Request for Penn to Serve as Single IRB of Record (sIRB)
- When Penn serves as the single IRB, it means that the Penn IRB, as the IRB of record, conducts the ethical review to establish that the protocol meets the regulatory criteria for IRB approval and other federal regulatory requirements. This review applies to Penn as well as all external sites that agree to rely on the Penn IRB through a Reliance or IRB authorization agreement. The Penn IRB will also be responsible for the ongoing ethical review of the study, including review of modifications, continuing review (as applicable), and review of reportable events and deviations.
- These reviews will occur at convened IRB meetings or through the expedited review process as appropriate per the Federal Regulations governing human subjects research and the Penn IRB’s Standard Operating Procedures. Single IRB review is not an option for research qualifying for review under an exempt category.
- When other sites rely on Penn as the single IRB, the other sites maintain their responsibility to ensure that it adheres to their institutional policies and practices established by their institution, as well as their applicable state laws. This local context review may be performed administratively by the other sites’ IRBs.
- Guidance is provided below on when Penn is willing to serve as the single IRB of Record (sIRB) and how to request Penn serve as the sIRB.
When is Penn willing to serve as the sIRB?
In general, the Penn IRB is willing to serve as the IRB of Record under the following scenarios listed below. Please contact the IRB if you have any questions about whether Penn is willing to serve as the IRB of Record.
-
A 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.
-
CHOP or Virtua is willing to rely on the Penn IRB through their respective executed Master Reliance Agreements.
-
Multi-site study where external sites are not enrolling subjects but are engaged in other research related activities.
Pre-submission Consultation
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.
Penn as the Single IRB of Record FAQ
This document is designed to answer questions frequently asked by individuals who want to know more about Penn’s policies and procedures related to Penn serving as the IRB of Record for external sites in multi-site trials.
Creating Consent Templates for External Sites
This document provides step by step guidance on how to convert the Penn IRB approved consent form into a consent form template that can be shared with external sites that will rely on the Penn IRB as the IRB of Record or Central IRB.
Post-Approval Submissions when Penn is the Single IRB of Record
The Post Approval Submission Guidance document is designed to provide guidance to both the Penn lead site team as well as relying sites on the requirements and submission processes for Amendments, Continuing Review, Reportable Events, and Study Closure. The Quick Reference for Relying Sites is an abridged version of the Post Approval Submission Guidance. It is meant to assist sites outside of Penn who have a fully executed reliance agreement in place for Penn to serve as their IRB of record.
Post Approval Submission Guidance
IRB Reliance Agreements
When an IRB serves as the single IRB of Record for external sites, 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 a Relying Site
If you’re looking for information on how to ask Penn to rely on an external IRB, please click below for How to Request a Reliance Agreement.