Reliance agreements (i.e. IAA's, IIA, etc...) are arrangements between institutions allowing the IRB of one institution to rely on the IRB of another institution for review of human subjects research. A Reliance Agreement can be in many different forms, but some of the main agreements are Institutional Authorization Agreements (IAA), Memorandum of Understanding (MOU) and Master Reliance Agreement (MRA). Investigators working at multiple institutions, each having an IRB, may choose to have one IRB become the IRB of record over some or all participating sites (commonly referred to as ceded review, reliance agreements, or deferral of IRB oversight.) This means that the NU IRB is either the reviewing IRB (IRB of Record) or is ceding (Relying) oversight of the research activity to another equally qualified IRB. Each individual IRB will communicate what form of agreement is appropriate for a specific study. Effective January 25, 2018, the National Institutes of Health will mandate the use of single IRBs as a contingency for funding of multi-center studies.
Request for Reliance Agreements should be submitted by the Northwestern internal study team. All request for Reliance Agreements should be submitted through eIRB+ following the procedures outlined in HRP_092 SOP. Any questions regarding the feasibility of the NU IRB serving as the IRB of Record for a multi-site study or for additional information please contact email@example.com.
IRB Authorization Agreement (IAA)
An IAA is an agreement between NU 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) receiving funds from HHS must have an FWA. This agreement type is used to establish the IRB-of-Record (whether that's NU or the other institution). The IAA is signed by the Institutional Officials or designee at each institution.
Individual Investigator Agreement (IIA)
An IIA is an agreement between NU and an individual collaborator who is not affiliated with an FWA institution (e.g., former student working after graduation with their faculty mentor, professional in the community with specific expertise, community partners). This agreement type 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
Master Reliance Agreements (MRA) can be utilized when multiple studies are ceding 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 and are negotiated on a case by case basis. The NU IRB currently has master agreements in place with the following external IRB's:
- Lurie Children's Hopsital
- Smart IRB
A Memorandum of Understanding may be drafted to acknowledge an ongoing and strategic relationship between institutions that is intended to be long term, and/or to support a specific research study. The information in 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.
Individual Investigator Agreement (contact firstname.lastname@example.org to request the form)
1. 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.
2. 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.
3. 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.
4. How Do I Determine If A Site Is Engaged?
- 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 the OHRP Guidance on Engagement of Institutions in Human Subjects Research.