The Standards & Registry Council Charter

A standard is only as strong as the body that governs it

The Readiness Standard, the Certification Framework, and the Common Outcome Protocol have each described an "independent Standards Council." This charter is where that promise becomes a real, accountable institution — with defined seats, defined rules for how the standard changes, a real conflict-of-interest firewall, and a real path to full independence from Operation Whole Health. Without this document, "independent council" is just a phrase. With it, it's an obligation the whole field can hold OWH to.

Built to the standard that clinical guideline bodies are held to

This charter is not improvised. It is deliberately built to match the National Academy of Medicine's Standards for Developing Trustworthy Clinical Practice Guidelines (2011) — the same bar bodies like the American Diabetes Association's Standards of Care are measured against — as operationalized by the NEATS instrument used to audit guideline trustworthiness.

Grounded in Jue LE, et al. Developing and Testing the NGC Extent of Adherence to Trustworthy Standards (NEATS) Instrument, Annals of Internal Medicine, 2019 — operationalizing the National Academy of Medicine's 2011 standards. See Sources.

What the Council governs

The OWH Standards & Registry Council ("the Council") governs two linked instruments:

The Council does not govern OWH's commercial products, and OWH's commercial products have no seat, no vote, and no veto over anything the Council decides. That separation is the entire point of this charter.

Who sits on the Council

Seven seats, each serving a defined purpose so no single discipline — or single company — can dominate a decision.

How independence is actually enforced — not just claimed

Operation Whole Health sells wellness products. Operation Whole Health also convened this Council. Both facts are stated here, together, on purpose — because a firewall that hides the conflict isn't a firewall.

• Structural separation. The Council operates as a distinct governance body with its own charter (this document), its own meeting record, and its own public change log — separate from any OWH product, sales, or marketing decision.
• Mandatory disclosure. Every Council member files a written disclosure of financial interests, consulting relationships, and equity in any company selling a substance, device, or product referenced by the standard — disclosed publicly alongside their seat.
• Recusal rule. A member with a financial interest in the outcome of a specific decision (e.g., a new annex for a medicine they hold equity in) must recuse from that vote. Recusals are logged in the public minutes.
• No pay-to-play. Certification, listing, or a favorable evidence grade is never contingent on purchasing any OWH product or service — restated from the Certification Framework and binding on the Council's own decisions.
• Funding transparency. The Council publishes its funding sources annually. Where OWH provides operating funds during the incubation period (Phase 0–1, below), that funding is disclosed and is structured as a grant with no decision rights attached — the model used by the American Diabetes Association, which funds its Standards of Care from general revenue with no industry funding for standards work.

Amendments happen in the open, on the record

1. Proposal. Any Council member, certified program, or member of the public may propose an amendment to the Common Core, a medicine annex, or the Common Outcome Protocol's dataset, citing the evidence behind it.
2. Public comment. Proposed amendments are posted publicly for a minimum 30-day comment period before a vote — the same open-comment discipline the ADA and ISO-style consensus bodies use.
3. Council review & vote. The Council reviews the evidence and comments, then votes under the quorum rule in §2. Safety-tightening amendments (new contraindication, new warning) may be fast-tracked with a 7-day comment period when new adverse-event evidence emerges.
4. Versioning & change log. Every ratified change increments a public version number (vMAJOR.MINOR) with a dated, permanent, publicly-viewable change log — nothing is edited silently.
5. Annual review. The full standard undergoes a scheduled annual review even absent a specific proposal, to catch evidence that has quietly gone stale.

Fair, consistent, and appealable

The Council owns final authority over the 4 certification tiers already published in the Certification Framework (Certified Program, Certified Provider, Certified Caregiver, Readiness-Prepared Patient Record).

• Independent review. Certification decisions are reviewed against the published criteria by Council-designated reviewers who are not employed by the applying program.
• Appeals. A denied or revoked certification may be appealed in writing to the full Council within 30 days; the Medical Director may not cast the deciding vote on their own program's appeal.
• Revocation. Certification may be suspended or revoked for a documented safety violation, a false attestation, or a breach of the COI rules above — with written notice and a right to respond before final action.
• Public registry of certified entities. Certified programs, providers, and caregivers are listed publicly (with the honest "listed ≠ endorsed" language already used on the Directory), so the credential can be verified by anyone.

Whose data this is — stated plainly

• Voluntary and de-identified. Contribution to the shared registry described in the Common Outcome Protocol is opt-in; only de-identified, aggregate-ready data enters the shared pool.
• Portable. A contributing clinic or study group may export and take their own data if they leave — no lock-in.
• Pre-registered analyses. Before any registry finding is published, the analysis plan is registered publicly, so results can't be quietly reshaped after the fact to favor a conclusion.
• Compliance gate. No individually identifiable health data is accepted into any OWH-hosted system until a HIPAA-compliant architecture and signed Business Associate Agreements are in place — a hard gate, not a target date.
• Publication rights. Registry-derived findings are published under the Council's name, not OWH's, and are open-access by default.

From OWH-incubated to field-owned

A standard that never leaves its founder's house is never fully trusted. This charter commits to a phased exit from OWH's operational control.

Status & how to join

If you are a psychedelic-medicine physician, toxicologist, neuropharmacologist, methodologist, ethics/IRB professional, veteran, or patient/caregiver willing to help found this Council — or a clinic or study group willing to be a Phase 1 design partner — contact michael@operationwholehealth.org or see Get involved.

This charter's credibility framework

1. Jue JS, et al. Developing and Testing the AHRQ National Guideline Clearinghouse Extent of Adherence to Trustworthy Standards (NEATS) Instrument. Annals of Internal Medicine, 2019 — operationalizes the National Academy of Medicine's 2011 Standards for Trustworthy Guidelines.
2. Kalyani RR, et al. Professional Practice Committee: Standards of Medical Care in Diabetes. Diabetes Care, 2017 — the real-world model for a disclosed, general-revenue-funded, publicly-commented standards process.