Does my site need to establish our own IRB?

No. A central IRB has been established for CHANGE AFib; the AHA trial team can help a site navigate the process. As the trial sponsor, the AHA is providing access to a Central IRB thru Advarra. The CHANGE AFib Central IRB is sponsor-provided and all Advarra IRB fees will be covered by the AHA.

Some sites participating in CHANGE AFib may have institutional requirements preventing use of a Central IRB. Your site may use your own IRB to participate in the trial. For those sites that must utilize their own IRBs, IRB costs and fees are not covered or reimbursed by the AHA.