Regulation 5 CCR 1006-2-14

Current through Register Vol. 47, No. 11, June 10, 2024

Regulation 5 CCR 1006-2-14 - Colorado medical research grant program

A. Procedures for grant application to the grant program

1. In order to ensure objectivity in evaluating research proposals, the grant program shall establish a scientific advisory council (council).

a. The council shall perform all of the following duties:

i. Provide policy guidance in the creation and implementation of the research grant program and in scientific oversight and review.

ii. Objectively evaluate research proposals and provide a peer review process that guards against funding research that is biased in favor of or against particular outcomes.

iii. Submit recommendations to the department and the state board of health for recommended grant recipients, grant amounts, and grant duration.

2. Grant application contents.

a. At a minimum, all applications shall be submitted to the department in accordance with these rules and shall contain the following information:

i. A description of key personnel, including clinicians, scientists, or epidemiologists and support personnel, demonstrating they are adequately trained to conduct this research.

ii. Procedures for outreach to patients with various medical conditions who may be suitable participants in research on marijuana.

iii. Protocols suitable for research on marijuana as medical treatment including procedures for collecting and analyzing data and statistical methods to be used to assess significant outcomes

iv. Demonstration that appropriate protocols for adequate patient consent and follow-up procedures are in place.

v. 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.

3. Timelines for grant application.

a. Absent approval from the board of health, the department will seek applications no more than three times per year.

b. The department will notify prospective applicants of the opportunity to apply.

c. Prospective applicants will have a minimum of thirty days to apply.

d. Applications will be reviewed within 120 days of submission and referral of recommended applications to the board of health will be within 180 days of submission.

B. Criteria for selecting entities

1. The following criteria shall be used for selecting potential grantees:

a. The applicant submits a completed application in accordance with the requirements in Section A.1;

b. The scientific merit of the research plan, including whether the research design and experimental procedures are potentially biased for or against a particular outcome.

c. 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.

d. The applicant has the capacity to adequately administer and implement the grant including the capacity to meet its responsibilities delineated in Section C.

2. The council shall submit recommendations for grants to the state board of health, which shall approve or disapprove of grants submitted by the council. If the state board of health disapproves a recommendation, the council may submit a replacement recommendation within thirty days.

3. The state board of health shall award grants to the selected entities, specifying the amount and duration of the award, which cannot exceed three years without renewal.

C. Grantee reporting

1. Progress reports. Grantees shall be responsible for ongoing reporting consisting of the following:

a. Quarterly progress reports

b. Annual updates which may replace the fourth fiscal quarter report

c. Final report at the end of the grant cycle.

2. At a minimum, all progress reports, annual updates and final reports shall include the numbers of patients enrolled in each study and any scientifically valid preliminary findings.

3. All progress reports, annual updates and final report shall be submitted to the Colorado medical marijuana research grant program. Reports shall be submitted electronically in any word processing software program compatible with Microsoft Word 2007 or higher format.

4. Grantees who fail to submit any of the required reports may be terminated from the grant program for non-performance. In the event that grantees fail to submit a final report after the conclusion of their grant, future applications of the grantee may be denied based on prior non-performance.

Regulation 5 CCR 1006-2-14

37 CR 20, October 25,2014, effective 11/14/2014

38 CR 15, August 10, 2015, effective 9/14/2015

38 CR 24, December 25, 2015, effective 1/14/2016

41 CR 08, April 25, 2018, effective 5/15/2018

42 CR 08, April 10, 2019, effective 5/15/2019

42 CR 20, October 25, 2019, effective 11/14/2019

45 CR 01, January 10, 2022, effective 2/14/2022

45 CR 06, March 25, 2022, effective 4/14/2022