Pre-Submission Checklist

Review every item before submitting your IRB application. Missing any of these is the most common reason for revision requests.

Investigator Qualifications

• PI and all study personnel have current CITI certificates.
• Conflict of interest disclosures completed.
• Faculty advisor named and signed (if student-led).

Protocol Document

• Specific aims or research questions clearly stated.
• Background with current literature citations.
• Sample size justified (power analysis or saturation rationale).
• Inclusion and exclusion criteria explicit.
• Procedures described step-by-step.
• All instruments attached.
• Risks identified and mitigation described.
• Benefits described (do not overstate).
• Data management plan included.
• Analysis plan included.

Consent and Assent

• Consent form contains all 45 CFR 46.116 elements.
• Consent form at 8th-grade reading level.
• Assent form present for minors (age-appropriate).
• Parental permission form present for minors.
• Translated versions included if applicable.
• Waiver of consent or documentation justified if requested.

Recruitment

• All recruitment materials attached.
• No coercive language or guarantees of benefit.
• Compensation described and non-coercive.

Special Populations

• Minors: parental permission and assent, risk category identified (45 CFR 46.404–407).
• Prisoners: Subpart C protections addressed.
• Pregnant individuals: Subpart B protections addressed.
• Cognitively impaired: capacity assessment and LAR consent described.

Data Security

• Data stored on encrypted, institutionally-approved systems.
• Identifiers separated from data when possible.
• Retention period specified.
• Destruction method specified.
• Data sharing plan described.

Administrative

• Funding source disclosed.
• External site approvals or letters of cooperation attached.
• Collaborator IRB authorizations (if multi-site) included.
• Budget aligned with protocol if externally funded.
• Application form complete and signed.

Final Review

• Read aloud — does it make sense to a non-expert?
• All attachments referenced in protocol are attached.
• File names clear and formatted per institutional requirements.