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
- IRB Authorization Agreement – Where NU IRB WILL be the IRB of record
- SMART IRB Letter of Acknowledgement (LOA) - See SMART IRB & IREx Webpage
- Individual Investigator Agreement - Contact email@example.com for further information
Resources for Serving as the IRB of Record
- HRP-093 - SOP Northwestern University Serving as the IRB of Record
- HRP-801 - SOP Establishing Authorization Agreements
- HRP-1801 - Worksheet Authorization Agreement Review
- HRP-1802 - Reliance Workflows
- HRP-1812 - Local Context Form
- HRP-1825 - Relying Site 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. 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.
- 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 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 or external investigators can be added. 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 firstname.lastname@example.org.
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?
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
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.