As used in this part, the following definitions apply:
(1) "Experimental treatment" means the provision of a medical intervention by a health care provider involving an investigational drug, biological product, device, or other treatment that has successfully completed phase 1 of a clinical trial but has not yet been approved for general use by the United States food and drug administration and either:
- (a) remains under investigation in a clinical trial approved by the United States food and drug administration; or
- (b) has a demonstrated safety record through documented clinical evidence from a qualified medical institution as defined by department rule.
- (2) "Experimental treatment center" has the same meaning as provided in 50-5-101.
- (3) "Health care facility" has the same meaning as provided in 50-5-101. The term includes an experimental treatment center.
(4) "Health care provider" means any of the following individuals licensed pursuant to Title 37:
- (a) a physician;
- (b) an advanced practice registered nurse authorized by the board of nursing to prescribe medicine;
- (c) a physician assistant; and
- (d) a registered nurse performing services at an experimental treatment center.
- (5) "Informed consent" means written documentation or digital recordation that meets the requirements of 50-12-105.
- (6) "Provider agreement" means a contract authorizing a health care provider to deliver an experimental treatment, or services related to the provision of an experimental treatment, under the supervision of an experimental treatment center's medical director.
History: En. Sec. 2, Ch. 135, L. 2015; amd. Sec. 14, Ch. 88, L. 2023; amd. Sec. 1, Ch. 413, L. 2023; amd. Sec. 6, Ch. 621, L. 2025.