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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 Charlotte Johnson 10 Jun 2010 08:36 EST

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)

 "Duryea, Kristina"
 <xxxxxx@BNL.GOV>
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 Subject
 06/10/2010 09:26 AM                 [RESADM-L] managing expiring human subject
 protocols with active grants

 Please respond to
 Research Administration
 Discussion List
 <xxxxxx@hrinet.org>

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.

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.

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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