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Cannabis Research

Cannabis Research at UC Merced

Background

Proposition 64 enacted in California on November 8, 2016 allows for the use, cultivation, and sale/distribution of marijuana for non-medical purposes among people over the age of 21. However, federal law categorizes marijuana as a Schedule I drug with “no currently accepted medical use” in the United States. There is no federal provision for the legal use of marijuana at UC except as established and in compliance with the Drug Enforcement Administration (DEA), Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA) policies and regulations. Specifically, research involving the possession and use of marijuana by researchers is allowable if the researcher has obtained a DEA Schedule I registration and follows all applicable DEA regulations and guidelines as well as applicable regulations of the FDA.  Marijuana remains prohibited on all University property and at all University events, except for as used in approved academic research.

Research with Hemp

Research with Hemp and Hemp products are allowed under the following parameters:

  • Hemp and hemp derivatives do not contain more than 0.3% concentration of THC, verified by documented laboratory analysis
  • The supplier of any hemp materials must : 1) be working in a state that has received USDA approval for its state regulatory plan and is operating in compliance with that plan, 2)  obtained a  license from hemp production directly from the USDA if the supplier is operating in a state that has opted not to seek USDA approval for hemp production, or 3) be part of a State Dept of Agriculture Pilot Program or University authorized to grow Hemp (this provision will expire in October 31, 2020).
  • Any International Suppliers must comply with USDA regulations.
  • The FDA will require an Investigational New Drug (IND) application for use of hemp products in human subjects prior to conducting a clinical study.

Research with Marijuana:

  • “Marijuana” is currently defined by federal regulations as any part of the Cannabis sativa L. plant. This definition includes any extracts or derivatives of the Cannabis sativa L. plant.
  • Research with marijuana or its extracts or derivatives will require a Schedule 1 registration from the DEA. To begin this process please contact Karen Smith, Chemical Hygiene Officer, Environmental Health and Safety, at ksmith23@ucmerced.edu.
  • The supplier of any marijuana products for research must be approved by the DEA. Currently the only approved supplier for marijuana for research is the University of Mississippi operating under a contract with NIDA.
  • Under CA state law all research using any Schedule 1 drug must be reviewed and approved by the CA Research Advisory Panel prior to initiation.
  • The FDA will require an Investigational New Drug (IND) application for use of marijuana drugs in human subjects prior to conducting a clinical study.
  • Additionally, all research with marijuana will have to go through campus compliance committee
  • review if using human (IRB) or animal (IACUC) subjects.

Research focusing on cannabidiol (CBD) from marijuana or hemp

As defined in the federal Controlled Substances Act (CSA), the term marijuana 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.” This definition does not include the mature stalks of such plant, fiber produced from such stalks, oil, or cake made from the seeds of such plant. Given the CSA definition of marijuana, research or any other activity involving the direct use of marijuana extracts, including CBD derived from marijuana, must be conducted under a DEA Schedule I registration.

Research using CBD derived from hemp no longer requires a DEA Schedule I registration. However, research involving human or animal subjects remain subject to FDA requirements. Specifically, the 2018 Farm Bill preserved FDA’s authority to regulate products containing cannabis and cannabis-derived products, including CBD that is derived from hemp. This means that the FDA continues to regulate cannabis, including hemp-derived CBD, as a drug that requires FDA authorization. In addition, it is still illegal to introduce food containing added CBD or THC into interstate commerce or to market such products as or in dietary supplements. Therefore, researchers conducting clinical trials involving the use of hemp products for human use, including products containing hemp-derived CBD, must submit an investigational new drug application (IND) to the FDA prior to conducting the clinical study. This is in addition to meeting the usual requisite approvals for research, including IRB approval for human subject research.

Research that doesn’t require the need to obtain a DEA Schedule I registration

Research that does not involve the cultivation, distribution, possession, or direct use of marijuana can be conducted without the need to obtain a DEA Schedule I registration. Specifically, are types of research are acceptable, although all normal approvals for research must be obtained, including those for the use of human and animal participants:

  1. Surveys of individuals already using marijuana for recreational or medical purposes.
  2. Environmental impact studies on the impact of marijuana cultivation on the environment.
  3. Research on the socioeconomic effects of marijuana cultivation, sale, or use.
  4. Research on policy and legislative issues concerning marijuana.
  5. Establishing websites or publishing newsletters through which results of the above-referenced research or other information on marijuana may be disseminated.
  6. Conducting conferences, seminars, or informal meetings intended to provide objective information to UCLA staff and the public on various marijuana-related issues.

Funding or other support from the marijuana industry

While California law allows certain commercial cannabis activities conducted in accordance with state regulations, the cultivation, sale, distribution, use, and marketing of marijuana is still prohibited under federal law. Therefore, accepting financial support from members of the marijuana industry creates risks for the University and raises potential concern over compliance with applicable money laundering laws. This applies to the solicitation of donations as well as to applications for financial support in the form of contracts or grants.

In accordance with UC RPAC Guidance Memo 19-02 (see below), UC campuses may not accept donations from entities or individuals known to derive most or all of their funding from marijuana-related activities. Research support from individuals or entities indirectly connected to the marijuana industry or from entities that provide services or products supporting the marijuana industry must be evaluated individually as there are considerations of potential risk and optics. 

UC Merced is the home of the Nicotine and Cannabis Policy Research Center (NCPC) The NCPC is funded by a $3.8 million grant from the Tobacco-Related Disease Research Program (TRDRP), and is the first center to be funded by this program. Led by Dr. Anna Song, NCPC will conduct research that enhances our understanding of tobacco & cannabis use, prevention and cessation, the social, economic and policy-related aspects of tobacco and cannabis use, along with related diseases in central California. All research will be conducted across 11 counties within the San Joaquin Valley (SJV) and Sierra Foothills and in collaboration and partnership with the local communities (including organizations like the American Heart Association, Healthy House, and the California Health Collaborative), with the aim of focusing on issues such as smoking bans, smokeless tobacco, e-cigarettes, vaping, and marijuana use. NCPC’s main mission is to provide empirical data to help support communities and policy makers as they develop tobacco and cannabis policies. NCPC is also engaged in capacity building to help support local advocates in tobacco and cannabis control efforts, particularly programs that are geared towards youth and ethnic communities. NCPC represents an extensive range of collaborations spanning different Californian universities, research disciplines, and community organizations at the national, state and local level and is one of the only centers focused on tobacco and cannabis issues among rural minority populations.

Website link below:

https://ncpc.ucmerced.edu/

For questions on Cannabis research:

Any UCM researcher who wishes to pursue research that involves marijuana research or industrial hemp, or whose research is sponsored by the marijuana industry should, prior to commencement of any such research, consult with the Office of Research and Economic Development. Please contact cannabisresearch@ucmerced.edu.

Guidance and Policies

UC Guidance Memo 19-02: Pilot Approach when Considering Funding from the Marijuana Industry

UC Guidance Memo 18-01: Updated Information for Researchers on Conducting Marijuana Research at the University of California

Federal Controlled Substances Act

BUS 50: University's Policy on Controlled Substances

UC guidance on use and possession of marijuana on UC property