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.

For multi-site studies, contact RELIANT if you’re unsure which application type is appropriate.

Selecting Application Type

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Non-Protocol Based Application (Regular IRB Application)

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.

* Grant proposals and dissertation proposals cannot be used as a substitute for a protocol.

View a Mock-up PBA Application

SIRB Application

Use the sIRB application for:

  • for studies with two or more sites for which UW will serve as the reviewing IRB

*This application type should not be used for exempt research.

Ceded Application

Use the ceded application for:

  • requests to rely on an external IRB

Resources

We recommend reviewing the following documents from the Human Research Protection Program (HRPP) Toolkit Library: