GMU Relying on an External IRB

Introduction

The GMU IRB is willing to consider requests to rely on external IRBs for non-exempt research. We are required to rely for studies subject to the Single IRB (sIRB) Policy for Multi-Site Research and subsequent expansion of the sIRB policy to cooperative research conducted or supported by a Federal department or agency. In other cases, we may recommend local IRB review when reliance on a sIRB is not a regulatory requirement. Upon agreement to rely, we will issue a cede documentation, confirming GMU’s agreement to rely on the designated sIRB; however, we retain authority to decide to participate or not in the study as part of our local context review.

External IRB Reliance Process

All requests to rely on an external IRB must be submitted in RAMP. The submission will look similar to a regular submission, with some key differences.

1. Indicate that the study will rely on an External IRB. Note: If the External IRB is not listed in RAMP, please contact us at [email protected].
2. Upload a copy of the protocol and/or study application approved by the external IRB.
3. List all GMU-affiliated study personnel.  Do not list external personnel in the RAMP application.
4. If participants will be recruited at GMU/by GMU affiliated personnel, upload copies of the approved consent, recruitment materials, and study instrumentation.
5. Upload a copy of the external IRB’s approval letter specifically listing GMU as an approved study site.
6. Upload any documents that muse be completed by GMU (e.g., reliance agreements, local context forms, etc.)

**NOTE: If approval documents are not available at the time of submission, you may include draft documents instead.  However, approval documents must be submitted and reviewed before the IRB issues its final reliance determination.