About Us & The IRB

Created with the Holistic Health Professional in Mind

Cellular Peptide was founded to empower holistic health professionals with a safe, legal, and easy-to-implement peptide therapy solution.

Our IRB-overseen research program opens access to peptides for all licensed practitioners, while our comprehensive at-home protocol packages make treatment simple and convenient for patients. We bridge holistic healthcare and cutting-edge peptide research — helping your patients feel their best, right from home.

What is an Institutional Review Board?

An Institutional Review Board (IRB) is an independent committee (required by U.S. federal regulations like the Common Rule and FDA rules) that reviews and monitors research involving human subjects. Its main job is to protect participants' rights, safety, and welfare.

Here's what that looks like in practice:

Risk-Benefit Analysis — The IRB evaluates whether the potential benefits of the research (or treatment under the protocol) justify the risks. They require researchers to minimize risks as much as possible using sound scientific design.
Protocol Review — Before anything starts, the IRB examines the full plan: dosing, monitoring, eligibility criteria, and procedures. They can approve, require changes, or reject protocols that don’t meet safety standards.
Informed Consent — Participants (or in this case, patients) must receive clear information about potential side effects, risks, and uncertainties so they can make a voluntary, informed decision. The IRB reviews and approves the consent forms.
Ongoing Monitoring — It’s not a one-time approval. The IRB requires regular reports, including any adverse events (side effects). If new risks appear, they can mandate protocol changes, pause the study, or stop it entirely.
Independent Oversight — IRBs include scientists, doctors, ethicists, and non-scientist community members. This reduces bias and ensures broader ethical scrutiny.

In the Context of Cellular Peptide:

Many peptides are not fully FDA-approved for general use and are sold as “research chemicals.” Partnering with an IRB allows health professionals to offer them legally under a structured research protocol. This framework adds accountability that pure “research chemical” sales often lack.

It helps ensure standardized protocols and patient monitoring, tracking of outcomes and side effects, and better quality controls and documentation compared to unregulated gray-market use.

A few important caveats to consider are that IRB oversight makes the process safer and more ethical than buying peptides without any oversight, but it does not equal full FDA drug approval. In addition, peptides can still have side effects, interactions, or unknown long-term risks. The safety of peptide use also depends heavily on product quality (purity, sourcing), proper dosing, and individual patient health. We provide testing reports for all peptides within our Testing Library for your convenience.

Protective Elements

FDA non-approval does not mean a product is illegal. It simply cannot be advertised to diagnose, treat, or cure diseases. Most peptides must be labeled "For Research Use Only" and "Not for Human Consumption" due to lack of FDA approval. Sellers use this loophole to legally distribute peptides without guidance or support materials.

Our IRB-Approved research protocols change that.

Through our IRB, we offer healthcare providers an alternative. Our protocols are reviewed and approved by a legally structured IRB. This gives providers the legal right to talk about, support, and administer peptide-based protocols.

The IRB approval allows for patient education, injection and reconstitution support, and documented medical involvement with research protocols.

IRBs are federally defined boards that protect human subjects in research. By the 1980s, IRBs became mandatory for all human studies in the U.S.

Our providers join an IRB-approved research project where they see and evaluate the patient, enroll the patient into a peptide protocol through our IRB Online Portal, and act as the patient’s point of contact. Because the protocol is IRB-approved providers are not liable for research outcomes.

Our IRB is legally structured as “The IRB/PR TR, a Private Ecclesiastic and Sovereign Entity, Faith-Based Private Ecclesiastic, Sovereign and Indigenous (Native American) Research Organization." It is a religious trust protected by the First Amendment. Composed of lawyers, providers, and researchers, it is self-regulated, with private arbitration and internal governance. It is not registered with the NIH or FDA as we are a private entity preforming non-FDA research not seeking approval or patents.

If a provider receives a regulatory inquiry:

Do not respond directly.
Forward the letter/email to us.
Our IRB handles the legal response and justification.

The IRB shoulders the burden of legal defense, so you don't have to.

Ready to Join?

