Privacy Policy
Last Updated: September 2026
Montana Governance Services Inc., operating as the Montana Experimental Treatment Review Board ("Montana ETRB," "METRB," "we," "us," or "our"), respects the privacy of individuals and organizations that visit our website, use our online portal, communicate with us, or submit information for review.
This Privacy Policy describes how we collect, use, disclose, retain, and protect information in connection with our website, online portal, review process, and related services (collectively, the "Services").
By accessing or using the Services, you acknowledge the practices described in this Privacy Policy.
1. About Montana ETRB
Montana Governance Services Inc. operates the Montana Experimental Treatment Review Board ("Montana ETRB"), an independent, private review board that evaluates experimental treatment protocols within the framework established under Montana law. Montana ETRB is not a state agency or official governmental body.
Our Services may include a public website, an online submission and case-management portal, communications with applicants and authorized users, review of treatment protocols and supporting materials, publication of certain review decisions or information, and related administrative services.
2. Information We Collect
We may collect information directly from you, automatically through your use of the Services, from organizations with which you are affiliated, and from other sources involved in a submission or review.
Information You Provide
Information you provide may include:
Name, email address, telephone number, and other contact information; Organization, company, or institutional information; Account credentials and authorized-user information; Treatment, protocol, clinical, scientific, regulatory, or research information; Clinical trial numbers, investigational new drug numbers, regulatory identifiers, and related information; Documents, attachments, correspondence, and other materials submitted for review; Responses to requests for additional information; Billing and transaction-related information; Communications with Montana ETRB, its staff, reviewers, or representatives; and Any other information you choose or are required to provide through the Services.
Health and Patient Information
Materials submitted to Montana ETRB may contain information relating to patients, research participants, treatment recipients, or other individuals.
Depending on the submission, this information may include health information, medical history, treatment information, clinical outcomes, adverse events, demographic information, genetic or biological information, or other sensitive or personally identifiable information.
Applicants and other persons submitting information are responsible for ensuring that they have all rights, permissions, consents, authorizations, or other lawful bases necessary to provide such information to Montana ETRB for the purposes of review.
Where patient-identifiable information is not necessary for review, submitters should avoid including it and should use de-identified or appropriately limited information whenever reasonably possible.
Montana ETRB does not represent through this Privacy Policy that it is a "covered entity" or "business associate" as those terms are defined under the Health Insurance Portability and Accountability Act ("HIPAA"). The applicability of HIPAA or other health privacy laws may depend on the circumstances, parties, and information involved.
Payment Information
Payments associated with submissions or other Services may be processed by third-party payment processors, including Stripe or another payment provider.
Montana ETRB generally does not receive or store complete payment-card numbers, security codes, or equivalent payment credentials processed directly by the payment provider. Payment processors may collect and process payment information under their own terms and privacy policies.
We may receive transaction-related information such as payment status, amount, transaction identifiers, billing contact information, and limited payment-method information.
Information Collected Automatically
When you use our Services, we or our service providers may automatically collect technical and usage information, including:
Internet Protocol (IP) address;Browser and device type;Operating system;Pages or features accessed;Date and time of access;Referring pages;Login and account activity;Session and diagnostic information; andOther information necessary to operate, secure, and improve the Services.
We may use cookies and similar technologies for authentication, security, functionality, analytics, and operation of the Services.
3. How We Use Information
We may use information we collect to:
Create, maintain, and administer user accounts;Receive and manage applications and submissions;Determine whether submissions are complete or ready for review;Conduct administrative, scientific, clinical, ethical, or other review activities;Communicate with applicants and authorized users;Request additional information or documentation;Facilitate review by Montana ETRB members, staff, advisors, or other authorized participants;Generate, maintain, and communicate review decisions and recommendations;Process payments and maintain transaction records;Maintain records relating to protocol review, approvals, safety evaluations, reports, and other review activities;Comply with applicable laws, regulations, administrative rules, legal obligations, governmental requests, and regulatory requirements;Detect, investigate, and prevent fraud, unauthorized access, misuse, security incidents, or other harmful activity;Maintain, troubleshoot, secure, and improve the Services;Produce required or appropriate reports, including aggregated or de-identified reports;Protect the rights, safety, property, and interests of Montana ETRB, applicants, reviewers, patients, and others; andCarry out other purposes reasonably related to operating Montana ETRB and its review activities.
4. How We Disclose Information
We may disclose information when reasonably necessary for the operation of the Services or the review process, including to:
Montana ETRB Reviewers and Personnel
Information may be made available to board members, reviewers, employees, contractors, advisors, administrators, and other individuals involved in administering or conducting reviews.
Service Providers
We may use third parties to provide hosting, cloud storage, database infrastructure, authentication, communications, analytics, security, payment processing, document management, and other technical or administrative services.These providers may process information on our behalf as necessary to provide their services.
Government and Regulatory Authorities
We may disclose information to the Montana Department of Public Health and Human Services ("DPHHS"), courts, law enforcement agencies, regulators, governmental bodies, or other authorities when required or permitted by applicable law, regulation, administrative rule, legal process, or governmental request.
Montana law and applicable administrative rules may require Montana ETRB or entities participating in the experimental-treatment framework to create, preserve, report, or make available certain records relating to treatment protocols, approvals, safety evaluations, outcomes, or other review activities.
Legal and Safety Purposes
We may disclose information when we reasonably believe disclosure is necessary to comply with law, enforce our agreements, investigate suspected misconduct, protect the security or integrity of the Services, or protect the rights, property, health, or safety of Montana ETRB or others.
Organizational Transactions
If Montana ETRB undergoes a reorganization, merger, transfer of operations, acquisition, financing, or similar organizational transaction, information may be disclosed or transferred as part of that transaction, subject to applicable law.
5. Public Information and Review Decisions
Certain information relating to Montana ETRB's activities, reviews, decisions, recommendations, approvals, or reporting obligations may be made publicly available.
