(a)
(1)It is the intent of the Legislature that the state commission objective scientific research by the premier research institute of the world, the University of California, regarding the efficacy and safety of administering cannabis, its naturally occurring constituents, and synthetic compounds, as part of medical treatment. If the Regents of the University of California, by appropriate resolution, accept this responsibility, the University of California shall create a program, to be known as the California Cannabis Research Program, hosted by the Center for Medicinal Cannabis Research. Whenever “California Marijuana Research Program” appears in any statute, regulation, or contract, or in any other code, it shall be
construed to refer to the California Cannabis Research Program.
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(a)
(1)
It is the intent of the Legislature that the state commission objective scientific research by the premier research institute of the world, the University of California, regarding the efficacy and safety of administering cannabis, its naturally occurring constituents, and synthetic compounds, as part of medical treatment. If the Regents of the University of California, by appropriate resolution, accept this responsibility, the University of California shall create a program, to be known as the California Cannabis Research Program, hosted by the Center for Medicinal Cannabis Research. Whenever “California Marijuana Research Program” appears in any statute, regulation, or contract, or in any other code, it shall be
construed to refer to the California Cannabis Research Program.
(2)
The program shall develop and conduct studies intended to ascertain the general medical safety and efficacy of cannabis and, if found valuable, shall develop medical guidelines for the appropriate administration and use of cannabis. The studies may examine the effect of cannabis on motor skills, the health and safety effects of cannabis, cannabinoids, and other related constituents, and other behavioral and health outcomes.
(b)
The program may immediately solicit proposals for research projects to be included in the cannabis studies. Program requirements to be used when evaluating responses to its solicitation for proposals shall include, but not be limited to, all of the following:
(1)
Proposals shall demonstrate the use of key personnel, including clinicians or scientists and support personnel, who are prepared to develop a program of research regarding the general medical efficacy and safety of cannabis.
(2)
Proposals shall contain procedures for outreach to patients with various medical conditions who may be suitable participants in research on cannabis.
(3)
Proposals shall contain provisions for a patient registry.
(4)
Proposals shall contain provisions for an information system that is designed to record information about possible study participants, investigators, and clinicians, and deposit and analyze data that accrues as part of
clinical trials.
(5)
Proposals shall contain protocols suitable for research on cannabis, addressing patients diagnosed with acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV), cancer, glaucoma, or seizures or muscle spasms associated with a chronic, debilitating condition. The proposal may also include research on other serious illnesses, provided that resources are available and medical information justifies the research.
(6)
Proposals shall demonstrate the use of a specimen laboratory capable of housing plasma, urine, and other specimens necessary to study the concentration of cannabinoids in various tissues, as well as housing specimens for studies of toxic effects of cannabis.
(7)
Proposals shall demonstrate the use of a laboratory capable of analyzing cannabis, provided to the program under this section, for purity and cannabinoid content and the capacity to detect contaminants.
(c)
In order to ensure objectivity in evaluating proposals, the program shall use a peer review process that is modeled on the process used by the National Institutes of Health, and that guards against funding research that is biased in favor of or against particular outcomes. Peer reviewers shall be selected for their expertise in the scientific substance and methods of the proposed research, and their lack of bias or conflict of interest regarding the applicants or the topic of an approach taken in the proposed research. Peer reviewers shall judge research proposals on several criteria, foremost among which shall be both of
the following:
(1)
The scientific merit of the research plan, including whether the research design and experimental procedures are potentially biased for or against a particular outcome.
(2)
Researchers’ expertise in the scientific substance and methods of the proposed research, and their lack of bias or conflict of interest regarding the topic of, and the approach taken in, the proposed research.
(d)
If the program is administered by the Regents of the University of California, any grant research proposals approved by the program shall also require review and approval by the research advisory panel.
(e)
It is the intent of the Legislature that the program be
established as follows:
(1)
The program shall be located at one or more University of California campuses that have a core of faculty experienced in organizing multidisciplinary scientific endeavors and, in particular, strong experience in clinical trials involving psychopharmacologic agents. The campuses at which research under the auspices of the program is to take place shall accommodate the administrative offices, including the director of the program, as well as a data management unit, and facilities for detection and analysis of various naturally occurring and synthetic cannabinoids, as well as storage of specimens.
(2)
When awarding grants under this section, the program shall utilize principles and parameters of the other well-tested statewide research programs
administered by the University of California, modeled after programs administered by the National Institutes of Health, including peer review evaluation of the scientific merit of applications.
(3)
The scientific and clinical operations of the program shall occur partly at University of California campuses and partly at other postsecondary institutions that have clinicians or scientists with expertise to conduct the required studies. Criteria for selection of research locations shall include the elements listed in subdivision (b) and, additionally, shall give particular weight to the organizational plan, leadership qualities of the program director, and plans to involve investigators and patient populations from multiple sites.
(4)
The funds received by the program shall be
allocated to various research studies in accordance with a scientific plan developed by the Scientific Advisory Council. As the first wave of studies is completed, it is anticipated that the program will receive requests for funding of additional studies. These requests shall be reviewed by the Scientific Advisory Council.