Click below to be redirected either:

to our IRB agreement (via docusign) to begin the Account Creation process on your own or

2. to our team's calendar to schedule your quick Zoom call in which one of our highly educated Onboarding Specialist can answer any additional questions and take care of Account Creation for you, tailored specifically to your clinic's needs (recommended)

Go to Agreement

Schedule Your Onboarding Call

Additional IRB Information

Types of IRBs

Institutional IRBs (Hospitals, universities)
Independent (Commercial) IRBs (Private companies, e.g. WCG, Advarra)
Central IRBs (Used for large, multi-site studies)
Single IRBs (sIRB) (NIH-funded multi-site studies)

Key Clauses in the IRB Agreement

These clauses offer protection and jurisdictional clarity for providers:

Private Jurisdiction: Parties agree to transition from public to private status under ecclesiastical and indigenous law.
Dispute Resolution: All conflicts must be resolved through the IRB’s private arbitration board.
Constitutional Protection: Our IRB is protected by multiple amendments including the 1st, 4th, 5th, 6th, 9th, and 14th.
Outside Complaints: Complaints or legal actions from patients or outside entities are handled within the IRB’s jurisdiction.

Structure, Policies, & Standard Operating Procedures

*Please note that this is a rewritten version of the original 70 page document. All private, ecclesiastic, indigenous, contractual, and constitutional claims remain fully intact. Email Support@cellularpeptide.com for a copy of the original, full document.

IRB/PR TR Institutional Review Board
Structure, Policies, and Standard Operating Procedures
(Simplified and Readable Version)
IRBEPP-1001.V1 | Review Date: January 2023

This document explains the rules, structure, and procedures for the IRB/PR TR in clear, straightforward language. It keeps all original legal protections, authorities, requirements, and obligations intact.

Chapter 1: Institutional Review Board and Structure
Chapter 2: Ethical Foundations for Human Subject Research
Chapter 3: Purpose of the Human Research Protection Office and IRB/PR TR
Chapter 4: Authority and Jurisdiction of the IRB/PR TR
Chapter 5: What Is Human Subject Research?
Chapter 6: Roles and Responsibilities of Principal Research Project Chairs and Staff
Chapter 7: General Procedures for IRB/PR TR Submissions and Reviews

Chapter 1: Institutional Review Board and Structure

An Institutional Review Board (IRB) is a committee that reviews, approves, and oversees research involving people. It ensures the research follows ethical standards and protects participants.

The IRB/PR TR is governed by a Private Ecclesiastic Trust. It operates through several boards and committees that review projects, decide eligibility, enforce policies, resolve disputes, and ensure compliance.

Chapter 2: Ethical Foundations for Human Subject Research

The IRB/PR TR follows the ethical principles in the Belmont Report (1979):

Respect for Persons: Treat people as autonomous individuals who can make their own decisions. Provide extra protections for those with reduced autonomy (e.g., minors, prisoners, cognitively impaired persons). This requires informed consent that is voluntary and free from coercion.
Beneficence: Maximize benefits and minimize harms. Conduct a careful risk/benefit analysis considering physical, psychological, social, legal, and economic risks.
Justice: Fairly distribute the benefits and burdens of research. Avoid unfairly targeting vulnerable groups (e.g., welfare patients, minorities, or institutionalized persons) for convenience.

Research must meet FDA or DHHS definitions of human subject research when applicable. “Engaged in research” follows current OHRP guidance.

Chapter 3: Purpose of the Human Research Protection Office (HRPO) and IRB/PR TR

HRPO Mission: Protect the rights and welfare of research participants while supporting ethical, compliant research. The office provides guidance to researchers and oversees the IRB.

IRB Purpose: Protect participants by ensuring studies meet these criteria:

Risks are minimized and reasonable compared to benefits.
Participant selection is fair and equitable.
Informed consent is obtained and documented properly.
Privacy and confidentiality are protected.
Extra safeguards are in place for vulnerable populations.
Data is monitored for safety.
Broad consent is not used.

The IRB also helps researchers design ethical studies and ensures overall compliance.

