When Cornell researchers plan to participate in a collaborative or multi-site study, there are a few options for IRB review of the project. Which IRB (or IRBs) should complete an ethical and regulatory review depends on several factors, including: funding agency requirements, the level of IRB oversight needed based on potential risk to participants; the nature of human participant research to be conducted by each institution; and which other institution(s) IRBs are involved, and what their internal processes and policies require in such cases.
Note: Before you begin the process of seeking IRB approval for multi-site or collaborative research, contact the IRB office to discuss your situation and find the best solution from the options described below. It is possible that not all collaborators are considered investigators from an IRB perspective, in which case multiple IRB review or a reliance agreement may not be necessary.
Option 1: Separate/Multiple IRBs Review
In some cases, it is most efficient for researchers from each participating institution to obtain IRB approval from their own institution's IRB, covering any regulated human participant activities that will occur at their site. This will almost always be the case when research is eligible for exemption from IRB review.
Option 2: One IRB Reviews (aka "Single IRB" or sIRB)
In some situations, to avoid duplicative reviews and increase efficiencies--or to comply with federal regulations--the Cornell IRB might agree to serve as the "IRB of Record" or cede IRB review to another institution. The IRB of Record--sometimes called the "Single IRB" or sIRB--is selected on a study-by-study basis, provides the ethical review and related administrative coordination for all sites/institutions participating in a collaborative or multi-site study, and assumes responsibility for all human participant research compliance. The IRB of Record is usually chosen from among participating institutions, but may be provided by an external, commercial provider of IRB services (e.g., BRANY). The IRB at each participating site will need to formally cede their IRB review to the reviewing IRB using a fully-executed reliance agreement (sometimes called an IRB authorization agreement or IAA).
More Information about sIRB Review
Under the revised (2018) Common Rule, federally-funded multi-institution studies--with very few exceptions--are required to use an sIRB for review and approval of cooperative studies conducted in the United States. This applies to all cooperative research applications and contract proposals submitted on or after January 20, 2020.
For NIH studies, a version of the sIRB requirement has been in effect since January 2018. For applications submitted on or after January 25, 2018, NIH-funded multi-site studies involving non-exempt research must use an sIRB, when the same protocol is used at multiple domestic study sites.
The Cornell IRB is not always equipped to serve as the sIRB, depending upon the specifics of the research. Researchers should contact the Cornell IRB office prior to submitting a proposal to NIH or any other federal agency for a multi-site project. The IRB staff will assist PIs with identifying a suitable partner to act as the sIRB, if Cornell is unable to serve in that capacity.
FAQs
- Collaborative research - when non-Cornell investigators come to Cornell to work on a Cornell study, or conduct a separate aspect of the study (such as data analysis) elsewhere.
- Multi-site research - when Cornell is one of many participating sites, with each site recruiting and consenting subjects and collecting data.
An IRB Reliance Agreement is a document permitting one institution's IRB to cede review (the “Relying IRB”) to another institution's IRB (the “IRB of Record”) for a particular study involving human participants. In this way, only one IRB reviews and approves human subject research activities for both institutions, avoiding duplicative review and regulatory oversight.
If you believe a reliance agreement makes sense for a study that you are involved in, and your co-investigators from the other institution(s) agree, we recommend that you first schedule a call with IRB staff to confirm that your proposed approach will work.
Once you have confirmed that a reliance agreement is needed, you can indicate if you want Cornell to serve as the IRB of Record, or if you want Cornell to rely on another IRB, within the protocol application in RASS-IRB. See the RASS Guide Site for instructions on how to do this.
If a reliance agreement is appropriate (or required by the sponsor), IRB staff will work with the other institution's IRB to negotiate and execute the agreement.
Cornell University includes both the Ithaca-based campuses (Ithaca, Geneva and Cornell Tech campus) and the Weill Cornell Medicine Campus (“WCM”). The campuses operate separate IRBs and maintain separate Federal Wide Assurances (FWAs) with the U.S. Department of Health and Human Services, so an umbrella reliance agreement has been put in place between the IRBs to facilitate the timely, streamlined review of research collaborations spanning the campuses.
Before submitting an application for an IRB project involving WCM and Ithaca researchers, please review this document addressing inter-campus human subject research collaborations and follow the steps for contacting both IRB offices.
It depends. If the other institution is collecting data for your project, they would be considered "engaged" in the research under federal regulations, and IRB review will be needed for their role on the project (either by their home IRB or by the Cornell IRB). If the other institution is only providing data or access to data that has already been collected, IRB review will not be needed for this aspect of the study. Instead, a Data Use Agreement should be entered into, in consultation with OSP.
When Cornell is acting as the Reviewing IRB, Cornell's training requirements apply. Likewise, if another institution is reviewing your project, you will need to comply with that institution's training requirements. Note that Weill and Cornell's Ithaca campuses have different training requirements; If Weill is providing IRB review for your study, you will need to complete training in Good Clinical Practices in addition to human subjects training.