Federal single IRB review requirements only apply to non-exempt studies, therefore UW-Madison is not required to provided IRB oversight for external sites or personnel involved in exempt research.

While UW-Madison/UWHC study teams are responsible for ensuring external personnel are appropriately trained to conduct research activities for exempt studies, these personnel do not need to be listed on the study team pages in the IRB application. The role of external personnel in the study, however, should be described elsewhere in the IRB application.

Before external personnel can participate in a project or study determined to be exempt by the UW-Madison IRBs, they must do the following:

• If the external personnel are affiliated with an organization (e.g., university, hospital) with its own IRB, they must ask their own IRB to assess their involvement in the study, including whether any training requirements need to be met.
• If the external personnel are affiliated with an organization that does not have its own IRB, a letter of cooperation from that organization may be needed. (See Letters of Cooperation section.)
• If the external personnel are not affiliated with any organization (e.g., an independent consultant), no additional documentation is typically required.