The National Institutes of Health is calling for a centralized marijuana-research center to help scientists overcome the barriers that prevent them from studying cannabis due to federal prohibition.
The NIH posted a funding opportunity on Thursday. It is looking for a qualified entity to run a new Resource Center for Cannabis and Cannabinoid Research under a cooperative agreement. This will “address the challenges and barriers in conducting research on marijuana and its constituents.”
The notice states that the center will “enable researchers in basic and clinical research to generate more rigorous scientific proof across a wide range of research domains.”
Resource Center for Cannabis and Cannabinoid Research (U24 Clinical Trial Not Allowed) https://t.co/MyuLwqax0b
October 26, 2020 — NIH funding (@NIHFunding).
NIH stated that “ultimately, the Center will facilitate research advancements through synergistic interaction among experts in commercial, basic science and clinical areas, as well as in collaboration with investigators who possess diverse expertise and backgrounds.”
Universities, non-profits, and local and federal government agencies are all eligible to apply. The deadline for letters of intent is March 16, 2024. This will also be the date when applications begin to accept.
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 this drug under 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 it be moved to Schedule III. NIH has provided some examples on how the center will be able to lessen its burdens.
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 the center’s goals: research standards, regulatory guidance and research support.
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 for extramural researchers.
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 chemical analyses of complex cannabis products. This will improve reproducibility.
- Create a repository for best practices, including a standard unit of 5 mg tetrahydrocannabinol THC (THC), which can be 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.
- Identifying and distributing opportunities for early career NIH Reviewers.
- Use seed funding to support registration and 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.
Interested parties must explain how they plan to achieve these core goals. These include establishing a “policy clearinghouse” for existing research guidelines, organizing regular meetings between DEA and Food and Drug Administration, developing best practices, distributing relevant scientific literature about cannabis, standardizing the research methodology, and administering seed funds to support research initiatives.
Seed funds are designed to support non-research activities that reduce barriers for future research in the field. This is in accordance with the stated interest of NIH partner ICs. The agency stated that regulatory requirements can often hinder the development of research proposals. The Research Support Core must provide seed funds to help reduce the barriers to research in the field.
The Resource Center is required to provide a plan that outlines how it will solicit, review and prioritize requests for seed funds, as well as evaluate the progress and results in accordance with RFA priorities. The applicants must provide a description of the potential projects for seed funding that will be requested. However, actual project descriptions should not be included. Researchers affiliated with the Resource Center may be eligible for seed funding. However, priority should be given researchers from a wider range of institutions and locations.”
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. The National Center for Complementary and Integrative Health, National Institute on Drug Abuse, National Institute on Aging and National Cancer Institute will all play a supportive role in the center’s work.
NCCIH will fund the Center with $1 million total in 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 notice refers to a request NCCIH made last year for information on barriers facing researchers who wish to study marijuana. The responses were cited by NIH as identifying barriers such as Schedule 1 Status for cannabis, difficulties in obtaining [DEA] registrations and issues with Investigational New Drug (IND), limited and inconsistently documented research, lack of validated measurements, increasing diversity of cannabis-based products and a lack of medical education for healthcare providers.
In the most recent notice, NIH stated that the success of a new project will be facilitated “by the adoption of clear and quantitative milestones along with realistic timelines.” The application must include milestones that will be assessed as part of the review. The timeline and milestones should also include the quantity and timing of the dissemination of the resource within the cannabis research community.
The announcement follows a meeting of the National Advisory Council for Complementary and Integrative Health where the members approved the idea for the centre, which “is expected to be a focus for researchers entering cannabis research and to support development and establishment research tools and studies, that will eventually improve and change the landscape for cannabis research.”
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