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). However, in recognition of the Common Rule NPRM proposals, which include creation of new exempt categories that will have limited IRB review and other regulatory requirements attached to them, the drafters of SMART IRB did not build an exception to this eligibility criterion for exempt research. If the Common Rule NPRM proposals are finalized in their current form, the expectation under the Agreement is that institutional oversight will be required (including limited IRB review in some cases) for the new exempt categories of human subjects research.