13.3 Specialized Categories of Sponsored Projects
In addition to sponsored projects as defined in the RPH: Categories of Sponsored Projects, the following specialized categories of agreements are defined and handled as sponsored projects.
1. Industry-Sponsored Clinical Trials
Clinical trials are a subset of clinical research and must include all four of the following factors in order to qualify for the clinical trial indirect cost rate:
- The objective of the study is either:
a. testing of a drug, device, diagnostic, treatment, intervention, or preventive measure, including testing for an unapproved indication or
b. data collection, or review of data generated or acquired in a clinical setting, to increase knowledge that would lead to enhanced safety and efficacy of a drug, device, diagnostic, treatment, intervention, or preventive measure.
2. The study will evaluate the effect of the drug, device, intervention on human subjects, or the review of patient care clinical data, with a focus on health-related biomedical or behavioral outcomes.
3. The study must be performed primarily in patient care space, clinical-quality space, or locations treated as off-campus space.
4. The study must be industry funded.
2. Research Participation Agreement
A Research Participation Agreement (RPA) is a form of sponsored project in which services of Stanford personnel, academic facilities, and/or laboratory equipment are employed on behalf of parties not otherwise affiliated with the University. A Research Participation Agreement is different from other forms of sponsored research projects in that a significant portion of the responsibility for the intellectual direction, interpretation, and/or outcome of the work rests with the outside user. Criteria for the establishment of Research Participation Agreements and process for their approval is outlined in RPH: Research Participation Agreements.
3. Beta Test Site Agreements
Beta Test Site Agreements are contracts by which commercial vendors test and evaluate early product development. The proposed agreements come from companies that have agreed to provide various products and/or software to academic departments in exchange for evaluation. Beta Test Site Agreements must be processed as sponsored research projects through the Office of Sponsored Research.
4. Equipment Loan Agreements
Equipment Loans are agreements whereby a sponsor may loan certain equipment to Stanford, such as hardware, software and/or documentation for research use. One such example is an agreement whereby Stanford and a private entity participate in a joint research program using the company's equipment and share the results, including data. This type of agreement usually does not involve money, but enables Stanford and industry researchers the opportunity to use each other's facilities.
5. Material Transfer Agreements
Material Transfer Agreements (MTAs) are contracts by which tangible research property, such as biological organisms, is provided by external sources to Stanford investigators for research, or by Stanford investigators to external researchers. Material Transfer Agreements are processed as sponsored research projects along with the fully endorsed MTA Routing Form through the Industrial Contracts Office within the Office of Technology Licensing.
6. Industrial Collaboration Agreements
Companies and universities are increasingly requiring documentation of inter-institutional research partnerships. Formal agreements in these cases will help to avoid misunderstandings and disputes over ownership of results. Collaboration contracts should be sent with a fully endorsed Proposal Routing and Development Form to the Industrial Contracts Office within the Office of Technology Licensing. Stanford has its own standard collaboration agreement that may be used as well.
7. Intergovernmental Personnel Act Agreements
An Intergovernmental Personnel Act Agreements (IPA) is a service agreement whereby Stanford employees may serve or cross train in federal agencies for limited periods of time. Some or all of their salary and staff benefits are paid by the federal agency under Title IV of the Intergovernmental Personnel Act, while they are still considered Stanford employees, and provision has been made for their return to Stanford. IPAs are not considered to be sponsored projects. However, in order to monitor compliance with applicable regulations, these agreements will be administered by Stanford's Office of Sponsored Research. IPA proposals should be submitted to each school dean's office. The dean will review the appropriateness of the arrangement, and the need for certification by Stanford that the participating employee will be returned to the same or similar position upon completion of the assignment. The dean's office will notify the Stanford employee of its decision and forward the approval to the Office of Sponsored Research for submission to the appropriate government agency.