# DenQAI Owner Case-Series Consent Design Preview

Version: 0.1.0-draft  
Status: Not approved; not a consent form; intake closed

This document lists the elements a future consent process must address. It cannot be used to enroll anyone. DenQAI currently has no recruitment, submission, or case-intake channel.

## Required opening

- State that participation is voluntary.
- State that declining has no effect on employment, lending, education, payer participation, advisor relationships, transactions, or access to DenQAI.
- Identify the research purpose without promising personal benefit.
- Identify the responsible investigator, independent review path, and participant-protection contact only after those roles are verified.

## What participation would involve

- A structured owner-decision baseline.
- A coded evidence index; no patient information and no routine source-document upload.
- Proposed 6- and 12-month follow-up.
- Estimated time for each interaction.
- Participant review of the structured case facts and attributed statements before public use.

## Foreseeable risks

- Re-identification from a rare role, geography, timeline, financial range, or distinctive event.
- Commercial, professional, employment, legal, financial, or reputational harm if confidentiality fails.
- Emotional discomfort when discussing debt, practice strain, sale, closure, family burden, or disputed advice.
- Discovery of contradictions or records that do not support the participant’s initial interpretation.
- Limits on withdrawal after information has been aggregated or published.

## Data and privacy

The final form must state:

- exactly what fields are collected;
- which identifiers, patient data, and third-party data are prohibited;
- whether any identity/contact key exists and how it is separated;
- where information is stored, who can access it, and which vendors are involved;
- retention and deletion periods;
- backup and incident rules;
- de-identification and public-release transformations;
- whether future use is allowed and how it is described;
- whether legally required disclosures could occur.

## Compensation and conflicts

- State the amount and timing of any compensation.
- Payment must not depend on outcome, viewpoint, completing every follow-up, or providing a dramatic case.
- Disclose founder, funder, advisor, vendor, publication, or commercial conflicts.
- State whether DenQAI may build products from aggregate findings.

## Withdrawal and correction

The approved form must define:

- how to stop future contact;
- the date until which coded case data can be deleted;
- what cannot practicably be removed after de-identified aggregation or public release;
- how factual errors and participant disagreement are corrected;
- how new information or material protocol changes are communicated.

## No waiver

The consent must not ask participants to waive legal rights or release investigators, reviewers, institutions, or vendors from negligence.

## Approval gate

This preview must be replaced by a version approved for the actual regulatory, institutional, privacy, security, recruitment, compensation, and publication context before anyone is enrolled.

Primary references:

- 45 C.F.R. Part 46: https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46
- OHRP decision charts: https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.html
- Belmont Report: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
- HHS research and PHI guidance: https://www.hhs.gov/hipaa/for-professionals/special-topics/research/index.html