Process for Reliance on an External IRB
1. After you have determined from the DUHS External IRB Policy that your study meets the criteria to allow the use of an external IRB, please obtain the external IRB’s reliance agreement. The reliance agreement could be in the form of an IRB Authorization Agreement (IAA) or if the external IRB is signed onto the SMART IRB Master Reliance Agreement, please reach out to the external IRB and ask how they would like to proceed (using the SMART IRB online reliance system, SMART IRB cede letter or IREx).
Note: DUHS’ FWA number is FWA00009025
Here is a list of Participating Institutions that have joined SMART IRB and may use the SMART IRB Agreement to enable IRB reliance.
If an IAA is used, forward the agreement to Minna Pak (email@example.com) for review by Duke. If acceptable, the DUHS IRB will sign the reliance agreement and return it to the Duke study team to facilitate the full execution by the external IRB. If unacceptable, the DUHS IRB will red-line revisions to the draft agreement and return to the Duke study team to facilitate the review by the external IRB.*
Important to note: Before the reliance agreement (IAA or SMART IRB) can be signed by the DUHS IRB, the Duke study team must complete and submit a New Study Application in iRIS and choose the external IRB pathway in the "Protocol Application Type" section of iRIS. List all normally required institutional reviews in the submission form and submit. This ensures that the DUHS IRB has enough information to assess whether to cede or not, and to begin the process of obtaining ancillary reviews (for example, CRU and applicable specialty committees).
2. Once the new study application in iRIS receives CRU approval and approval from all required specialty committees, stop and send it to the external IRB. Waiting til this point, ensures that all ancillary reviews have been done and changes (if applicable) are incorporated into the consent form or other documents prior to submitting to your external IRB for approval.
3. Once the external IRB’s approval has been obtained, upload the following documents into your submission in iRIS:
- Duke specific approved consent form and other documents approved by the external IRB
- Applicable fully signed reliance agreement
- IRB approval notice from the external IRB—approving the Duke site
- Initial approval letter from the external IRB which approved the study in general
4. The DUHS IRB will complete its administrative review within 2-3 business days of receipt. The DUHS IRB will not watermark the consent form.
5. The expiration date in iRIS will be set to match the external IRB’s expiration date.
6. Please note that Institutional Approval (which occurs in Oncore) must be complete prior to recruiting any potential participants.
*The DUHS IRB has master agreements with WIRB-Copernicus Group IRB and Advarra IRB. However, please note in these cases, you still have a required one page IAA to fill out and be fully signed by both parties on a study-by-study basis.