A top federal health agency says it recognizes that there are ample concerns among scientists about how they’ve “encountered barriers that have hampered their research” into marijuana under federal prohibition, including “complex” federal regulations and inadequate supplies of cannabis.
That’s why the National Institutes of Health (NIH) is now seeking to resolve some of those challenges by standing up a Resource Center for Cannabis and Cannabinoid Research, an official said in a blog post on Tuesday.
NIH posted a notice of funding opportunity late last month, explaining how it’s seeking an entity to operate the center through a cooperative agreement in order to “address challenges and barriers to conducting research on cannabis and its constituents.”
To help facilitate that process, the National Center for Complementary and Integrative Health’s (NCCIH) Patrick Still announced that the health agency will be holding a webinar on January 25 to provide potential applicants with technical assistance.
“There’s growing interest in potential therapeutic uses of cannabis and its constituents among both health care providers and the public,” Still, who is a program director for NCCIH’s Basic and Mechanistic Research branch, wrote. “Substances in cannabis have a variety of pharmacologic effects, and rigorous research is needed to understand their mechanisms of action and investigate their possible value in helping to manage health conditions.”
“However, investigators working in this field have encountered barriers that have hampered their research,” he said, pointing to feedback NCCIH received as part of a request for information last year.
“The barriers that many of them have mentioned include difficulty meeting complex federal and state regulatory requirements, problems obtaining cannabis products suitable for research, a lack of validated measures of cannabis use and exposure, and inadequate scientific infrastructure to support research studies,” Still wrote.
To help account for those issues, he said that the forthcoming center is “expected to be a focal point for investigators who are studying cannabis or cannabinoids or who are interested in entering this research space.”
Institutions that are invited to submit applications to operate the center include universities, non-profit organizations, local and federal government agencies and more. Letters of intent are due by March 16, which is also when applications will begin to be accepted.
In the interim, NCCIH said it will be holding a webinar in January to “discuss the funding opportunity and answer questions.”
“Participating in the webinar is not a requirement for submitting an application, but it’s a great way to get details about this unique project from NIH program and review staff,” Still said.
Addressing marijuana research barriers has been a key priority for multiple federal health agencies as scientists continue to face an onerous and costly registration process in order to access cannabis due to its current status as a Schedule I drug under the Controlled Substances Act (CSA).
The center won’t be able to independently change that policy, which is actively under review by the Drug Enforcement Administration (DEA) following a U.S. Department of Health and Human Services (HHS) recommendation to move cannabis to Schedule III. But NIH offered some examples of how it plans to have the center lessen the burdens.
For instance, it could assist with DEA Schedule I research registration costs and “other relevant federal regulatory requirements.” It could also address equipment and material needs for storage and monitoring purposes.
NIH outlined three “core components” of the center’s objectives: regulatory guidance, research standards and research support.
Regulatory Guidance Core
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- Establish a policy clearinghouse to consolidate and link to existing DEA/FDA guidance.
- Organize regular meetings with DEA/FDA to receive updates regarding regulatory information relevant to researchers.
- Provide summaries and updates on policy changes to a centralized Center webpage on policy changes related to the regulatory environment surrounding cannabis research for the extramural community.
Research Standards Core
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- Identify and disseminate information on high-quality cannabis research products and provide guidance on matching specific cannabis product vendors to the research objectives of investigators utilizing the Center.
- Develop research standards and metrics to enhance the rigor of chemical analysis of complex cannabis products to improve the reproducibility of research.
- Build a repository of best practices (e.g., reagents, standards, survey measures, data elements, and analytical methods), including the 5 mg tetrahydrocannabinol (THC) standard unit for measuring and reporting research results (NOT-DA-21-049).
Research Support Core
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- Organize annual meetings (e.g., annual investigator meetings).
- Use social media to transmit scientific information.
- Organize and convene webinar series on topics that reflect Center core activities in regulatory guidance, research standards, and research support.
- Organize and convene both virtual and hands-on events such as workshops at meetings, summer institutes, and grant writing assistance and workshops.
- Identify and disseminate early career NIH reviewer opportunities.
- Administer seed funding for registration support and proposal development (see seed funding description below and Section IV.
- Application and Submission Information, R&R Budget and R&R Subaward Budget sections, for more information).
Regardless of how many awards are granted, seed funding will be capped at $50,000 per year for each project.
Several agencies under NIH will play supportive roles in the center’s work. They are NCCIH, National Institute on Drug Abuse (NIDA), National Institute on Aging (NIA) and National Cancer Institute (NCI).
NCCIH will provide $1 million in total costs in fiscal year 2025 to fund the center. NIDA and NIA will each contribute $100,000 in co-funding, while NCI will provide $200,000 in co-funding. Separately, NCI recently awarded researchers $3.2 million to study the effects of using cannabis while receiving immunotherapy for cancer treatment.
The announcement about the center came months after a National Advisory Council for Complementary and Integrative Health (NACCIH) meeting, where members approved the concept for the institute, which is “expected to be a focal point for researchers entering the cannabis research space and to support the development and establishment of research tools and studies that will improve upon and eventually change the landscape of cannabis research.”
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