sIRBs can use IREx to capture local considerations from participating sites. This creates consistency in (a) the data collected by sIRBs and (b) provided by participating sites. Two types of data are collected in IREx:
Study-specific Local Considerations: On a study-by-study basis, participating sites must document local considerations for the sIRB. IREx can be used to capture this information, which includes consent form language and applicable state or local laws, regulations, institutional policies, standards, or other local factors, including ancillary reviews, that would affect the conduct or approval of the study at an institution.
The Institutional Profile (IP): All sites complete an IP upon joining IREx. The IP captures (1) general FWA/IRB information; (2) overarching local and state laws/policies affecting all research; (3) processes and requirements when relying on an sIRB; and (4) preferences for handling the flexible elements of reliance when serving as the sIRB. The IP is completed once and can be updated as the information changes.