Research Agreement guidance

A Research Agreement (RA) is a contract that establishes the relationship between Duke and another party (the “External Entity”) under which Duke receives funding and/or a study drug or device to support the research project.  The research may be non-clinical, preclinical, or clinical.  The RA defines the terms under which the research will be conducted, such as the specific research scope of work, the budget and payment terms, and the research timeline.  A few contract terms that are particularly important to Duke are those terms preserving Duke’s academic freedoms regarding intellectual property, publication, confidentiality, liability, and those terms addressing human subjects protections and the handling of human subject data and samples.  In exchange for the External Entity providing funding and/or the drug or device to be studied, 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. Therefore, all RAs for industry sponsored research must be forwarded to ORC for review and processing.    

If an invention is made during the course of a research project, the Duke researcher must formally disclose the invention to the Office for Translation and Commercialization (OTC) which will then work with the External Entity and the Duke researcher to develop the appropriate steps for intellectual property protection and appropriate licensing. It is important that OTC be informed that the invention was made as a result of research conducted under an RA so that OTC can properly consider intellectual property issues. 

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 study, the contracting experience of the External Entity, whether the project is a researcher initiated study or a External Entity protocol, and whether the RA must address human subject protections or detailed intellectual property terms.  In general, an acceptable industry standard holds that RAs are usually finalized within about ninety (90) days from the point of first exchanging a proposed RA.  Additional time may be needed if other Duke offices, such as the Office of Licensing and Ventures, the IRB, Export Control, or the Information Security Office, need to review aspects of the RA.

As a 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. Additionally, Duke researchers supplementing any industry sponsored research with NIH or other government funding are required to maximize the use of their research findings by making them available to the research community and the public at large and through their timely and effective transfer to industry for development.

Research Agreement processing

  • If the Duke researcher has received an RA from an External Entity, the RA should be submitted to ORC for review and negotiation as soon as possible.  The submission should include a complete statement of work, a budget if available at the time, the SPS number if available at the time , any relevant IACUC or IRB numbers relating to the proposed research, and the name of the Clinical Research Unit if relevant. Even if all the information is not available at that time, 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, the researcher should contact ORC to request a Duke RA.
  • 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 a SPS number 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 RA cannot be signed by Duke unless there  is a routed and approved SPS entry. 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, and ORC has received the SPS# and the IRB# (if applicable, and in such case, confirmed that the RA and Informed Consent Form are in synch regarding research related injury obligations), ORC will send the RA to the appropriate signatory office (either ORA or DOCR) for final processing and signature.  Once signed, the appropriate office will notify the researcher’s group that the RA signed by Duke can be retrieved. 

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