Amendment to Contract Negotiated by SPAdmin
An amendment is an agreement signed by both parties to accept changes to an earlier agreement. Changes may pertain to:
- Change in investigator (required for all agreement types)
- Scope of work
- Terms and conditions
- Period dates or extension of project
- Costs (addition or removal of funds)
- Change in payment schedule
Business Associate Agreements
Business Associate Agreements are required when a covered entity such as UNMC shares protected health information (PHI) with an external entity that perform a business service for UNMC but has no research interest. Examples may include data extraction or telehealth services. A business associate may be an academic partner providing a business service, or it may be industry partner. Always, they are external to the covered entity that owns the data.
- Contact SPAdmin if PHI sharing is directly related to a funded research project (402-559-7456 or email)
- Contact Procurement if PHI sharing is tied to a vendor agreement (Procurement Director, Jeff Elliott, at 402-559-9688 or email)
Consulting Agreements are entered into when a UNMC faculty member agrees to lend his/her expertise to an outside entity for a fee. Consulting agreements fall into two categories:
- University consulting agreements are reviewed by SPAdmin and executed between the university and sponsor when UNMC resources are used to support the work and UNMC receives funds that are placed in the investigator’s development account. Contact SPAdmin to submit a university consulting agreement (402-559-7456 or email)
- Personal consulting agreements are reviewed by the investigator and executed between the investigator and sponsor when UNMC resources are not used to support the work and UNMC does not receive payment. Prior to signing, the investigator is encouraged to submit the contract to UNeMed for review. NOTE: Personal consulting agreements cannot pertain to human subject research in any way. Contact UNeMed for a personal consulting agreement.
Additional Requirements: Consulting agreements often create conflict of interest concerns and may necessitate a conflict management plan. All consulting agreements trigger a need for the investigator to submit an Outside Employment Form to Compliance and to disclose the activity in COI-SMART within 60 days of performing the work.
Cooperative Group Agreements
Cooperative Group Agreements are most often federally funded and mirror grants in that the key purpose is public good vs. commercial profit. They are essentially an “assistance” mechanism in which the institution receives limited funds to perform work in which the sponsor is substantially involved. Such involvement often means the investigator can expect federal programmatic collaboration or participation in carrying out the effort.
Contact: SPAdmin Associate, 402-559-7456 or email
Data Use Agreements
Contact: SPAdmin Associate, 402-559-7456 or email
Master Agreements include terms and conditions that apply broadly to multiple studies by a given sponsor. They may be institution-wide or specific to an investigator who plans to conduct a series of projects with that sponsor. Masters have no funding but become part of subsequent work orders, each of which receives funding for a specific protocol or scope of work.
Significant time is required to arrive at terms that broadly apply across numerous projects, but work orders that flow under them are expedited and therefore an excellent way to reduce contract timelines. Click her for a list of institutional master clinical trial agreements. If a study is PI-initiated and/or the master does not sufficiently address intellectual property concerns for a given study, a stand-alone agreement may be executed instead of a work order.
Contact: UNeHealth Coordinator, 402-559-7614 or email
Material Transfer Agreements or MTAs
A material transfer agreement is required when transferring drug for patient-oriented research or human samples or biologic material for research purposes. Contact SPAdmin (402-559-7456 or email) for transfer of drug; contact UNeMed (Jeff Anderson or 402-559-3274 or email) for transfer of human samples or biologic material.
SBIRs and STTRs
Small Business Innovation Research (SBIR) and Small Business Technology Transfer Program STTR) projects are typically backed by federal funding and are therefore managed by the SPA grant team. Contact your grant specialist for more information.
UNeMed provides intellectual property protection and commercialization services for inventions developed at the University of Nebraska Medical Center. When a sponsored project is likely to lead to significant discoveries involving intellectual property UNeMed negotiates the contract and partners with SPAdmin to manage the award. Click here to transfer to the UNeMed website.
UNMC Procurement manages and signs vendor agreements that may be needed to support your project. Click here to transfer to the Sapphire portal.