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 |