Hey Geoff:

Reading all the responses, they all pretty much hit on the hi points.  In my experience have found the following to be good for facilitating the whole process:

1.  Do paperwork now to hire the person (and any one they are bringing) on staff only, no payroll.  Once their real start comes, then a revised Personnel Form to put them on payroll should do the trick for pay and benefits.  Primarily, this then lets the IRB consider that person as one of your own.  Also allows for the internal process to begin with approvals that may be involved in addition to the IRB.
2.  Have the new person give you a copy of the protocol with the other institutions approval for submission to your IRB. This serves only as back-up as the other institution's approval isn't valid with your institution or with the NIH.
3.  Same with animal protocol if they have one.  For both the IRB and the IAUACC, the NIH across the board will not allow funding, mostly, as they would be giving money for something not approved and that is against their regs.  See below about some charges that "could" be authorized.
4.  Internally, even if you did get a restricted notice of award, your accounting folks would need a separate account for the charges on the protocols.  While usually t&e in prepping the protocols is allowed, no charges directly associated with the protocol/work are allowed to be posted without the approvals.  Note that an approval is valid at the NIH only when they have certification.  This usually means something like a cover letter transmitting protocol approval with our authoirzed institutional signature.
5.  Have the person do two things also:  cancel any standing orders at the old institution and have them start the process to have them put in place where you are.  Further, as a suggestion, have them do the terminating paperwork at the old (for payroll) institution now.  This will dis-encumber funds on the NIH dollars, thereby giving a better idea of how much money you will have for budgeting in the transfer paperwork you submit.  If someone is staying on longer at the old institution, I would recommend a purchase order from your institution.  This also enables a better and more realistic idea of the funds available for transfer.  And, almost as important, it allows the old institution to clear the account and submit the FSR, which will be needed for NIH before they can issue a NOA to your instituion.
6.  Be aware that whatever amount you submit as the dollars for the transfer, NIH may hold back a little in case the old insitution revises the FSR for any late charges/expenses.
7.  And, because his/her start-up funds or other cost center will cover the initial expenses, they "should" be able to be cost transferred once the NOA comes in.  Justification would be "pending receipt of the transfer Notice of Award from NIH".  Something to that effect.  Double check that with our Accounting/Audit people before any processing.
8.  Hope this helps you and your new person out.  Has worked for me in the past and generally fosters a faster and smoother transition for everyone involved.
9.  Take care - let us all know how you make out.
10.  End.

jay throp.  xxxxxx@tufts.edu

--- On Fri, 5/27/11, Geoffrey Schick <xxxxxx@AURORA.ORG> wrote:

From: Geoffrey Schick <xxxxxx@AURORA.ORG>
Subject: [RESADM-L] Transfer of NIH R01 Grant & IRB Approval
To: xxxxxx@lists.healthresearch.org
Date: Friday, May 27, 2011, 11:26 AM

Looking for input from sites far more experienced in the world of grants than we are...and that includes just about everyone!

So we have a (potential) physician investigator recruit that is coming to our Institution with an NIH R01 grant that is already underway. The PI has met with his Program Officer at NIH and we are in the process of satisfying NIH that we can accommodate the project with minimal disruption to the research.

We have a question regarding IRB approval. The study currently has IRB approval (human tissue that would have been discarded is gathered for research purposes) and we are struggling to determine whether we need to officially submit the protocol for our local IRB review/approval BEFORE the transition date. Or...will the NIH be satisfied with a "just in time" letter that indicates the Study will have IRB approval by a certain date, when the grant is actually transferred between institutions.

The only guidelines I can find for using the Just In Time methodology are on new submissions...nothing regarding transfer of grants already underway.

Suggestions?

Geoffrey A. Schick
Director, Clinical Research

====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.healthresearch.org (click on the "LISTSERV" link in the upper right corner)
A link directly to helpful tips: http://tinyurl.com/resadm-l-help ======================================================================

======================================================================
 Instructions on how to use the RESADM-L Mailing List, including
 subscription information and a web-searchable archive, are available
 via our web site at http://www.healthresearch.org (click on the
 "LISTSERV" link in the upper right corner)

 A link directly to helpful tips:  http://tinyurl.com/resadm-l-help
======================================================================