Checklist

IRB & Ethics Submission Checklist

An interactive, saveable checklist to prepare a complete IRB submission for human-subjects research. Track required documents, identify gaps, note owners and target dates, and mark submission readiness. Adapt fields to local IRB requirements.

Interactive Tool

IRB & Ethics Submission Checklist

This checklist helps you prepare a complete IRB submission for human-subjects research. Use it to track documents, identify gaps, capture owners and target dates, and record whether the package is ready for submission. Edit items to reflect your institutional IRB policies.

Name and email of the PI or primary contact for the submission.
Short descriptive title of the study.
Choose the review pathway you expect.
Planned date for initial submission (YYYY-MM-DD).
Concise protocol or study summary describing objectives, methods, population, and timeline.
Final consent and any short forms, translated versions, and assent forms for minors if applicable.
Surveys, case report forms (CRFs), interview guides, scripts, sensor plans, or software data capture descriptions.
De-identification strategy, storage location, access control, retention, sharing and data use agreements (DUAs).
Description of foreseeable risks, mitigation measures, and expected benefits to participants or science.
Ads, flyers, email/text scripts, clinician scripts, social media posts, and eligibility screening forms.
Payment amounts, timing, method, and justification. Include safeguards against undue influence.
PI and key personnel CVs/resumes, human-subjects training certificates (e.g., CITI), and COI disclosures.
Additional documents often requested by IRBs.
Consent translations, interpreter plans, and accommodations for low literacy.
HIPAA authorizations, FDA IND/IDE documents, or other regulatory filings if required.
Study-specific SOPs, monitoring procedures, and data access controls.
Vulnerable populations, coercion risks, consent capacity, and community considerations.
Quick readiness check after reviewing all items.
Note any missing items, assigned owners, and target dates for completion.
Use this field for clarifications, requests for pre-review, or IRB-specific questions.
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