External Studies

This Institution may rely upon an IRB of another institution or organization. First, speak to your IRB Administrator regarding the study. If the IRB Administrative Team agrees that relying on an external IRB is the appropriate approach for your study, then work with your IRB Administrator to complete the following steps.

If the determination of the external IRB is not human subjects research (HRS) or exempt HSR, a Reliance Agreement is not required. The study still must be submitted in the IRB system.

Refer to the HRP-103-GENERAL-ORSIRB Principal Investigator Manual for more detailed information. The manual can be found in the IRB library within the electronic IRB system.

Reliance Agreements

When research involves more than one Institution a Reliance Agreement is needed. Investigators must still obtain IRB determination from the IRB of record (reviewing IRB) before beginning any study activities. See Reliance Agreements for more information.

How to Submit an External IRB Study

First, speak to your IRB Administrator regarding the study. If the IRB Administrative Team agrees that relying on an external IRB is the appropriate approach for your study, then work with your IRB Administrator.

Once you are in the electronic IRB system, begin the submission by clicking the “Create New Study” button. On the Basic Information page, the question “Will an external IRB act as the IRB of record for this study?” select Yes. This indicates that the external IRB will serve as the IRB of record. Follow the SmartForm and attach all requested documents.

To submit the study, click the “Submit” activity on the study workspace. Maintain electronic copies of all information submitted to the IRB in case revisions are required. If revisions are needed to documents already in the electronic system, submit a clean version document by using the “Update” button next to the document. Do not upload a track-changed document.

How to Submit a Modification or Closure for External Study

Any modifications to the study must also be submitted in the IRB system so that the submission stays up to date.  Once you are in the electronic IRB system, begin the submission by clicking the “Update Study Details” on the study workspace, and following the SmartForm in the electronic IRB system. Attach the updated external IRB’s determination document (if applicable) and other documents submitted to the relying external IRB with the submission. To submit the study, click the “Submit” activity on the study workspace.

Once the study is closed, provide a comment to the study in the IRB system or email the IRB administrator to close the External Study in the IRB system