This may include review decisions, summaries, aggregate statistics, general treatment or protocol information, safety or outcome information, review time frames, quality-improvement information, or other information appropriate or required for public reporting.
Where applicable law or regulation requires patient personally identifiable information to be removed from public reporting, Montana ETRB will endeavor to comply with those requirements.
Information submitted through the portal should not be assumed to be publicly available merely because it has been submitted. However, submission to Montana ETRB does not create an absolute guarantee of confidentiality, and information may be used or disclosed as described in this Privacy Policy, as necessary to conduct the review, or as required by law.
6. Data Retention
We retain information for as long as reasonably necessary for the purposes described in this Privacy Policy and to satisfy applicable legal, regulatory, contractual, operational, security, and recordkeeping requirements.
Applicable Montana rules require certain records relating to protocol review, approvals, safety evaluations, and reports to be preserved for at least five years.
Accordingly, deletion of an account or a request to delete information does not necessarily result in deletion of information that Montana ETRB is required or reasonably needs to retain.
Information may also remain in backups, archives, audit records, security logs, or other systems for a reasonable period after it is no longer actively used.
7. Data Security
We use reasonable administrative, technical, and organizational measures designed to protect information against unauthorized access, loss, misuse, alteration, or disclosure.
However, no website, online portal, electronic transmission, database, or storage system can be guaranteed to be completely secure. You provide and transmit information electronically at your own risk.
Users are responsible for maintaining the confidentiality of their account credentials and for promptly notifying Montana ETRB of suspected unauthorized access.
8. Your Responsibilities When Submitting Information
If you submit information concerning another person, including a patient, treatment recipient, employee, researcher, or other individual, you represent that you are authorized to provide that information for the purposes for which it is submitted.
You are responsible for determining whether patient-identifiable or other sensitive information is necessary for a submission and for complying with applicable privacy, confidentiality, consent, authorization, and data-protection requirements before providing such information.
Submitters should minimize sensitive or personally identifiable information where it is not reasonably necessary for Montana ETRB's review.
9. Your Choices and Requests
You may contact us to request access to, correction of, or deletion of certain personal information associated with you.
Some requests may be limited or denied where retention or processing is necessary to comply with legal or regulatory obligations, maintain review records, protect security or legal rights, complete transactions, resolve disputes, or fulfill other legitimate purposes.
We may take reasonable steps to verify your identity and authority before acting on a request.
10. Third-Party Services and Links
Our Services may contain links to third-party websites or integrate with services operated by third parties.
Those third parties operate independently from Montana ETRB, and their collection and use of information are governed by their own privacy practices. Montana ETRB is not responsible for the privacy, security, content, or practices of third-party websites or services.
11. Children's Privacy
The Services are intended for professional, organizational, regulatory, research, and related use and are not directed to children.
We do not knowingly solicit children to create accounts or directly submit personal information through the Services.
This provision does not prohibit authorized applicants from submitting information relating to minors where such information is lawful, necessary, and appropriate for a treatment-protocol review.
12. Changes to This Privacy Policy
We may update this Privacy Policy from time to time to reflect changes in our Services, practices, technology, legal requirements, or regulatory framework.
When we make changes, we may update the "Last Updated" date above. Your continued use of the Services after an updated Privacy Policy becomes effective constitutes acknowledgment of the updated policy to the extent permitted by law.
13. Contact Us
Questions, concerns, or requests regarding this Privacy Policy or our privacy practices may be directed to:
Montana Governance Services Inc.
d/b/a Montana Experimental Treatment Review Board
contact@montanaetrb.org
.
Last Updated: September 2026
Montana Governance Services Inc., operating as the Montana Experimental Treatment Review Board ("Montana ETRB," "METRB," "we," "us," or "our"), respects the privacy of individuals and organizations that visit our website, use our online portal, communicate with us, or submit information for review.
This Privacy Policy describes how we collect, use, disclose, retain, and protect information in connection with our website, online portal, review process, and related services (collectively, the "Services").
By accessing or using the Services, you acknowledge the practices described in this Privacy Policy.
1. About Montana ETRB
Montana Governance Services Inc. operates the Montana Experimental Treatment Review Board ("Montana ETRB"), an independent, private review board that evaluates experimental treatment protocols within the framework established under Montana law. Montana ETRB is not a state agency or official governmental body.
Our Services may include a public website, an online submission and case-management portal, communications with applicants and authorized users, review of treatment protocols and supporting materials, publication of certain review decisions or information, and related administrative services.
2. Information We Collect
We may collect information directly from you, automatically through your use of the Services, from organizations with which you are affiliated, and from other sources involved in a submission or review.
Information You Provide
Information you provide may include:
Name, email address, telephone number, and other contact information; Organization, company, or institutional information; Account credentials and authorized-user information; Treatment, protocol, clinical, scientific, regulatory, or research information; Clinical trial numbers, investigational new drug numbers, regulatory identifiers, and related information; Documents, attachments, correspondence, and other materials submitted for review; Responses to requests for additional information; Billing and transaction-related information; Communications with Montana ETRB, its staff, reviewers, or representatives; and Any other information you choose or are required to provide through the Services.
Health and Patient Information
Materials submitted to Montana ETRB may contain information relating to patients, research participants, treatment recipients, or other individuals.
Depending on the submission, this information may include health information, medical history, treatment information, clinical outcomes, adverse events, demographic information, genetic or biological information, or other sensitive or personally identifiable information.
Applicants and other persons submitting information are responsible for ensuring that they have all rights, permissions, consents, authorizations, or other lawful bases necessary to provide such information to Montana ETRB for the purposes of review.
Where patient-identifiable information is not necessary for review, submitters should avoid including it and should use de-identified or appropriately limited information whenever reasonably possible.
