Cannabis Research with Human Subjects?

By Jason Liu, second-year stu­dent at the Uni­ver­sity of Wash­ing­ton School of Law. 

Image used under Cre­ative Com­mons License.

Image used under Cre­ative Com­mons License.

As state-legal cannabis systems are developing, there is a growing interest in the research in cannabis. The Portland Tribune reported today that on Oregon creating a new task force (Senate Bill 844) to develop research frameworks for the study of cannabis.  The task force aims to lay the groundwork for state-backed medical marijuana research.  Other states have implemented similar frameworks.  However, because cannabis is listed as Schedule I under the Controlled Substances Act, the federal legal frameworks on cannabis provide researchers very limited opportunities to research cannabis.  The FDA noted that it “has not approved marijuana as a safe and effective drug,” however it “is aware there is considerable interest in its use to attempt to treat a number of medical conditions.”  With all of this interest, what is the proper regulatory pathway a researcher must take to research cannabis?

As “research” is broad, there are many ways cannabis can be researched (e.g., chemical analyses, genomic studies, animal studies).  In this post, we will review the U.S. Department of Health and Human Services’ (HHS) guidelines for research on human subjects.  Because HHS heavily regulates the research of human subjects, looking at HHS protocols is a good place to start.

Earlier this year, HHS stated in a Federal Register notice it was eliminating a controversial requirement for Public Health Service (PHS) to review non-federal research processes on cannabis.  Along with FDA and DEA approvals needed with cannabis, researchers also needed to go through a National Institute on Drug Abuse (NIDA) and PHS approval process as well.  Besides removing a barrier for researchers, the HHS provided a useful roadmap in the approval process for cannabis researchers.

The following is taken from the notice:

For non-NIH (National Institute of Health) funded human research projects:

  1. Demonstrate scientific validity and ethical soundness through review by the FDA’s IND process. Research protocols will undergo a scientific review which assures the safety and rights of subjects and the scientific quality of the clinical investigations, and assesses the likelihood that investigations will yield data capable of meeting the statutory standards for drug marketing approval; and
  1. Possess a DEA registration for marijuana, a Schedule I controlled substance under the CSA.

For NIH-funded projects:

  1. Demonstrate scientific validity and ethical soundness through the NIH grant review process which consists of three steps: (1) The NIH peer review system, which assesses the scientific and technical merit of all grant applications; (2) the National Advisory Council of the funding institute, comprising eminent scientists as well as public members; and (3) the funding institute’s Director, who makes the final funding decision on the merit of an application, based on peer review, public health significance, and institute priorities. To find studies approved through the NIH review process go to:http://projectreporter.nih.gov/reporter.cfm;
  1. Have an active-status IND application on file with the FDA (for human research only), which has been evaluated by FDA and found safe to proceed. For additional information go to:http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm; and
  1. Possess a DEA registration for marijuana, a Schedule I controlled substance under the CSA.

(Once the above steps have been completed for NIH funding, investigators should contact the NIDA Drug Supply Program to place an order for marijuana with specific characteristics with regard to concentrations of delta-9-tetrahydro-cannabinol (THC), cannabidiol (CBD), and other cannabinoids.)

Although still burdensome, the research hurdles are slowly getting streamlined to meet the need for more cannabis research.  The UW Cannabis Law & Policy Project will continue to monitor ongoing changes in these regulatory pathways as well.  For more information, complete guidance can be found on the NIH/National Institute on Drug Abuse (NIDA) Web site: (http://www.drugabuse.gov/researchers/research-resources/nida-drug-supply-program).

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