At UCLA we use a 22.5 TDC rate for clinical trial fixed price contracts in
which we are simply providing the site and the patients- - carrying out a
protocol designed by others.  Our agreement contains no provisions which
give the sponsor any licensing or other intellectual property rights and we
require complete indemnification from the sponsor for any liability arising
from proper conduct of the protocol.

We do not think the negotiated research rate is appropriate for these
agreements for a number of reasons - - Because these are fixed price
agreements, PIs have much more flexibility in spending than they would have
with a grant or cost reimbursement agreement and could charge items that
would be exempt under the negotiated MTDC rate (e.g., equipment, patient
care) to the account, resulting in a very low indirect cost recovery.
 Because these agreements are not subject to the same accounting and costing
rules applicable to federal and other research agreements, there are lower
administrative costs associated with them.  And, because University
intellectual property and independent research design are not, in our mind,
a part of our activity, the factors upon which calculation of  the research
rate is based are not applicable.

On the other hand, if the PI develops the protocol for use with a Sponsor's
drug, or if the Sponsor demands intellectual property rights or other
changes that make it appear that they view this as more of a research
project, then we apply the negotiated research rate.

With respect to UBIT, our exemption claim is not based upon the argument
that these are "research agreements."  Rather, it is based upon the
demonstrated fact that these activities are directly related to the teaching
and patient care purposes of the University, either because they are for the
benefit of hospital patients who have the disease for which the eventual
commerical use of the drug is intended , or because they are necessary for
the teaching activities of the university.  A survey which was conducted of
our clinical trials indicates that students are actively involved in nearly
all of the studies as a part of their required training.  Over 80% of the
studies involve the participation of residents, and nearly half include the
training of medical students, interns and jurnior faculty.  In nearly 90% of
the studies, results are used as instructional material.  Over 81% of the
studies involve the conduct of "for benefit" tests in which drugs were
offered to patients who have the disease or medical condition for which
commercial use of the drug was intended.

Hope this is helpful.

Dan Hutchinson, Associate Director
Office of Contract and Grant Administration
xxxxxx@ocga.ucla.edu