Problem Statement
Academic medical centers (AMCs) are now frequently asked to be a CIRB for multi-site research. Challenges are numerous, not the least of which is communication between relying sites and the CIRB. We identify three distinct processes that present specific communication challenges and describe an approach to meet these needs.
Solution
Given the complexity of multi-site research, communications must be coordinated and adequately funded. We describe delegation to a CIRB point person and a formal CIRB liaison (liaison) funded by the study, and usually located at the lead site. Three distinct processes considered: (1) Setting up the CIRB: due diligence of sites, Reliance Agreement negotiation; (2) Initial review of new protocols; and (3) Post approval IRB processes (e.g., continuing review, amendments, unanticipated events).
1. Setting up the CIRB
CIRB point person working with institutional leadership develops: (1) site information sheet; (2) reliance agreement; and (3) standard operating procedures, including CIRB operations and communications. The liaison distributes these to sites and coordinates feedback. Feedback is encouraged by a webinar presenting the CIRB process to sites.
2. Initial review of the protocol
Liaison working with study team sends a protocol to the CIRB. When the protocol is determined (by CIRB administrative review) to be complete and ready for CIRB regulatory review, it is sent to all participating sites for general comments and local concerns. Sites have two weeks to provide comments to the liaison who collates and forwards them to the CIRB for inclusion in the protocol review. To encourage feedback, a webinar is held during this two-week period with presentation by the PI and CIRB. Once the ‘parent’ protocol is approved sites are added via a site-amendment process.
3. Post-approval IRB processes
The liaison is the coordination node for all communications between the sites and the CIRB. For continuing review (single review for all sites tethered parent protocol approval date), the liaison prompts all sites for required information and collates into a single submission. Similar processes are completed for amendments, adverse events and deviations, etc.
Implications for other institutions
AMCs supporting a CIRB must identify and fund associated tasks. Communication and coordination are critical tasks and should be co-owned and adequately supported by the CIRB and the study itself. Setting up a CIRB (step one above) is a significant undertaking and requires sophisticated IRB and legal staff time.