.
- Research involving human subjects requires prior-Institutional Review Board (IRB) approval.
- The Commission’s permit review will focus on whether the research project is allowed, demonstrates adequate safety protocols, is adequately funded, and provides scientific/research value.
Some example research projects the Commission lists in its regulations include:
- Researching the potency and composition of cannabis and cannabis products
- Clinical investigations on dosage forms
- Safety and efficacy research as a component of using cannabis as medical treatment
- Genomic, horticultural and agricultural research