External individuals may need IRB oversight if they are engaged in human research for a non-exempt study and not affiliated with an entity with an IRB. In such cases, UW-Madison may agree to serve as their reviewing IRB. Decisions about whether the institution can serve as the reviewing IRB for external individuals who are not affiliated with an entity with an IRB/HRPP are made on a case-by-case basis per federal regulations and institutional guidance.

In some cases, though, UW-Madison IRBs will not serve as the reviewing IRB for external individuals when:

• UW-Madison, UWHC, or Madison VA faculty, staff, or students are not involved in the research;
• The IRB does not have sufficient knowledge of the local context (as required by federal guidelines) to assume IRB oversight for personnel that are requesting UW-Madison serve as IRB of record including personnel:
  • Located in states other than Wisconsin or international locations, particularly if external personnel will be performing study activities for which specific state law apply.
• The study qualifies for exemption.