It is now common practice for multi-site research studies to seek ethical review and approval of the proposed research by a single IRB. The IRB conducting this review is often referred to as the IRB of Record or Reviewing IRB. The IRBs affiliated with the research sites are then asked to enter into Reliance Agreements or IRB Authorization Agreements and accept the initial and ongoing ethical review and approval of the IRB of Record rather than performing their own separate IRB review and approval. The IRBs that accept the approval of the IRB of Record are referred to as Relying IRBs.
The University of Pennsylvania is willing to enter into these reliance agreements with IRBs external to Penn. The University of Pennsylvania is willing to serve as the IRB of Record for multi-site studies and as a Relying Site.
Directions for Submitting Reliance Agreement Requests
Asking Penn to Rely on an External IRB
In general, the Penn IRB is willing to rely on an external IRB under the following scenarios:
- CHOP is willing to serve as the IRB of Record through a Penn/CHOP Agreement.
- Study is a later Phase industry sponsored protocol and a single IRB has been selected by the sponsor
- Study is a federally funded multi-site clinical trial and the lead site is serving as the IRB of Record or the IRB of Record was selected as part of the funding approval process.
- Multi-site study where Penn is not enrolling Subjects but is engaged in other research related activities and the lead site is willing to serve as the IRB of Record
There are other scenarios where the Penn IRB is willing to rely on an external IRB of Record. Please contact the IRB if you have any questions about whether Penn is willing to rely on an external IRB.
How to Request a Reliance Agreement
To execute a Reliance Agreement with an External IRB, an HS-ERA application must be created and submitted to the Penn IRB. For instructions on how to create this submission, please view the How to apply for external IRB review guidance document.
Reliance Agreement Guidance:
(click to download)
- How to apply for external IRB review
- Requirements for external consent templates
- External IRB Review FAQ
- SMART IRB Agreement FAQ
Master Reliance Agreements
The Penn IRB has executed master reliance agreements with multiple external IRBs. If you are requesting a reliance agreement with an IRB listed below, a separate IRB authorization agreement will not be required as part of your submission. (This list will be updated when additional master agreements are executed)
- The Western IRB (WIRB)
- Quorum IRB
- The NCI Central IRB
- Schulman IRB - Per the terms of the Master Agreement with Schulman IRB, the Penn IRB is required to sign a Cover Page. Please include this cover page in any HS-ERA submission where you are asking the Penn IRB to rely on the Schulman IRB. The Penn IRB will sign the form after completing a local context review.Click here to download the cover page.
In addition, the Penn IRB has joined both the Smart IRB and IRB Choice joinder agreements and can execute reliance agreements with other academic centers that have also joined either agreement.
Asking Penn to serve as the IRB of Record for Multi-site studies
In general, the Penn IRB is willing to serve as the IRB of Record under the following scenarios:
- CHOP is willing to rely on the Penn IRB through a Penn/CHOP Agreement.
- Study is a federally funded multi-site clinical trial and Penn is serving as the lead site or has been selected as the IRB of Record as part of the funding approval process
- An Investigator Initiated multi-site trial where the Penn Investigator is the lead PI.
- Multi-site study where external sites are not enrolling subjects but are engaged in other research related activities.
There are other scenarios where the Penn IRB is willing to serve as the IRB of Record. Please contact the IRB if you have any questions about whether Penn is willing to serve as the IRB of Record.
It is strongly recommended that you contact the IRB prior to submission of any new multi-site protocol where you plan to request that the Penn IRB serve as the single IRB. The role of single IRB requires additional efforts from the IRB staff but also from the Penn research team during the conduct of the study. A pre-submission consultation with the IRB can help ensure that staff is aware of the additional submission requirements and steps that may be needed for the particular study.
Please view the Penn as Central IRB FAQ for instructions on how to submit the initial application for review as the single IRB of Record for a multi-site study. The guidance also includes instructions on how to add sites that will rely on the Penn IRB.
Guidance Documents related to Submissions when Penn is the IRB of Record
(click to download)
Who to contact with questions