The requirements for sIRB review of multi-site research have introduced new challenges for reviewing IRBs and relying organizations and have changed how HRPPs and IRBs operationalize review, particularly when involving multiple institutions in differing roles. Reviewing IRBs have adopted a variety of strategies for what types of submissions should be considered at an IRB-level, and what types may be the responsibility of the HRPP. For IRBs, these strategies include reviewing and approving short forms, recruitment material, and other study documents at a study-wide level to reduce the need for multiple site-specific amendments from the relying sites. For HRPPs, these strategies may include maintaining Health Insurance Portability and Accountability Act Privacy responsibilities locally, efforts to determine which institutions are engaged, and implementation of non-IRB institutional policies. This session will highlight some of the key challenges in HRPP/IRB review for multi-site studies reviewed by a sIRB and offer practical tools and strategies for participating sites to consider.
Identify the challenges faced by reviewing IRBs related to volume of submissions from multiple sites and the IRB's responsibilities
Describe the differing responsibilities of the reviewing IRB and the HRPPs of reviewing and relying organizations
Identify best practices for addressing the distinct role different institutions might play in a multi-site project, including engagement in human subjects research
Share tools and strategies to enhance review for multi-site research for HRPPs/IRBs
Explore opportunities for potential harmonization and best practice for what constitutes HRPP/IRB responsibilities