IRB / Ethics Submission Template

IRB / ETHICS SUBMISSION
========================

Title: {{cohort_title}}
Cohort id: {{cohort_id}}
Host: {{host_name}}, {{host_jurisdiction}}
Submission date: {{signing_date}}

A. RATIONALE
{{rationale_paragraph}}

B. PROTOCOL
- Peptide(s): {{peptides}}
- Dose / schedule: {{dose_schedule}}
- Cycle / duration: {{cycle_duration}}
- Population: adults aged {{age_range}} meeting eligibility criteria below.
- Sample size: {{target_n}}, with a pre-registered {{primary_endpoint}}
  effect-size assumption.

C. ELIGIBILITY
Inclusion: {{inclusion_criteria}}
Exclusion: {{exclusion_criteria}}

D. PRIMARY ENDPOINT (PRE-REGISTERED)
{{primary_endpoint}}
Pre-registration commit hash: {{commit_hash}}
Reveal window: {{reveal_window}}

E. ANALYSIS PLAN (PRE-REGISTERED)
The full analysis plan is hashed in the OEA-V1 commit at {{plan_hash}}.
Plain-text plan is bound to that hash and reveals at the reveal window.

F. RISKS AND MITIGATIONS
{{risks_and_mitigations}}

G. INFORMED CONSENT
The participant IC template is attached. Each participant signs
electronically; the SHA-256 of the canonical IC is appended to the
participant leaf.

H. DATA HANDLING
Wearable and PRO data is anonymized by participant id. The Host commits
to retention for {{retention_years}} years and to publishing aggregate
results at the reveal window.

I. CONFLICTS OF INTEREST
{{coi_disclosures}}

J. PRIOR APPROVALS
{{prior_approvals}}

- TEMPLATE ONLY · NOT LEGAL ADVICE · YOUR LOCAL IRB SETS THE BINDING FORMAT -