Northwestern Serving as the IRB of Record

An IRB Authorization Agreement (IAA) is an agreement between Northwestern and another institution that holds a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (HHS). Entities use this agreement type to establish which institution will serve as the IRB-of-Record.  Each institution’s Institutional Official or designee signs the IAA.

An Individual Investigator Agreement (IIA) is an agreement between Northwestern University and an individual collaborator who is not affiliated with an institution with an FWA (e.g., former student working after graduation with their faculty mentor, professional in the community with specific expertise, community partners). 

Master Reliance Agreements (MRA) and Memorandums of Understanding (MOU) are similar types of master agreements.  They may be utilized when multiple studies cede review to a specific external IRB. They may also be reciprocal in that signatory institutions can act as the site providing IRB review and oversight or the site relying. Uniquely, a MOU can acknowledge an ongoing and strategic relationship and describe mutual understandings, goals, and plans shared by the signatories.  It may also list areas of possible joint activities, without creating financial obligations or committing resources.

The NU IRB currently has master agreements in place with Lurie Children’s Hospital, Northwestern Memorial Health Care (Northwestern Medicine), and SMART IRB.

In order for Northwestern IRB to serve as the IRB of record for an external site, a new study submission or modification to an existing study must be submitted in eIRB+.

• Please review the Reliance Welcome Packet, particularly HRP-1832 Reliance Process Overview, for step-by-step instructions.

In order for NU IRB to serve as the IRB of record for an external site, we would need to ensure that the site is engaged in research and the protocol accurately reflects the role of each site involved. The external site would also need to have a Federal Wide Assurance (FWA) in place prior to executing the agreement.

• Please review the Reliance Welcome Packet, particularly HRP-1832 Reliance Process Overview, for step-by-step instructions.

Documentation and other materials necessary to submit in eIRB+ and proceed with a reliance request includes but is not limited to:

• Preparing a reliance plan in the study protocol's Multi-Site or Collaborative Research section.
• A draft reliance agreement for use with relying site(s) in the "Supporting Documents" section or reference to the SMART IRB ID number. We kindly ask that drafted reliance agreements be submitted in eIRB+ without external signatures. This allows us to review the document and provide feedback. We do not sign reliance agreements outside of eIRB+.
• Appropriate updates to the eIRB+ submission, including the Basic Information, Personnel, Funding, and/or Sites pages.
• A Single IRB Letter of Support (sIRB LOS) is also necessary for federally funded multisite or collaborative projects.

Reliance is feasible for studies where the activities constitute engagement in non-exempt human research. Reliance may be necessary for non-exempt studies where multiple institutions or entities will be engaged in human subjects research when federally mandated, required by sponsors, or on a case-by-case basis.

• 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.

For studies with multiple engaged entities where reliance is not mandated and where there is no strong justification for reliance, separate IRB review by each institution for local study activities may be advisable. Additionally, Northwestern may not be able to enter into a reliance agreement for exempt studies and/or with certain for-profit entities. In these and other scenarios, separate local IRB reviews or review by an external IRB may be necessary.

A site is engaged in the conduct of human research when the following are taking place:

• Informed consent
• Interaction or intervention with participants as part of the research
• Obtain or analyze personally-identifiable subject data
• Funding

For more information regarding how to determine if a site is engaged, see our HRP-311 WORKSHEET Engagement Determination and OHRP Guidance on Engagement of Institutions in Human Subjects Research.

Minimally any proposed external site(s) must be engaged in human subjects research and the protocol must accurately reflect the role of each site involved.  The external site also needs to have an Federal Wide Assurance (FWA) in place prior to executing the agreement. 

• You may submit any questions regarding the feasibility of the Northwestern University serving as the IRB of Record to irbreliance@northwestern.edu.  
• More information on FWAs can be found on OHRP's website:  https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/file-a-new-fwa/index.html

The NU IRB understands that all research is important and we want to facilitate the process for all investigators.  We also need to ensure the parameters outlined in the agreements are feasible for all involved parties.  We are paying very close attention to assure the terms we agree upon uphold the core principles of our Human Research Protection Program (HRPP) and also honor our commitments to our clinical partners.  In doing this it may add additional time for processing of new agreements. 

At this time the approximate timeline for processing of a Reliance Agreement is from 2-4 weeks, depending on the type of agreement; however, the timeline may vary considerably depending on the number of sites, complexity of the reliance agreements, responsiveness of the study team and relying entities, and other factors.