RESEARCH & PILOT GOVERNANCE
Research & Pilot Governance
The prelaunch controls separating product beta work from human-subjects research, including consent, IRB triggers, vulnerable populations, model-development research, safety, and publication integrity.
Status: Prelaunch governance standard. The public RestartingTheHeart.com website does not currently accept external health records or wearable-health feeds through these future product workflows. This notice defines controls that must be in place before the described capability is activated.
1. Separate beta, quality improvement, and research
A product beta, customer-discovery interview, usability test, internal quality review, and human-subjects research study can have different purposes and obligations. RTH will label the activity and will not describe participation as research merely to make a product test sound scientific.
2. No enrollment through a general contact form
A general website inquiry may register interest but does not enroll a person into a research study or authorize use of personal health data for research or model training.
3. Informed consent
Research participation must use an appropriate consent process explaining purpose, procedures, foreseeable risks, expected benefits, alternatives, compensation if any, privacy/data use, retention, withdrawal, contacts, and whether data may be used for future research or model development.
4. IRB and regulatory review
When law, institution, sponsor, journal expectations, or research ethics require Institutional Review Board or equivalent oversight, data collection will not begin until the necessary approval or documented exemption/determination is in place. RTH will not use "IRB-compatible" architecture as a substitute for actual approval when approval is required.
5. Vulnerable populations and minors
Research involving minors, high-acuity participants, people with impaired decision-making capacity, students, employees, or other potentially vulnerable populations requires heightened review, recruitment safeguards, consent/assent or representative authorization as appropriate, and measures to reduce coercion or undue influence.
6. Data governance
Research datasets require provenance, consent linkage, access control, retention, de-identification or coding as appropriate, approved sharing terms, and a rule for returning or withholding individual results. Product data must not flow into research merely because it is technically available.
7. Model-development research
If research data may be used to train, fine-tune, evaluate, or benchmark an RTH-owned model, that purpose must be stated separately enough for a participant to understand it. Broad future-use consent should not be interpreted beyond its lawful and ethical scope.
8. Publication and claims
RTH distinguishes hypotheses, founder observations, exploratory analyses, preregistered studies, completed analyses, peer review, publication, replication, and independent validation. Publication language must not imply stronger evidence than the underlying research supports.
9. Conflicts and independence
Founder, commercial, intellectual-property, sponsor, or partnership interests that could reasonably affect interpretation should be disclosed and managed. External collaborators should have clear roles, authorship expectations, data access, publication rights, and conflict-of-interest responsibilities.
10. Safety and adverse events
A study or pilot involving health-adjacent workflows requires a defined process for safety signals, adverse events, false reassurance, inappropriate escalation, privacy incidents, and participant withdrawal. Product safety boundaries remain in force during research.
Privacy and data requests: privacy@restartingtheheart.com. Do not send medical records, passwords, authentication codes, government identifiers, or other unnecessary sensitive information by ordinary email.
General questions may use the RTH contact page.