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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