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

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Protocol-Based Application (PBA)

Use the PBA for:

  • Clinical trials and/or more than minimal risk studies or those that involve multiple physical interventions
  • Studies requiring review by the ICTR Scientific Review Committee
  • Non-exempt studies where UW-Madison will serve as the reviewing IRB for multiple 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.

View a Mock-up PBA Application

Non-Protocol Based Application (Regular IRB Application)

Use the non-PBA for:

  • Exempt research
  • Studies that qualify for expedited review
  • Health care records review studies
  • Statistical Data Analysis Center (SDAC) studies
  • Protocol Development Activities (PDA)
SIRB Application

Use the sIRB application for:

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