IRB Reliance Requirements
Both OHRP and the FDA permit an IRB the option to rely on the review of another IRB. When this is the intention, the two institutions enter into an agreement referred to variously as either a Cooperative Agreement, an IRB Authorization Agreement or an IRB Reliance Agreement. These agreements are executed between a Reviewing IRB and one or more Relying Institutions and delineate the roles and responsibilities of the involved parties. The agreements can be for a single research study or for multiple studies (e.g., a Master Reliance Agreement).
Effective January 20 2020: All federally funded cooperative human research projects receiving initial IRB approval on or after January 20, 2020 will be required to utilize Single IRB Review. That is, studies that involve more than one institution conducting research with human subjects. See the Single IRB web page for more information.
IRB Authorization Agreement (IAA)
An IAA is an agreement between FIU 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 FIU or the other institution) for non-Exempt research. The IAA is signed by the Institutional Officials or designee at each institution.
Individual Investigator Agreement (IIA)
An IIA is an agreement between FIU 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 in non-Exempt research. The IIA is signed by the Individual investigator and the FIU 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 for non-Exempt research. 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 FIU IRB currently has master agreements in place with the following external IRBs/institutions:
- WCG IRB (formerly WIRB)
- WCG IRB approval is required for studies involving drugs, biologics, and significant risk devices
- View the WCG IRB Application Submission Steps (used when FIU is the entity submitting the study to WCG IRB)
- Baptist Health South Florida
- Jackson Health System (for minimal risk research studies)
- State University System of Florida
- Includes: Florida A&M University, Florida Atlantic University, Florida Gulf Coast University, Florida International University, Florida State University, New College of Florida, University of Central Florida, University of Florida, University of North Florida, University of South Florida, and University of West Florida
- Smart IRB
Reliance Request Process
For FIU to Rely Upon an External IRB
All requests to use an External IRB for an FIU collaborative non-Exempt research study must be submitted via the online “IRB Reliance Request Form“, which is accessible in the FIU TOPAZ Protocol Submission System. This will create a “shell” version of the study in the TOPAZ system, which will be used for future tracking purposes. The PI will be notified once it has been determined if FIU can rely upon an External IRB.
If it is determined that FIU can rely upon an External IRB, FIU investigators will be responsible for keeping their FIU “shell” studies active in the TOPAZ system by submitting amendments, renewals, and adverse events after they have been processed and approved by the external IRB. These submissions will be done via the “IRB Reliance Amendment Form”, the “IRB Reliance Renewal Form”, and the “IRB Reliance Event Report Form”.
Request for an External Institution to Rely Upon the FIU IRB
When completing the “IRB Approval Form” in the FIU TOPAZ Protocol Submission System, you will be prompted to list external collaborators that will be “engaged” in conducting human subject research on your research project.
For those external individuals that come from an institution with a Federalwide Assurance (FWA), you will be prompted to attach a completed External Site IRB Reliance Request Form (Microsoft Word Document) in order to request for that external institution to rely upon the FIU IRB approval.
For those external individuals that do not come from an institution with an FWA, you will be prompted to attach an Individual Investigator Agreement for each individual.
Frequently Asked Questions
1. How long does it take to get an IRB Authorization Agreement?
If it has been determined that the IRB Reliance Request Form contains all of the necessary details, the next step is to execute an IRB Authorization Agreement (IAA) between both institutions. The IAA process will typically take several days, but can sometimes take several weeks depending on different factors (e.g., the complexity of the agreement, the availability of signatory officials, etc.).
2. What if my research qualifies for IRB Exempt review?
IRB Authorization Agreements are not intended for use when collaborators are engaged in IRB Exempt research. If all research activities qualify for IRB Exemption, then the researchers will have to secure an IRB Exemption determination from their home institutions.
3. What if my collaborator’s institution doesn’t want to enter into an IRB Authorization Agreement?
Some institutions only enter into IRB Authorization Agreements (IAAs) for certain types of research studies. At FIU, IAA requests are assessed on a case-by-case basis (unless federally required). If the collaborating institution doesn’t want to enter into an IAA (and single IRB review is not federally required), then researcher will have to submit the protocol for approval at their home institution IRB.
4. I will be relying on an External IRB. At what point will I be permitted to begin my research with human subjects?
Research activities involving human subjects can only begin after you have received confirmation of the following two items: 1) IRB approval letter from the External IRB for your research project; and 2) IRB reliance memorandum from ORI. The memorandum from ORI confirms that the reliance is formally in place and also outlines your requirements as the FIU PI.
5. Are there any Florida Laws or Local Context issues that I should inform an External IRB about?
Please refer to the Florida Laws and Human Subject Research document for further information
6. Who should I contact if I have any questions about the IRB Reliance Request process?
Please contact Chris Grayson, Director of Research Integrity (305-348-8379 or email@example.com).