Montana ETRB does not represent through this Privacy Policy that it is a "covered entity" or "business associate" as those terms are defined under the Health Insurance Portability and Accountability Act ("HIPAA"). The applicability of HIPAA or other health privacy laws may depend on the circumstances, parties, and information involved.
Payment Information
Payments associated with submissions or other Services may be processed by third-party payment processors, including Stripe or another payment provider.
Montana ETRB generally does not receive or store complete payment-card numbers, security codes, or equivalent payment credentials processed directly by the payment provider. Payment processors may collect and process payment information under their own terms and privacy policies.
We may receive transaction-related information such as payment status, amount, transaction identifiers, billing contact information, and limited payment-method information.
Information Collected Automatically
When you use our Services, we or our service providers may automatically collect technical and usage information, including:
Internet Protocol (IP) address;Browser and device type;Operating system;Pages or features accessed;Date and time of access;Referring pages;Login and account activity;Session and diagnostic information; andOther information necessary to operate, secure, and improve the Services.
We may use cookies and similar technologies for authentication, security, functionality, analytics, and operation of the Services.
3. How We Use Information
We may use information we collect to:
Create, maintain, and administer user accounts;Receive and manage applications and submissions;Determine whether submissions are complete or ready for review;Conduct administrative, scientific, clinical, ethical, or other review activities;Communicate with applicants and authorized users;Request additional information or documentation;Facilitate review by Montana ETRB members, staff, advisors, or other authorized participants;Generate, maintain, and communicate review decisions and recommendations;Process payments and maintain transaction records;Maintain records relating to protocol review, approvals, safety evaluations, reports, and other review activities;Comply with applicable laws, regulations, administrative rules, legal obligations, governmental requests, and regulatory requirements;Detect, investigate, and prevent fraud, unauthorized access, misuse, security incidents, or other harmful activity;Maintain, troubleshoot, secure, and improve the Services;Produce required or appropriate reports, including aggregated or de-identified reports;Protect the rights, safety, property, and interests of Montana ETRB, applicants, reviewers, patients, and others; andCarry out other purposes reasonably related to operating Montana ETRB and its review activities.
4. How We Disclose Information
We may disclose information when reasonably necessary for the operation of the Services or the review process, including to:
Montana ETRB Reviewers and Personnel
Information may be made available to board members, reviewers, employees, contractors, advisors, administrators, and other individuals involved in administering or conducting reviews.
Service Providers
We may use third parties to provide hosting, cloud storage, database infrastructure, authentication, communications, analytics, security, payment processing, document management, and other technical or administrative services.These providers may process information on our behalf as necessary to provide their services.
Government and Regulatory Authorities
We may disclose information to the Montana Department of Public Health and Human Services ("DPHHS"), courts, law enforcement agencies, regulators, governmental bodies, or other authorities when required or permitted by applicable law, regulation, administrative rule, legal process, or governmental request.
Montana law and applicable administrative rules may require Montana ETRB or entities participating in the experimental-treatment framework to create, preserve, report, or make available certain records relating to treatment protocols, approvals, safety evaluations, outcomes, or other review activities.
Legal and Safety Purposes
We may disclose information when we reasonably believe disclosure is necessary to comply with law, enforce our agreements, investigate suspected misconduct, protect the security or integrity of the Services, or protect the rights, property, health, or safety of Montana ETRB or others.
Organizational Transactions
If Montana ETRB undergoes a reorganization, merger, transfer of operations, acquisition, financing, or similar organizational transaction, information may be disclosed or transferred as part of that transaction, subject to applicable law.
5. Public Information and Review Decisions
Certain information relating to Montana ETRB's activities, reviews, decisions, recommendations, approvals, or reporting obligations may be made publicly available.
This may include review decisions, summaries, aggregate statistics, general treatment or protocol information, safety or outcome information, review time frames, quality-improvement information, or other information appropriate or required for public reporting.
Where applicable law or regulation requires patient personally identifiable information to be removed from public reporting, Montana ETRB will endeavor to comply with those requirements.
Information submitted through the portal should not be assumed to be publicly available merely because it has been submitted. However, submission to Montana ETRB does not create an absolute guarantee of confidentiality, and information may be used or disclosed as described in this Privacy Policy, as necessary to conduct the review, or as required by law.
6. Data Retention
We retain information for as long as reasonably necessary for the purposes described in this Privacy Policy and to satisfy applicable legal, regulatory, contractual, operational, security, and recordkeeping requirements.
Applicable Montana rules require certain records relating to protocol review, approvals, safety evaluations, and reports to be preserved for at least five years.
Accordingly, deletion of an account or a request to delete information does not necessarily result in deletion of information that Montana ETRB is required or reasonably needs to retain.
Information may also remain in backups, archives, audit records, security logs, or other systems for a reasonable period after it is no longer actively used.
7. Data Security
We use reasonable administrative, technical, and organizational measures designed to protect information against unauthorized access, loss, misuse, alteration, or disclosure.
However, no website, online portal, electronic transmission, database, or storage system can be guaranteed to be completely secure. You provide and transmit information electronically at your own risk.
Users are responsible for maintaining the confidentiality of their account credentials and for promptly notifying Montana ETRB of suspected unauthorized access.
8. Your Responsibilities When Submitting Information
If you submit information concerning another person, including a patient, treatment recipient, employee, researcher, or other individual, you represent that you are authorized to provide that information for the purposes for which it is submitted.
You are responsible for determining whether patient-identifiable or other sensitive information is necessary for a submission and for complying with applicable privacy, confidentiality, consent, authorization, and data-protection requirements before providing such information.
Submitters should minimize sensitive or personally identifiable information where it is not reasonably necessary for Montana ETRB's review.
9. Your Choices and Requests
You may contact us to request access to, correction of, or deletion of certain personal information associated with you.
