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IRB Authorization Agreement

Definitions

IRB Authorization Agreement (IAA) is an agreement between two institutions/organizations that are engaged in human subjects research to establish the Single IRB (sIRB) reviewing, or IRB of record. In this agreement, there is a the reviewing institution (IRB of Record) that serves as the reviewing IRB, and a relying institution that is relying on the reviewing IRB.

IRB of Record

Determining who is the IRB of record is dependent on where the majority of the research will be conducted, the main funding recipient, or the institution that the main PI is affiliated with. Sometimes it is best to choose an institution whose IRB has expertise reviewing the type of research that is proposed in the protocol. If you are unsure of which IRB should act as the IRB of record, you should first discuss this with your co-PIs.

W&M IRB of Record Form

W&M IAA Submission Box FoldeR

Table shows instructions for IAAs

W&M is the Reviewing Institution When W&M is the reviewing institution, the process is as follows: Ensure all personnel are up-to-date on required CITI trainings before protocol is submitted Submit protocol to the W&M IRB and complete the IAA section (shown below) with all relevant details. Wait for approval from IRB. Research cannot begin until your protocol has been approved. Notify your collaborators of submission. The other institution should be made aware that an IAA will be processed for a protocol. Some institutions require additional documentation for IAAs so please make sure to notify the Research Compliance office so that those documents can be processed in a timely manner. Once approval for the protocol has been received, the PI must submit the IAA form to the W&M IAA Box Folder. The form should include: Relying Institution Name and FWA # Protocol Number Principal Investigators Site Principal Investigators (of relying institution) Sponsoring Agency (if applicable) Contact information of the FWA official from relying institution The IAA will be signed by W&M's FWA official then passed to the relying institution for signature. Once all parties have signed, the PI is responsible for keeping the IAA on file in case it is requested in the future.

W&M is the Relying Institution When W&M is the relying institution, the process is as follows: Notify W&M Research Compliance office an IAA will be initiated. Ensure all personnel are up-to-date on required CITI trainings. The FWA or PI should send the IAA and approved protocol to the W&M IAA Box Folder Please also email researchcompliance@wm.edu when files have been submitted. W&M Research Compliance will request signatures from W&M's FWA official. Once all parties have signed, submit protocol to the W&M IRB and complete the IAA section (shown below) with all relevant details. Make sure to attach the IAA and reviewing institution's approved protocol/certification to the W&M Protocol Submission. Once all parties have signed, the PI is responsible for keeping the IAA on file in case it is requested in the future.