Author: Nathan Veil (Applied Coherence Institute) Date: May 12, 2026 Classification: Research Ethics / Governance / Human Subjects Protection Document Type: Ethics Protocol / Governance Framework (Proposed)
Status Notice
Status
This document describes proposed ethics and governance standards for future coherence research. No human subjects data have been collected. This protocol is intended for submission to Institutional Review Boards (IRBs) and ethics committees prior to any validation studies.
Abstract
The Coherence Metrics Framework (Humble, 2026) proposes multi‑domain measurement of regulatory stability. Any empirical validation of this framework will involve human subjects, including self‑report data, physiological measurements (HRV via wearables), behavioral logs, and potentially observer reports. This protocol defines the ethical and governance standards for such research. It addresses: (1) informed consent procedures, (2) data minimization and privacy protection, (3) physiological data governance, (4) participant distress and adverse event protocols, (5) exclusion criteria, (6) intervention escalation and referral pathways, (7) observer‑report ethics, (8) data retention and deletion, (9) institutional transparency requirements, and (10) explicit boundaries against coercive, surveillance, or punitive applications of coherence measurement. The protocol is offered as a template for IRB submissions and as a commitment to ethical research practice.
Keywords: research ethics, informed consent, data governance, human subjects protection, IRB, coherence research
1. Introduction
Any empirical validation of the Coherence Metrics Framework will involve human subjects. This protocol establishes the ethical and governance standards for such research. It is guided by:
Belmont Report principles (respect for persons, beneficence, justice)
GDPR and equivalent privacy regulations
American Psychological Association (APA) Ethical Principles
Declaration of Helsinki
Status Note: This is a proposed protocol. No human subjects data have been collected. All procedures described are for future IRB submission.
2. Informed Consent
2.1 Core Elements
Element
Description
Purpose
Explain the research: measuring regulatory stability (coherence) across multiple domains
Specify expected time commitment (e.g., 20 minutes for CP-100, 5 minutes daily for CP-25, 14 days for EMA)
Risks
Minimal risks: fatigue, boredom, mild distress from self‑reflection; physiological monitoring risks (skin irritation from wearable, minimal)
Benefits
No direct benefits; potential indirect benefit of contributing to understanding of regulatory stability
Confidentiality
Describe data protection, de‑identification, and access limitations
Withdrawal
Participants may withdraw at any time without penalty; data already collected may be retained (with consent)
Contact
Provide researcher and IRB contact information
2.2 Special Considerations for Physiological Data
Consideration
Protocol
Wearable data
Explain what HRV is, what it measures, and that it is not a medical diagnostic
Data access
Specify that raw physiological data will not be shared with participants’ employers, insurers, or other third parties
Incidental findings
No clinical diagnoses will be made; if concerning patterns emerge, participants will be informed and referred to appropriate resources
2.3 Consent for Observer Reports
If observer reports (peer, family, partner) are collected:
Element
Protocol
Separate consent
Observers provide independent informed consent
Target participant authorization
Target participant authorizes which observers may be contacted
Scope limitation
Observers report only on observable behaviors, not on internal states
Confidentiality
Observer data linked to target participant but not shared with target participant without consent
3. Data Minimization and Privacy Protection
3.1 Data Minimization Principles
Principle
Implementation
Collect only necessary data
No unnecessary demographic, health, or identifying information
Anonymization where possible
Use participant codes rather than names in datasets
De‑identification
Remove direct identifiers (name, address, phone, email) from analysis datasets
Aggregation
Report only group‑level or de‑identified individual data
3.2 Data Collected and Retention
Data Type
Retention Period
Deletion Protocol
Self‑report responses
Duration of study + 5 years (or per IRB requirement)
Secure deletion from servers
HRV/wearable data
Duration of study + 5 years
Anonymized or deleted
Behavioral logs
Duration of study + 5 years
Anonymized or deleted
Observer reports
Duration of study + 5 years
Anonymized or deleted
Consent forms
Separate from data; retained per legal requirement
Secure paper or digital storage
Identifiers (name, contact)
Stored separately from research data; deleted after study completion unless participants consent to recontact
Deleted within 30 days of study completion (or per consent)
3.3 Access Controls
Access Level
Permitted Access
Principal investigator
Full access to de‑identified data
Research assistants
Access only to data necessary for their role (e.g., scheduling, data entry)
External collaborators
Access only to fully de‑identified data under data sharing agreement
Third parties (employers, insurers, etc.)