Some requests may be limited or denied where retention or processing is necessary to comply with legal or regulatory obligations, maintain review records, protect security or legal rights, complete transactions, resolve disputes, or fulfill other legitimate purposes.
We may take reasonable steps to verify your identity and authority before acting on a request.
10. Third-Party Services and Links
Our Services may contain links to third-party websites or integrate with services operated by third parties.
Those third parties operate independently from Montana ETRB, and their collection and use of information are governed by their own privacy practices. Montana ETRB is not responsible for the privacy, security, content, or practices of third-party websites or services.
11. Children's Privacy
The Services are intended for professional, organizational, regulatory, research, and related use and are not directed to children.
We do not knowingly solicit children to create accounts or directly submit personal information through the Services.
This provision does not prohibit authorized applicants from submitting information relating to minors where such information is lawful, necessary, and appropriate for a treatment-protocol review.
12. Changes to This Privacy Policy
We may update this Privacy Policy from time to time to reflect changes in our Services, practices, technology, legal requirements, or regulatory framework.
When we make changes, we may update the "Last Updated" date above. Your continued use of the Services after an updated Privacy Policy becomes effective constitutes acknowledgment of the updated policy to the extent permitted by law.
13. Contact Us
Questions, concerns, or requests regarding this Privacy Policy or our privacy practices may be directed to:
Montana Governance Services Inc.
d/b/a Montana Experimental Treatment Review Board
contact@montanaetrb.org
.
Terms of Use
Last Updated: September 2026
These Terms of Use ("Terms") govern access to and use of the website, online portal, submission system, review services, and related services (collectively, the "Services") provided by Montana Governance Services Inc., operating as the Montana Experimental Treatment Review Board ("Montana ETRB," "METRB," "we," "us," or "our").
By accessing or using the Services, creating an account, or submitting materials to Montana ETRB, you agree to these Terms.
If you use the Services on behalf of a company, experimental treatment center, research organization, treatment developer, institution, or other entity, you represent that you have authority to bind that entity to these Terms.
1. About Montana ETRB
Montana Governance Services Inc. operates the Montana Experimental Treatment Review Board ("Montana ETRB"), an independent, private review board that evaluates experimental treatment protocols within the framework established under Montana law, including applicable statutes and rules governing experimental treatment centers.
Montana ETRB is not a state agency or official governmental body.
Montana ETRB's role may include reviewing treatment protocols, evaluating submitted materials, requesting additional information, evaluating safety and quality considerations, assessing informed-consent procedures, conducting risk-benefit review, issuing review outcomes or recommendations, maintaining required records, and carrying out other activities contemplated by applicable Montana law and administrative rules.
2. Eligibility and Authority to Use the Services
You may use the Services only if you have legal authority to do so and can comply with these Terms.
If you use the Services on behalf of an organization, you represent and warrant that you are authorized to act for that organization and to provide the information and materials submitted through your account.
You may not use the Services in violation of applicable law, regulation, professional obligation, contractual obligation, or third-party rights.
3. Accounts and Authorized Users
Certain portions of the Services require an account.
You are responsible for:
Providing accurate account information;Maintaining the confidentiality of your login credentials;Controlling access by individuals authorized to use your account or organization;Ensuring that authorized users comply with these Terms;Promptly updating information when appropriate; andNotifying Montana ETRB promptly if you become aware of unauthorized access or use.
You are responsible for activity conducted through your account to the extent permitted by applicable law.
You may not share credentials with unauthorized persons, impersonate another person or organization, or attempt to gain unauthorized access to another user's account, submission, or information.
4. Submissions
Applicants may submit treatment protocols, clinical information, research materials, safety information, regulatory documentation, informed-consent materials, supporting documents, correspondence, and other information through the Services.
By submitting materials, you represent and warrant that:The information is accurate and complete to the best of your knowledge;You are authorized to submit the materials;Submission and use of the materials for Montana ETRB's review do not violate applicable law or third-party rights;You have obtained any permissions, consents, authorizations, or other legal bases necessary for information concerning third parties;You will not knowingly provide false, fraudulent, misleading, or materially incomplete information; andYou will provide additional or corrected information when reasonably necessary for the review.
Montana ETRB may rely on information supplied by applicants and is not responsible for independently verifying every factual representation contained in a submission.
5. Sensitive and Patient Information
Submissions may contain confidential, medical, clinical, patient-level, or otherwise sensitive information.
You are responsible for determining whether such information is necessary and lawful to submit.
Where patient-identifiable information is unnecessary for the review, you should use de-identified or appropriately limited information whenever reasonably possible.
You are responsible for complying with privacy, confidentiality, informed-consent, authorization, professional, institutional, and data-protection obligations applicable to information you submit.
Submission of information to Montana ETRB does not, by itself, establish that Montana ETRB is acting as a HIPAA covered entity, business associate, health-care provider, physician, fiduciary, or other regulated party in relation to the submitter or any patient.
6. Review Process
Submission of materials does not guarantee acceptance for review, approval, a particular review schedule, or any particular outcome.
Montana ETRB may:Conduct preliminary or administrative review;Determine that additional information is required;Request clarification or supplemental documentation;Refer materials to appropriate reviewers;Evaluate the submission under applicable review criteria;Defer or pause review;Decline to review a submission;Approve or decline to approve a protocol;Impose or recommend conditions, monitoring, reporting, or other requirements where appropriate; andReconsider, modify, suspend, or withdraw a prior determination where permitted or required.
Review timing may depend on completeness, complexity, reviewer availability, responses to requests for information, payment status, and other circumstances.
7. Nature and Limitations of ETRB Review
A Montana ETRB review, recommendation, decision, or approval is limited to the scope of Montana ETRB's review and the applicable Montana experimental-treatment framework.
