indirect cost rates on clinical trials Jane A. Youngers 23 May 1994 10:19 EST

I thought I'd add my two cents worth on the clinical trial issue.
At Rochester we charge 25% MTDC and, in thinking about raising it
to 30%, decided we really needed to sit back and see what we were
doing.  I had particular concerns about the consistency aspects
regarding costing ala A-21.

I think the reason all of us have been charging lower than our
normal research rates is that clinical studies don't often take
place in a our laboratories, but rather are done in clinical or
hospital settings.  But there are differences in the amount of
effort depending on the trial.  When we simply participate as one
of many centers utilizing a company-developed protocol, we probably
put forth less effort than if we develop the protocol or we are
the coordinating center on a multicenter trial.

What we are trying to do, then, is somewhat the model that Chicago
wrote about.  We are trying to differentiate the types of trials.
Where we are simply a participant, we are going to use our off campus
research rate (converted to an TDC rate);  where we are writing
protocols, or are the lead center, or the like, we will use our
on campus research rate (again, converted to a TDC rate).  We
have not done the computations yet, but I think we will fall out
in the low 20's in the first case; the low 30's in the second.

We also think this will provide a good rationale for auditors,
particularly since we are in a number of federally-funded trials.

(I might add that we only have a research rate on and off campus,
unlike some of you who have multiple rates depending upon circum-
stances.)

If I can add one more comment:  I think this rate issue is difficult
for most of us because we have trouble deciding what clinical trials
are.  Are they research?  You bet, when we are talking about UBIT
considerations.  Are they testing studies?  You bet, when we are
talking about our A-21 research base.  And therein lies the rub...

Again, just my humble opinion talking about a policy we haven't
finalized yet.

Jane Youngers
Director, Office of Research & Project Administration
University of Rochester
xxxxxx@mvs.cc.rochester.edu