IRB Reliance Agreements

  • When an IRB serves as the single IRB of Record for external sites, a reliance agreement (also known as an IRB Authorization Agreement, or IAA) must be executed with each site.
  • A reliance agreement is a written agreement between an Institution conducting human subjects research and another Institution or Organization that is operating an IRB. The written agreement outlines the relationship between the two entities and how the Institution conducting the research is willing to rely on the other Institution’s IRB for ethical review of the research. The agreement also includes a commitment that the IRB will adhere to the requirements of the Institution’s Federalwide Assurance (FWA).
  • A copy of the agreement must be kept on file at both institutions and be made available upon request to OHRP or any U.S. Federal department or agency conducting or supporting the research covered by the agreement.

Master IRB Reliance Agreements

Reliance agreements can be executed for an individual study, or they can cover multiple studies. When a reliance agreement covers multiple studies, it’s called a Master IRB Reliance Agreement. The Penn IRB has executed master reliance agreements with multiple external IRBs.

Executed Master IRB Reliance Agreements

Central IRBs

If you are requesting a reliance agreement with an IRB listed below, a separate IRB authorization agreement is not be required as part of your submission.

  • WIRB-Copernicus Group (WCG) IRB
  • NCI Central IRB (CIRB)
  • Advarra IRB

Local Academic IRBs

If you are conducting collaborative research with CHOP, Lancaster General Hospital, or Virtua Health, a separate IRB authorization agreement is not required to be executed. Please review the guidance below for more information on collaborative research between Penn and these institutions.

Joinder Agreements

The Penn IRB has joined both the SMART IRB and IRB Reliance Exchange (IREx) joinder agreements and can execute reliance agreements with other academic centers that have also joined either agreement. The Penn IRB is willing to serve as the IRB of Record IRB according to the terms set in the SMART IRB agreement. Additional information on this agreement and what documentation is necessary can be found in the SMART IRB Agreement FAQ Guidance document linked below.

SMART IRB Agreement FAQ

Penn Cooperative Agreements

Penn-CHOP

Investigators are encouraged to review the Penn-CHOP IRB Cooperative Agreement to determine if their study is eligible for consideration under the agreement. Requests to rely on the CHOP IRB must be submitted in HSERA and follow the IRB reliance procedures.

Penn-CHOP Cooperative Agreement

Penn-Virtua

Investigators are encouraged to review the Penn-Virtua IRB Cooperative Agreement Guidance to determine if their study is eligible for consideration under the agreement. Requests to rely on the Virtua IRB for minimal risk research undergoing expedited review must be submitted in HSERA and follow the IRB reliance procedures. Penn will not rely on Virtua for greater than minimal risk research. Penn-employed clinicians leased to Virtua are expected to submit to the Penn IRB.

Penn-Virtua Cooperative Agreement
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Cooperative Research without a Master Agreement

If you are executing a Reliance Agreement with an IRB that has not signed either a Master agreement with Penn or the SMART IRB agreement, the reliance agreement with be executed via a standalone IRB Authorization Agreement. The University of Pennsylvania has a template IRB Authorization Agreement that can be downloaded from the forms page of the IRB website. The Penn IRB is also willing to execute agreements using a template provided by an external Institution or Organization. This document can be used when asking the Penn IRB to serve as the IRB of record OR when asking the Penn IRB to rely on another IRB.

IRB Authorization Agreement (IAA) Template

Collaborative Research with External Individual Investigators

If a collaborating investigator without an institutional IRB is engaged in human subjects’ research, they can be covered under Penn’s Federalwide Assurance (FWA) using the Individual Investigator Agreement Template. This agreement is only used for research qualifying for expedited or convened review.

 

Examples of individual investigators may include physicians in private practice or individuals employed by institutions that do not routinely conduct research.


NOTE: Engaged external investigators who are affiliated with an institution that has an IRB and are acting as an employee or agent of that institution with respect to their involvement in the research should either obtain IRB approval at their institution, or the team should consider a reliance agreement between the IRBs.

 

Review OHRP website for more information.

 

Requirements

 

If an Individual Investigator Agreement is the appropriate pathway the following is required:

  1. Individual Investigator Agreement

    Submit a copy of the Individual Investigator Agreement completed and signed by the external collaborating investigator(s). If there is more than one external collaborating investigator, please combine all completed agreements into 1 PDF to facilitate Penn IRB signing.
    Individual Investigator Agreement Template

  2. Human Subjects Research Training

    Submit a copy of the external collaborating investigator(s)’ completed Human Subjects Research training. Click below for acceptable training documentation.
    IRB Education

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Relevant Links

 

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