IRB Reliance
IRB Reliance / Single IRB Review
When multiple institutions are engaged in one research project that involves human subjects, it often makes sense for only one of the institutions' IRB to conduct the review and approval of the study. This is known as IRB reliance, or single IRB review. Single IRB review is required for federally funded, collaborative research.
If an Ohio University researcher collaborating with another institution wishes for Ohio University to serve as the IRB of record for a non-exempt study or wishes for Ohio University to rely on the IRB review of the other institution, an authorization agreement must be in place. Authorization agreements must be signed by the Institutional Officials (IO) of both institutions. Ohio University has master authorization agreements with several institutions with whom we frequently collaborate and participates in SMART IRB. Ohio University can only enter into an IRB authorization agreement with an institution with an active Federalwide Assurance (FWA). If you have questions about the process, please contact the Office of Research Compliance (ORC), compliance@ohio.edu.
IRB authorization agreements are not required for exempt research, but certain documentation will be needed.
When Ohio University will be the Reviewing IRB
You will submit to the Ohio University IRB as usual. In your IRB protocol, please clearly indicate that the research team is requesting that Ohio University serve as the reviewing IRB for another institution. External (non-Ohio University) researchers are not added to Cayuse, but there is a question where you can list them in a text box. We recommend that these external researchers communicate with their own IRB office early on about their intent to be listed as personnel on the study; many institutions have their own internal processes that must be followed and, in some cases, they may decline to have Ohio University serve as the reviewing IRB and instead elect to conduct their own IRB review.
When we receive an IRB submission that includes external researchers, ORC will either reach out to the other institutions directly (for non-exempt research) or ask the study team to provide documentation that the external sites are aware of and have authorized the inclusion of their researchers on the protocol (exempt studies). When a new IRB authorization agreement is needed, ORC will facilitate the process with the other institution.
Please be aware that the additional steps for external researchers will likely prolong the IRB review process, as IRB approval cannot occur until all required documentation is finalized.
Ohio University reserves the right to decline to serve as the reviewing IRB for other sites.
When Ohio University will be the Relying IRB (deferrals)
A deferral is needed when Ohio University faculty, staff, or students will be engaged in research with human subjects reviewed by another institution. Before the deferral is submitted, it is a good idea that the study team check in with the reviewing IRB to see if reliance will be possible; in some cases, the external IRB may decline to serve as the reviewing IRB for non-federally funded research. When that happens, the Ohio University researchers must instead submit to an Ohio University IRB for review and approval.
Please be aware that per Ohio University policy 19.052, approval of research by another IRB does not negate the need for IRB review at Ohio University or, in lieu of IRB review at Ohio University, a fully executed IRB Authorization Agreement. Ohio University must either approve the deferral or issue its own IRB approval before our researchers may begin the research activities regardless of IRB approval elsewhere.
Ohio University Heritage College of Osteopathic Medicine students need to submit a deferral request for all research activities conducted outside of Ohio University, even though in many cases the external site may consider you to be an affiliate of their institution at the time of the research activity. Currently enrolled medical students are always considered an agent of Ohio University when engaged in research and scholarly activities, per Heritage College of Osteopathic Medicine policy 7.11.
To request a deferral:
Log into Cayuse Human Ethics and create a new study. Within the study, begin a new Initial Submission.
When you get to section 2 of the Initial Submission form, for the first question that appears, choose "Yes, I am submitting a deferral request."
Answer the rest of the questions that appear. At the bottom of the page, you can attach relevant documents. These include but are not limited to the most recent IRB approval letter, the protocol as submitted to the reviewing IRB, and a copy of any consent forms if Ohio University researchers will be involved in explaining or obtaining consent. We will need something that shows the level of review (exempt, expedited, or full board).
In section 5, study team, do not list any external researchers. The PI should be the person submitting the form, or if multiple Ohio University researchers are being listed, the PI should be the person who will assume the lead role. (If additional Ohio University researchers need to request a deferral later for the same study, this can be done via a modification request; a new deferral is not needed).
For the PI qualifications question, you may enter "N/A" unless the overall project PI is an Ohio University investigator (this is uncommon for deferrals).
For the COI question, please only include Ohio University researchers.
Complete the questions in section 6, study funding. If the study is receiving external funding, please be sure to indicate in the “how will the funds be used” question whether Ohio University will receive any of the funds, either directly or via a subaward.
ORC will review the submission once it is fully submitted. If the reviewing IRB is one with whom we do not have an existing IRB authorization agreement, and the study is not exempt, we will contact the reviewing IRB to facilitate a new agreement. Please be aware that the timeline for this process can vary from days to weeks. If the study has received an exempt determination from another institution, Ohio University may choose to accept that determination, or we may instead elect to conduct our own exempt review.
External Individual Investigators Not Affiliated with an FWA-Holding institution
If you are submitting to an Ohio University IRB and your protocol includes external researchers who are not affiliated with another university or other FWA-holding institution, then the IRB authorization agreement is not the appropriate mechanism. Instead, the external researcher will need to sign an Individual Investigator Agreement. The agreement will also be signed by an Ohio University representative in the Research Division before final IRB approval is granted.
International Studies
Collaborative research with international institutions should be reviewed by both Ohio University and the international IRB or equivalent. Ohio University will not cede review to an international institution, nor will it serve as the reviewing IRB for an international institution, unless required under a research funding agreement. When appropriate, the Ohio University IRB will incorporate the findings of the international IRB or ethics board into their review to ensure local context considerations are addressed.