prepare-an-ethics-application

# prepare-an-ethics-application Describe the actual study, not an idealized version of it. ## When to use - Use for initial review, amendment, continuing review, reliance, exemption determination, or protocol closure. - Only the authorized ethics body may determine review category or approve participant-facing activity. ## Procedure 1. Confirm institutional jurisdiction, submission type, deadlines, required training, and current official forms. 2. Align title, objectives, population, sites, methods, sample size, and dates across every document. 3. Explain recruitment, inclusion, exclusion, relationships, incentives, and protections against undue influence. 4. Describe procedures in participant order with duration, location, recording, follow-up, and withdrawal handling. 5. Identify physical, psychological, social, legal, economic, privacy, community, and researcher risks. 6. Match each risk with prevention, monitoring, response, referral, reporting, and stopping rules. 7. Write accessible consent and assent materials, capacity checks, translator processes, and guardian roles where relevant. 8. Map data collection, identifiers, access, transfer, storage, sharing, retention, and deletion. 9. Attach instruments, scripts, advertisements, permissions, safety plans, agreements, and conflicts. 10. Cross-check the package, obtain sponsor review, submit, answer questions transparently, and version approved materials. ## Worked example An application says interviews are anonymous while the protocol records video and recruits employees through their manager. Review catches both conflicts. The team changes the claim to confidential, limits manager involvement, adds refusal protections, updates deletion rules, and resubmits consistent documents. ## Done - A verified ethics application package consistently records study design, participants, consent, risks, safeguards, data lifecycle, and attachments - A cross-document verification report lists every required approval, condition, version, response, and remaining pre-study restriction