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managing expiring human subject protocols with active grants Duryea, Kristina (10 Jun 2010 08:25 EST)
Re: managing expiring human subject protocols with active grants Charlotte Johnson (10 Jun 2010 08:36 EST)
Re: managing expiring human subject protocols with active grants chowfornow (11 Jun 2010 10:17 EST)

Re: managing expiring human subject protocols with active grants chowfornow 11 Jun 2010 10:17 EST

As central office, that is usually where the monitoring is best done.  First off, when the account is authorized for set-upto Accounting, animal and IRB approval expiration dates should be noted in the set-up paperwork (e-mail).  The responsibility would then lay with Accounting to monitor charges being appropriately charged.  Once expired, the charges have to be moved to a discrtionary or other account until notice received from central office that a current approval is back in place.  This would also include occurences where an IRB protocol is approved and at the same time replaces the previously approved protocol.  Also, per your message, the IRB should add central office as a cc when sending out approvals so that you can then give that updated authorization to Accounting.  Also, to facilitate all of the above when non-competing/Type 5 submissions are due, they don't go out until the protocol is in place and uptodate.  This helps keep protocols and
 charges uptodate and the institution in compliance, not mention pre-award and IPAS actions not being required later.

jay throp.

--- On Thu, 6/10/10, Charlotte Johnson <xxxxxx@HARVARDPILGRIM.ORG> wrote:

> From: Charlotte Johnson <xxxxxx@HARVARDPILGRIM.ORG>
> Subject: Re: [RESADM-L] managing expiring human subject protocols with active grants
> To: xxxxxx@hrinet.org
> Date: Thursday, June 10, 2010, 9:36 AM
> Our office receives a copy of the
> yearly IRB approval and we are notified if there is a
> problem with
> that yearly review.
>
> Charlotte A. Johnson
> Associate Director
> Office of Sponsored Programs
> Harvard Pilgrim Health Care
> 133 Brookline Ave., 5th Floor
> Boston, MA 02215
> Telephone:  617/509-9929
> Fax:  617/509-9859
> www.harvardpilgrim.org/providers (research and teaching)
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> I have a question on how your institution handles expiring
> human subject protocols on awards that
> are still active.  Specifically, if the protocol
> expired because the PI did not file their renewal
> on time, how do you handle the award to which it pertains
> if there is sponsored funding? I’m asking
> because of federal requirements that if human subjects
> approval is not active, then there cannot be
> any expenditure on the grant until such time it’s
> reinstated.
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> At our institution, the grants office is not notified that
> a protocol has expired.  If there is an
> active grant to which the protocol belongs, we do not know
> that it expired.  The account information
> is not collected by our IRB to include in the protocol
> file.  When the protocol expires, the account
> is not reviewed.  The IRB notifies the study
> coordinator and CRC staff of this so they know not to
> schedule subjects, but that’s it.
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> Does a review of any sponsored award occur at your
> institutions to insure that no active sponsored
> funding is tied to that study?  I  can’t figure
> out how else we would stop expenditures without
> knowing this.
>
> Thanks.
>
> Kris
>
> Kristina Duryea
> Departmental Grants Administrator
> Brookhaven National Laboratory
> Biology Department, Bldg. 463
> Upton, NY  11973-5000
> 631-344-7850 voice
> 631-344-6398 fax
> xxxxxx@BNL.gov
> Check out the grant writing library!
> http://www.bnl.gov/lifesciences/GrantWriting/GrantWriting-electronic_res.asp
> http://www.bnl.gov/lifesciences/GrantWriting/GrantWriting-books.asp
>
>
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