ARM 37.106.3325. AGREEMENT WITH OUTSIDE ENTITIES

(1) When an experimental treatment or medical device has been evaluated by the experimental treatment review board and deemed to have minimal potential risk to a patient and determined to be safe to administer outside of the experimental treatment center, the center may make the treatment or device available for administration to private practicing physicians if there is a signed written agreement between the experimental treatment center and the physician that includes at a minimum: (a) the name of the disease or health condition that the treatment is approved to treat; (b) the requirement that the physician document the treatment outcomes; (c) the requirement that the physician report any adverse side effects to the experimental treatment center within 24 hours; (d) that the physician provides all patients with the name, number, and address of the experimental treatment center that the physician is contracting with for the treatment; and (e) that the physician agrees to share all treatment documentation, laboratory, and other test results of a patient receiving experimental treatments or devices with the contracted experimental treatment center. (2) There must be a written and signed agreement for each treatment or device that is approved for administration or delivery. (3) The agreement must have a documented renewal annually by both parties. (4) If a treatment or device is discontinued from use outside of the experimental treatment center or when a treatment or device clears Food and Drug Administration (FDA) approval and no longer meets experimental treatment criteria, there must be a documented termination of the agreement.