Subject: IRB of Record

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to serve as the IRB of Record for an external site engaged in research as set forth below.

1. IRB of Record
   1. Mayo Clinic's IRB may serve as the IRB of Record as set forth in this policy
   2. A 'coordinating center' of a multi-center trial is responsible for assuring that IRB approval is granted at the participating sites prior to the initiation of the research at that site. Mayo Clinic's IRB is not necessarily the IRB of Record for other participating sites unless it has agreed to do so in accordance with IRB Policy I.A.^[1] The coordinating center assumes responsibility for assuring that the participating sites have received IRB approval.
2. Authorization Agreements and Cooperative Research Projects
   1. An Authorization Agreement ^[2] or an agreement entered into as part of a cooperative research project ^[3], ^[4] are the only methods by which Mayo Clinic's IRB will serve as the IRB of Record for a site which is not covered by Mayo Clinic's FWA. ^[5] This agreement will outline specific responsibilities for each party entering into the agreement.

^[1] IRB Policy I.A

^[2] OHRP Website - Assurances

^[3] 45 CFR 46.114

^[4] 21 CFR 56.114

^[5] Mayo Clinic's Federalwide Assurance