Clinical Trial Agreements

Study in which human subjects are assigned to a group that receives a clinical/medical intervention (e.g., medication, clinical/medical procedure, device) and/or a control group for a clinical condition1 and who interact with study personnel, having provided an informed consent2.

Projects which fall under this definition are handled by our Clinical Contracts Division.

1Clinical condition – symptom, set of symptoms or a diagnosis as determined by a qualified investigator
2 Consenting to the use of a biological fluid or tissue sample only for subsequent study does not constitute a clinical trial as there is no ongoing interaction between the investigator/study personnel and the human subject.

University of Louisville

The University of Louisville is a public institution of postsecondary education of the Commonwealth of Kentucky. UofL is a body politic and corporate in law. The University of Louisville Research Foundation, Inc. (ULRF) is a 501(c)3 non-profit corporation acting as the agent of the University of Louisville for receiving grants and research agreements from external funding sources. ULRF also owns and controls intellectual property on behalf of the University.

University of Louisville Research Foundation, Inc.

Contracting Information

What are common contract questions in sponsored research agreements?

The University of Louisville Research Foundation, Inc. (ULRF) is the legal entity which executes sponsored research agreements for the University of Louisville. ULRF is a limited agent for the University for the purpose of receiving grants and research agreements from external funding sources.

Kentucky law does not permit the University to indemnify or hold harmless another party. Negligence claims against the University are subject to the Kentucky Board of Claims (KRS 44.070 et. seq.) The hospital/facility sites will not indemnify the CRO or Sponsor (nor provide cross-indemnification.)

Claims against the University must be brought under the Kentucky Board of Claims Act so we cannot be bound by another state’s laws or agree to the jurisdiction of another state’s courts. However, we can agree to leave the contract silent on governing law/choice of law.

The University cannot agree to binding arbitration, but we can agree to other alternative dispute resolution processes.

The University generally does not provide warranties. Alternative promises are acceptable, such as to promise, represent, certify or agree.

The University is bound by the Kentucky prompt payment statute which allows for recovery of interest on late payments.

University intellectual property (IP) rights are governed by the University’s Intellectual Property policy. Rarely can the University assign or exclusively license intellectual property in advance of its creation. The University can assign ownership in specific work products (e.g. reports) generated as a result of the research, but not the underlying technology or tools.  The University’s preference is to follow the academic standard and to grant exclusive options for licenses on terms customary in the industry; however, OIE deals with IP on a case-by-case basis, and is open to negotiations on this point.

University researchers and their students need the ability to use data and other research work product for non-commercial educational and research purposes and the right to independently publish. This right can be provided under license, can be limited by a Sponsor’s right of review or can be delayed for a short period to permit the protection of IP rights.

In the case of multi-center, industry sponsored, industry created clinical trial protocols, the University researcher’s right to independently publish may be waived with the researcher and his/her department chair’s permission; provided the sponsor is willing to agree to make the clinical trial/study results public within two years of completion of the study.

Under IRS regulations, non-profit status can be jeopardized if royalty rates are set in advance. Instead, the University grants exclusive options to license on terms reasonable for the industry, including a good faith negotiation of fair royalties

Proposals/Agreements—Where to Begin

I will be conducting a research project. What type of agreement do I need and where do I start when…

Start here: Industry-Sponsored Project for Review: Proposal Clearance Form (Word document) and PCF Instructions