No access. Explicitly prohibited.
4. Physiological Data Governance
4.1 Data Collection
Parameter
Protocol
Devices
Consumer wearables (Oura Ring, Apple Watch, Whoop, Polar H10) or equivalent
Metrics
RMSSD, resting heart rate, HF power (where available)
Frequency
Daily averages; continuous monitoring for EMA periods (7‑14 days)
Storage
Encrypted; separated from identifiers
4.2 Data Interpretation
Principle
Implementation
No medical diagnosis
HRV data are not used to diagnose medical conditions
Normative reference
HRV values compared to published normative data, not clinical cutoffs
Individual variability
Within‑person change emphasized over between‑person comparisons
Transparency
Participants provided with educational materials about HRV (what it is, what it is not)
4.3 Incidental Findings Protocol
Finding
Action
Extremely low HRV (e.g., consistently < 10 ms RMSSD)
Inform participant; provide referral to primary care (without diagnosis)
Resting heart rate consistently > 100 bpm
Inform participant; provide referral to primary care
Extreme variability indicating possible arrhythmia
Inform participant; recommend medical follow‑up
Note: These are not medical diagnoses. They are flags for potential follow‑up with a physician.
5. Participant Distress and Adverse Events
5.1 Distress Protocol
Trigger
Action
Participant reports distress during study
Research assistant checks in; offers to pause or terminate
CP-25 score drops > 1.0 points from baseline with reported distress
Research assistant contacts participant; offers support resources
Participant requests to withdraw
Immediate withdrawal; data already collected retained or deleted per participant preference
5.2 Adverse Event Reporting
Event
Reporting Requirement
Minor distress (e.g., fatigue, boredom)
Logged internally; no IRB notification unless required
Moderate distress (e.g., temporary anxiety)
Logged; PI notified; participant support offered
Severe distress (e.g., panic, suicidal ideation)
Immediate IRB notification; participant referred to mental health services; study procedures paused for participant
5.3 Participant Support Resources
Resource
Provision
Mental health crisis hotline
Provided to all participants at enrollment and in distress protocol
Low‑cost mental health referral
Provided to participants who request support
Study‑related distress
PI available for consultation; referral to appropriate services
6. Exclusion Criteria
6.1 Standard Exclusion Criteria
Condition
Rationale
Age < 18
Not appropriate for adult‑focused measures
Acute psychosis
Cannot provide informed consent; data may be unreliable
Severe cognitive impairment
Cannot complete self‑report measures reliably
Unstable medical condition (e.g., recent heart attack)
HRV monitoring may be contraindicated; consult physician
6.2 Temporary Exclusion Criteria
Condition
Action
Severe acute stress (e.g., recent trauma)
Defer participation; offer resources; reassess after 30 days
Current substance intoxication
Reschedule when sober
6.3 Non‑Exclusion Criteria
Condition
Rationale
Chronic mental health conditions (depression, anxiety, PTSD)
These populations are of research interest; exclusion would bias sample
Low coherence scores
These are data, not exclusion criteria
Wearable device incompatibility
Participants without wearables can still complete self‑report measures
7. Intervention Escalation and Referral Pathways
If intervention studies are conducted:
Phase
Participant Condition
Action
1
Mild dysregulation
Continued monitoring; self‑directed intervention modules
2
Moderate dysregulation with distress
Research assistant check‑in; offer additional support modules
3
Severe dysregulation with functional impairment
Referral to mental health services; study participation may continue or pause as appropriate
4
Suicidal ideation
Immediate referral to crisis services; study participation paused
Note: The coherence intervention is not a substitute for mental health treatment. Participants experiencing significant distress are referred to appropriate professionals.
