ARM 37.106.3311. PATIENT AGREEMENT

(1) An experimental treatment center must enter into a written patient agreement with each prospective patient prior to admission. (2) The patient agreement must include: (a) documentation that the patient, or their legal representative, agrees to the treatment; (b) the criteria for admitting and discharging from the center; (c) the treatment name, form, and what phase in the clinical trials the treatment the patient is to be receiving; (d) the full text of the provisions contained in 50-12-110, MCA (Immunity From Suit); (e) a detailed description of all the anticipated costs to the patients, if any, and how the center intends to bill or receive payments; (f) the acknowledgment related to the patient’s health insurance as stated in 50-12-105(2)(e), MCA; and (g) the center’s patient grievance policy. (3) The patient agreement must be signed and dated by both the patient or the patient’s legal representative and a licensed health care professional of the center prior to the initiation of any treatment.