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Northwestern Serving as the IRB of Record

Northwestern University IRB is willing serve as the IRB of Record for external sites when federally mandated, required by sponsors, or on a case-by-case basis. Serving as the IRB of Record for another site or institution 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

Resources for Serving as the IRB of Record

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. In this scenario, the Northwestern IRB is willing to serve as the reviewing IRB (IRB of Record) or will cede oversight (rely) to another qualified institution’s IRB. 

  • It is the responsibility of the principal investigators and study teams to propose which site or institution will be the IRB of Record. 

In order to 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+. The submission must include any corresponding protocol details about external site activities and a draft reliance agreement for our review. We kindly ask that reliance agreements be provided for our review before external signatures are acquired. We do not sign reliance agreements outside of eIRB+.

  • If your project is federally funded a Single IRB Letter of Support may be necessary before IRB review can begin. See our Single IRB Planning webpage for more information.

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

Types of Reliance Agreements

A reliance agreement is an agreement between two or more institutions that allows an institution’s IRB to rely on another, unrelated institution’s IRB for review of human subjects’ research. A reliance agreement comes in multiple formats, with the most common being  Institutional Authorization Agreements (IAA). Each individual IRB will indicate which agreement format is appropriate for a specific study.

IRB Authorization Agreement (IAA)

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). Any institution (e.g., university, medical centers, NGOs, community organization, survey research organization) that receives funds from HHS must have an FWA.  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.

Individual Investigator Agreement (IIA)

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).  This agreement outlines the responsibilities of the individual investigator for the protection of human subjects.  The IIA is signed by the:

  • Individual investigator
  • NU Principal Investigator (PI)
  • NU Institutional Official or designee

Master Reliance Agreement

A Master Reliance Agreement (MRA) is utilized when multiple studies cede review to a specific external IRB.  Master Agreements may be reciprocal in that signatory institutions can act as the site providing IRB review and oversight or the site relying.  Master Reliance Agreements may be for a single protocol or a number of protocols that are negotiated on a case by case basis.  The NU IRB currently has master agreements in place with the following external IRB’s:

Memorandum of Understanding

We may draft a Memorandum of Understanding (MOU) to acknowledge an ongoing and strategic relationship between institutions. An MOU is intended to be a long-term agreement and/or to support a specific research study. The agreement generally describes a very broad concept of mutual understanding, goals, and plans shared by the parties.  It may also list areas of possible joint activities, without creating financial obligations or committing resources.

Reliance Agreement FAQs

What Documentation Is Needed When Submitting The Reliance Agreement Request?

This would depend on the type of submission and request (cede/rely) needed for the study. In order to process a request for NU IRB to serve as the IRB of record, 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 an Federal Wide Assurance (FWA) in place prior to executing the agreement. For studies requesting the NU IRB cede review to an external IRB, we would need to review the protocol, consent template, and any other relevant study documentation. In addition the research staff member preparing the submission in eIRB+ should be trained on the requirements for submitting an external IRB study.

How Do I Determine If A Site Is Engaged?

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.

What Are The Main Elements The IRB Looks At When Reviewing A New 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; and where the research is taking place. We are also reviewing the language included in the institutional authorization agreement. It is best to utilize the internal NU institutional authorization agreement templates as the language 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.

How Long Is The Review Process?

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.