Research Policy Analysis and Coordination
Human Clinical Trials
Campuses have agreed to a minimum recovery of 26% of the Total Direct Costs for human clinical trials that fall under the following definition:
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 (FDA), under an Investigational New Drug (IND) application or as IND exempt for drug studies (as Phase I, II, III, or IV), or under an Investigational Device Exemption for device studies, although studies can 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 conditions. In the case of a non-FDA regulated drug, device, treatment or diagnostic (including dietary supplements), the study must use medical facilities and University personnel in the performance of the study. In all cases, the study must include the prospective enrollment of human subjects and the controlled testing of a drug, device, treatment 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. The clinical trial IDC rate may not be used unless financial support for the clinical trial is provided by a for-profit, commercial entity, such as a pharmaceutical or device company.
Each campus may establish higher rates than this minimum.