Unless expressly required by applicable law, a Montana ETRB review, recommendation, decision, or approval does not constitute: Medical advice or patient-specific medical care;A physician-patient relationship;A guarantee that any treatment is safe;A guarantee that any treatment is effective;A guarantee of any clinical result or patient outcome;Approval, authorization, clearance, or endorsement by the U.S. Food and Drug Administration or any other federal agency;Satisfaction of every federal, state, local, professional, institutional, licensing, research, or regulatory requirement that may apply;A substitute for independent medical judgment;A recommendation that a particular patient receive a particular treatment;A guarantee that an experimental treatment center or other person may lawfully provide a treatment under every applicable law or regulatory regime; orAn assumption by Montana ETRB of responsibility for the administration, manufacture, prescription, provision, monitoring, or clinical use of a treatment.
Applicants, treatment centers, clinicians, manufacturers, researchers, and other involved parties remain independently responsible for their respective legal, regulatory, ethical, professional, clinical, and safety obligations.
8. No Guarantee of Safety or Efficacy
Experimental treatments inherently may involve known and unknown risks.
Montana ETRB's evaluation of a treatment protocol is based on information available to the board during the review process and within the scope of the applicable review criteria.
An approval or favorable review outcome should not be interpreted as a representation, warranty, or guarantee that a treatment is free from risk, will be effective, is appropriate for any specific patient, or will produce a particular outcome.
Medical decisions concerning individual patients remain the responsibility of appropriately qualified health-care professionals and patients.
9. Continuing Obligations
Approval or completion of an initial review does not eliminate continuing obligations that may apply to applicants, treatment centers, clinicians, or other parties.
Where applicable, relevant parties remain responsible for monitoring safety, maintaining required records, reporting adverse events or material developments, complying with informed-consent requirements, satisfying regulatory obligations, and providing information required by Montana ETRB or governmental authorities.
10. Fees and Payments
Montana ETRB may charge fees associated with submissions, reviews, administrative services, or other Services.
Payments may be processed through third-party payment providers, including Stripe.
You agree to provide accurate billing information and pay applicable fees when due.
Unless otherwise stated in writing, payment of a fee does not guarantee approval, a favorable decision, completion within a particular time period, or any particular review outcome.
Third-party payment processors may impose additional terms governing payment transactions.
Refunds, if any, will be governed by the applicable payment terms or other written policies in effect at the time of payment.
11. Records and Regulatory Access
Montana ETRB may create and maintain records relating to submissions, protocol reviews, approvals, safety evaluations, decisions, communications, and reports.
Records may be retained for periods required by applicable law or reasonably necessary for Montana ETRB's operations.
Certain records may be provided to DPHHS or other governmental or regulatory authorities where required or permitted by law.
Applicable Montana rules require certain records relating to protocol review, approvals, safety evaluations, and reports to be preserved for at least five years.
12. Public Decisions and Reporting
Montana ETRB may publish or otherwise make available review decisions, recommendations, summaries, reports, aggregate information, treatment or protocol information, safety or outcome information, review time frames, quality-improvement information, or other information relating to its activities where appropriate or required.
Public reporting may be subject to requirements concerning removal of patient personally identifiable information.
Submission materials should not be assumed to be public solely because they are provided to Montana ETRB. However, Montana ETRB does not guarantee absolute confidentiality and may use, retain, disclose, or publish information as permitted by these Terms, the Privacy Policy, applicable law, applicable administrative rules, or requirements of the review process.
13. License to Submitted Materials
You retain any ownership rights you may have in materials you submit.
By submitting materials, you grant Montana ETRB a non-exclusive, worldwide, royalty-free license to access, reproduce, store, process, transmit, display, distribute internally, and otherwise use those materials as reasonably necessary to:Administer the submission;Conduct the review;Communicate with relevant parties;Maintain records;Generate decisions, reports, or other review materials;Comply with legal and regulatory obligations; andOperate and protect the Services.
This license continues for as long as reasonably necessary to fulfill these purposes, including applicable record-retention obligations.
Nothing in these Terms transfers ownership of your intellectual property to Montana ETRB.
14. Montana ETRB Content
Unless otherwise indicated, the Services and their design, text, graphics, logos, software, templates, documentation, and other content created by or for Montana ETRB are owned by Montana ETRB or its licensors and are protected by applicable intellectual-property laws.
You may use such content for legitimate purposes associated with the Services but may not reproduce, distribute, modify, sell, exploit, or misrepresent Montana ETRB content without authorization.
15. Acceptable Use
You may not:Use the Services for unlawful, fraudulent, or deceptive purposes;Submit information you know to be materially false or misleading;Access information or accounts without authorization;Attempt to bypass authentication, security, or access controls;Introduce malware, malicious code, or harmful material;Interfere with the operation or security of the Services;Scrape, harvest, or systematically extract non-public information without authorization;Reverse engineer or attempt to discover protected source code except where applicable law expressly permits it;Misrepresent a Montana ETRB review, decision, recommendation, or approval;Imply that Montana ETRB, DPHHS, the State of Montana, or another authority endorses a treatment beyond the actual scope of a documented determination; orUse Montana ETRB's name, marks, decisions, or materials in a materially false or misleading manner.
16. Suspension and Termination
Montana ETRB may restrict, suspend, or terminate access to the Services where reasonably necessary to protect the Services or other users, respond to suspected misuse or security concerns, enforce these Terms, address nonpayment, comply with law, or maintain the integrity of the review process.
Termination of portal access does not require Montana ETRB to delete records that it is required or reasonably entitled to retain.
17. Third-Party Services
The Services may use or link to third-party platforms, payment processors, hosting providers, communication tools, or other services.
Montana ETRB does not control and is not responsible for the availability, content, security, privacy practices, or independent actions of third-party services.
Use of third-party services may be subject to separate terms and policies.
18. Disclaimer of Warranties
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE SERVICES ARE PROVIDED "AS IS" AND "AS AVAILABLE."
