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.

Regulations concerning research involving Marijuana, Hemp and Hemp-derived products are particularly complex. This website is designed to provide an overview of the particularly complex regulations and compliance. 

Please reach out to Michael Sanderson via email composp@uccs.edu for additional information or with questions.


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

There are currently only two ways to conduct approved marijuana research at UCCS:

  1. Human Observational
  • This is a type of correlational research in which researchers observe ongoing behavior without prescribing or randomizing participants to specific interventions.
  • Research subjects may use marijuana, but the researcher can not procure the marijuana, and the marijuana can not be used on the University campus.
  • To comply with the Drug Free Schools and Communities Act, Human Observational Marijuana Studies may not recruit CU students or employees as subjects.
  • Requires Institutional Review Board (IRB) approval. Please visit the UCCS IRB website for more information.

      2. Marijuana Research Under a DEA Schedule 1 License

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 Offices 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.

  • Researchers looking to do other marijuana research would need to apply for a Schedule 1 license through the DEA using Form 225. The application process takes a few months and will likely include an on-site inspection of the registered area.
  • As part of the application, each of the studies/projects covered by the application must be listed separately. If you are looking to conduct animal research, you must have prior IACUC approval and provide the protocol(s). Please note UCCS does not currently have an IACUC to review research of this nature. If you are looking to conduct human research, you must have prior IRB approval, an approved active Notice of Claimed Investigational Exemption for an IND, and provide the protocol(s). For all other types of research, you must provide the protocol(s). Please note currently the UCCS IRB is not able to review human subjects research involving an IND and FDA regulations. The complete DEA Pre-Application Checklist can be found here.
  • Researchers with a Schedule 1 License can only utilize marijuana products obtained from National Institute on Drug Abuse (NIDA) approved sources. 

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.

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 the CDA through OSPRI. For more information on registering with this program, contact Mike Sanderson (composp@uccs.edu) in the Offices 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.  


Cannabis Research FAQs

Visit our FAQs for common questions regarding research or work involving cannabis and cannabis-related and derived materials


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