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.
New applications must be submitted through ARROW. Only the PI and POC(s) can edit the application and submit. Once submitted, the protocol will be assigned to the appropriate IRB based on the described study activities. The IRB application wizard offers several options and it is important to choose the right option for your study. Not choosing the correct option may require you to start your application over. The IRB may request a change in application type if a different submission would be more appropriate.
Selecting Application Type
Select each tab below to learn more.
Non-Protocol Based Application (nPBA)
Use the non-PBA for minimal risk research, including:
- Exempt research and most education, social, and behavioral research
- Studies that qualify for expedited review
- Full review single site studies
- Health care records review studies
- Statistical Data Analysis Center (SDAC) studies
- Protocol Development Activities (PDA)
- Training grant, umbrella grant, or core grant
Protocol-Based Application (PBA)
Use the PBA for:
- Clinical trials
- More than minimal risk studies
- Biomedical studies with multiple physical interventions
- Studies requiring review by the ICTR Scientific Review Committee
- Non-exempt minimal risk studies where UW-Madison will serve as the reviewing IRB for 2-3 sites (excepting UnityPoint Health-Meriter)
- Studies investigating a drug or device
- Registry and repository studies
The IRB has protocol templates that can be used for these types of studies. You are not required to use these templates if you already have a protocol that addresses the same elements found in the templates. You may use other templates to create your study protocol, such as UW ICTR’s Drug/Device/Behavioral Intervention Template, which includes more detailed guidance for studies evaluating the safety or efficacy of drugs or devices.
* Grant proposals and dissertation proposals cannot be used as a substitute for a protocol.
Resources:
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- Mock-up PBA Application
Example of a protocol-based application. - Protocol and Consent Templates
Templates to assist researchers in preparation for IRB submission.
- Mock-up PBA Application
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- Help with Creating a Protocol-Based Application
Step-by-step instructions for selecting the PBA in ARROW.
- Help with Creating a Protocol-Based Application
SIRB Application
Use the sIRB application for:
- for studies with two or more sites for which UW will serve as the reviewing IRB
Contact RELIANT if you have questions about whether an sIRB application is appropriate.
*This application type should not be used for exempt research.
Ceded Application
Use the ceded application for:
- requests to rely on an external IRB
Contact RELIANT if you have questions about whether a ceded application is appropriate.
Resources
We recommend reviewing the following resources:
- IRB Submission Process
Visual workflow of the IRB review process from the pre-submission state to approval. - 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. - 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. - COVID Questions Answered
Answers to COVID questions related to human subjects research. - UW-Madison Fee Schedule
Fees for HRPP review of industry sponsored studies.