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.
Depending on the type of contract, research, or sponsor, the following will be handled by Sponsored Programs Administration (SPAdmin) or UNeHealth (in the case of industry-sponsored clinical trials).
Submit a New Contract
Submit your request to Amanda Leingang, Contracts/office Associate with the following documents:
- Final scope of work (protocol)
- Editable contract template
- SPAdmin/UNeHealth questionnaire
Your email communication with the sponsor may also provide valuable information to SPAdmin/UNeHealth that helps ensure timely negotiation.
A SPAdmin/UNeHealth contract negotiator will review and negotiate your contract. New contracts are parked in a queue and available to all until a negotiator is able to start the review.
Projects involving intellectual property development may require specialized contract terms that are best negotiated by UNeMed, the for-profit arm of the university that provides intellectual property protection and commercialization services for inventions. If SPAdmin/UNeHealth determines your contract is a better fit for UNeMed, SPAdmin/UNeHealth will transfer the agreement to them and keep you informed.
Industry-sponsored clinical research contracts are signed by the sponsor and an authorized institutional signatory. The investigator also signs but only as having read and acknowledged the contract terms. SPAdmin/UNeHealth coordinates the signature process.
SPAdmin/UNeHealth strives to execute contracts within 75 days of receiving the required documents from the department. Some take less time; some more. Variables that impact timelines include volume of contracts under review, sponsor responsiveness, terms requiring negotiation, and whether UNMC has an institutional master agreement with the sponsor.
SPAdmin/UNeHealth sets up the WBS as soon as the contract is fully-executed, the IRB is released, financial conflicts of interest are managed, and internal forms are fully-approved. SPAdmin/UNeHealth monitors each process to completion, then bundles the award and notifies the investigator and department administrator when the WBS account is set up.
SPAdmin/UNeHealth also handles WBS account set-up for contracts negotiated by UneMed. However, UNeMed stays involved for the life of the project. Click here to view the UNeMed site.