Site Participant Consent — Mortensen Medical Research Network

This consent is the agreement a licensed healthcare provider signs to participate as a site in the observational registry operated by the Mortensen Medical Research Network under Protocol PPRN-001-2025, with oversight by the IRCM Institutional Review Board (IRCM-2025-467). It is identical for every site. By signing, the provider agrees to the terms below for the duration of participation.

1. Purpose of the registry

The registry collects real-world data on the safety, tolerability and outcomes of peptide and regenerative therapies that participating clinicians prescribe within their normal scope of practice. It is observational. It does not assign, direct or require any treatment. It documents treatment decisions made by the treating clinician.

The IRB oversees the collection of registry data and the protection of participants. It has not approved any product, dose or treatment protocol, and nothing in the registry may be described as "IRB approved."

2. Site responsibilities

As a participating site, the undersigned provider agrees to:

• Prescribe only within the scope of their license and independent clinical judgment.
• Enroll a patient in the registry only after obtaining the registry's IRB-approved data-collection consent. That consent is separate from the clinic's own treatment consent, which remains the clinic's responsibility.
• Report serious adverse events to the registry within 7 calendar days, and all other adverse events within 5 business days, of becoming aware of them.
• Submit visit data within 14 days of each visit, de-identified and keyed only to the site code and the registry subject identifier.
• Keep the key that links subject identifiers to patients at the clinic, and never transmit names, dates of birth, contact details, record numbers, full dates or images of patients to the registry.
• Retain registry records for at least 7 years.

3. Sourcing

Each site chooses its own sources. Products recorded in the registry may come from any licensed pharmacy or supplier. For each product recorded, the site keeps the lot number and a certificate of analysis. Sourcing through any particular company, including Peptide Pure LLC, is optional and is never a condition of participation.

4. Participant protections

• Registry participation is voluntary for every patient and is documented by the IRB-approved data-collection consent.
• A participant may withdraw from the registry at any time without any effect on their care.
• Only de-identified data reaches the registry. Identifiable records stay at the enrolling site.
• Participants may contact the IRCM Institutional Review Board about their rights at (786) 271-2157.

5. Use of registry data

De-identified registry data may be used by the Mortensen Medical Research Network and its research collaborators for peer-reviewed publication and presentation, regulatory submissions that support the legitimate clinical use of these therapies, aggregate safety and outcome reports to participating sites, and quality improvement of the registry.

The site keeps all rights to its own clinical records. The registry claims nothing outside what the site submits to it.

6. Registry integrity

The site will not represent a treatment as part of the registry unless it is recorded in the registry, will not use registry participation in advertising or as a reason to buy any product, and will not describe any product, dose or protocol as "IRB approved."

7. Term and withdrawal

Participation continues for the duration of the protocol or until either party gives 30 days' written notice. After withdrawal, the site keeps its own records and remains bound by confidentiality for registry data.

8. Acknowledgements

The provider acknowledges that the therapies recorded in the registry are not FDA-approved for the indications observed; that registry participation is not FDA approval, clearance or endorsement; that participation offers no protection from patent, regulatory or legal claims; and that the provider remains solely responsible for clinical decisions and for compliance with state and federal law, including DEA rules where relevant. Participation is voluntary and creates no employment or agency relationship.

9. Contact

Registry questions and adverse event reporting: contact@mortensenmedical.com. Questions about the rights of registry participants: the IRCM Institutional Review Board, (786) 271-2157.

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