Request to Rely on an External IRB
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 single review is often referred to as the IRB of Record or Reviewing IRB.
The IRBs affiliated with the research sites are asked to enter into Reliance Agreements or IRB Authorization Agreements. This agreement serves as acceptance of the initial and ongoing ethical review by the IRB of Record, rather than performing multiple site IRB reviews. The IRBs that accept the approval of the IRB of Record are referred to as Relying IRBs.
The University of Pennsylvania is willing to rely on external IRBs, in alignment with the 2018 Common Rule, if certain conditions are met.
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 listed below. There are other scenarios where the Penn IRB is willing to rely on an external IRB of Record. Please contact the IRB Reliance Manager if you have any questions about whether Penn is willing to rely.
- CHOP is willing to serve as the IRB of Record through a Penn/CHOP Agreement.
- Study is a later phase (P3-4) 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 participants but is engaged in other research related activities and the lead site is willing to serve as the IRB of Record
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 in the following circumstances:
- The study is a First in Human (FIH) clinical trial without documented experience in humans. For industry device trials this includes Pilot/Early Feasibility trials.
- FIH/Phase 1 trials administering gene therapy /transfer products
- Phase 2 trials administering gene therapy /transfer products with documented risk of cytokine release syndrome
- Other Phase 1/2 trials administering high risk/novel agents
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 such as stem cell therapies; investigational surgical techniques; antibodies or other human or immunotherapies produced in an animal cell line or using recombinant DNA technology; other agents where CRS is a risk; other novel agents that might be politicized or publicized, etc.)
- Risk of the study (e.g., FIH clinical trial, targets high risk populations, or involves high risk procedures, etc.)
- Other risk factors
Reliance Request Fees
An initial fee is applied for industry funded research reviewed by an external IRB. Please consult with the IRB about fees if you have questions.
Penn as a Relying Site
How to Request Reliance on an External IRB
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.
Requirements for Penn Informed Consents when Using an External IRB
This document provides step by step guidance on how to revise the informed consent form templates when the Penn IRB has agreed to rely on an External IRB. Teams should ensure that required institutional language is included in their consent forms when relying on external IRBs.
External IRB Review FAQs
This document is designed to answer questions frequently asked by individuals who want to know more about Penn’s policies and procedures related to relying on external IRBs.
IRB Reliance Agreements
When Penn relies on an external IRB, a reliance agreement (or IRB Authorization Agreement) must be executed with each site. Click for more information on the execution of reliance agreements with central and academic IRBs (including SMART IRB) as well as individual investigators.
Penn as Single IRB of Record
If you’re looking for information on how to ask Penn to serve as the single IRB of Record for multiple sites, please click below for single IRB guidance.