This guidance applies to new applications for an umbrella protocol submitted after December 10, 2025.

An “umbrella protocol” covers multiple studies that have a common hypothesis, set of investigators, and data set, and have a similar research design. Studies that will only collect data from an electronic medical record (e.g., Health Link) should be submitted as single studies using the “Health care records research only” application type within the nPBA.

Before submitting an umbrella protocol, please contact the IRB at asktheirb@hsirb.wisc.edu to determine whether or not an umbrella protocol would be appropriate for your work. The IRB may determine that an umbrella protocol is not appropriate in certain circumstances and may require that separate protocols be submitted for each project.