(1) Legislative intent. There is a need for objective scientific research regarding the
efficacy of marijuana and its component parts as part of medical treatment. It is the
intent of the general assembly that the department gather objective scientific
research regarding the efficacy of administering marijuana and its component parts
as part of medical treatment.
(2) Medical marijuana research grant program - rules. (a) (I) The
department shall be responsible for the administration of the Colorado medical
marijuana research grant program created within the department and referred to in
this section as the grant program.
(II) The department shall coordinate the grant program to fund research
intended to ascertain the general medical efficacy and appropriate administration
of marijuana and its component parts. The grant program shall be limited to
providing for objective scientific research to ascertain the efficacy of marijuana and
its component parts as part of medical treatment and should not be construed as
encouraging or sanctioning the social or recreational use of marijuana. The grant
program shall fund observational trials and clinical trials.
(b) The state board of health shall promulgate rules for the administration of
the grant program, including:
(I) The procedures and timelines by which an entity may apply for program
grants;
(II) Grant application contents, including:
(A) Descriptions of key personnel, including clinicians, scientists, or
epidemiologists and support personnel, demonstrating they are adequately trained
to conduct this research;
(B) Procedures for outreach to patients with various medical conditions who
may be suitable participants in research on marijuana and its component parts;
(C) Protocols suitable for research on marijuana and its component parts as
medical treatment;
(D) For any research studies, demonstration that appropriate protocols for
adequate patient consent and follow-up procedures are in place; and
(E) A process for a grant research proposal approved by the grant program
to be reviewed and approved by an institutional review board that is able to
approve, monitor, and review biomedical and behavioral research involving human
subjects;
(III) Criteria for selecting entities to receive grants and determining the
amount and duration of the grants, which shall include the following:
(A) The scientific merit of the research plan, including whether the research
design and experimental procedures are potentially biased for or against a
particular outcome; and
(B) The 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; and
(IV) Reporting requirements for entities that receive grants pursuant to this
section.
(c) Program grants will be paid from the health research subaccount in the
medical marijuana program cash fund created in section 25-1.5-106 (17).
(d) In order to maximize the scope and size of the marijuana studies:
(I) The grant program may solicit, apply for, and accept moneys from
foundations, private individuals, and all other funding sources that can be used to
expand the scope or time frame of the marijuana studies that are authorized under
this section; except that the program shall not accept any moneys that are offered
with any conditions other than that the moneys be used to study the efficacy of
marijuana and its component parts as part of medical treatment; and
(II) All donors shall be advised that moneys given for purposes of this section
will be used to study both the possible medical benefits and detriments of
marijuana and its component parts and that he or she will have no control over the
use of these moneys.
(3) Review of applications. (a) Scientific advisory council. (I) In order to
ensure objectivity in evaluating research proposals, the grant program shall
establish a scientific advisory council, referred to in this section as the council, to
provide a peer review process that guards against funding research that is biased in
favor of or against particular outcomes. The executive director of the department
shall appoint at least six members and no more than thirteen members to the
council to provide policy guidance in the creation and implementation of the grant
program and in scientific oversight and review. The chief medical officer of the
department, or his or her designee, is also a member of the council and is chair of
the council. Except for the representative specified in sub-subparagraph (L) of this
subparagraph (I), the executive director shall choose members on the basis of their
expertise in the scientific substance and methods of the proposed research and for
their lack of bias or conflict of interest regarding the applicants or the topic of an
approach taken in the proposed research and may choose members from around
the country. Members of the council must include the following types of experts:
(A) At least one epidemiologist with expertise in designing and conducting
large, observational studies and clinical trials;
(B) At least one clinician with expertise in designing and conducting clinical
trials;
(C) A clinician familiar with the prescription, dosage, and administration of
medical marijuana under current state laws;
(D) A medical toxicologist;
(E) A neurologist;
(F) A pediatrician;
(G) A psychiatrist;
(H) An internal medicine physician or other specialist in adult medicine;
(I) A preventive medicine specialist or public health professional;
(J) A substance abuse specialist;
(K) An alternative medicine specialist with expertise in herbal or alternative
medicine;
(L) A person who represents medical marijuana patient interests; and
(M) An ad hoc member with clinical expertise in the medical condition under
study.
(II) Members of the council, other than the chief medical officer or his or her
designee, shall serve on a voluntary basis for a two-year term and may be
reappointed. Members shall be reimbursed for their travel expenses incurred in the
course of their participation.
(III) Members of the council shall evaluate research proposals and submit
recommendations to the department and the state board of health for
recommended grant recipients, grant amounts, and grant duration.
(b) Grant approval. (I) The council shall submit recommendations for grants
to the state board of health. The state board of health shall approve or disapprove
of grants submitted by the council. The state board of health is encouraged to
prioritize grants to gather objective scientific research regarding the efficacy and
the safety of administering medical marijuana for ovarian cancer; dementia;
pediatric conditions, including but not limited to autism spectrum disorder; and
other conditions that the state board deems suitable. If the state board of health
disapproves a recommendation, the council may submit a replacement
recommendation within thirty days.
(II) The state board of health shall award grants to the selected entities,
specifying the amount and duration of the award. A grant awarded pursuant to this
section shall not exceed three years without renewal. The size, scope, and number
of studies funded shall be commensurate with the amount of appropriated and
available grant program funding.
(4) Reporting. (a) No later than January 1, 2016, the grant program shall
report to the state board of health on the progress of the medical marijuana
studies.
(b) Thereafter, the grant program shall issue a report to the state board of
health by January 1 of each year detailing the progress of the medical marijuana
studies. The interim reports required under this paragraph (b) shall include data on
all of the following:
(I) The names and number of diseases or conditions under study;
(II) The number of patients enrolled in each study by disease; and
(III) Any scientifically valid preliminary findings.
(5) Sources of marijuana. (a) The attorney general shall seek authority from
the federal government to permit Colorado institutions of higher education to
contract with the national institute of drug abuse to cultivate marijuana and its
component parts for use in research studies funded pursuant to this section.
(b) Repealed.
(6) Definition. For purposes of this section, marijuana means usable form
of marijuana as that term is defined in section 14 (1)(i) of article XVIII of the
Colorado constitution and also includes industrial hemp as that term is defined in
section 16 (2)(d) of article XVIII of the Colorado constitution.