Hi,
Has the IRB specifically requested the sponsor to receive a study risk determination from the FDA (#3) or to submit an IDE application to the FDA (#2)? If not, there are a few considerations although you seem to have a plan already.
- If the sponsor already has all required information for an IDE application and is ready for a submission, your approach may work better for initiating the (either NSR or SR) study soon (assuming the FDA will not request additional information nor disapprove the IDE).
- Has the sponsor discussed the study risk determination rationale with the IRB to see if the sponsor could modify the protocol (e.g., eligibility criteria, safety monitoring, other controls to prevent/mitigate risks) to change the IRB's risk determination?
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Ji-Eun Kim RAC, RPH, PhD
Director, Regulatory Affairs
Scarsdale NY
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Original Message:
Sent: 30-Sep-2021 17:26
From: Anonymous Member
Subject: IRB significant risk determination
This message was posted by a user wishing to remain anonymous
Hi All,
i wonder what is the course of action when the IRB doesn't agree with the sponsor's non significant risk determination. I see that the sponsor is required to report this determination to the FDA within 5 working days.
what happens next?
i have in mind three possibilities:
1) FDA asks the sponsor for the documentation (protocol etc) kind of interactively and gives a second opinion on the determination
2) FDA asks for an IDE (if so, can the conclusion of the IDE be that the study is NSR?)
3) FDA asks the sponsor to submit a risk determination request (q-sub)
Has any of you had experience with a similar situation? If so, it would be great if you could please share it. I am trying to think of the best strategy, in case we have the possibility to choose. For example between an IDE and a Q-sub I prefer an IDE in terms of timeline (30 vs 70 days). However, I would like to be reassured that the outcome can still be: no, the IRB is wrong, you are NSR.
Thanks for any advice you can provide
ps. i am very confident that the IRB is wrong and is misunderstanding the definitions of significant risk study. I am honestly pretty sure that FDA will finally agree with us, so all this is just a big loss of time and energy