External IRB submission checklist for investigators
Estimated Reading Time: 2 MinutesApplies to: Studies submitted in Huron for review by an external IRB
Last reviewed: 07/02/2026 by Office of Responsible Research Practices
1. Create study
- Select "Create New Study"
2. Basic study information
- Enter and confirm study title
- Provide brief description (question, objectives, methods)
- Select study type (multi-site/collaborative or single-site)
- Enter Ohio State PI
- Indicate financial interest (COI)
Upload required documents:
- Main protocol
- HRP-504 – External IRB Site Supplement
- Local appendices (if applicable)
Common pitfalls at this step
- Selecting incorrect study type (single-site vs. multi-site)
- Missing HRP-504 External IRB Site Supplement
- Forgetting to upload protocol or required attachments
- HIPAA section of the External IRB Site Supplement not completed appropriately
- Failure to list applicable ancillary/institutional approvals in the Site Supplement
3. Local site information
- Describe Ohio State site activities (brief summary)
Common pitfall at this step: vague or missing site activities description.
4. External IRB
- Select reviewing IRB
5. Study scope
- Drug/biologic involvement: Yes/No
- Device evaluation: Yes/No
6. Local research locations
- Select at least one Ohio State location
Common pitfall at this step: not selecting a research location.
7. Study-wide documents
Upload the following, if applicable:
- Informed consent templates (study-wide or templates for sites)
- Recruitment material templates (study-wide or templates for sites)
- Other IRB-approved shared materials
- External IRB approval letter or application
Common pitfall at this step: uploading local documents in the Study-Wide section, or the reverse.
8. Local site documents
Upload the following, if applicable:
- Ohio State-specific consent forms, including required Ohio State institutional consent and HIPAA authorization language.
- Site-specific recruitment materials (Ohio State versions)
- Other local materials, for example institutional approvals such as CSRC or HSRC, if applicable
Common pitfalls at this step
- Uploading local documents in the Study-Wide section, or the reverse
- Institutional approvals not uploaded in "Other local materials" when applicable
Final check before submission
- All required documents uploaded
- Correct document placement (study-wide vs. local)
- External IRB selected
- Ohio State activities clearly described
- Site-specific consent forms include Ohio State-required consent and HIPAA authorization language
- Confirmed whether the external IRB or Ohio State will serve as the HIPAA Privacy Board, as applicable
- Institutional approvals listed in the Site Supplement and uploaded, if applicable