(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:
Descriptions of key personnel, including clinicians, scientists, or epidemiologistsand support personnel, demonstrating they are adequately trained to conduct this research;
Procedures for outreach to patients with various medical conditions who may besuitable participants in research on marijuana and its component parts;
Protocols suitable for research on marijuana and its component parts as medicaltreatment;
For any research studies, demonstration that appropriate protocols for adequate patient consent and follow-up procedures are in place; and
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:
The scientific merit of the research plan, including whether the research design andexperimental procedures are potentially biased for or against a particular outcome; and
The researchers' expertise in the scientific substance and methods of the proposedresearch 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.
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).
In order to maximize the scope and size of the marijuana studies:
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
All donors shall be advised that moneys given for purposes of this section will beused 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.
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:
At least one epidemiologist with expertise in designing and conducting large, observational studies and clinical trials;
At least one clinician with expertise in designing and conducting clinical trials;
A clinician familiar with the prescription, dosage, and administration of medicalmarijuana under current state laws;
A medical toxicologist;
A neurologist;
A pediatrician;
A psychiatrist;
An internal medicine physician or other specialist in adult medicine;
A preventive medicine specialist or public health professional;
A substance abuse specialist;
An alternative medicine specialist with expertise in herbal or alternative medicine;
A person who represents medical marijuana patient interests; and
An ad hoc member with clinical expertise in the medical condition under study.
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.
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.
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.
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.
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.
Source: L. 2014: Entire section added, (SB 14-155), ch. 237, p. 874, § 3, effective July
1. L. 2017: (5) amended, (HB 17-1367), ch. 406, p. 2121, § 6, effective January 1, 2018. L. 2018: (3)(b)(I) amended, (SB 18-271), ch. 329, p. 1972, § 6, effective May 30. L. 2019: (3)(b)(I) amended, (HB 19-1028), ch. 71, p. 256, § 2, effective April 2; (5)(b) repealed, (SB 19-224), ch. 315, p. 2940, § 24, effective January 1, 2020.
Cross references: For the legislative declaration in SB 14-155, see section 1 of chapter 237, Session Laws of Colorado 2014.