Research infrastructure · protocol v0.3.0-draft

Prepare the owner case series before asking anyone to participate.

DenQAI needs longitudinal owner evidence. It does not need an uncontrolled story form. This wave publishes the draft questions, evidence rules, privacy boundary, consent design, analysis plan, and launch gates while keeping intake closed.

Current statusIntake closedProtocol design and independent governance review
Participants enrolled0No one is being recruited
Files accepted0No upload or submission channel
Published findingsNoneNo owner cases collected or published

The governing question

This may be research. A website cannot determine its own exemption.

The proposed case series is a systematic investigation designed to produce knowledge beyond one owner’s decision, so it may meet the federal definition of research in 45 C.F.R. § 46.102. Interaction with living owners or use of identifiable private information can also raise human-subject questions. Whether the Common Rule applies, whether an exemption is available, and who may make that determination depend on funding, institutional coverage, methods, identifiers, and other law.

Before enrollment, DenQAI will require a dated written determination from a qualified independent reviewer or appropriate IRB/institutional official. The public protocol will not call itself “exempt,” “not human-subjects research,” or “HIPAA compliant” without that documented basis.

Pilot boundary

Study owner mechanisms—not patients, accusations, or market gossip.

In scope

Firsthand owner decisions, practice and household runway, debt and guarantees, delays, unpaid management time, advisor incentives, staffing, payer friction, entry-mode changes, and owner-defined outcomes.

Not in scope

Patient-level information, chart images, clinical-necessity adjudication, employee allegations, named-practice rankings, advisor blacklists, malpractice conclusions, or prevalence estimates.

Initial design ceiling

Up to 20 voluntarily enrolled adult U.S. current or former owners in a maximum-variation pilot. The ceiling limits exposure; it is not a statistically representative sample.

Observation design

A structured baseline and evidence index, then proposed 6- and 12-month follow-up. Any 24- or 48-month extension requires a revised protocol and renewed governance review.

Pre-specified questions

Ask what records can help answer.

The pilot is designed to identify mechanisms and improve evidence requests. It cannot estimate how common a mechanism is among all dentists.

  1. 01

    Which mechanisms create first-48-month practice and household cash strain?

  2. 02

    How do guarantees, delay, capital calls, and unpaid management time change the ownership-versus-employment tradeoff?

  3. 03

    Which advisor incentives or information boundaries changed a decision, and what contemporaneous evidence supports that account?

  4. 04

    Which facts caused an owner to proceed, redesign, delay, renegotiate, sell, close, or walk away?

  5. 05

    Which plausible alternative explanations survive a within-case evidence review?

Evidence treatment

One account can be important without becoming a statistic.

Direct record

Direct contemporaneous record

A target, transaction, accounting, contract, or operating record tied to the proposition. Its verification state still depends on reconciliation and review.

Reconciled summary

Reconciled summary

A participant or reviewer summary tied to supporting records and at least one independent control. State which records and totals were checked.

Firsthand account

Attributable firsthand account

The participant directly experienced the event. Record what is remembered, what is documented, and what remains unverified.

Inference or unverified report

Inference or unverified report

An interpretation, memory, hearsay report, or unsupported claim. Use it to generate a question, not as a verified finding.

No completeness score.

Each material proposition keeps source kind, support relationship, verification state, period, contradiction, reviewer, limitation, and public-use status separate. Missing evidence cannot be averaged away.

Analysis plan

Preserve chronology, contradictions, and negative cases.

Within-case chronology

Separate what the participant knew at the time from hindsight, then tie turning points to dated records and decision gates.

Mechanism matrix

Compare mechanisms across cases without treating case frequency as population prevalence.

Contradiction pass

Record evidence against the preferred explanation and preserve unresolved disagreement.

Negative-case search

Actively look for owners who faced the same exposure without the same outcome—or reached the same outcome through a different mechanism.

Release transformation

Use broad periods, ranges, and geography; suppress small cells and unique combinations after a qualified re-identification review.

Claim discipline

Report bounded observations such as “observed in X of Y pilot cases,” never causal, national, or failure-rate claims from a purposive pilot.

Participant control

Consent is a process, not a checkbox at the bottom of a form.

Voluntary choiceNo lender, employer, broker, DSO, school, payer, or advisor controls eligibility or learns who declined.

Recruitment and any compensation must be neutral and must not depend on the owner’s outcome or viewpoint.

Plain-language riskRe-identification, commercial, professional, employment, legal, and emotional risks must be stated.

A small community and a distinctive timeline can identify a practice even after names are removed.

Participant reviewParticipants review the structured case facts and attributed statements before release.

Reviewer disagreement, unresolved contradiction, and requested corrections remain visible.

Withdrawal boundaryThe consent must explain what can be deleted—and when aggregation or publication makes removal impracticable.

The cutoff and correction path must be approved before enrollment, not invented after a request.

Seven launch gates

Enrollment remains closed until every gate has dated evidence.

A green design note is not approval. The public status must name the reviewer, scope, date, expiration, and unresolved condition without inventing credentials.

GOV-01Regulatory determinationNot cleared

Required ownerQualified independent human-subjects or research-governance reviewer

Evidence to clearDated written determination addressing 45 C.F.R. Part 46 applicability, human-subject status, exemption or review path, and other applicable law.

GOV-02Protocol and analysis freezeDrafted; independent review pending

Required ownerResearch lead plus independent methods reviewer

Evidence to clearVersioned questions, eligibility, recruitment ceiling, data dictionary, independent evidence axes, negative-case method, and publication rules.

GOV-03Consent and withdrawalDraft preview only

Required ownerResearch-governance and privacy reviewers

Evidence to clearApproved plain-language consent, voluntariness, compensation, risks, data use, participant review, withdrawal timing, and contact route.

GOV-04Privacy and de-identificationDesign drafted; no production system

Required ownerQualified privacy counsel and de-identification reviewer

Evidence to clearData-flow map, prohibited fields, code-key separation, release transformation, small-cell suppression, re-identification test, and state-law review.

GOV-05Secure operating environmentNot built

Required ownerSecurity lead and independent assessor

Evidence to clearApproved collection channel, least privilege, encryption, logging, backup, retention, deletion, incident response, vendor review, and tested recovery.

GOV-06Recruitment and conflictsNot approved

Required ownerResearch-governance reviewer

Evidence to clearNeutral recruitment text, inclusion/exclusion rules, fixed compensation if any, no outcome-contingent payment, conflict disclosure, and anti-retaliation safeguards.

GOV-07Publication and correctionDrafted; independent review pending

Required ownerMethods editor and participant-protection reviewer

Evidence to clearParticipant fact-check, attribution rule, small-cell rule, withdrawal cutoff, correction path, adverse-event escalation, and non-prevalence language.

Privacy architecture

Do not collect what the pilot does not need.

The draft design prohibits patient information and separates any future identity/contact key from the coded case file. Public analysis would use broad ranges and periods, suppress rare combinations, and require qualified re-identification review. Removing names alone is not de-identification.

HIPAA uses specific de-identification paths—Expert Determination or Safe Harbor—for protected health information held by covered entities. DenQAI’s no-PHI rule is stricter for this pilot: owners should not submit patient-level material even if they believe it has been de-identified.

Controlled work products

Inspect the draft before any intake system exists.

Local preparation only

Structure a case without sending it to DenQAI.

The preparation tool runs in the active browser tab, rejects declared privacy hazards, and exports a draft file to the user’s device. It is not enrollment, consent, submission, or approval.

Open the local case builder