(5)
The size, scope, and number of studies funded shall be commensurate with the amount of appropriated and available program funding.
(f)
All personnel involved in implementing approved proposals shall be authorized as required by Section 11604.
(g)
Studies conducted pursuant to this section shall include the greatest amount of new scientific research possible on the medical uses of, and medical
hazards associated with, cannabis. The program shall consult with the Research Advisory Panel analogous agencies in other states, and appropriate federal agencies in an attempt to avoid duplicative research and the wasting of research dollars.
(h)
The program shall make every effort to recruit qualified patients and qualified physicians from throughout the state.
(i)
The cannabis studies shall employ state-of-the-art research methodologies.
(j)
The program shall ensure that all cannabis used in the studies is of the appropriate medicinal quality. Cannabis used by the program may be obtained from the National Institute on Drug Abuse or any other entity authorized by the appropriate federal agencies, the Attorney
General pursuant to Section 11478, or may be cultivated by the program pursuant to applicable federal and state laws and regulations.
(k)
The program may review, approve, or incorporate studies and research by independent groups presenting scientifically valid protocols for medical research, regardless of whether the areas of study are being researched by the committee.
(
l
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(1)
To enhance understanding of the efficacy and adverse effects of cannabis as a pharmacological agent, the program shall conduct focused controlled clinical trials on the usefulness of cannabis in
patients diagnosed with AIDS or HIV, cancer, glaucoma, or seizures or muscle spasms associated with a chronic, debilitating condition. The program may add research on other serious illnesses, provided that resources are available and medical information justifies the research. The studies shall focus on comparisons of both the efficacy and safety of methods of administering the drug to patients, including inhalational, tinctural, and oral, evaluate possible uses of cannabis as a primary or adjunctive treatment, and develop further information on optimal dosage, timing, mode of administration, and variations in the effects of different cannabinoids and varieties of cannabis or synthetic compounds that simulate the effects of naturally occurring cannabinoids. The studies may also focus on examining testing methods for detecting harmful contaminants in cannabis, including, but not limited to, mold, bacteria,
and mycotoxins that could cause harm to patients.
(2)
The program shall examine the safety of cannabis in patients with various medical disorders, including the interaction of cannabis with other drugs, relative safety of inhalation versus oral forms, and the effects on mental function in medically ill persons.
(3)
The program shall be limited to providing for objective scientific research to ascertain the efficacy and safety of cannabis as part of medical treatment, and should not be construed as encouraging or sanctioning the social or recreational use of cannabis.
(m)
(1)
Subject to paragraph (2), the program shall, prior to approving proposals, seek to obtain research protocol guidelines from
the National Institutes of Health and shall, if the National Institutes of Health issues research protocol guidelines, comply with those guidelines.
(2)
If, after a reasonable period of time of not less than six months and not more than a year has elapsed from the date the program seeks to obtain guidelines pursuant to paragraph (1), no guidelines have been approved, the program may proceed using the research protocol guidelines it develops.
(n)
In order to maximize the scope and size of the cannabis studies, the program may do any of the following:
(1)
Solicit, apply for, and accept funds from foundations, private individuals, and all other funding sources that can be used to expand the scope or timeframe of the
cannabis studies that are authorized under this section. The program shall not expend more than 5 percent of its General Fund allocation in efforts to obtain money from outside sources.
(2)
Include within the scope of the cannabis studies other cannabis research projects that are independently funded and that meet the requirements set forth in subdivisions (a) to (c), inclusive. In no case shall the program accept funds that are offered with any conditions other than that the funds be used to study the efficacy and safety of cannabis as part of medical treatment.
(o)
(1)
Within six months of the effective date of this section, the program shall report to the Legislature, the Governor, and the Attorney General on the progress of the cannabis studies.
(2)
Thereafter, the program shall issue a report to the Legislature every 24 months detailing the progress of the studies. The interim reports required under this paragraph shall include, but not be limited to, data on all of the following:
(A)
The names and number of diseases or conditions under study.
(B)
The
number of patients enrolled in each study, by disease.
(C)
Any scientifically valid preliminary findings.
(p)
If the Regents of the University of California implement this section, the President of the University of California, or the president’s designee, shall appoint a multidisciplinary Scientific Advisory Council, not to exceed 15 members, to provide policy guidance in the creation and implementation of the program. Members shall be chosen on the basis of scientific expertise. Members of the council shall serve on a voluntary basis, with reimbursement for expenses
incurred in the course of their participation. The members shall be reimbursed for travel and other necessary expenses incurred in their performance of the duties of the council.
(q)
No more than 10 percent of the total funds appropriated may be used for all aspects of the administration of this section.
(r)
This section shall be implemented only to the extent that funding for its purposes is appropriated by the Legislature.
(s)
Money appropriated to the program pursuant to subdivision (e) of Section 34019 of the Revenue and Taxation Code shall only be used as authorized by the Control, Regulate and Tax Adult Use of Marijuana Act (AUMA).
(t)
This section does not limit or preclude cannabis-related research activities at any campus of the University of California.