8. Observer‑Report Ethics
When observer reports (peer, family, partner, supervisor) are collected:
Principle
Implementation
Separate consent
Observers provide independent informed consent
Scope limitation
Observers report only on observable behaviors (e.g., “This person follows through on commitments” not “This person has high coherence”)
No coercion
Participation as observer is voluntary; refusal does not affect target participant’s study participation
Confidentiality
Observer data linked to target participant but not shared with target participant without consent
Limits of observation
Observers informed that their report is one of multiple data sources; no single observer determines outcomes
9. Data Retention and Deletion
Data Type
Retention Period
Deletion Method
Raw self‑report data
5 years after study completion
Secure deletion (digital shredding)
Anonymized datasets
Indefinite (for open science)
N/A (no identifiers)
Consent forms
5‑10 years per legal requirement
Secure destruction (paper) or deletion (digital)
Identifiers (name, contact)
Deleted within 30 days of study completion
Secure deletion
Physiological data
5 years after study completion
Secure deletion
Observer data
5 years after study completion
Secure deletion
10. Boundaries Against Coercive, Surveillance, or Punitive Use
The coherence framework is intended for research and voluntary self‑regulation only. The following applications are explicitly prohibited under this ethics protocol:
Prohibited Use
Rationale
Employment screening
Coherence scores should not be used to hire, fire, or promote employees
Insurance underwriting
Coherence scores should not be used to set premiums or deny coverage
Educational tracking
Coherence scores should not be used to track, rank, or punish students
Surveillance by institutions
Coherence data should not be collected without informed consent for institutional monitoring
“Coherence compliance” systems
No person should be penalized for low coherence scores
Coercive wellness programs
Participation in coherence measurement must be voluntary
Predictive policing / behavioral risk scoring
Coherence data should not be used to predict criminality or behavioral risk
Punitive interventions
Coherence measurement should not be used to justify coercive treatment
Commitment: Any research conducted under this protocol will include explicit language in informed consent that data will not be shared with employers, insurers, or government agencies for these purposes.
11. Institutional Transparency Requirements
Requirement
Implementation
Preregistration
All confirmatory analyses preregistered (AsPredicted.org, OSF)
Data availability
Anonymized data deposited on OSF or Zenodo
Code availability
Analysis scripts publicly available
Conflicts of interest
PI discloses any financial or institutional relationships
Funding sources
All funding sources disclosed
IRB approval
IRB approval letter posted on study website or OSF
Adverse event reporting
Aggregate adverse event data reported in publications
12. Limitations
Limitation
Mitigation
Not yet IRB approved
This protocol is proposed; actual IRB approval required before data collection
Jurisdiction variance
Local regulations may require additional protections
Protocol evolution
Updates will be documented with version control
Participant vulnerability
Special populations (prisoners, minors, cognitively impaired) excluded unless specific protocols added
13. Conclusion
This protocol establishes the ethical and governance standards for future coherence research. It addresses informed consent, data minimization, physiological data governance, distress protocols, exclusion criteria, intervention escalation, observer ethics, data retention, and explicit boundaries against coercive use.
The framework is committed to:
Respect for persons (autonomy, informed consent)
Beneficence (maximize benefits, minimize harms)
Justice (fair distribution of risks and benefits)
Transparency (preregistration, open data, open code)
Boundaries (no coercive, surveillance, or punitive applications)
“Coherence is for flourishing, not for control. This protocol enforces that distinction.”
14. References
American Psychological Association. (2017). Ethical Principles of Psychologists and Code of Conduct.
Council for International Organizations of Medical Sciences (CIOMS). (2016). International Ethical Guidelines for Health‑related Research Involving Humans.
General Data Protection Regulation (GDPR). (2016). Regulation (EU) 2016/679.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report.
World Medical Association. (2013). Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA, 310(20), 2191‑2194.
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