Industry-Sponsored Research (Sponsored Programs Administration)

Industry-sponsored contracts must be reviewed and negotiated before being signed. SPA negotiates non-clinical and clinical research agreements with the exception of Phase I-IV Clinical Trial Agreements negotiated by UNeHealth.

Non-clinical research is wide ranging and may be most easily defined by what it is not. Non-clinical research does not require informed consent by human subjects or involve data or specimens with Protected Health Information (PHI). The work may or may not involve animals and may be described as laboratory research, testing, or provision of services. Non-clinical industry-funded projects typically have a defined period, scope of work, and deliverables such as research data or reports.

NOTE:  SPA negotiates non-clinical agreements

Clinical research is defined as research that involves human subjects as participants and/or requires the informed consent of a human subject. In addition to clinical trials, clinical research encompasses physiologic studies as well as any projects involving human subject data or specimens.

NOTE:  With the exception of Phase I-V Clinical Trials, SPA negotiates these agreements

Your Role

To initiate the negotiation process, submit these documents to SPA:

Contract negotiations begin after SPA receives all three components.

SPA’s Role

SPA negotiates the terms and conditions of your contract with the sponsor’s legal representatives. Our negotiation standards balance the need to protect our investigators and institution with maintaining long-term relationships with our sponsors.

Who Signs

SPA coordinates the signature process for industry sponsored agreements. Typically, the sponsor and an authorized institutional signatory (e.g., SPA Director) sign industry-sponsored research contracts. On occasion investigators may be asked to sign that they have “Read and Acknowledged” the terms of the agreement.

Strategies to Avoid Delays

SPA offers these tips to minimize time to contracts: