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
- IRB Authorization Agreement – Where NU IRB will NOT be the IRB of record
- SMART IRB Letter of Acknowledgement (LOA) - See SMART IRB & IREx Webpage
- Advarra Master Agreement Acknowledgement Letter
- Western Copernicus Group (WCG) Master Agreement Acknowledgement Letter
eIRB+ Tutorials for Relying on an External IRB
Submitting a New Study Submission (External IRB) – Requiring an IRB Authorization Agreement Tutorial
- 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 a commercial IRB where a master agreement is place please use the dedicated Master Agreement Acknowledgement Letter in lieu of a IRB Authorization Agreement.
Submitting a New Study Submission (External IRB) – With a Master Agreement Tutorial
- This tutorial is intended for use when Northwestern will cede IRB review to entities like Lurie Children's Hospital IRB.
Submitting a Modification and/or Continuing Review Submission (External IRB) Tutorial
- This tutorial is intended for use when submitting a modification for studies where Northwestern has ceded review to an external IRB.
- If you have continuing review or study closure documentation to submit for Northwestern's acknowledgement, please use this tutorial.
Resources for Relying on an External IRB
- HRP-092 – SOP External IRBs
- HRP-801 – SOP Establishing Authorization Agreements
- HRP-1801 – Worksheet Authorization Agreement Review
- HRP-1802 - Reliance Workflows
- HRP-1812 – Local Context Form
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 firstname.lastname@example.org
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 email@example.com 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 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 firstname.lastname@example.org 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.