In addition to the federally-negotiated Facilities and Administrative (F&A or “indirect”) costs applicable to research at UH, “Clinical Trials”, as defined below are subject to a 31% indirect cost rate. This rate is applied to the Total Direct Cost; no budgeted item is excluded from the application of indirect costs. This rate applies regardless of whether a Clinical Trial is based on a sponsor-initiated, or an investigator-Initiated protocol.
Definition of “Clinical Trial”, for the purpose using the 31% rate: The controlled, clinical testing in human subjects of investigational new drugs, devices, treatments, or diagnostics, or comparisons of approved drugs, devices, treatments, or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes. Such studies may be conducted under an industry-developed protocol or an investigator-developed protocol.
These studies are most often conducted in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration, but may also be designed with the sole purpose of collecting and analyzing data about approved drugs or devices in order to contribute to medical knowledge about the treatment of a disease or medical condition. Financial support for a clinical trial must be provided by a private entity, including pharmaceutical companies, interest groups, or charities. In all cases, the study must include the prospective enrollment of human subjects and the controlled testing of a drug, device, or diagnostic under an approved protocol. Retrospective chart reviews, analysis of existing medical data and records, laboratory research, animal studies, and federally funded projects are not categorized as clinical trials for purposes of applying the approved clinical trial indirect cost rate.