.png)
Why
JOIN THE IORE IRB?
Practice Medicine Incorporating Biologics, With the Added Benefit of IRB Oversight
Join our accredited IRB and retrospective research repository, designed specifically for clinicians using autologous, allogenic, and umbilical derived biologics.
Built for Real-World Clinical Medicine
Aligned with FDA Expectations Standards for Investigational Research
Designed to Support Providers
Regulatory
Expectations
are Evolving.
Most physicians are not acting irresponsibly. In many cases, clinical innovation has simply outpaced the regulatory frameworks designed to oversee it.
However, certain realities are important to understand:
-
Federal oversight may apply regardless of state-level guidance
-
Clinical norms do not replace federal biologics regulations
-
Research involving non-homologous questions receives heightened regulatory attention when conducted outside structured oversight
-
Cash-pay and concierge models are subject to the same federal considerations as traditional practices
The use of biologics itself is rarely the issue; scrutiny tends to focus on marketing practices and overstated or unsubstantiated claims.
For Physicians Using Biologics,
IRB Oversight Provides a Supportive, Structured Pathway with Meaningful Benefits for Clinicians & Clinics
Providers have always had the right to practice medicine. However, pairing that autonomy with shared infrastructure and collective learning helps providers move forward with consistency.
​
In these settings, IRB alignment often helps provide clarity and confidence around:
-
Communicating clinical experience while distinguishing it from formal research
-
Sharing educational insights without crossing into promotional overstatement
-
using structured data to support thoughtful outcome discussions
-
Engaging more openly and responsibly within established regulatory frameworks
An accredited IRB supports a federally recognized framework for:
​
-
Structured investigational protocols
-
Outcomes-driven biologic research initiatives
-
Retrospective and prospective data review
-
Evaluation of how biologics are utilized in clinical practice, including application methods and observed patient outcomes
The IORE is not a Product Company. It's a Research & Governance Infrastructure.
The Institute of Regenerative Education (IORE) provides physicians with a compliant, defensible, and scalable framework for advancing biologic research in clinical practice.
The IORE Provides:
Access to an independent, accredited IRB
Pre-built biologics-appropriate research frameworks
Retrospective data repository enrollment
Ongoing protocol support and documentation
Alignment with applicable FDA expectations for investigational research
IORE was built specifically for this clinical and regulatory space, not repurposed from traditional pharmaceutical trials.
Our research framework is designed to support and document real-world clinical decision-making.
I +
RE
All Major Modalities.
ONE IRB
Covered Under the IORE Framework:
-
PRP & PRF (advanced and modified protocols)
-
Exosome-based biologics derived from human secretomes
-
Wharton’s Jelly & extracellular matrix‑based products
-
Amniotic‑derived biologics
-
Stem‑cell–adjacent and cellular signaling factors
-
Combination protocols and emerging investigational applications
If it’s regenerative — and outcomes matter
...it belongs under research.
Benefits
Practice with Structure in a Complex Regulatory Environment
Strong Regulatory Alignment
Operating within an IRB framework demonstrates scientific intent, regulatory awareness, and a proactive compliance posture.
Clear Distinction Between Research & Promotion
IRB participation helps distinguish clinical research activity from product-driven promotion, reinforcing an outcomes-focused approach.
Defense Documentation
Protocols, consent language, data capture, and oversight structured for review and auditability.
Clarity of Intent & Scope
IRB oversight clearly defines research intent, scope, and boundaries, helping align documentation, data use, and communication across the practice.
Long-Term Practice Stability
IRB oversight clearly defines research intent, scope, and boundaries, helping align documentation, data use, and communication across the practice.
Data Ownership & Future Value
Research data collected under appropriate oversight may support future analysis, publications, presentations, and collaboration.
Item Title
Describe the item and include any relevant details. Click to edit the text.
Item Title
Describe the item and include any relevant details. Click to edit the text.
Item Title
Describe the item and include any relevant details. Click to edit the text.