ARM 37.106.3316. EXPERIMENTAL TREATMENT REVIEW BOARD

(1) An experimental treatment center must establish or contract with an experimental treatment review board. (2) The review board may be: (a) independently contracted through competitive selection; or (b) shared among multiple experimental treatment centers. (3) The review board must be comprised only of members who have no personal, financial, employment, or ownership interest, or any other conflict of interest in the experimental treatment center or centers for which it is contracted. (a) Each experimental treatment center must maintain a list of all board members and documentation supporting that each member declares no interest in the experimental treatment center as described in (3). (b) The declaration must align with the requirements set forth in 1-6-105, MCA. (4) An experimental treatment review board may serve multiple experimental treatment centers, provided that: (a) adequate capacity exists to review all assigned protocols within competitive time frames; (b) each center designates the board through a written agreement; (c) consolidated quarterly safety outcome reports are prepared by the review board and must clearly identify outcomes by center. These reports shall be maintained for internal quality assurance and made available to: (i) the department during survey or upon request; and (ii) the QAPI program; (d) all board members meet the requirements of (3) for each center to which the board provides review services. (5) The experimental treatment review board shall consist of at least five members. It shall include at least one Montana-licensed physician, at least one researcher with expertise in clinical outcome data, and at least one ethicist. (a) The credentials of each board member shall be provided to the department. (b) Members of the board shall adhere to professional standards regarding disclosure and management of financial conflicts of interest. (6) The experimental treatment review board shall: (a) review and approve treatment protocols to be offered at an experimental treatment center that meet the standards of 50-12-102(1), MCA, documenting that: (i) safety standards equivalent to or higher than those of recognized regulatory authorities are met; (ii) informed consent procedures are comprehensive and understandable; (iii) risk-benefit analysis demonstrates a reasonable safety profile; and (iv) alternative treatments have been appropriately evaluated; (b) evaluate quality and safety outcomes using recognized metrics; (c) prepare, at least annually, a public summary report to be published on the center’s website or otherwise made accessible for public review. The report must include: (i) aggregate numbers and types of experimental treatments reviewed and approved; (ii) aggregate safety outcome data (including number and general categories of serious adverse events, with a patient’s personal identifiable information removed); (iii) aggregate treatment outcome data; (iv) general approval or review time frames; and (v) recommended system-wide quality improvements; (d) preserve all records related to protocol review, approvals, safety evaluations, and reports for at least five years, and make such records available to the department upon request; (e) review adverse event data as reported under ARM 37.106.3317; and (f) evaluate each experimental treatment and medical device to determine the level of risk to patients, and whether the treatment or device is safe for administration outside of an experimental treatment center. (i) An experimental treatment center is responsible for formulating an evaluation assessment and standard to determine the level of risk to patients and guidelines for determining whether the treatment or device is safe for delivery outside of the center. (7) An experimental treatment center may be licensed provisionally without the establishment of an experimental treatment review board, but may not provide any treatments or devices until a review board is established and provides the evaluation requirements in (6)(f). (8) The experimental treatment review board must meet at least monthly.