Evaluating cannabis research programs: Barriers from federal, state, and other external sources.

  • May 14, 2024

Cannabis research programs are an important factor in determining efficacy as a therapeutic, as well as optimizing factors like crop yield, pest management, and agricultural biotechnology. Despite the benefits of these programs, barriers exist that make evaluating such research difficult. The most limiting factors include federal scheduling, state regulations, methodological challenges, and a dearth of peer-reviewed published data.

Federal Scheduling

While research has indicated that cannabis is suitable for therapeutic purposes, non-addictive (compared to synthetic pharmaceutical treatments for pain relief), and impossible to overdose on, updates have not been made at a federal level to remove it from the Schedule I substance list. This creates a permanent loop in which insufficient scholarly, peer-reviewed literature exists to overturn these laws, yet the laws make large-scale federally funded research impossible. Since cannabis is technically still on the Schedule I list, federal funds can not be used to study it, and researchers must obtain licenses and permits to handle it. The bureaucratic complexities of this process often present a barrier to researchers and evaluators alike. The few researchers and evaluators who are able and willing to obtain such permits must then contend with the stigma involved in being associated with such research. In an academic community, analyzing aspects related to Schedule I substances can undermine the researcher’s credibility among peers, limiting their career trajectory.

State cannabis regulations

States do have the ability to determine if they recognize cannabis as legal or illegal, with other states choosing total ambiguity on the matter and declaring it “decriminalized”. This means that researchers in different states have different allowability to conduct their research. This leads to a high degree of variability and a low degree of repeatability. As anyone familiar with research and evaluation knows, repeatability is key to proving validity in research. Being confined to one state means any human subjects will all be residents of the same state, and potentially, all strains of cannabis will have been grown in the same state, too. Enter confounding variables. Is it a compound in the cannabis causing reaction “x”, or is the soil/water/air quality/resiliency of the local population causing the effect? Without being able to repeat the experiment many other times, in multiple other locations, with additional and inhomogeneous cohorts of participants, one can never be sure. An additional consideration is state funding. With a limited pool of resources, states will likely fund existing programs that solve large-scale problems already in effect before funding high-risk exploratory research.

Methodological barriers due to the nature of cannabis

Since cannabis is a complex plant with many different strains, over 550 chemical compounds and over 100 phytocannabinoids, it can be difficult to properly evaluate sweeping generalizations about treatment for specific conditions and why and how they work. Patient characteristics, the condition itself, the type of cannabis used, how it is administered, and the concentration of each phytocannabinoid can all influence outcomes. To add to the confusion, many of the conditions that cannabis is a prime treatment candidate for are rooted in symptoms that patients express as purely subjective – chronic pain, depression, and anxiety, to name a few. As there is no universal, objective scale to measure sensations like pain, sadness, and panic, the results found in any therapeutic to treat these symptoms are purely subjective and evade traditional evaluation methods. The only methodology appropriate to evaluate such improvements would be patient self-reporting through qualitative feedback assessments, and the last time an attitudinal survey led to FDA clearance was…never.

Scarcity in published data

The very first step in any solid research plan starts with a literature review. Long before approaching funders, planning the experiment, determining the methodology, and selecting an evaluator, researchers scour the web to find every peer-reviewed material relating to the subject published within the last five years. Ideally, these publications will include validated data to use as a springboard, proving the initial feasibility of the idea and paving the way for more in-depth and high-risk research on the subject. This means that all cannabis researchers are essentially starting from baseline with no published data proving initial feasibility. Data is insufficient to prove to the scientific community that cannabis has no long-term effects or to identify and quantify specific potential risks to protect human subjects properly. This leads to mandates for stricter research protocols (lower doses, smaller, less diverse cohorts, etc.) and, in many cases, a reluctance or refusal to approve such studies in humans by either an IRB or a funding agency.

Despite these challenges, dedicated researchers and evaluators are still finding ways to perform and validate this pivotal research, often resorting to such extremes as self-funding their studies. Thanks to these brave folks, there is a growing body of research on the potential benefits and risks of cannabis for medical use. This research can help treat illnesses and pave the way for future researchers to discover more about this fascinating medicinal plant.

For anyone involved in such research, E.B. Howard Consulting has experience as an external independent evaluator for cannabis-related projects and would love to chat with you about how we can help.

We work with high-growth startups and organizations that support the startup and innovation ecosystem. We build highly specific non-dilutive funding menus, provide proposal preparation services, and measure outcomes of funding through evaluation. Schedule a consult call with us HERE.