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. Author manuscript; available in PMC: 2018 Feb 1.
Published in final edited form as: J Pediatr Gastroenterol Nutr. 2017 Feb;64(2):265–271. doi: 10.1097/MPG.0000000000001393

Table 3.

University of Colorado School of Medicine guidelines for human subject research involving cannabis (marijuana) as of February 2016

For all studies:
 Cannot accept funding for research from cannabis industry
For observational studies:
 Can survey or evaluate subjects who are already using drug for medical or recreational
 purposes (e.g. can ask subject to come in for a blood draw 1 hour after taking drug)
 Should obtain federal Certificate of Confidentiality for the study
 Cannot subsidize the purchase of the cannabis products
 Cannot pay subjects to participate in the study
 Cannot bring to campus cannabis products to test level of cannabinoids (e.g. from grower or
 retailer)
 Cannot advise or prescribe to start taking the drug, or manage it in any way.
 Cannot dictate when the drug is to be given (e.g. specific times to enable pharmacokinetic
 studies)
 Cannot ask users to stop cannabis use to be eligible to participate in a study (e.g. no baseline
 studies)
 Cannot ask to stop using drug for a washout period
 Cannot have subjects smoke or ingest drug anywhere on campus prior to being interviewed
 or evaluated for research
 Cannot advise or prescribe to start taking the drug
 Cannot move people higher on waiting list for a certain product at the dispensary if they
 agree to participate in a study
For interventional studies (including animal studies):
 Must be conducted under an IND from the FDA
 Can only use cannabis purchased from NIDA or a cannabis-derived product that has an FDA
 record (FDA approved, or under IND)
 Must apply for a DEA Researcher registration
 Cannot add marijuana to clinical DEA license
 Must use specifically designed and dedicated locations for storage and administration of the
 drug
 Must post study on ClinicalTrials.gov posting as Applicable Clinical Trial. Study results need to
 be posted no later than 12 months after the final collection of the primary outcome data