Guidelines for Conducting Cannabis Research
The following guidance is provided as an overview of the federal, state, and University requirements for use of marijuana in research and is based on the UC Office of the President (UCOP) Research Administration and Compliance (RPAC) RPAC-18-01: Updated Information for Researchers on Conducting Marijuana Research at the University of California.
Legal Use of Marijuana for Research
There is no provision for the legal use of marijuana for research at UC except as already established and in compliance with DEA, FDA and NIDA policies and regulations. This applies to any research conducted in the United States under the auspices of the University of California, regardless of whether or not the research is conducted on a UC campus or UC property. Marijuana remains prohibited on all University property and at all University events, except for approved academic research.
For the purposes of this Guidance, marijuana research is defined as research that involves the growth, production, procurement, possession, distribution, administering, or use of marijuana. It does not refer to observational research or other research (e.g., policy research) for which a researcher does not grow, produce, procure, possess, distribute, or administer marijuana. As defined in the federal Controlled Substances Act (21 U.S.C., Chapter 13, §801 et seq.), the term marijuana (or “marihuana”) means: “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.
The Federal Controlled Substances Act excludes from the definition of marijuana certain parts of the Cannabis sativa L. plant, such the mature stalks of the plant, fiber produced from such stalks, and sterilized seeds incapable of germination. Thus, UC faculty, staff and students may legally conduct research involving such substances without a DEA license.
Obtaining Marijuana for Research
UC Berkeley researchers wishing to conduct other forms of marijuana research must obtain the marijuana through NIDA, submit an investigational new drug (IND) application to the FDA (if there are human research participants involved), and register with and obtain a license from the DEA to conduct the research. Researchers who wish to conduct research that involves obtaining a Schedule I Controlled Substance like marijuana should consult with the Office of Environment, Health and Safety about applying for a DEA registration/license. Researcher must apply for and be granted DEA registration for Schedule I controlled substances.
Researchers must abide by all applicable University, local, state, and federal policies, statutes and regulations, including but not limited to the federal Controlled Substances Act, the University’s Policy on Controlled Substances (BFB-BUS-50), and California law (Health & Safety Code Sections §11480 and §11481) that requires that certain studies involving Schedule I and II Controlled Substances be submitted to and approved by the Research Advisory Panel of California. Principal Investigators must follow the guidance on the state’s Research Advisory Panel website.
Research about marijuana that does not involve the direct use of marijuana in a research procedure is allowed, provided all the usual requisite approvals for research have been obtained (including IRB and/or IACUC review, where applicable, for studies involving human subjects or animals). Examples might include: surveying individuals about their use of, and experiences with, marijuana; analyzing public records of arrests for marijuana use or distribution; studying the effects of interventions for individuals who use, but wish to moderate or discontinue their use of marijuana; and obtaining symptom rating diaries from individuals who, on their own, obtain and use marijuana with the hope of alleviating those symptoms.
Paid outside work related to marijuana must comply with standard UC policies and procedures governing these activities including but not limited to:
- APM 025
- APM 670
- APM 671
- Regents Standing Order 103.1(b)
- UC Contracts & Grants Manual Chapter 1-800: Conflict of Interest | UCOP; Chapter 2-600: Award Acceptance and Administration | UCOP; and Chapter 7-200: Types of Allowable Costs | UCOP
Risks Associated with Marijuana Research
Some of these outside work activities, though legal under California state law, may not be allowable under federal law without a Schedule I DEA license and fulfillment of other federal requirements. In such circumstances, UC faculty and staff should be aware that they are assuming the same risks as any other California state private citizen who chooses to engage in such activities. Also, because of UC’s obligation to comply with federal laws, UC faculty and staff engaging in activities which are not allowed under federal law should make no use of UC resources (not even the usually permissible de minimis or incidental and occasional personal use of UC resources).
Finally, UC faculty and staff should make it clear to all parties that they are conducting such activities as private citizens, not as UC faculty or staff. Though they may identify themselves as holding a UC position, there should be clear and consistent statements such as:
“This work was performed as a private individual, not as a UC faculty member. No UC resources, facilities, or funds were used. No UC employees or students participated in this research in their roles as a UC employee or student.”
UC researchers choosing to pursue funding opportunities related to marijuana should consider and address the following issues before applying for or accepting marijuana-related funding:
- Source of funding: Before applying for and before accepting research funding that comes directly from individuals or entities (e.g., companies, associations) whose funding is derived from the marijuana industry (for example, from a professional association of marijuana growers legally licensed in the state of California) campuses must contact the UC Office of the President’s Research and Graduate Studies Office, which may seek advice from the Office of General Counsel as needed. In evaluating requests to accept funding from such sources, a significant consideration is the need to comply with applicable money laundering laws and laws re: aiding/abetting illegal activities.
- Research activities. Research with marijuana must comply with the guidelines and procedures described above in this Guidance.
- Mechanism of Funding. The UC campus Sponsored Projects offices (SPO) are the only UC campus entities authorized to submit or negotiate proposals to external sponsors for possible contracts, grants or cooperative agreements. The SPO will ensure that each proposal meets the requirements of the University, sponsor and applicable federal and state rules and regulations. Funders who prefer to use the gift mechanism work with UC campus external relations and development offices. Researchers interested in marijuana research funding are strongly encouraged to use the SPO mechanism rather than a gift mechanism, even for funding that would otherwise meet the criteria for being handled as a gift.
Industrial Hemp Related Research
Any UC Berkeley researcher who wishes to pursue research that involves cultivation of industrial hemp should, prior to commencement of any such research, first consult with the Office of Environment, Health & Safety (EH&S) to ascertain whether and how their protocol may be subject to the Federal Controlled Substances Act, the University’s Policy on Controlled Substances (BFB-BUS-50), or other State and UC policies.
Please note: The application process for federal (DEA) and State (Research Advisory Panel of California) permits/ licenses takes many weeks or even months. Therefore, consultation with EH&S is recommended at the early stage of proposal development to facilitate/help the researcher with these administrative processes.