The top federal agency for health says that it is aware that scientists have “encountered obstacles that have hindered their research” on marijuana under federal prohibition. These include “complex” regulations from the federal government and insufficient supplies of cannabis.
In a Tuesday blog post, an official explained that the National Institutes of Health is trying to solve some of these challenges by establishing a Resource Center for Cannabis and Cannabinoid Research.
The NIH published a funding opportunity notice late last month. It explained that it is looking for an entity to run the center under a cooperative agreement to “address barriers and challenges to conducting research on marijuana and its constituents.”
Patrick Still, from the National Center for Complementary and Integrative Health (NCCIH), announced that the agency would be hosting a webinar to offer technical assistance to potential applicants on the 25th of January.
Still, who is the program director of NCCIH’s Basic and Mechanistic Research Branch, wrote that there was a growing interest among health care providers and members of the public in possible therapeutic uses for cannabis and its constituents. “Substances found in cannabis can have different pharmacological effects. Research is required to investigate these mechanisms and their potential value in managing health conditions.”
“However, researchers working in this area have encountered barriers which have hampered research,” he stated, pointing out feedback NCCIH had received last year as part of an information request.
“The barriers they have mentioned include the difficulty in meeting complex federal and/or state regulatory requirements, difficulties obtaining cannabis products that are suitable for research purposes, a lack validated measures of marijuana use and exposure and an inadequate scientific infrastructure supporting research studies,” wrote Still.
He said the center would “be a focal point” for researchers who study cannabis or cannabinoids, or are interested in this research area.
Universities, non-profit groups, local and federal governments agencies, and others are all invited to apply to run the center. The deadline for submitting letters of intent is March 16th, which coincides with the start date of accepting applications.
NCCIH has announced that it will hold a webinar on January 15th to “discuss funding opportunities and answer questions.”
Still stated that “participation in the webinar was not a prerequisite for submitting a grant application but it is a great opportunity to learn more about this unique project directly from NIH staff who are involved with program review and evaluation.”
Multiple federal agencies have made removing marijuana research barriers a priority. Scientists continue to be faced with an expensive and onerous registration process to gain access to cannabis, due to the current Schedule I status of the Controlled Substances Act.
The Drug Enforcement Administration (DEA), following a U.S. recommendation, is currently reviewing this policy. The Department of Health and Human Services’ (HHS) recommendation that cannabis be moved to Schedule III. But NIH gave some examples on how it intends to make the center more burden-free.
The program could help with DEA Schedule I registration costs, as well as “other federal regulatory requirements”. It could also assist in addressing equipment and materials needed for storage and monitoring.
The NIH outlined the three “core components” that will be at the core of its objectives: research standards, regulatory guidance and support for research.
Core Regulatory Guidance
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- Create a policy clearinghouse that will consolidate existing DEA/FDA guidelines and provide links to them.
- Organise regular meetings with DEA/FDA in order to get updates on regulatory information that is relevant to researchers.
- Summaries and updates of policy changes will be provided to a central Center webpage regarding policy changes relating to the regulatory framework surrounding cannabis research.
Research Standards core
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- Provide guidance to investigators using the Center on how to match specific cannabis product vendors with their research objectives.
- Research standards and metrics are needed to increase the accuracy of the chemical analysis of cannabis products. This will improve the reproducibility.
- Create a repository for best practices, including the 5 mg tetrahydrocannabinol standard unit (THC), which is used to measure and report research results.
Core Research Support
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- Organise annual meetings, e.g. annual investigator meetings.
- Use social media for the dissemination of scientific information.
- Organise and convene a webinar series that reflects the core activities of the Center in terms of regulatory guidance, standards for research, and support for research.
- Organise and convene virtual and hands-on activities such as workshops during meetings, summer institutes and grant writing workshops and assistance.
- Identifying and disseminating opportunities for early career NIH Reviewers.
- Apply for seed funding to support registration and the development of proposals (see description of seed funding below and Section IV).
- For more information, please see the sections on Budgets and Subawards, Budgets and Applications, and Budgets and Submissions.
No matter how many awards you receive, the maximum seed funding per project will be $50,000.
NIH agencies will support the work of the center. NCCIH is comprised of the National Institute on Drug Abuse, National Institute on Aging, and National Cancer Institute.
NCCIH will fund the Center with $1 million total in the fiscal year 2025. NIDA, NIA and NCI each will contribute $100,000 as co-funding. NCI awarded $3.2 million in funding to researchers for a study on effects of cannabis use while receiving immunotherapy chemotherapy.
The announcement came after a meeting of the National Advisory Council for Complementary and Integrative Health, in which members approved the concept for an institute that “is expected to be a focus for researchers entering cannabis research and to support development and establishment research tools and studies, improving upon and ultimately changing the landscape of cannabis science.”
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