Basic science, non-clinical, and translational Research Agreement guidance

Research Agreements (“RA”) define the terms established between Duke University and another party (“the “External Entity”) for the performance of research, which may include a specific research scope of work, the provision of materials or data, a budget and payment terms (if applicable), and the research timeline.

In exchange for the External Entity entering into an RA, the External Entity will usually be offered contractual rights to use the research data and limited rights to inventions and discoveries arising from the performance of the research. In all cases the terms and conditions in an RA must reflect the educational and research mission of Duke in a manner consistent with its status as a nonprofit educational institution. 

If an invention is made during the course of a research project please contact Office for Translation and Commercialization (OTC). 

The amount of time needed to finalize an RA can vary depending on a number of factors, including but not limited to, the complexity of the research, the contracting experience of the External Entity, whether the project is a investigator initiated research or an External Entity protocol, and whether the RA must address human subject protections or detailed intellectual property terms.  In general, the expected time-frame for a finalized, legal, terms and conditions in an RA  is about sixty (60) business days from the first exchange of a proposed RA.  

To note:  Whenever a Duke researcher’s research is funded either in whole or in part by NIH or other government agencies, that activity is subject to the requirements of Public Law 96-517, known as the Bayh-Dole Act of 1980, which protects Duke’s rights in inventions made in the research while granting the government certain rights in those inventions and limits what rights can be granted to an industry sponsor. 

Research Agreement processing

  • If the Duke researcher has received an RA from an External Entity, the RA should be submitted to the Office of Research Contracts (ORC) for review and negotiation as soon as possible. The submission should include:
    • A complete statement of work
    • A budget (if applicable and available at the time)
    • The SPS number (if applicable and available at the time)
    • Any relevant IACUC or IRB numbers relating to the proposed research, if available at the time
    • The name of the Department/Clinical Research Unit if relevant. 
    • Even if all the information is not available, it is important to involve ORC as soon as possible so that the RA review and negotiation can begin. If the External Entity has not provided a proposed RA and would like Duke to provide the RA, the researcher should contact ORC to request a Duke RA.
    • The Agreement Submission Information form can be used to submit information to ORC
       
  • ORC will either review or draft the RA to ensure compliance with Duke research policies and guidelines and applicable federal regulations for research being conducted at Duke.
     
  • During ORC’s negotiation time, if an SPS number is needed and has not yet been generated, the researcher should submit the RA and budget to their finance office in order for the agreement to be entered into the SPS database system, which tracks the status and execution of sponsored agreements. The funded-RA cannot be signed by Duke unless the SPS record is in PCA status. Additionally, the researcher should ensure that the research has been submitted to the IRB if applicable.  
     
  • Once the terms of the RA are finalized by ORC, the SPS number (for funded agreements) and the IRB have been provided to ORC, then ORC will send the RA for final processing and signature.  

Duke researchers are not authorized to sign RAs on behalf of Duke

Assistance with basic science, pre-clinical, or translational Research Agreements

Including sample analysis with or without data associated with the samples, or work proposed to be under a Research Analysis Quotation and Agreement (RAQA), contact:

Curtis Bradney, Ph.D. (Director)
Tel:  919-668-3127
Fax:  919-684-4595
Email: curtis.bradney@duke.edu