ARTICLE 14. ACADEMIC CLINICAL RESEARCH CENTERS.

§16A-14-1. Definitions.

The following words and phrases when used in this chapter shall have the meanings given to them in this section unless the context clearly indicates otherwise:

(1) “Academic clinical research center” means an accredited medical school within this state that operates or partners with an acute care hospital licensed within this state.

(2) “Clinical registrant” means an entity that:

(A)  Holds a permit as a grower, processor and a dispensary; and

(B)  Has a contractual relationship with an academic clinical research center under which the academic clinical research center or its affiliate provides advice to the entity, regarding, among other areas, patient health and safety, medical applications and dispensing and management of controlled substances.

§16A-14-2. Clinical registrants.

Notwithstanding the limitations in section thirteen, article six of this chapter, the bureau may register up to four clinical registrants, and subject to the following:

(1) A clinical registrant must pay the fees and meet all other requirements under this act for obtaining a permit as a grower, processor and a dispensary.

(2) The clinical registrant must comply with all other requirements of this act regarding growing, processing and dispensing medical cannabis.

§16A-14-3. Research study.

Notwithstanding any provision of this act to the contrary, the bureau may, upon application, approve the dispensing of medical cannabis by a clinical registrant to the academic clinical research center for the purpose of conducting a research study. The bureau shall develop the application and standards for approval of such dispensing by the clinical registrant. The following apply to the research study:

(1)  The clinical registrant shall disclose the following information to the bureau in its application:

(i)  The reason for the research project, including the reason for the trial.

(ii)  The strain of medical cannabis to be used and the strength of the medical cannabis to be used in the research study.

(iii)  The anticipated duration of the study.

(iv)  Evidence of approval of the trial by an accredited institutional review board, including any other required regulatory approvals.

(v)  Other information required by the bureau, except that the bureau may not require disclosure of any information that would infringe upon the academic clinical research center’s exclusive right to intellectual property or legal obligations for patient confidentiality.

(2)  The academic clinical research center shall provide its findings to the bureau within three hundred sixty-five days of the conclusion of the research study or within three hundred sixty-five days of publication of the results of the research study in a peer-reviewed medical journal, whichever is later.

(3)  The bureau shall allow the exchange of medical cannabis seed between clinical registrants for the conduct of research.