External IRB

Yes, an external application in iRIS is required so we can address all local concerns, ancillary reviews etc. It is important to understand that even when relying on an external IRB, the DUHS IRB and institution still must retain important responsibilities for the oversight and ongoing local conduct of the study.

The following must be in place:

• Duke as a site approved by the external IRB
• DUHS IRB administrative review in iRIS complete and administrative review notice sent out to the Duke study team
• Institutional Approval (which occurs in Oncore)

Yes, all approved amendments and their approval notices and revised documentation issued by the external IRB must be uploaded into the iRIS system for administrative review by the DUHS IRB.

No, the Duke study team must obtain the administrative acknowledgement letter from the DUHS IRB prior to initiating any such amendments. Exceptions can be made if the amendment involves participant safety or truly holds up enrollment. The Duke study team must email the DUHS IRB Executive Director to receive approval for exceptions.

All submissions submitted to and approved by your external IRB must then be submitted to the DUHS IRB for administrative review.

For example: amendments, continuing reviews, safety events and the final report.

*In particular, any Safety Events, including serious adverse events, protocol deviations/violations or unanticipated problems involving risks to subjects or others that involve DUHS personnel or DUHS research participants must be reported promptly to the DUHS IRB using  iRIS’s Safety Event reporting mechanism. The Safety Event must include the review of the external IRB and any corrective actions issued by that IRB.  Upon completion of its review, the DUHS IRB may require additional corrective actions.

Yes

No, consent forms approved by the external IRB are not watermarked by the DUHS IRB.  The only exception is for protocols that use NCI CIRB as their IRB of record.

No, the external IRB approves the research study. When documents in this case are “acknowledged”—it does not mean the DUHS IRB approved it. Duke as a relying site is just acknowledging that the local context review is complete.

Please contact Minna Pak at minna.pak@duke.edu