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What is the IRB Reliance?
The IRB Reliance is an agreement between MSU and Sparrow Hospital which allows an investigator to have a research protocol undergo IRB review through MSU's Biomedical & Health Institutional Review Board (BRIB),
MSU Social Sciences IRB (SIRB) as appropriate and Sparrow will accept the review of the lead institution. In essence there is only one IRB review instead of two and thus the investigators save time.
The
Sparrow IRB Reliance does have a very brief application and the only new information required (not on the original MSU IRBs application) is an Impact Statement in which signatures are required from departments impacted
by the research at Sparrow Hospital (e.g. Medical Records). It is suggested that the investigator procure these signatures and complete the IRB Reliance application while the MSU IRBs application is under review,
and then may be submitted to the Sparrow Institutional Research Review Committee (IRRC) immediately upon receipt of the MSU IRBs approval letter. Click here to visit the MSU IRBs website.
Who may apply for IRB Reliance review?
If the Principal Investigator is a paid MSU faculty member, the IRB application must go through MSU IRBs and a Sparrow IRB Reliance review can be applied for.
Note that if the MSU faculty member does not have privileges at Sparrow Hospital, the application must name a co-investigator at Sparrow,
someone who does have privileges at the hospital and is qualified in the area of the research.
If the Principal Investigator is not a paid MSU faculty member, they should go through the Sparrow IRRC.
All MSU student projects conducted at Sparrow Hospital must go through MSU IRBs, and then apply for an IRB Reliance waiver at Sparrow before conducting the project.
All Resident and Student research projects must be sponsored by a responsible principal investigator with privileges at, or paid by, Sparrow Hospital and be qualified in the area of research to be conducted.
For Resident/Student research projects: if the responsible principal investigator is a paid MSU faculty member, the IRB application must go through MSU IRBs first,
and then a Sparrow IRB Reliance Waiver applied for. If the responsible principal investigator is not a paid MSU faculty member, the IRB application must go directly through the Sparrow IRRC.
What is the process to obtain IRB approval of an HDE/HUD Device project?
For MSU-paid faculty members wishing to conduct a Humanitarian Device Exemption/Humanitarian Use Device (HDE/HUD) project at Sparrow facilities, the responsible investigator will submit the IRRC initial project application
directly to the Sparrow IRRC for approval and continued review. The Sparrow IRRC will be the IRB of record for all HDE/HUD projects conducted at Sparrow facilities.
After approval, what IRB do I deal with?
Whichever IRB reviews and approves the project (MSU IRBs or IRRC), will become the IRB of record, and that IRB should receive all future correspondence and discussion. If accepted under the IRB Reliance agreement, MSU IRBs and Sparrow
IRRC will communicate information between IRBs as appropriate.
Who do I report adverse events to?
External (non-local) Adverse Events should be reported to the IRB of record. Again, MSU IRBs and Sparrow IRRC will be communicating information between IRBs when appropriate, including adverse events. Note: if an
adverse event occurs with a Sparrow patient (internal or local), the principal investigator is required to report this event to the IRRC within 48 hours of the incident as well as MSU IRBs.
How do I submit changes, amendments, annual reviews and continuing applications?
Changes, amendments, annual reviews/continuation applications are to be sent through the IRB of record.
Under the terms of the SHS/MSU IRB Reliance Agreement, Sparrow retains the right to not approve any MSU IRBs - approved study for conduct at Sparrow facilities.
Click here to visit BIRB website.
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