Introduction and Purpose

The University of California has established the Center for Medicinal Cannabis Research (CMCR). The funding from the State of California is provided to undertake rigorous scientific studies to assess the safety and efficacy of cannabis compounds as the best alternative for treating certain medical conditions. The funding of the CMCR is the result of SB 847 (Vasconcellos), passed by the State Legislature and signed into law by Governor Gray Davis. The legislation calls for a three year program overseeing objective, high quality medical research that will “enhance understanding of the efficacy and adverse effects of marijuana as a pharmacological agent,” stressing that the project "should not be construed as encouraging or sanctioning the social or recreational use of marijuana."

Eligibility

Proposals may be submitted by any nonprofit research institution in the state of California. The principal investigator must be an individual who qualifies for that status under the proposing institution's principal investigator policies. The principal investigator is expected to supervise or conduct the proposed project personally and directly, and must contribute a minimum of 10% effort on the project.

Clinical Trials

The Center will support and coordinate research throughout the state of California. Research will focus on the potential medicinal benefits of cannabis for specific diseases and conditions as defined by the National Academy of Sciences/Institute of Medicine report (1999) and by the report to the Director, National Institutes of Health, by the Ad Hoc group of experts (1997). The following diseases and conditions constitute areas of emphasis for CMCR funding:

Application Procedure

Investigators who have potential interest in conducting clinical trials involving medicinal cannabis should first consult the CMCR website at www.cmcr.ucsd.edu. More background on the Center is provided on the website. The Institute of Medicine/National Academy of Sciences report and the report of the expert panel to the National Institutes of Health are also available on the CMCR website. Both reports contain reviews of relevant literature that will be important 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 letter of intent or concept sheet can be faxed to the CMCR Project Manager at 619-543-5073 or sent by e-mail to bgouaux@ucsd.edu.

The elements for proposal submission are modified from the Public Health Service grant application developed for NIH submission. The main difference will be that the research plan should not exceed twelve pages. Application forms can be obtained on the CMCR website.

The components of the proposal packet include:

Submit the complete application through your Institution’s Contracts and Grants Office. Please note that your grant must be reviewed by your contracts and grants before submission to CMCR. Applications must be received by the CMCR by 4:00 PM, Thursday, June 1, 2006. .

Process of Review

Applications will be assigned for review by an independent scientific review board appointed by the CMCR Directors. Grants will be reviewed and it is anticipated that applicants will be notified of the results by August 4, 2006. In some instances, applications that are not given highest priority may be invited to resubmit with revisions responding to comments by reviewers. This process of resubmission will be made as rapid as possible in order that resubmitted grants are not unduly delayed. It is the intent of the CMCR to fund successful applications by January 2007. However, timing of final awards will depend on additional factors, such as securing appropriate regulatory consent (e.g., Schedule 1 registration, IND, etc.). Details of these regulatory steps are available on the CMCR website..

Inquiries

Inquiries are encouraged. The CMCR staff is available to assist you with your proposal including study design questions, dosage and product information. The CMCR also will provide step by step information and assistance with meeting federal and state regulatory policies regarding use of a Schedule I Substance in research studies

Applicants wishing assistance during proposal development may contact the CMCR by phone at 619-543-5024.

Funding

Projects are funded one year at a time for a maximum of two years, subject to the availability of funds.

Prior to funding, prospective awardees are expected to:

Terms of the Award

Allowable expenses include salaries and fringe benefits for professional and support personnel, consultant and contractual costs, supplies and expenses, equipment, and travel. However, award funds may not be used to increase or supplement total approved compensation for institution personnel (e.g., a University faculty member who is already 100% full-time equivalent/FTE cannot be supported with these funds unless partial FTE release is granted). Nine month appointees may request summer salaries. Funds for anticipated range adjustments and employee benefits must be included in the personnel budget.

Equipment is defined as non-expendable, tangible, personal property, which has an acquisition cost of $1500 or more, is free standing and has a normal life expectancy of one year or more. Upon termination of an award, all materials and equipment purchased with award funds become the property of the department or equivalent administrative unit concerned.

Allowable expenses may also include graduate student stipends and fees. However, the maximum allowable total combined expenditure for graduate student stipends and fees is $35,000 per year. The $35,000 cap represents the total annual cap on graduate student stipends and fees, regardless of the number of students.

Applications from University of California institutions will not be eligible for indirect costs. Non-UC institutions will be eligible for indirect costs up to 10% of total direct costs, minus equipment, or at the rate established for the institution through a U.S. Department of Health and Human Services (DHHS) indirect cost negotiated rate agreement (or other similarly established rate), whichever is lower. Indirect costs should be calculated at the lower rate, and shown on the budget. A copy of the institution’s DHHS rate agreement, or alternate rate agreement, must be included with the proposal, even if that rate is higher than the maximum 10% permitted by the CMCR.

Awardees are expected to account in a timely manner for the expenditure of grant funds and for the performance of work as agreed upon. The Institutional Officials’ and Principal Investigator’s signatures on the Verifications page of the application signify that the individuals are aware of the conditions for receiving a grant from the University of California and agree to comply with all applicable UC Policies and Procedures, including the following:

Policy Regarding Scientific Misconduct

The University of California manages the CMCR in general accord with the policies and procedures employed by the National Institutes of Health (NIH), including those that apply to scientific misconduct. The Department of Health and Human Service’s (HHS) Office of Research Integrity is responsible for implementing HHS regulations regarding scientific misconduct in research conducted with NIH and other support from the US Public Health Service.

The administrative actions imposed by HHS include the following: correction of the scientific literature; special plan of supervision to ensure integrity of the scientific research; certification of the accuracy of the scientific data; certification of the accuracy of sources and contributions for scientific ideas and writings; prohibition against service on PHS advisory committees or as a consultant; and debarment from receipt of federal funds. These actions are for specified durations, depending on the nature and the seriousness of the misconduct.

Applicants for, or recipients of, grants from the CMCR must promptly inform the University via the CMCR Director of an administrative action for scientific misconduct that is imposed by HHS by providing a copy of the final notice of the administrative action (i.e., after the disposition of an appeal), either at the time of application or within thirty days of the imposition of the administrative action. In general, the University will apply the same administrative action. For example, if HHS has debarred an investigator from applying for or receiving NIH awards for a specified period of time, that investigator would also be excluded from applying for or receiving awards from the CMCR. To take another example, if an investigator has entered into a voluntary agreement with HHS for special oversight and supervision of the investigator’s grant applications, research and publications, that agreement would apply to that investigator’s grant applications with, or awards from, the CMCR.

Grant applicants or recipients may request that HHS administrative actions be waived or modified with respect to a grant application or award from CMCR. In such cases, the applicant must present a justification for the request.

Further Information

Consult CMCR website at www.cmcr.ucsd.edu or call 619-543-5024 to speak to a CMCR representative.