IREx

IREx facilitates operationalization of single Institutional Review Board (sIRB) review processes for multisite studies, supporting compliance with the Department of Health and Human Services and National Institutes of Health requirements and centralized management of reliance relationships.

Key Features:

• Centralized communication and documentation: Provides a centralized system for communication and documentation between sIRBs and relying sites to harmonize review processes across multiple research locations.
• Support for extensive reliance networks: Supports management of reliance relationships across extensive networks, including over 2,300 reliance relationships with an average of seven sites per study.
• Promotion of transparency and standardization: Reduces workflow variation and promotes transparency and standardization of IRB review practices and documentation across relying sites.
• Adaptability to evolving policies: Adapts to evolving IRB practices and policies to accommodate changes in regulatory and operational requirements.

Scientific Applications:

• Operationalizing sIRB review for multisite studies: Coordinates reliance relationships and centralizes review documentation to enable consistent ethical review across multiple sites.
• Regulatory compliance and oversight: Supports compliance with Department of Health and Human Services and National Institutes of Health mandates and centralizes records for institutional research oversight.

Methodology:

Leverages web-based technology to create a centralized system that supports sIRBs and relying sites in managing reliance relationships.