CENTER FOR MEDICINAL CANNABIS RESEARCH

INSTRUCTIONS FOR PROPOSAL SUBMISSION
SUMMER 2006

Investigators who have potential interest in conducting clinical trials involving medicinal cannabis should first consult the various components of CMCR website. Read about the background of the Center, as well as the Institute of Medicine/National Academy of Sciences report and the report of the expert panel to the National Institutes of Health. Both reports contain reviews of relevant literature for investigators to consult prior to developing an application.

Applicants are encouraged to submit a letter of intent and/or a brief one or two page concept statement or study schema outlining the objectives, rationale, study design and a brief description by May 1, 2006. The concept sheet can be faxed to the CMCR Project Manager at 619-543-5073 or sent via e-mail to bgouaux@ucsd.edu.

The elements for proposal submission are modified from the Public Health Service grant application developed for NIH submissions (PHS 398). The main difference will be that the research plan should not exceed twelve pages.

Electronic application forms are available on the CMCR website (www.cmcr.ucsd.edu). The components of the proposal packet include:

  1. Face Page.
  2. Abstract - not to exceed 300 words - summarizing the objectives, rationale, and approach within the application.
  3. Table of Contents.
  4. Budget Pages - - including a detailed first year budget and budgets for second and third year (if needed). The CMCR is not using “modular” grant format. Detailed budgets and budget justifications are required. NOTE: Projects are funded one year at a time for a maximum of two years, subject to the availability of funds.
  5. Biographical Sketch (NIH format).
  6. Other Support (NIH format).
  7. Resources.
  8. Checklist.
  9. Personal Data Form.
  10. Research Plan - total narrative, (excluding human subjects statement) should not exceed 12 pages and the format should be as follows: (a) Objective, (b) Hypotheses or Research Questions, (c) Background, (d) Preliminary Studies (if any), (e) Methods (include here the design of the experiment, types of human or animal subjects, specific procedures, project timeline, discussion of statistical power, statistical analysis), (f) Description of delivery system and administration of cannabis product (see CMCR website at www.cmcr.ucsd.edu/invinfo/index.htm), (g) Description of facilities for the storage and security of cannabis (see DEA guidelines at www.cmcr.ucsd.edu/invinfo/guidelines.htm).
  11. Human Subjects (complete a human subjects statement using NIH guidelines – this does not count in the 12 page narrative, but should not exceed 3 pages; provide evidence that the study has been reviewed by the relevant institutional review board). Proof of IRB submission and a copy of the consent form must be included.
  12. Literature Cited.
  13. Consortium or Cooperative Agreements/Relationships (if applicable).
  14. Investigational New Drug Application Forms. Attach completed forms 1571 and 1572 available on the CMCR website.
  15. Research Advisory Panel of California Application. - Attach completed "Application for Review" cover page to one copy of your proposal for submission to the RAPC. This is for clinical protocols only. Information on RAPC can be found at http://caag.state.ca.us/research/index.htm.
  16. DEA (Drug Enforcement Administration) Application Form 225 - must be requested directly from the DEA (phone: 800-882-9539). Form 225 is the application for Schedule I registration as a researcher. Please submit original with application.

Submit the original and twenty copies of the complete application through your Institution's Contracts and Grants Office by no later than 4:00 PM on Thursday, June 1, 2006.. Please note that your grant must have been reviewed by your contracts and grants office before submission to CMCR. Submit applications to:

Center for Medicinal Cannabis Research
150 W. Washington Street, 2nd Floor
San Diego, CA 92103

Also submit an electronic copy of the full proposal by email to bgouaux@ucsd.edu.