Indirect Costs on Clinical Trials Hutchinson, Daniel 27 May 1994 18:16 EST
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