MONTANA SENATE BILL 535

Montana Experimental Treatment Review Board

An independent board of accredited physicians, scientists, and ethicists that evaluates experimental treatments through structured review of safety, monitoring, and informed consent under Montana Senate Bill 535.

LEGAL FRAMEWORK

Authority & Legal Basis
under Montana's
Senate Bill 535

The Montana Experimental Treatment Review Board operates under Montana Senate Bill 535, enacted in 2025.

The board provides independent review of experimental treatment proposals, evaluating safety considerations, patient monitoring plans, informed consent procedures, and treatment eligibility criteria within the scope established by Montana law.

The board's role is to provide structured review and recommendations through a multidisciplinary panel of physicians, scientists, and ethicists.

MT SB 535 Authorized Print Version ↗
REVIEW CRITERIA

What the Board Reviews

The board evaluates experimental treatment proposals through review of safety, monitoring, informed consent, and patient eligibility frameworks.

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Safety Information

Assessment of available safety data, known risks, and supporting evidence relevant to the proposed treatment.

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Monitoring Plans

Review of patient monitoring procedures, adverse event reporting, and follow-up protocols.

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Informed Consent

Evaluation of informed consent materials to ensure patients receive clear and accurate information regarding potential risks and benefits.

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Eligibility Criteria

Review of patient inclusion and exclusion criteria and the rationale supporting treatment eligibility.

REVIEW PROCESS

How Review Works

1 — Submission


The applicant provides treatment information, supporting documentation, safety materials, monitoring plans, informed consent documents, and eligibility criteria.

2 — Board Review


Board members evaluate submitted materials and assess the proposal against the review criteria established under the board's framework.

3 — Recommendation


The board issues its review outcome and recommendations based on the information provided and the review conducted.

Review requirements and discuss whether your proposal is appropriate for board review.

Faq

Frequently Asked Question

What is the role of the Montana ETRB?
Is the board independent?
Does the board approve treatments?
What treatments are eligible for review?
How long does the review process take?
Who may submit a treatment proposal?
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