This section of the Reliance Manual outlines criteria for relying on an external IRB, including engagement, exempt research, and international research.


Criteria for Relying on External IRB

UW-Madison has broad parameters for when it will cede IRB review to an external IRB. Exceptions include when:

  • The study is not funded
  • UW-Madison is not engaged in human research, the project does not constitute human
    research, or the study is exempt
  • The study involves the Madison VA
  • Fetal tissue research will be conducted at UW Madison/UWHC

Please note that other factors may affect the decision to cede IRB review (e.g., the proposed reviewing IRB declines to serve or is not in good standing with federal agencies).

For more information, see HRP-832-WORKSHEET-Critera for Relying on an External IRB.

Engagement

IRB oversight may not be required for your role in a study if you are not engaged in human research per federal guidance. This is important because you may not need to submit a request to cede IRB review if UW-Madison is not engaged in human research. Examples of when you might not be engaged include conducting analysis on data or samples that are de-identified or coded, assisting with study recruitment, or providing guidance on study design. Engagement determinations can be complicated, so we encourage you to contact us for assistance in making this assessment.

For more information, see OHRP’s engagement guidance and HRP 311-WORKSHEET-Engagement Determination.

Exemptions

Federal regulations do not require single IRB (sIRB) review for multisite studies and UW-Madison will not cede IRB review for exempt studies except in rare cases (e.g., sponsor requirements). Please keep in mind the review process for an exemption application at UW-Madison is typically faster than that for establishing a reliance agreement.

International Ethics Boards

Countries outside the United States often have ethics boards that serve the same role as an IRB, although they generally follow their own country’s regulations. UW-Madison may consider ceding IRB review to an ethics board on a case-by-case basis with input from UW-Madison legal counsel.