Relying on an external IRB to conduct IRB review and provide oversight of a study must be approved by University officials. Investigators who are approached by an outside investigator, sponsor, or central IRB to participate in a multi-site research study, and use their designated IRB for review, must submit a request to the HRPP Office.
Various factors are considered when reviewing requests to rely on an external IRB such as: the risk level of a study, exempt/non-exempt status, the funding/sponsoring entity, and whether the outside institution is accredited.
After a reliance agreement is finalized and executed, investigators must create a research file in iRIS by submitting a Relying on an External IRB application.
- When relying on an external IRB, it is the local (OU) Principal Investigator's responsibility to learn and comply with the policies and procedures of the external, reviewing IRB. In cases where research is reviewing by an external IRB, their policies will prevail. For example, it is imperative that PI's are aware of the external IRB's reporting requirements and timelines for protocol deviations and unanticipated problems because the process and timeline may differ from OUHSC's IRB reporting requirements.
- Studies covered by a master agreement are excluded from submitting REDCap requests to rely on the external IRB so long as the research falls within the defined scope of the master agreement. Studies that fall outside the scope of a master agreement must submit a request in REDCap to the HRPP Office.
- ALL studies using an outside IRB covered by a master agreement or individual reliance agreement must submit the Relying on an External IRB application in iRIS.
Unsure which requirements or procedures apply? Have other questions about the SIRB process? Submit a Consultation Request
to request/schedule a meeting with IRB staff.