University of Nevada, Reno Research Agreement Templates
Sample Sponsored Research Contract
A standard contract includes the following components:
- Research agreement
- Material transfer agreement
- Outline of intellectual property rights
Material Transfer Agreement (MTA)
- Uniform Biological Material Transfer Agreement
- Material Transfer Agreement (incoming)
- Material Transfer Agreement (outgoing)
Non-disclosure agreements (NDAs) set the stage to begin discussions regarding licensing, partnerships and commercialization of research by protecting confidential information that will be exchanged in order to evaluate the technical and commercial potential of the disclosed information.
Data Use Agreement
A data use agreement (DUA) is a legal agreement between one or more entities (e.g., contractor, private organization, academic institution, federal agency/department or state agency/department), when one of the entities requests the use of "identifiable records" that are covered by a legal authority.
"Record," is defined as any item, collection or grouping of information about an individual that is maintained by an organization when information is retrieved as follows:
- By the name of the individual.
- By a code that is assigned to the individual (when a key to decipher the code exists).
- By another personal identifier (e.g., finger print, voice print, or digital or photographic image).
Protected Personally Identifiable Information (Protected PII) includes but is not limited to the following:
- Finger or voice print
- Facial images (print or digital)
- Education records
- Criminal history
- Medical history or records (including provision of care and payment for care)
- Employment history or records
- Financial transactions
For simplification, the entity requesting the records is referred to as the Data Recipient, and the entity providing the records is referred to as the Data Provider. DUAs specify the conditions for use and disclosure of records by Data Providers and Data Recipients.
Regulations regarding the privacy of health information (HIPAA Privacy Rule) allow limited data sets for use and disclosure of Protected Health Information for research, public health or health care operations.
DUAs for Human Research Activities
The following requirements apply to university and affiliate researchers establishing DUAs for human research activities:
- Institutional Review Board (IRB) approval is required before DUAs are executed and signed;
- Requirements for informed consent are met or waived, and documented accordingly; and
- Individuals handling the data for transfer and researchers receiving the data are trained on the terms of the agreement including safeguards to protect confidential information.
IRB ApprovalThe Data Recipient is responsible ensuring requirements for IRB approval are met for the proposed uses of the data set. The Data Provider may request documentation of IRB approval before finalizing the agreement.
Requirements for Informed ConsentThe Data Provider is responsible for ensuring requirements for informed consent for the proposed uses of the data set are met or waived as follows:
- For active studies, if the proposed uses of the data were addressed in the consent process for research participation, further action is not necessary.
- For active studies, if the proposed uses of the data were not addressed in the consent process for research participation, an amendment to describe the consent process or request a waiver of the consent process for the new uses may be required.
- For studies that have closed, contact the Research Integrity Office to discuss options.