# 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 (or institutional equivalent) human subjects training certificates.
- [ ] Conflict of interest disclosures completed for all study personnel.
- [ ] Faculty advisor named and has signed the application (if student-led).

## Protocol Document
- [ ] Specific aims or research questions clearly stated.
- [ ] Background with current literature citations.
- [ ] Sample size justified (power analysis for quantitative; saturation rationale for qualitative).
- [ ] Inclusion and exclusion criteria explicit and defensible.
- [ ] Procedures described step-by-step from first contact to study completion.
- [ ] All instruments (surveys, interview guides, measures) attached.
- [ ] Risks identified and mitigation described.
- [ ] Benefits described (direct and societal — do not overstate).
- [ ] Data management plan included (storage, access, retention, destruction).
- [ ] Analysis plan included.

## Consent and Assent
- [ ] Informed consent form contains all 45 CFR 46.116 elements.
- [ ] Consent form at 8th-grade reading level (run a readability check).
- [ ] Assent form present for minors (age-appropriate variant chosen).
- [ ] Parental permission form present for minors.
- [ ] Translated versions included if applicable.
- [ ] Waiver of consent or documentation justified if requested.

## Recruitment
- [ ] All recruitment materials attached (email, flyer, verbal script, social media posts).
- [ ] No coercive language or guarantees of benefit.
- [ ] Compensation described and justified as non-coercive.

## Special Populations
- [ ] If minors: appropriate parental permission and assent included; 45 CFR 46.404–407 risk category identified.
- [ ] If prisoners: additional protections under Subpart C addressed.
- [ ] If pregnant individuals: Subpart B protections addressed.
- [ ] If 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 (if any) 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 the application aloud — does it make sense to a non-expert?
- [ ] All attachments referenced in the protocol are actually attached.
- [ ] File names are clear and the document is formatted per institutional requirements.

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(C) 2026 Angel Reyes / Subthesis — Licensed CC BY-NC 4.0. Not affiliated with OHRP or any IRB.