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.
- 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