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Request for Information (RFI): Investigators’ Interests in and Barriers to Research Studies on the Health Effects of Cannabis and its Constituents

The purpose of this Request for Information (RFI) is to solicit information from the scientific research community about its interest in and barriers to research on the health effects of cannabis and its constituents. (Published as NOT-AT-22-026)

Background

Cannabis has been used medicinally for over 3,000 years. Recently, there has been growing interest from health care providers and the public in the potential medicinal properties of cannabis-related products. The U.S. Food and Drug Administration (FDA) has approved several natural and synthetic cannabinoids (dronabinol, nabilone, and Epidiolex) for treatment of specific health conditions. Additionally, 37 states and the District of Columbia have legalized cannabis use for broad medical purposes, beyond those approved by the FDA, with often inadequate scientific research to support the benefit of their intended use. As a result, there is a need to strengthen the scientific evidence underlying the clinical impact and potential harms of cannabis products for specific diseases and conditions.

The National Institutes of Health (NIH) supports rigorous investigator-initiated research on many potential therapeutic uses of cannabis and cannabis-related compounds, but there is a need to expand the number of studies and strengthen the scientific evidence related to the clinical uses of cannabis products. Some researchers have reported barriers that hinder an expansion of research. These barriers include lack of necessary experience and/or information regarding Federal/state regulatory requirements needed to conduct research on cannabis products; unforeseen costs and effort related to obtaining such Federal/state licensure; availability of and access to appropriate cannabis and cannabis products/constituents; lack of validated measures of cannabis use and exposure; and inadequate scientific infrastructure to support research studies. NIH is seeking to better understand these issues and potentially develop strategies to overcome them. To that end, NIH seeks input from the research community regarding these and additional barriers, scientific interests, and needs related to therapeutic cannabis or cannabinoid research.

Information Requested

NIH is interested in gathering information about barriers, scientific interests, and needs associated with therapeutic cannabis or cannabinoid research from investigators conducting or interested in conducting research on cannabis, cannabinoid phytochemical constituents, and related compounds (synthetic compounds, terpenes, etc.). Such information will be useful to NIH as it seeks to address the research infrastructure needs and identify areas of interest within this field. Interested individuals are requested to provide responses to any of the following topics, as well as any additional ideas not included below:

  1. Cannabinoid/cannabis-related research topics of interest/importance
  2. Existing and desirable scientific infrastructure and capacity to conduct cannabinoid/cannabis-related research
  3. Barriers to initiating and conducting cannabinoid/cannabis-related research including but not limited to the Schedule I license process
  4. NIH-coordinated activities that could help expand the field of therapeutic cannabinoid/cannabis-related research
  5. Methods, tools, or resources needed to increase cannabinoid/cannabis-related research, particularly:
    • Strengthening the cannabinoid/cannabis research community
    • Guidance and assistance on regulatory requirements
    • Funding for regulatory compliance activities
    • Research reagents such as marijuana varieties, strains, constituent chemotypes, or specific cannabinoids
    • Standard, validated measures of use/exposure and recommended research procedures
    • Information sharing
  6. Access to cannabis-related information (i.e., regulatory, clinical, scientific)

How To Submit a Response

Responses will be accepted until October 15, 2022. Please provide any feedback to this RFI through this webform (nccih.nih.gov/research/respond-to-request-for-information-investigators-interests-in-and-barriers-to-research-studies-on-the-health-effects-of-cannabis-and-its-constituents). Responses are voluntary and may be submitted anonymously.

Note: This RFI is for planning purposes only and should not be construed as a solicitation for applications or an obligation on the part of the Government. The Government will not pay for the preparation of any information submitted or for the Government’s use of that information. Responses are voluntary and may be submitted anonymously.

NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder’s submission. However, responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed and may be shared publicly or appear in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any nonproprietary technical information in any resultant solicitation(s).

Participating NIH Institutes and Centers

National Center for Complementary and Integrative Health (NCCIH

National Eye Institute (NEI

National Heart, Lung, and Blood Institute (NHLBI

National Institute on Aging (NIA) `

National Institute on Alcohol Abuse and Alcoholism (NIAAA

National Institute of Dental and Craniofacial Research (NIDCR

National Institute on Drug Abuse (NIDA

National Cancer Institute (NCI

Inquiries About the Cannabis RFI

Inquiries concerning this notice may be directed to cannabisRFI@nih.gov