MONTANA ETRB DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, ACCURACY, AVAILABILITY, SECURITY, OR RELIABILITY.
MONTANA ETRB DOES NOT WARRANT THAT THE SERVICES WILL BE UNINTERRUPTED, ERROR-FREE, COMPLETELY SECURE, OR FREE FROM HARMFUL COMPONENTS.
Nothing in this section limits obligations or liabilities that cannot lawfully be disclaimed.
19. Limitation of Liability
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, MONTANA ETRB AND ITS BOARD MEMBERS, OFFICERS, EMPLOYEES, CONTRACTORS, ADVISORS, AGENTS, AND REPRESENTATIVES WILL NOT BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR FOR LOSS OF PROFITS, REVENUE, DATA, BUSINESS OPPORTUNITIES, GOODWILL, OR ANTICIPATED SAVINGS, ARISING FROM OR RELATED TO THE SERVICES.
TO THE MAXIMUM EXTENT PERMITTED BY LAW, MONTANA ETRB WILL NOT BE LIABLE FOR INJURY, ADVERSE EVENTS, CLINICAL OUTCOMES, TREATMENT RESULTS, OR OTHER CONSEQUENCES ARISING FROM THE MANUFACTURE, PRESCRIPTION, ADMINISTRATION, PROVISION, USE, OR NON-USE OF AN EXPERIMENTAL TREATMENT EXCEPT TO THE EXTENT SUCH LIABILITY CANNOT LAWFULLY BE EXCLUDED.
Nothing in these Terms excludes or limits liability where exclusion or limitation is prohibited by applicable law.
20. Indemnification
To the extent permitted by applicable law, you agree to indemnify, defend, and hold harmless Montana ETRB and its board members, officers, employees, contractors, advisors, agents, and representatives from claims, liabilities, damages, losses, costs, and expenses, including reasonable attorneys' fees, arising from or related to:Your violation of these Terms;Your unlawful or unauthorized submission or use of information;Materials you submit;Your violation of third-party rights;Your misuse of a Montana ETRB review, decision, recommendation, or approval; orYour violation of applicable law.
This provision does not require indemnification to the extent prohibited by applicable law.
21. Privacy
Use of the Services is also subject to the Montana ETRB Privacy Policy.
The Privacy Policy describes how Montana ETRB collects, uses, discloses, retains, and protects information associated with the Services.
22. Changes to the Services or Terms
Montana ETRB may modify the Services or these Terms from time to time to reflect operational, technological, regulatory, legal, or other changes.
When these Terms are updated, the "Last Updated" date may be revised.
Your continued use of the Services after updated Terms become effective constitutes acceptance of those updated Terms to the extent permitted by applicable law.
23. Governing Law
These Terms and disputes arising from or relating to these Terms or the Services are governed by the laws of the State of Montana, without regard to conflict-of-laws principles, except to the extent another law must apply as a matter of law.
Nothing in these Terms limits any rights, obligations, jurisdiction, or venue established by applicable law.
24. Severability
If any provision of these Terms is determined to be unlawful, invalid, or unenforceable, that provision will be enforced to the maximum extent permissible and the remaining provisions will remain in effect.
25. No Waiver
Failure by Montana ETRB to enforce a provision of these Terms does not constitute a waiver of that provision or any other provision.
26. Entire Agreement
These Terms, together with the Privacy Policy and any additional written terms expressly applicable to a particular Service or submission, constitute the agreement governing your use of the Services with respect to their subject matter.
27. Contact Us
Questions regarding these Terms may be directed to:
Montana Governance Services Inc.
d/b/a Montana Experimental Treatment Review Board
contact@montanaetrb.org
Last Updated: September 2026
These Terms of Use ("Terms") govern access to and use of the website, online portal, submission system, review services, and related services (collectively, the "Services") provided by Montana Governance Services Inc., operating as the Montana Experimental Treatment Review Board ("Montana ETRB," "METRB," "we," "us," or "our").
By accessing or using the Services, creating an account, or submitting materials to Montana ETRB, you agree to these Terms.
If you use the Services on behalf of a company, experimental treatment center, research organization, treatment developer, institution, or other entity, you represent that you have authority to bind that entity to these Terms.
1. About Montana ETRB
Montana Governance Services Inc. operates the Montana Experimental Treatment Review Board ("Montana ETRB"), an independent, private review board that evaluates experimental treatment protocols within the framework established under Montana law, including applicable statutes and rules governing experimental treatment centers.
Montana ETRB is not a state agency or official governmental body.
Montana ETRB's role may include reviewing treatment protocols, evaluating submitted materials, requesting additional information, evaluating safety and quality considerations, assessing informed-consent procedures, conducting risk-benefit review, issuing review outcomes or recommendations, maintaining required records, and carrying out other activities contemplated by applicable Montana law and administrative rules.
2. Eligibility and Authority to Use the Services
You may use the Services only if you have legal authority to do so and can comply with these Terms.
If you use the Services on behalf of an organization, you represent and warrant that you are authorized to act for that organization and to provide the information and materials submitted through your account.
You may not use the Services in violation of applicable law, regulation, professional obligation, contractual obligation, or third-party rights.
3. Accounts and Authorized Users
Certain portions of the Services require an account.
You are responsible for:
Providing accurate account information;Maintaining the confidentiality of your login credentials;Controlling access by individuals authorized to use your account or organization;Ensuring that authorized users comply with these Terms;Promptly updating information when appropriate; andNotifying Montana ETRB promptly if you become aware of unauthorized access or use.
You are responsible for activity conducted through your account to the extent permitted by applicable law.
You may not share credentials with unauthorized persons, impersonate another person or organization, or attempt to gain unauthorized access to another user's account, submission, or information.
4. Submissions
Applicants may submit treatment protocols, clinical information, research materials, safety information, regulatory documentation, informed-consent materials, supporting documents, correspondence, and other information through the Services.
