Staff Manual
Last Updated: 6/24/2025
Purpose: The purpose of this manual is to detail considerations and provide additional resources for staff conducting reviews. Details included in other Toolkit materials will not be repeated here.
Acronyms and Definitions: This list includes some acronyms and definitions that will be used throughout the Staff Manual.
Review Guidance & Resources
This section includes guidance and resources for IRB Analysts in their review work.
- Review Basics
- Sending Studies Back to Pre-submission
- Send to IRB Member Activity during Pre-Review
- Protocol Review
- Completing HRP-401
- Completing Other Checklists at Initial Review
- Ancillary Committee Reviews
- Funding Considerations
- Reviewing Financial Conflicts of Interest
- Reliance Considerations
- Data & Specimen Sharing
- Handling Requests for Deposition of Genomic Data into a Federal Repository
- Data & Safety Monitoring
- Certificates of Confidentiality
- VA Considerations
- Prisoners
- Registries & Repositories
- Reviewing studies involving drugs, biologics, devices
- AI/Machine Learning Technologies Research
- International Research
- Expanded Access Submissions
- Hospitals and Clinics Under the Purview of the UW
- HIPAA
- Records Covered by HIPAA and Part 2
- Reconsent Considerations
- IRB Noncompliance
- Additional Review Considerations
- Convened Board Reviews
- Exempt & Expedited Reviews
- Post-Approval Reviews
- Other Protocol Templates
- Resources for Answering Study Team Questions
- Data Privacy & Security Contacts
Office Administration
Visit IRB Office Administration for information about office administration, including:
Navigating ARROW
Visit Navigating ARROW for information about ARROW.