Chapter 4: Authority and Jurisdiction of the IRB/PR TR

The IRB/PR TR receives its authority from the Board of Trustees through the Institutional Official. It has full approval from FDA and HHS to operate as an IRB.

Key Protections:

Operates as a Private Research Organization under Private Ecclesiastic, Trust, Indigenous/Native American, Common Law, and Constitutional protections (1st, 4th, 5th, 6th, 9th, 14th Amendments).
Protected by Private Contract Law, Private Membership Association rules, and International Intellectual Property laws.
Exercises Indigenous Sovereignty as a Native American Faith-Based Organization.
All participants agree to operate in the private domain and not involve public or federal jurisdictions unless required by the IRB/PR TR.

Powers of the IRB/PR TR:

Approve, modify, or disapprove research.
Require ongoing compliance and reporting.
Terminate membership for non-compliance.
Enforce private administrative remedies (minimum $100,000,000 USD per injury/violation at the Board’s discretion).

By joining, all parties become private members and agree to keep matters within the private ecclesiastic jurisdiction.

Chapter 5: Human Subject Research – Definitions

Human Subject Research includes systematic investigations designed to develop generalizable knowledge involving living individuals.

Key Terms (aligned with DHHS and FDA):

Human Subject: A living person about whom the researcher obtains data through interaction, intervention, or identifiable private information/biospecimens.
Intervention: Physical procedures or manipulation of the environment for research.
Interaction: Communication or contact between researcher and subject.
Private Information: Information an individual expects will not be public or observed.
Research: Systematic investigation (including development, testing, evaluation) meant to contribute to generalizable knowledge.

Certain public health, criminal justice, and intelligence activities are excluded.

Chapter 6: Roles and Responsibilities

Principal Research Project Chair (PRPC): The lead person responsible for the study’s ethical conduct and compliance. Must be a qualified member of the organization.

PRPC Responsibilities (summary):

Minimize risks and ensure they are reasonable.
Ensure fair selection of participants.
Obtain and document proper informed consent.
Protect privacy and confidentiality.
Monitor safety and report problems promptly.
Follow the approved protocol exactly (except to prevent immediate harm).
Submit modifications, continuing reviews, and progress reports on time.
Ensure all staff are trained and qualified.
Maintain accurate records.

Sub-investigators and staff may perform delegated tasks but the PRPC retains ultimate responsibility. All key personnel must be disclosed during application.

Chapter 7: General Procedures for Submissions and Reviews

All research must receive IRB/PR TR approval before starting. Retroactive approval is not allowed.

Required Agreements and Forms

All participants sign private ecclesiastic contracts, informed consents, and NDAs. Forms include:

CIF1001 (Principal Organization/Main Contract)
CIF1002 (Subordinate Individuals/Organizations – SD designation)
CIF1003 (Individual Research Subjects – RS designation)

These must be properly signed, notarized where required, and sealed by the IRB/PR TR Compliance Office.

Application Requirements

Detailed research summary (hypothesis, methods, risks/benefits, personnel qualifications, etc.).
Licenses, credentials, and site information (kept private).
OHRP Human Research Protection Training (Lessons 1–3 only) for key personnel.
Data security and conflict-of-interest disclosures as needed.

Ongoing Reviews

Every 6 months and annually: Submit progress reports (Form RPP-1001 G & I), including safety, efficacy, side effects, and participant data summaries.
Modifications: Submit via CIF1004 (MOD/MODCR) before implementation if they affect design, risks, or procedures.
Continuing Review: Required to maintain approval.

All reports must be sealed by both the principal organization and IRB/PR TR. Failure to comply results in immediate revocation of membership and loss of protections.

Reporting Obligations

Report immediately:

Unanticipated problems or serious adverse events.
Protocol deviations.
Suspension or termination of the study.
Non-compliance.

Important Note: Approval applies only to the specific reviewed project. Using it as a blanket approval for other activities is strictly prohibited and triggers severe penalties.

Penalties for Non-Compliance: Revocation of membership, loss of all protections/privileges, and private administrative remedies (minimum $100,000,000 USD per violation/injury).

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