One of the eligibility criteria for participation in SMART IRB is that my institution require IRB review and institutional oversight for our human subjects research regardless of funding source and regardless whether we have “checked the box” on our FWA. This requirement does not appear to have an exception for exempt human subjects research, which under the current Common Rule does not require IRB review or trigger any other regulatory obligations. Can you explain why?
The intent of this criterion, which is stated in Section 1.1 of the Agreement, is not to require IRB review or institutional oversight for human subjects research that is currently exempt from IRB review and other regulatory requirements under the Common Rule (as of the date the SMART IRB Agreement was released). With regard to the 2018 requirements of the final revised Common Rule, and the newly introduced concept of "limited IRB review," the expectation under the Agreement is that institutions will require institutional oversight, which may include limited IRB review in some cases, for the new exempt categories of human subjects research that will require such review or have other regulatory requirements attached to them.