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Northwestern Serving as the IRB of Record

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.

Effective January 20, 2020, most federally funded research must utilize a single IRB (sIRB). Please see our webpage Single IRB Planning for more information.

IRB of Record Study Start-Up: Reliance Welcome Packet

The instructions and documents included in this packet have been designed to help study teams communicate with their collaborators and streamline the reliance process when Northwestern is serving as the IRB of Record. Depending on the details of your project, your assigned IRB analysts may ask for information or documents which are not included in this packet.

This table serves as your guide to the contents of the Welcome Packet. Please review the chart below for the list of documents included in the Welcome Packet and instructions on what to do with them.

Document	Action
Reliance Process Overview	Review.
Reliance Process Flowchart	Review.
Email Template	Review, fill in appropriate information, and send to collaborator(s).
Cover Letter	Review, fill in appropriate information, and send to collaborator(s).
Reliance Mechanism	See "Reliance Process Overview" for instructions. Download from the “Reliance Agreement Templates” section below or SMART IRB & IREx webpage.
Local Context Form	(If applicable) Download from the “Resources” section below, review, send to collaborator(s), and upload to eIRB+ once received from collaborator(s).

Reliance Agreement Templates

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). 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.

IRB Authorization Agreement – Where NU IRB WILL be the IRB of record

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).

Individual Investigator Agreement - Contact irbreliance@northwestern.edu for further information

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 Lurie Children’s Hospital and SMART IRB.

SMART IRB Letter of Acknowledgement (LOA) - See SMART IRB & IREx Webpage

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.

Resources

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.
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 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 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+.

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 irbreliance@northwestern.edu.

Reliance Agreement FAQs

What is required when submitting a reliance agreement request?

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 a Federal Wide Assurance (FWA) in place prior to executing the agreement.

Documentation and other materials necessary to proceed with a reliance request generally includes:

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
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.

Further materials may be necessary depending on the type of submission and request (cede/rely) needed for the study.

How long is the reliance 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; 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.

How do I determine if reliance is necessary? When can/must each site conduct its own IRB review?

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.

Note that when not mandated, there should be strong justification for reliance described in the protocol. 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.

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.

Note that, per current policies, 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.