California Health and Safety Code Section 11362.9
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California Laws > Health and Safety Code > California Health and Safety Code Section 11362.9
11362.9. (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 marijuana 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
Marijuana Research Program.
(2) The program shall develop and conduct studies intended to
ascertain the general medical safety and efficacy of marijuana and,
if found valuable, shall develop medical guidelines for the
appropriate administration and use of marijuana.
(b) The program may immediately solicit proposals for research
projects to be included in the marijuana studies. Program
requirements to be used when evaluating responses to its solicitation
for proposals, shall include, but not be limited to, all of the
(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 marijuana's
general medical efficacy and safety.
(2) Proposals shall contain procedures for outreach to patients
with various medical conditions who may be suitable participants in
research on marijuana.
(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
marijuana, addressing patients diagnosed with the acquired
immunodeficiency syndrome (AIDS) or the 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 marijuana.
(7) Proposals shall demonstrate the use of a laboratory capable of
analyzing marijuana, provided to the program under this section, for
purity and cannabinoid content and the capacity to detect
(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
(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
(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 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
(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
(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, marijuana. 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 marijuana studies shall employ state-of-the-art research
(j) The program shall ensure that all marijuana used in the
studies is of the appropriate medical quality and shall be obtained
from the National Institute on Drug Abuse or any other federal agency
designated to supply marijuana for authorized research. If these
federal agencies fail to provide a supply of adequate quality and
quantity within six months of the effective date of this section, the
Attorney General shall provide an adequate supply pursuant to
(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) (1) To enhance understanding of the efficacy and adverse
effects of marijuana as a pharmacological agent, the program shall
conduct focused controlled clinical trials on the usefulness of
marijuana 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 marijuana 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 marijuana.
(2) The program shall examine the safety of marijuana in patients
with various medical disorders, including marijuana's interaction
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 marijuana
as part of medical treatment, and should not be construed as
encouraging or sanctioning the social or recreational use of
(m) (1) Subject to paragraph (2), the program shall, prior to any
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
(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 marijuana
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 marijuana 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 marijuana studies other
marijuana 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 any funds that are
offered with any conditions other than that the funds be used to
study the efficacy and safety of marijuana as part of medical
treatment. Any donor shall be advised that funds given for purposes
of this section will be used to study both the possible benefits and
detriments of marijuana and that he or she will have no control over
the use of these funds.
(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 marijuana studies.
(2) Thereafter, the program shall issue a report to the
Legislature every six 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 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 in the
annual Budget Act.
Last modified: February 22, 2013