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.鈥
If an 91探花 researcher collaborating with another institution wishes for 91探花 to serve as the IRB of record for a non-exempt study or wishes for 91探花 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. 91探花 has master authorization agreements with several institutions with whom we frequently collaborate and participates in SMART IRB. 91探花 can only enter into an IRB authorization agreement with an institution with an . 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.鈥
鈥When 91探花 will be the Reviewing IRB
You will submit to the 91探花 IRB as usual. In your IRB protocol, please clearly indicate that the research team is requesting that 91探花 serve as the reviewing IRB for another institution. External (non-91探花) 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 91探花 serve as the reviewing IRB and instead elect to conduct their own IRB review. 鈥
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.鈥
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.
91探花 reserves the right to decline to serve as the reviewing IRB for other sites.
鈥When 91探花 will be the Relying IRB (deferrals)
A deferral is needed when 91探花 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.鈥疻hen that happens, the 91探花 researchers must instead submit to an 91探花 IRB for review and approval.
Please be aware that per 91探花 policy 19.052, approval of research by another IRB does not negate the need for IRB review at 91探花 or, in lieu of IRB review at 91探花, a fully executed IRB Authorization Agreement. 91探花 must either approve the deferral or issue its own IRB approval before our researchers may begin the research activities regardless of IRB approval elsewhere.
91探花 Heritage College of Osteopathic Medicine students need to submit a deferral request for all research activities conducted outside of 91探花, 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 91探花 when engaged in research and scholarly activities, per Heritage College of Osteopathic Medicine .
To request a deferral:鈥
Log into Cayuse Human Ethics and create a new study. Within the study, begin a new Initial Submission.鈥
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 91探花 researchers will be involved in explaining or obtaining consent. We will need something that shows the level of review (exempt, expedited, or full board).鈥
In section 5, study team, do not list any external researchers. The PI should be the person submitting the form, or if multiple 91探花 researchers are being listed, the PI should be the person who will assume the lead role. (If additional 91探花 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).鈥
For the PI qualifications question, you may enter "N/A" unless the overall project PI is an 91探花 investigator (this is uncommon for deferrals).鈥
For the COI question, please only include 91探花 researchers.鈥
Complete the questions in section 6, study funding.鈥疘f the study is receiving external funding, please be sure to indicate in the 鈥渉ow will the funds be used鈥 question whether 91探花 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, 91探花 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 91探花 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 91探花 representative in the Research Division before final IRB approval is granted.
International Studies
Collaborative research with international institutions should be reviewed by both 91探花 and the international IRB or equivalent. 91探花 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 91探花 IRB will incorporate the findings of the international IRB or ethics board into their review to ensure local context considerations are addressed.