Deb,

Circular A-122 is similar to A-21, it applies to grants, contracts and other
agreements.  I think it's great they would love to have a party for the
volunteers, but I would be very cautious.  Was this in the proposal and approved
by the agency?  I am sure there was excitement for this activity at the study
meeting (program personnel always have great ideas), but I know if my
contracting officer for any of our fixed-priced trials heard about a "party"
there would be questions raised immediately.

Proceed with caution and see what the contracting officer has to say about this
activity.

Good luck - John

"Hansen, Debra" wrote:

> We have a federally-funded clinical trial for which we receive payments
> under a per patient (fixed fee) type agreement.  The P.I. submitted a
> consent form change to our IRB indicating that it was suggested at a
> national meeting (directly related to this study), that the funded sites for
> this clinical trial have a "THANK YOU" get together for all of the patients
> enrolled in the study.  Hors d'oveuvers and punch would be served and door
> prizes would be distributed.  Obviously, our IRB approved his request and
> the study staff are now chomping at the bit to purchase the door prizes
> using these fixed fee dollars because they have "approval"!  (I guess we
> still have some educating to do on the difference between IRB approval and
> Sponsored Programs approval!)
>
> Anyway, in the past we have always operated under the premise that these
> types of costs were unallowable under A-122, regardless of the funding
> mechanism, as they are audited by our external auditors like any other
> federally funded activity.  Typically, our position would be that the P.I.
> would need to find some other source of internal funds to cover this type of
> cost vs. charging it directly to the specific federally-funded study
> account.
>
> Can someone provide clarification (or reference to specific regulation) on
> whether or not the federal regulations need to be consistently applied to
> federally funded fixed fee type arrangements?  Any other advise on this
> specific situation would also be appreciated!
>
> Thanking you in advance for any responses received and extending a Happy
> Friday to all!
>
> Deb
>
> Debra K. Hansen
> Director of Sponsored Programs and Fiscal Affairs
> Marshfield Medical Research and Education Foundation, a Division of
> Marshfield Clinic
> 1000 N Oak Avenue - 1R3
> Marshfield, WI   54449
> 715-387-9130
> xxxxxx@mfldclin.edu
>
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--
F. John Case
Executive Director
Office of Contracts and Grants
University of North Carolina at Chapel Hill
CB #1350, 440 W. Franklin Street
Chapel Hill, NC 27599-1350
(919) 966-2542
(919) 962-3352 (fax)
xxxxxx@unc.edu

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