The following types of studies are NOT appropriate for an umbrella protocol without a specific IRB exception:

• A single umbrella protocol covering an entire department’s work or spanning the work of multiple faculty members’ labs.
• Those with populations subject to additional protections under federal regulations (children, prisoners, pregnant participants, fetuses).
• Federally funded projects (including the Department of Defense) should be submitted under their own protocol to meet additional federal agency requirements.
• Studies that are FDA regulated. This includes studies seeking a non-significant risk (NSR) determination for a device, and those that validate the safety or efficacy of AI algorithms that meet the definition of a medical device.
• Protocols that are clinical trials and require submission of data to CT.gov.
• Multi-site studies where data will be received from or disclosed to other collaborating sites (this does not include sites like Meriter or ACHC where UW faculty treat patients.
• VA regulated studies.
• Studies using data subject to additional state and federal laws, such as HIV test results and substance use disorder records covered by 42 CFR Part 2. These studies are subject to additional legal requirements that can be more difficult to ensure are met under an umbrella protocol.