use one IRB for review
Single IRB Process
The single IRB model allows multiple institutions conducting the same protocol to use a single IRB for review, instead of using multiple IRBs to review the research at the sites individually.
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Determining Whether an sIRB Process is Appropriate
Federal regulations mandate the use of an sIRB process for many federally-funded, multi-site, non-exempt, human subject research projects. Several exceptions exist, and the regulations continue to be updated.
Note: University of Rochester charges fees for provision of Single IRB review for external institutions.
When you are in the planning stages of a project or grant, discuss with OHSP if the single IRB model is appropriate for your project, and obtain fee information and other considerations. To do so, please submit a reliance consultation request.
What is Reliance?
The IRB that conducts the review for all of the sites may be called the Reviewing IRB, External IRB, Single IRB, or Central IRB interchangeably. The research sites that use the reviewing IRB to conduct the IRB review, rather than their own institutional IRBs, are called Relying Sites.
In order for an institution to rely on an external IRB, both institutions must negotiate and sign a reliance agreement. At University of Rochester, OHSP manages and negotiates this agreement.
If you are planning or considering a multi-center study, you should contact OHSP early in the process. Make sure to do so before a grant application is submitted to discuss the appropriate IRB review model for your project.
Note: OHSP Must Make the Determination to use an External IRB
Individual investigators at University of Rochester may not determine if an external IRB can be used and may not enter into any agreement to use an external IRB. Instead, they should work with OHSP.
Determining Whether the Single IRB Process is Right for Your Project
The first step whether you would like to use an external IRB or University of Rochester to act as the IRB for a non-University of Rochester investigator or research partner is to submit a Reliance Consultation Request.
OHSP will then contact you to schedule a meeting or obtain further information. OHSP will determine the model and provide you with additional information on the next steps and requirements for your project.
In cases where a single IRB review model is not appropriate, each site or investigator is responsible for obtaining IRB approval from their own IRB before beginning any research.
In some cases, a definitive IRB review model cannot be determined until after the protocol has been submitted and reviewed by an IRB. This usually occurs in situations where it is unclear whether the project will meet the criteria for exempt research until the PI submits the full protocol to the IRB for review. The single IRB review model is not used for exempt research, non-U.S. sites, career development (k) awards, research training (T) awards, or fellowship awards (F), or research sites involving tribal nations.
University of Rochester uses the single IRB process when acting as the IRB for non-academic sites, such as businesses, community partners, K-12 schools, or individual investigators.
Understanding the Scope of Human Research Protection Programs
In order to fully understand the single IRB review model and process, it is important to understand how IRB review fits into the overall responsibilities of the university when its faculty, staff, and students conduct human subject research.
University of Rochester is responsible for all aspects of a Human Research Protection Program, which includes IRB review. When University of Rochester relies on an external IRB, it is still responsible for all other aspects of the Human Research Protection Program before researchers can conduct human subject research.
For more information, please see:
Single IRB and Exempt Research
The single IRB review process will not be used for exempt research. University of Rochester will neither rely on an external IRB nor act as the IRB for any non-University of Rochester site or individual for research that has been determined to be exempt.
Often during the reliance consultation, OHSP can ascertain which projects will be exempt or not so that the reliance decision can be made at that time. However, in some cases, until an IRB application has been submitted and reviewed, it is not possible to know what the determination will be. In these cases, a final reliance decision may not be made until after the initial IRB review of the project.
Researchers at other academic institutions should follow their local IRB’s process for review of exempt research. For research team members not affiliated with an academic institution, OHSP can advise the researchers on how to proceed.
Single IRB and Non-Human Subject Research
Non-Human Subject Research determinations are made at the institutional level. A single IRB review process is not used for this type of review. Each institution must make its own NHSR determination. In some cases, a study may be human subject research at one site and non-human subject research at another site based on the research activities being performed at each site. It is important during the reliance consultation to be very clear about what research activities will be conducted at each site.