By submitting materials, you represent and warrant that:The information is accurate and complete to the best of your knowledge;You are authorized to submit the materials;Submission and use of the materials for Montana ETRB's review do not violate applicable law or third-party rights;You have obtained any permissions, consents, authorizations, or other legal bases necessary for information concerning third parties;You will not knowingly provide false, fraudulent, misleading, or materially incomplete information; andYou will provide additional or corrected information when reasonably necessary for the review.
Montana ETRB may rely on information supplied by applicants and is not responsible for independently verifying every factual representation contained in a submission.
5. Sensitive and Patient Information
Submissions may contain confidential, medical, clinical, patient-level, or otherwise sensitive information.
You are responsible for determining whether such information is necessary and lawful to submit.
Where patient-identifiable information is unnecessary for the review, you should use de-identified or appropriately limited information whenever reasonably possible.
You are responsible for complying with privacy, confidentiality, informed-consent, authorization, professional, institutional, and data-protection obligations applicable to information you submit.
Submission of information to Montana ETRB does not, by itself, establish that Montana ETRB is acting as a HIPAA covered entity, business associate, health-care provider, physician, fiduciary, or other regulated party in relation to the submitter or any patient.
6. Review Process
Submission of materials does not guarantee acceptance for review, approval, a particular review schedule, or any particular outcome.
Montana ETRB may:Conduct preliminary or administrative review;Determine that additional information is required;Request clarification or supplemental documentation;Refer materials to appropriate reviewers;Evaluate the submission under applicable review criteria;Defer or pause review;Decline to review a submission;Approve or decline to approve a protocol;Impose or recommend conditions, monitoring, reporting, or other requirements where appropriate; andReconsider, modify, suspend, or withdraw a prior determination where permitted or required.
Review timing may depend on completeness, complexity, reviewer availability, responses to requests for information, payment status, and other circumstances.
7. Nature and Limitations of ETRB Review
A Montana ETRB review, recommendation, decision, or approval is limited to the scope of Montana ETRB's review and the applicable Montana experimental-treatment framework.
Unless expressly required by applicable law, a Montana ETRB review, recommendation, decision, or approval does not constitute: Medical advice or patient-specific medical care;A physician-patient relationship;A guarantee that any treatment is safe;A guarantee that any treatment is effective;A guarantee of any clinical result or patient outcome;Approval, authorization, clearance, or endorsement by the U.S. Food and Drug Administration or any other federal agency;Satisfaction of every federal, state, local, professional, institutional, licensing, research, or regulatory requirement that may apply;A substitute for independent medical judgment;A recommendation that a particular patient receive a particular treatment;A guarantee that an experimental treatment center or other person may lawfully provide a treatment under every applicable law or regulatory regime; orAn assumption by Montana ETRB of responsibility for the administration, manufacture, prescription, provision, monitoring, or clinical use of a treatment.
Applicants, treatment centers, clinicians, manufacturers, researchers, and other involved parties remain independently responsible for their respective legal, regulatory, ethical, professional, clinical, and safety obligations.
8. No Guarantee of Safety or Efficacy
Experimental treatments inherently may involve known and unknown risks.
Montana ETRB's evaluation of a treatment protocol is based on information available to the board during the review process and within the scope of the applicable review criteria.
An approval or favorable review outcome should not be interpreted as a representation, warranty, or guarantee that a treatment is free from risk, will be effective, is appropriate for any specific patient, or will produce a particular outcome.
Medical decisions concerning individual patients remain the responsibility of appropriately qualified health-care professionals and patients.
9. Continuing Obligations
Approval or completion of an initial review does not eliminate continuing obligations that may apply to applicants, treatment centers, clinicians, or other parties.
Where applicable, relevant parties remain responsible for monitoring safety, maintaining required records, reporting adverse events or material developments, complying with informed-consent requirements, satisfying regulatory obligations, and providing information required by Montana ETRB or governmental authorities.
10. Fees and Payments
Montana ETRB may charge fees associated with submissions, reviews, administrative services, or other Services.
Payments may be processed through third-party payment providers, including Stripe.
You agree to provide accurate billing information and pay applicable fees when due.
Unless otherwise stated in writing, payment of a fee does not guarantee approval, a favorable decision, completion within a particular time period, or any particular review outcome.
Third-party payment processors may impose additional terms governing payment transactions.
Refunds, if any, will be governed by the applicable payment terms or other written policies in effect at the time of payment.
11. Records and Regulatory Access
Montana ETRB may create and maintain records relating to submissions, protocol reviews, approvals, safety evaluations, decisions, communications, and reports.
Records may be retained for periods required by applicable law or reasonably necessary for Montana ETRB's operations.
Certain records may be provided to DPHHS or other governmental or regulatory authorities where required or permitted by law.
Applicable Montana rules require certain records relating to protocol review, approvals, safety evaluations, and reports to be preserved for at least five years.
12. Public Decisions and Reporting
Montana ETRB may publish or otherwise make available review decisions, recommendations, summaries, reports, aggregate information, treatment or protocol information, safety or outcome information, review time frames, quality-improvement information, or other information relating to its activities where appropriate or required.
Public reporting may be subject to requirements concerning removal of patient personally identifiable information.
Submission materials should not be assumed to be public solely because they are provided to Montana ETRB. However, Montana ETRB does not guarantee absolute confidentiality and may use, retain, disclose, or publish information as permitted by these Terms, the Privacy Policy, applicable law, applicable administrative rules, or requirements of the review process.
13. License to Submitted Materials
You retain any ownership rights you may have in materials you submit.
By submitting materials, you grant Montana ETRB a non-exclusive, worldwide, royalty-free license to access, reproduce, store, process, transmit, display, distribute internally, and otherwise use those materials as reasonably necessary to:Administer the submission;Conduct the review;Communicate with relevant parties;Maintain records;Generate decisions, reports, or other review materials;Comply with legal and regulatory obligations; andOperate and protect the Services.
