The IRB reviews all activities that meet the federal definition of human research or clinical investigation. See the Human Research determination worksheet for more information.
Selecting Application Type
Protocol-Based Application (PBA)
Use the PBA for:
- Biomedical studies with multiple interventions
- Biomedical studies of more than minimal risk
- Clinical trials
- Studies investigating a drug or device
- Registry and repository studies
Non-Protocol Based Application (Regular IRB Application)
Use the non-PBA for:
- Exempt research
- Studies that qualify for expedited review
- Statistical Data Analysis Center (SDAC) studies
- Emergency Use/Expanded Access Requests
Use the sIRB application for:
- for studies with two or more sites for which UW will serve as the reviewing IRB
Use the ceded application for:
- requests to rely on an external IRB
We recommend reviewing the following documents from the Human Research Protection Program (HRPP) Toolkit Library:
- Investigator Manual (HRP-103)
Comprehensive guide of all policies, procedures, and resources related to the conduct of human research at the University of Wisconsin-Madison.
- Pre-Review (HRP-301, Worksheet)
Used by IRB staff who are conducting screening of submission materials.
- Criteria for Approval (HRP-314, Worksheet)
Used by IRB members who are reviewing research protocols that have been submitted.
- Protocol and Consent Templates
Templates to assist researchers in preparation for IRB submission.
- ED/SBS Consent Form Wizard
For educational and social-behavioral studies, you can use the Consent Form Wizard. The Wizard does not include HIPAA authorization language.
- Help with Creating a Protocol-Based Application
Step-by-step instructions for selecting the PBA in ARROW.