Supporting Single IRB Documentation and Coordination
Basic Reliance Documentation
Track cede decisions and agreements completion
Advance Reliance Documentation
Capture site-specific local considerations and sIRB approvals for relying sites
Single IRB Coordination
Coordinate site readiness for sIRB review, facilitate submissions, and share approvals
For Single IRB Collaborators
Single IRBs
Relying Institutions
Local Study Teams
Lead Study Managers
Standardize the reliance process across sIRBs
Harmonize sIRB data collection
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.
Facilitate sIRB coordination with participating sites
Systematize the collection of sIRB metrics
