Federal Agencies Fund New Marijuana Research Center To Overcome Study Barriers Imposed By Prohibition

October 27, 2023 · marijuanamoment.net

The National Institutes of Health (NIH) is calling for the creation of a centralized marijuana research center that’s designed to help scientists overcome barriers to studying cannabis under federal prohibition.

In a notice of funding opportunity posted on Thursday, NIH said it’s looking for an eligible entity to operate a new Resource Center for Cannabis and Cannabinoid Research through a cooperative agreement in order to “address challenges and barriers to conducting research on cannabis and its constituents.”

The center should also “enable researchers to successfully generate more rigorous scientific evidence across a variety of research domains in both basic and clinical research,” the notice says.

“Ultimately, the Center may facilitate research advances through synergistic interactions among experts in relevant commercial, basic science, clinical, and regulatory areas both within the Center itself and in collaboration with other investigators possessing diverse expertise and research backgrounds,” NIH said.

Institutions that are invited to submit applications include universities, non-profit organizations, local and federal government agencies and more. Letters of intent are due by March 16, 2024, which is also when applications will begin to be accepted.

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 it 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

  • 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

  • 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

  • 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).

Interested parties should explain how they intend to meet those core goals, which involve establishing a “policy clearinghouse” for existing research guidance, organizing regular meetings with DEA and the Food and Drug Administration (FDA), developing best practices, disseminating relevant scientific literature on cannabis, standardizing research methodologies and administering seed funding to support research initiatives.

“Seed funds are intended to support non-research regulatory activities to reduce barriers to conduct future research projects within the field, in line with the stated interests of the NIH partner ICs. Regulatory requirements often impede the progress of research proposal development,” the agency said. “Seed funds, therefore, provided by the Research Support Core, must serve to reduce barriers to research within the field.”

“The Resource Center must provide a formal plan to solicit, review, and select/prioritize requests for seed funding, and to evaluate progress and outcomes, in line with the RFA priorities. Applicants must describe the type and focus of potential seed funding projects that would be solicited; however, descriptions of actual projects should not be included in the application. Researchers associated with the Resource Center itself may be considered for seed funding, but priority should be given to researchers from a broader range of locations and institutions.”

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 the National Center for Complementary and Integrative Health (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 new notice references a request for information that NCCIH put out last year on challenges facing researchers who want to study marijuana. The responses, NIH said, “identified barriers that included Schedule 1 Status designation for cannabis, challenges in obtaining and maintaining [DEA] registrations, issues related to Investigational New Drug (IND) applications, limited and inconsistently documented studies, lack of validated measures, the increasing diversity of cannabis products, and lack of medical education on cannabis for health care providers.”

NIH said the success of the new project “will be facilitated by the adoption of clear, quantitative milestones with realistic and efficient timelines,” NIH said in the latest notice. “Applications must include proposed milestones for each year of requested support, which will be evaluated as part of the review process. The milestones and timeline should include the timing and quantity of dissemination of the resource to the cannabis research community.”

The announcement comes months after a National Advisory Council for Complementary and Integrative Health (NACCIH) meeting, where members approved the concept for the center, 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.” (Full Story)

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