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.
10/1/2019 - In April 2019, the IRB released significant updates to the process for Continuing Review. Since then we have been working to apply these updates to multi-site situations. We have completed reviewing and revising ALL guidance and submission materials related to reliance agreements. Please click here to review a breif summary of changes.
NOTE: Starting July 1, 2022, all new requests to rely on the CHOP IRB must be submitted in HSERA and follow the IRB reliance procedures outlined here. These requests will no longer be accepted and processed via email with the new fiscal year. Please email Patrick Stanko with any associated questions about submitting reliance agreements.
When is Penn IRB willing 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 an AAHRPP accredited 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.
When is Penn IRB not willing to rely on an external IRB?
In consultation with Penn Medicine leadership, Penn IRB is not willing to rely on a commercial IRB when the study is a First in Human (FIH) clinical trial without documented experience in humans.
Penn IRB may also deny a reliance agreement if the study is high risk to participants and/or the institution, in terms of the following types of risk:
- Execution of the research
- Involvement of community sites /environment in which the research is being conducted
- Type of research technology (e.g., high risk therapies such as gene therapy or other novel agents, etc.)
- Risk of the study (e.g., FIH clinical trial, targets high risk populations, or involves high risk procedures, etc.)
- Other risk factors
How to Request Reliance on an External IRB (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- UPDATED 4/16/2021
- 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)
- WIRB-Copernicus Group IRB
- The NCI Central IRB
- Advarra IRB
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 study 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.
sIRB fees are only applied for grants submitted to the NIH after the effective date of the sIRB requirement (January 2018). New grant proposals submitted to NIH after January 2018 have to account for fees in the budget and NIH notes that those should be listed as direct costs. The IRB will review the grant, the date it was submitted, and whether IRB fees were written into the funding agreement. More information about fees can be found online here: https://irb.upenn.edu/mission-institutional-review-board-irb/irb-fees as well as in the Penn as Central IRB FAQ below. Please consult with the IRB about sIRB fees if you have questions.
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