Considerations for Accepting or Ceding IRB Review Guidance

Version Date: September 22, 2015

When a UW-Madison IRB is asked to assume responsibility for the review of human participants research through an IRB Authorization Agreement (IAA), and especially through an Individual Investigator Agreement (IIA) or collaborating investigator summary whereby a non-UW employee’s activities are covered by UW-Madison’s Federalwide Assurance, the University through its Institutional Official or his/her designee(s) considers whether accepting IRB oversight poses unacceptable challenges or risks to the integrity of its Human Research Protection Program (HRPP). Similar considerations exist when a UW-Madison IRB is asked to cede responsibility for IRB review because the University maintains responsibility for ensuring that any human participants research conducted by its employees is consistent with the terms of its Federalwide Assurance and with the accreditation standards for its HRPP.

A non-exhaustive list of criteria that are considered in making IRB reliance decisions is set forth below. The more likely that research poses significant challenges or risks to UW-Madison’s HRPP, the less likely it is that the University would agree to a deferral.

Accepting or Ceding IRB oversight

Accepting IRB Oversight

Ceding IRB Oversight