Research Involving Cannabis and Cannabis Related or Derived Materials

Research

Research Involving Cannabis and Cannabis Related or Derived Materials

 

Guidance Regarding Research Involving Cannabis and Cannabis Related or Derived Materials

The University of Colorado Colorado Springs (UCCS) is committed to complying with all applicable laws in performing any research or work with cannabis or cannabis-related or derived materials.

Cannabis research at UCCS that involves industrial hemp or marijuana is guided by a March 11, 2014 memorandum from CU President Bruce Benson . In brief, President Benson's memorandum states that cannabis-related research must conform with federal and state laws as well as University of Colorado policies.

 

Definitions

  • Industrial Hemp: under Colorado law, "a plant of the genus Cannabis and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration of no more than three-tenths of one percent (0.3%) on a dry weight basis (8 Colo. Code Regs. § 1203-23:1 ).

  • Viable Hemp Seed: the seed from which Industrial Hemp can be grown which has not been rendered non-viable and so is capable of germination.

  • Certified Hemp Seed: in Colorado, hemp seed may only be certified by the Colorado Department of Agriculture (CDA). Only certified, foundation, or registered categories of hemp seed may be labeled as 'certified' which is CDA Approved Certified seed if the seed is part of the Colorado Hemp seed certification program. Any seed variety labeled as 'certified' that is not part of the Colorado Hemp seed certification program will be considered misbranded and is a violation of the Colorado Seed Act . See also, Colorado Department of Agriculture Memorandum to Hemp Seed Purchasers dated 1/24/2017 .

  • Marijuana: a plant of the genus Cannabis and any part of the plant, whether growing or not, containing a delta-9 tetrahydrocannabinol (THC) concentration greater than three-tenths of one percent (0.3%) on a dry weight basis. See Colorado Department of Agriculture Industrial Hemp Quick Facts .

  • Marijuana Industry: a Direct Beneficial Owner of a Retail Marijuana Establishment or a Medical Marijuana Business as these terms are defined in Colorado Senate Bill 16-040; or a commercial grower, processor, distributor or seller of Marijuana.  

 

Research or Projects Involving Marijuana

If you have plans to work with marijuana, regardless of whether or not you are growing it, a plant of the genus cannabis, or any part of the plant, containing a tetrahydrocannabinol (THC) concentration of MORE THAN three-tenths of one percent (0.3%) on a dry weight basis, you must contact the Office of Sponsored Programs and Research Integrity (OSPRI) before the research/project starts. OSPRI will assist you in exploring how the Federal Controlled Substance Act (CSA) applies and determining whether you need approval from the Drug Enforcement Administration (DEA) via a Schedule 1 Registration.

Please note that DEA registration is not required for human observational studies, provided:

  1. the research does not involve handling or procuring the marijuana;
  2. the marijuana is not used on campus; and
  3. the marijuana is not consumed on campus.

Observational studies must obtain approval from the UCCS Institutional Review Broad.

A compliance control plan may be required to be in place for work of this nature. Work with OSPRI to explore the need for a control plan.  

 

Research or Projects Involving Industrial Hemp

If you plan to work with industrial hemp, defined above, as part of your work at UCCS, you must reach out to OSPRI before starting your research/project to explore adding your lab/research space to an OSPRI managed UCCS registration with the Colorado Department of Agriculture (CDA) Industrial Hemp Program . If your work involves other components of the cannabis plant, you must work with OSPRI to explore other compliance concerns.

Please note that work with industrial hemp that has not been registered with the CDA may be treated as marijuana under the CSA. It is important to work with OSPRI to register your work with industrial hemp in a timely manner to prevent any risk of you being in violation of the CSA.

The Federal Farm Bill  (see also, Agricultural Improvement Act of 2018, Pub. L. No. 115-334, Sec. 7605 ) allows institutions of higher education in Colorado to cultivate, as well as to conduct research on, industrial hemp grown under a registration permit from the Colorado Department of Agriculture's Industrial Hemp Pilot Program. Seeds or clones for growing industrial hemp must be obtained from CDA through OSPRI. For more information on registering with this program, contact Mike Sanderson (composp@uccs.edu) in the Office of Sponsored Programs and Research Integrity (OSPRI).

Research permitted under the Industrial Hemp Pilot Program ranges from basic scientific research on plant materials (e.g., genetic sequencing) to applied scientific research with animal models (with Institutional Animal Care and Use Committee (IACUC) approval). Permissible research does not include human clinical trials, as such research may require a researcher to submit an Investigational New Drug Application to the Food & Drug Administration and obtain the cannabis from Drug Enforcement Administration approved sources, among other requirements.

Researchers may also conduct research involving industrial hemp by obtaining the hemp, or derivatives thereof, from commercial entities. To conduct business with an industrial hemp entity or organization, the entity must:

  1. be registered with the Colorado Department of Agriculture's Industrial Hemp Program, or demonstrate they are exempt from required registration;
  2. have a federally insured bank account; and
  3. not work with the Marijuana Industry. For the purposes of this guidance, "Marijuana Industry" means a Direct Beneficial Owner of a Retail Marijuana Establishment or a Medical Marijuana Business as these terms are defined in Colorado Senate Bill 16-040; or a commercial grower, processor, distributor or seller of Marijuana.

If an industrial hemp business meets these criteria, UCCS may enter agreements to perform sponsored research and services, conduct collaborative research and development, and transfer materials pursuant to approved research, collaborative, or other agreements. Depending on what hemp material is at issue, researchers may need to document CDA seed registration certificates for vendors, seed labels, and other items relevant to the project. Please work with OSPRI to develop these agreements.

Please note that a compliance control plan may be required to be in place for work of this nature. Work with OSPRI to explore the need for a control plan.  

 

Resources