TIPRE provides Institutional Review Board oversight and a real-world evidence registry for licensed clinics conducting peptide therapy research. Our standing protocols are governed by Tier 1 evidence and reviewed by an independent ethics board.
The peptide therapy field is growing rapidly in clinical practice but the systematic evidence base has not kept pace. Patients deserve to know that the treatments they receive are governed by documented standards. Doctors deserve a framework for participating in evidence generation without bearing the full regulatory burden alone.
TIPRE exists to be that framework. We approve standing protocols only where Tier 1 PubMed and NIH-indexed evidence supports them. We require informed consent, HIPAA authorization, and tamper-evident audit records for every enrollment. We monitor outcomes across participating clinics so that safety signals can be detected at scale.
We are explicitly not a treatment provider, a compounding pharmacy, or a sales channel. We are oversight infrastructure for the clinics and physicians doing the work.
Michael leads TIPRE's governance, technology, and operational infrastructure. He brings two decades of experience designing systems for regulated environments, with operational leadership in FDA-regulated pharmaceutical manufacturing and training in clinical and naturopathic care.
His role at TIPRE focuses on building the institute's research infrastructure, audit architecture, and operational standards.
Lizbeth is a published academic researcher with deep institutional research experience. Her professional background includes regulatory and quality-assurance roles at a Fortune 100 company, with subject-matter expertise in Medicare and Medicaid compliance.
She has extensive experience in nonprofit management and serves as TIPRE's registered agent.
Every protocol in our library is anchored to peer-reviewed literature graded by tier. Citations are versioned, attributable, and retired when evidence weakens. The board does not approve what the evidence does not support.
TIPRE does not write prescriptions, dispense medications, or share in clinical revenue. Our board operates under documented conflict-of-interest policies. Annual independence audits will be published.
Consent, adverse events, and IRB decisions are encrypted, audit-logged, and cryptographically timestamped to a public blockchain. The complete record of what was approved and when remains independently verifiable, indefinitely.
If your clinic prescribes peptides as part of clinical practice, TIPRE membership provides IRB oversight, structured outcome capture, and a documented framework for the work you are already doing.
If your doctor is a TIPRE-credentialed physician at a participating clinic, your treatment occurs under a standing protocol reviewed by our IRB. Your participation in the registry is voluntary and you may withdraw at any time.
A new peptide-condition pair does not appear in the TIPRE library casually. The board reviews the evidence base, the regulatory pathway, the safety profile, and the clinical context — and may decline.
Curators compile the candidate peptide-condition pair's published literature. Citations are graded by tier (Tier 1: randomized trials, meta-analyses, regulatory documents). Below a minimum tier threshold, the candidate does not advance.
The peptide's compounding pathway is verified (503A or 503B). FDA bulks list status, prior agency actions, and current shortage status are documented. Any unresolved regulatory question stops the review.
The IRB convenes to evaluate the candidate against 45 CFR 46.111 and 21 CFR 56.111 criteria. Members with conflicts recuse. The vote is recorded, attributable, and retained.
Approved protocols are not static. Cross-clinic outcomes, new published evidence, and adverse event patterns trigger periodic re-review. Protocols can be amended, suspended, or retired.
No. TIPRE does not prescribe, dispense, or sell any peptide or other treatment. Prescriptions are written by independently licensed physicians at participating clinics, using their own clinical judgment, and filled by independent compounding pharmacies under separate regulatory authority.
TIPRE's role is limited to: approving standing protocols based on evidence, credentialing participating physicians, providing the infrastructure for consent and outcomes capture, and conducting cross-clinic safety surveillance.
The current standing protocol library is under review and will be published when finalized. The library will be limited to peptides for which Tier 1 evidence supports specific indications, and for which a defensible compounding pathway is documented.
If you are a clinic interested in participation, we will share the current candidate list during the application process.
TIPRE is funded primarily through clinic membership fees. Each participating clinic pays an annual membership fee of $1,000. TIPRE does not receive payment from compounding pharmacies, peptide manufacturers, or any party with a financial interest in specific protocols being approved or rejected.
TIPRE's annual financial statements will be made available to participating clinics and to the public.
Every participating patient signs both an informed consent for registry participation and a separate HIPAA authorization. Protected health information is encrypted at rest, in transit, and at the field level using per-clinic encryption keys.
Each patient can view who has accessed their record, when, and why, through their patient portal — a HIPAA right-of-access feature we have built in as a first-class capability rather than something requiring a written request.
Patients may withdraw at any time. De-identified registry outputs use the HIPAA Safe Harbor or Expert Determination methods depending on the publication context.
TIPRE will register with relevant federal authorities prior to operational launch. TIPRE will report adverse events and safety signals to FDA in accordance with applicable regulations. Specific reporting structures are being finalized with regulatory counsel.
For tamper-evident integrity, not for novelty. TIPRE uses OpenTimestamps to anchor a daily Merkle root of consent, IRB, and adverse event records to the Bitcoin blockchain. No personal health information is ever placed on chain — only cryptographic hashes.
The result is that TIPRE — or any future auditor — can prove that a given consent existed at a given time and has not been altered, without trusting any party. This matters most for the records people care most about: who consented to what, when an adverse event was first known, and what the IRB approved.
The founding directors are listed above. Additional IRB members will be recruited prior to operational launch in accordance with 45 CFR 46.107 and 21 CFR 56.107 membership requirements, including a non-affiliated member, a non-scientific member, and members with relevant clinical expertise.
TIPRE is currently in pre-launch. We are completing regulatory review with counsel, building HIPAA-compliant infrastructure, and recruiting initial IRB board members.
We expect to begin a limited pilot with a small number of participating clinics later in 2026, followed by broader availability after pilot validation. Clinics interested in early participation are invited to contact us.