BruinIRB Protocol Templates and IRB Supplements
BruinIRB relies on the upload of a protocol document to address much of the information required by the IRB to address criteria for IRB review. To assist in the new protocol requirement, OHRPP has created protocol templates that can be used for each submission.
The following templates can be used for study teams to develop the protocol that is required in BruinIRB. PDF Fillable formats are recommended for Mac users.
- Behavioral, Health Services, Epidemiological, Social Science & Education Research Template
- Biomedical Research Template
- Secondary Analysis Template – No Subject Contact
- Reliance studies – please submit the protocol that is being used at all sites
- Emergency Use
- Humanitarian Use Device
- Right to Try
- Expanded Access – Please see OHRPP Guidance and Procedures: Use of Drugs and Biologics in Clinical Research and Treatment or OHRPP Guidance and Procedures: Use of Devices in Clinical Research and Treatment for required sponsor or FDA documents that will serve as a protocol.
Note: These protocol templates are also available within BruinIRB Library.
In some cases, the protocol may not address issues specific to human subject protections and so it may be necessary to complete an IRB protocol supplement. Supplements address specific research scenarios or address protections specific to certain populations.
Investigator and Research Team Quick Guides
- Account – Obtain a BruinIRB Account
- Agree to Participate Requirement
- Assign Primary Contact
- Assurances – Initial-CR Assurances for Principal Investigator and Faculty Sponsor
- Attestation – Annual Attestation Required for Principal Investigator and Faculty Sponsor
- Contacts – Assigning and Removing a PI Proxy
- Contacts and Study Personnel – Change in PI
- Contacts and Study Personnel – Guest List Management
- Devices – Completing the Device Section of BruinIRB
- Document Management
- Edit Study Personnel
- Expanded Access Protocol
- Follow-on Submissions – Create and Submit a CR, AM
- Follow-on Submissions – Create and Submit a Post Approval Report (PAR)
- Follow-on Submissions – Request to Continue During Lapse of Approval
- Funding Sources
- Migration – Migrated webIRB Applications
- Migration – Migration of Exempt Studies from webIRB to BruinIRB
- Migration – Updating BruinIRB after Migration
- Navigating BruinIRB for Researchers
- New Submission: Creating a New Study
- Protocols – How to Create a Protocol from Migrated webIRB Snapshot
- Protocols – Protocols and Supplements
- Reliance – New Reliance Study
- Review – How to Respond to IRB Requests
- Simple Study or Site Closure
- Update Study Details
- Updating Your Contact Information and Profile in BruinIRB
- Withdraw or Discard Submissions
View the OHRPP YouTube Channel for Additional Training Videos
IRB Members Quick Guides