Can SMART IRB be used for making and documenting determinations of exemption from IRB review?
Yes. Although the main purpose of SMART IRB is to cover ceding of IRB review responsibilities for research for which IRB review is required, it is recognized that currently at some institutions, IRBs also determine whether human subjects research is exempt from review under the Common Rule and other applicable federal regulations and policies. If a Participating Institution would like to have another Participating Institution’s IRB make and document exemption determinations on its behalf, the Participating Institution may use the SMART IRB Agreement for such an arrangement. In such cases, some of terms of the SMART IRB Agreement will not apply to the arrangement.