External IRB Review Process
For an NIH-funded multi-site project, investigators must designate the single IRB-of-Record as part of the grant or contract application. The IRB-of-Record may be an external IRB (either an accredited commercial or other academic IRB). To comply with the NIH sIRB policy, when a USC Principal Investigator (PI) is involved in a multi-site grant, USC plans to cede IRB oversight to an external IRB.
When ceding review to an external IRB, whether commercial or other institutional partner, the USC study team:
- Indicates the selected external IRB in the grant application.
- Contacts the external IRB to determine the IRB review fees for incorporation into the proposal budget. Commercial IRBs post their rates on their websites. Some academic IRBs may also charge a fee.
- Works with the external IRB and the USC IRB to request an IRB Authorization Agreement
(a.k.a. "reliance agreement"). This is the legal contract negotiated and signed by
the ORC that cedes IRB oversight authority to the external IRB.
No one on the study team has the authority to negotiate or sign the IRB Authorization Agreement.
- Completes an External Review application in eIRB.