Research in the cannabis industry is vital and should not be undervalued. Cannabis research is a systematic investigation into cannabis in order to establish facts as well as to reach new conclusions. Researchers have to follow predetermined procedures and they have to remain as objective as humanly positive. But how does it work? Who or what agencies fund the research? Is there any bias that could potentially sway the results?
With the increase in legalization, use, and acceptance of the plants, our understanding of the plant needs to increase too. The increase in legalization has meant that the research can become more progressive as skilled professionals and resources become more available for the understanding of this plant. There is still much that we don’t know, yet there is so much that we do know.
How Does It All Work?
Research that involves the direct use or possession of cannabis in any form can be conducted if the researcher:
- Has received approval from the research advisory panel of the Attorney General’s office, especially since cannabis is still a schedule 1 drug under federal law.
- Has an approved Schedule I Researcher registration to conduct the research and follows all applicable DEA regulations and guidelines, including those pertaining to storage and disposal.
- Submitted an investigational new drug (IND) application to the FDA (if there are human research participants involved).
- Obtains research-grade marijuana from a DEA-approved source.
- In addition, any research involving humans or animals must go through the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) respectively.
The Process for Clinical Trial Research:
Please note that this process is based on cannabis containing hemp with no more than 0.3% THC on the dry weight basis.
- The sponsor needs to obtain a pre-IND* number through CDER** review division to request a pre-IND meeting.
- The sponsor needs to provide all the applicable chemistry, manufacturing and controls (CMC) as well as the botanical raw material (BRM) information in the IND review.
- The sponsor must obtain a letter of authorization (LOA) to reference CMC and BRM information. The submission needs to contain all the necessary data for their study drug (cannabis) and they need to ensure that safe for use in humans.
- The sponsor sends a copy of the IND and clinical protocol, including the LOA, to the FDA.
- The FDA reviews the submitted IND. The sponsor will then have to wait 30 days following the IND submission before initiating any clinical trials unless the FDA notifies the sponsor that the trials may begin sooner.
*IND =Investigational new drug
**CDER= Centre for Drug Evaluation and Research
Broad Research Protocol:
- Documentation to be in place for standardization and to ensure you comply with authority rules and regulations.
- Investigators brochure describing previous experience with experimental intervention.
- Operations manual providing details on the actual procedures needed to perform.
- Standard operating procedures which detail how the actual procedures will be carried out.
- Protocol that provides a plan for the essential aspects of the proposed research and it must be approved before it begins. The protocol must answer: why its’ being done, what the aim of the study is and what will be done, where the study will be done, who is involved in the study and when the interventions will take place.
How Much Money Goes Into It?
The NIH report displayed the following statistics for the years 2014, 2015, 2016 and 2017.
Which Agencies Provide Funding?
We could never compile a list of ALL the agencies and individuals who have funded or contributed to funding cannabis research. Below are some examples of those who do.
- The National Centre for Complementary and Integrative Health (NCCIH), which is part of the National Institute of Health (NIH)
- The National Institute of Drug Abuse (NIDA)
- The Arcview Group
- Benchmark Capital
- Peter Thiel, co-founder of PayPal
- Alcoholic Beverage Companies such as Molson Coors Brewing Co. and Heineken
- Pharmaceutical Companies such as Epidiolex and GW Pharmaceuticals
- Tobacco companies such as Altria Group Inc. and Imperial Brands.
Do Agencies Have Agendas That Could Sway Results?
Although one can make a fairly certain assumption on the agenda behind the funding party, we can never be certain as to whether it will sway results due to ethics and obligation. Researchers are obligated to remain ethical and thus remain objective in their findings. Results that are biased in any manner are considered unethical research and should then also be dismissed…which isn’t always the case anyway.