Does my site need to establish our own IRB?

No.

Some sites participating in CHANGE-AFib may already have their own IRBs to oversee research conducted within the institution or by staff of the institution. Your site may use your own IRB to participate.

For those sites without an IRB, FDA regulations permit an institution without an IRB to arrange for an “outside” IRB to be responsible for initial and continuing review of studies conducted at a non-IRB institution. A central IRB has been established for CHANGE-AFib; AHA and DCRI staff can help a site navigate the process.