This license continues for as long as reasonably necessary to fulfill these purposes, including applicable record-retention obligations.
Nothing in these Terms transfers ownership of your intellectual property to Montana ETRB.
14. Montana ETRB Content
Unless otherwise indicated, the Services and their design, text, graphics, logos, software, templates, documentation, and other content created by or for Montana ETRB are owned by Montana ETRB or its licensors and are protected by applicable intellectual-property laws.
You may use such content for legitimate purposes associated with the Services but may not reproduce, distribute, modify, sell, exploit, or misrepresent Montana ETRB content without authorization.
15. Acceptable Use
You may not:Use the Services for unlawful, fraudulent, or deceptive purposes;Submit information you know to be materially false or misleading;Access information or accounts without authorization;Attempt to bypass authentication, security, or access controls;Introduce malware, malicious code, or harmful material;Interfere with the operation or security of the Services;Scrape, harvest, or systematically extract non-public information without authorization;Reverse engineer or attempt to discover protected source code except where applicable law expressly permits it;Misrepresent a Montana ETRB review, decision, recommendation, or approval;Imply that Montana ETRB, DPHHS, the State of Montana, or another authority endorses a treatment beyond the actual scope of a documented determination; orUse Montana ETRB's name, marks, decisions, or materials in a materially false or misleading manner.
16. Suspension and Termination
Montana ETRB may restrict, suspend, or terminate access to the Services where reasonably necessary to protect the Services or other users, respond to suspected misuse or security concerns, enforce these Terms, address nonpayment, comply with law, or maintain the integrity of the review process.
Termination of portal access does not require Montana ETRB to delete records that it is required or reasonably entitled to retain.
17. Third-Party Services
The Services may use or link to third-party platforms, payment processors, hosting providers, communication tools, or other services.
Montana ETRB does not control and is not responsible for the availability, content, security, privacy practices, or independent actions of third-party services.
Use of third-party services may be subject to separate terms and policies.
18. Disclaimer of Warranties
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE SERVICES ARE PROVIDED "AS IS" AND "AS AVAILABLE."
MONTANA ETRB DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, ACCURACY, AVAILABILITY, SECURITY, OR RELIABILITY.
MONTANA ETRB DOES NOT WARRANT THAT THE SERVICES WILL BE UNINTERRUPTED, ERROR-FREE, COMPLETELY SECURE, OR FREE FROM HARMFUL COMPONENTS.
Nothing in this section limits obligations or liabilities that cannot lawfully be disclaimed.
19. Limitation of Liability
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, MONTANA ETRB AND ITS BOARD MEMBERS, OFFICERS, EMPLOYEES, CONTRACTORS, ADVISORS, AGENTS, AND REPRESENTATIVES WILL NOT BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, CONSEQUENTIAL, OR PUNITIVE DAMAGES, OR FOR LOSS OF PROFITS, REVENUE, DATA, BUSINESS OPPORTUNITIES, GOODWILL, OR ANTICIPATED SAVINGS, ARISING FROM OR RELATED TO THE SERVICES.
TO THE MAXIMUM EXTENT PERMITTED BY LAW, MONTANA ETRB WILL NOT BE LIABLE FOR INJURY, ADVERSE EVENTS, CLINICAL OUTCOMES, TREATMENT RESULTS, OR OTHER CONSEQUENCES ARISING FROM THE MANUFACTURE, PRESCRIPTION, ADMINISTRATION, PROVISION, USE, OR NON-USE OF AN EXPERIMENTAL TREATMENT EXCEPT TO THE EXTENT SUCH LIABILITY CANNOT LAWFULLY BE EXCLUDED.
Nothing in these Terms excludes or limits liability where exclusion or limitation is prohibited by applicable law.
20. Indemnification
To the extent permitted by applicable law, you agree to indemnify, defend, and hold harmless Montana ETRB and its board members, officers, employees, contractors, advisors, agents, and representatives from claims, liabilities, damages, losses, costs, and expenses, including reasonable attorneys' fees, arising from or related to:Your violation of these Terms;Your unlawful or unauthorized submission or use of information;Materials you submit;Your violation of third-party rights;Your misuse of a Montana ETRB review, decision, recommendation, or approval; orYour violation of applicable law.
This provision does not require indemnification to the extent prohibited by applicable law.
21. Privacy
Use of the Services is also subject to the Montana ETRB Privacy Policy.
The Privacy Policy describes how Montana ETRB collects, uses, discloses, retains, and protects information associated with the Services.
22. Changes to the Services or Terms
Montana ETRB may modify the Services or these Terms from time to time to reflect operational, technological, regulatory, legal, or other changes.
When these Terms are updated, the "Last Updated" date may be revised.
Your continued use of the Services after updated Terms become effective constitutes acceptance of those updated Terms to the extent permitted by applicable law.
23. Governing Law
These Terms and disputes arising from or relating to these Terms or the Services are governed by the laws of the State of Montana, without regard to conflict-of-laws principles, except to the extent another law must apply as a matter of law.
Nothing in these Terms limits any rights, obligations, jurisdiction, or venue established by applicable law.
24. Severability
If any provision of these Terms is determined to be unlawful, invalid, or unenforceable, that provision will be enforced to the maximum extent permissible and the remaining provisions will remain in effect.
25. No Waiver
Failure by Montana ETRB to enforce a provision of these Terms does not constitute a waiver of that provision or any other provision.
26. Entire Agreement
These Terms, together with the Privacy Policy and any additional written terms expressly applicable to a particular Service or submission, constitute the agreement governing your use of the Services with respect to their subject matter.
27. Contact Us
Questions regarding these Terms may be directed to:
Montana Governance Services Inc.
d/b/a Montana Experimental Treatment Review Board
contact@montanaetrb.org