Quite honestly, other than one minor differential, I would have suggested exactly the same thing. Because we never know how long it’s going to be from the initial just in time until the actual Justin time is requested, often we end up having to do it twice. The only thing that I may have done differently is that I always recommend to my faculty but if they get the just in time notification and believe that they have a fundable score, that they need to get their protocols submitted to the regulatory boards ASAP because happy NIH is becoming less and less agreeable to restricted notices. But, otherwise we would have likely maintained the same process.

On Wed, Sep 8, 2021 at 9:12 AM Kirsten Torguson <xxxxxx@torgusonassociates.com> wrote:

Good morning,

I have a faculty member who is poised to receive an R01. We saw the pre-JIT button on Commons some time ago, but I suggested that we wait until we receive the formal JIT email request from the grants management specialist since we would be requesting information from our two subawards as well (which, as you know, is cumbersome and can change quickly). So we waited. The formal JIT request came in and we responded in 24 hours. NIH only asked for other support documents and clarifications on a few effort calculations from our subs. I asked my faculty member for the anticipated date of our CRO's IACUC committee meeting so I could include that timeline in our cover letter forwarding the JIT information. I gave them a heads-up that we might receive a restricted award given that our IACUC protocol would not be reviewed until mid-October, but that NIH (and the greater federal agencies) wants to get awards issued by their fiscal year-end (9/30).

We then received an email from the GMS asking whether our institution has an animal welfare number (no), and if not, that we'd need to enter into an IIA (routine). Our faculty member is now worried that because we didn't respond to the original (informal) JIT button in Commons, and further that we didn't upload a biosafety document (not required in the JIT) that we have somehow jeopardized our chances of getting this award. I have tried to explain the process (that I have gone through more times than I can count), but I feel that they'd like to see how other institutions might handle the JIT process and what your experiences may have been in similar circumstances with restrictions on awards.

I suggested that the faculty member reach out to the GMS directly to assuage concerns, but I'd love other opinions here that I can share with them as well.

Thank you for your time this morning! Kirsten

--
Kirsten Torguson, MS, CRA
Founder & Senior Consultant
Torguson & Associates, LLC
www.torgusonassociates.com

541.499.0400

You do the science ... we do compliance!

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