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Northwestern Relying on an External IRB

Northwestern University is willing to rely on an External IRB when federally mandated, required by sponsors, or on a case-by-case basis. Relying on another site or institution’s IRB is established by reliance agreements. A reliance agreement is an agreement between two or more institutions that allows an institution’s IRB to rely on another institution’s IRB for review of human subjects’ research. A reliance agreement comes in multiple formats, including Institutional Authorization Agreements (IAA), Memorandum of Understanding (MOU), and Master Reliance Agreement (MRA). 

  • Effective January 20, 2020, most federally funded research must utilize a single IRB (sIRB). An sIRB is the selected IRB of Record that conducts the ethical review for each site participating in cooperative research. Please see our webpage Single IRB Planning for more information.

Reliance Agreement Templates

eIRB+ Tutorials for Relying on an External IRB

Submitting a New Study Tutorial – External IRB Requiring a Signed Reliance Agreement - HRP - 1829

  • This tutorial is intended for use when Northwestern will cede IRB review to an external IRB via an IRB Authorization Agreement (IAA) or another reliance pathway like SMART IRB.
  • If your study involves Northwestern ceding IRB review to WCG or Advarra please follow this tutorial and the corresponding Master Agreement Acknowledgement Letter in lieu of another reliance pathway.

Submitting a New Study Tutorial – External IRB with a Master Reliance Agreement - HRP - 1830

  • This tutorial is intended for use when Northwestern will cede IRB review to entities like Lurie Children's Hospital IRB.

Submitting a Study Update: Modification, Continuing Review or Site Closure (External IRB)  

  • This tutorial is intended for use when submitting a study update (i.e. modification, continuing review, site closure) for studies where Northwestern has ceded review to an external IRB.

Resources for Relying on an External IRB

Guidance 

An investigator working with multiple institutions, each having their own IRB, may decide to have one IRB serve as the IRB of record for some or all participating sites. This practice is commonly referred to as ceded review, reliance agreements, or deferral of IRB oversight. The Northwestern IRB is generally willing to cede oversight (rely) to a qualified IRB or serve as the IRB of Record for external sites. 

  • It is the responsibility of the principal investigators and study teams to propose which site or institution will be the IRB of Record. 
  • If your project is federally funded please make a Single IRB plan at grant proposal time. See our Single IRB Planning webpage for more information.
  • Reliance is feasible for studies where the activities constitute engagement in non-exempt human research. Considerations and/or justification for reliance must be also be detailed in the protocol or eIRB+ application. See HRP-1801 - Worksheet Authorization Agreement Review for more information.

In order to for the Northwestern IRB to rely on an external IRB a new study submission must be submitted in eIRB+. Northwestern's activities must constitute engagement in human research to be eligible for reliance agreements. A protocol and draft reliance agreement, or indication that SMART IRB will be used, must be included with your submission. We do not sign reliance agreements outside of eIRB+.

  • If the Northwestern IRB is currently the IRB for the Northwestern activities and you intend to transition to an External IRB please contact us at irbreliance@northwestern.edu 

Commercial IRBs

Advarra 

 Advarra is fully AAHRPP accredited, and serves over 3,200 institutions as well as the top pharmaceutical, biotech, medical device, and CRO companies. Advarra is headquartered in Columbia, Maryland with 4 other office locations across the United States and 2 in Canada.  Northwestern has an executed Master Agreement with Advarra and the following template should be used in lieu of a IIA or reliance agreement:

 Submitting to Advarra’s CIRBI platform: 

  • Go to www.cirbi.net  
  • Create a new user profile if you are new 
  • Log in and select either the protocol or the investigator application 
  • Complete and submit  

If you would like Advarra to serve as the IRB of Record for your study, and you do not already have a sponsor facilitating the use of Advarra, please contact irbreliance@northwestern.edu and we will help facilitate the process of obtaining a quote for Advarra’s services. Note: all industry sponsored studies are subject to fees charged by Northwestern.

WCG IRB

WCG announced October 12, 2020 the unification of its five industry-leading IRBs – Western IRB (WIRB), Copernicus Group IRB (CGIRB), Midlands IRB (MLIRB), New England IRB (NEIRB), and Aspire IRB – into the single WCG IRB brand. Please note that this change includes the launch of a new submission platform, WCG IRB Connexus. Their new website is here: https://www.wcgirb.com/. Northwestern has an executed Master Agreement with WCG IRB and the following template should be used in lieu of a IIA or reliance agreement:

Starting November 30, 2020 WCG will allow Sponsor/CRO’s to submit updates and modifications on behalf of the Northwestern study teams. This update will only trigger for new review requests and any submission currently in process will still go through the existing workflow where site approval is required before proceeding.  

If you would like WCG IRB to serve as the IRB of Record for your study, and you do not already have a sponsor facilitating the use of WCG IRB, please contact irbreliance@northwestern.edu and we will help facilitate the process of obtaining a quote for WCG’s services. Note: all industry sponsored studies are subject to fees charged by Northwestern.

External IRB FAQs

What are the main elements the IRB looks at when reviewing a new reliance request?

Upon receiving a new request to cede/rely the main elements of review the NU IRB is looking at are:
• the qualifications of the investigator
• the external IRB
• the research procedures
• the study population
• where the research is taking place
• the language included in the proposed reliance agreement and any addenda
Note that the language in the internal NU institutional authorization agreement templates has been approved by all necessary institutional parties. When submitting a request to utilize an external institutional authorization agreement template, there may be additional institutional reviews needed prior to moving forward, which could result in additional time for processing.