FAQs and Tools for navigating requirements and policies associated with research collaborations

Short Answer: It depends on the work that is required of the collaborator, how that work is classified, and the relationship to Duke.  Consult with the appropriate pre-award office and this tool to determine the correct classification:

• Office of Research Administration (ORA) for Medicine/Nursing
• Office of Research Support (ORS) for Campus Schools

The Details: Determining the proper relationship with an external collaborator is critical to ensure that Duke University is adhering to federal compliance requirements and sponsor terms and conditions. Misclassification can delay the award or project start-up, lead to non-compliance, and potentially result in serious and costly audit findings for the University.

Duke University, as the applicant organization or as a subawardee, has the responsibility to determine the appropriate classification of an external entity or collaborator participating on a sponsored project.

Use this tool to distinguish among the types of mechanisms used.  

Specifically, the grant administrator of the project owning org is responsible for determining the proper mechanism for engaging a collaborator PRIOR to proposal submission. The grant administrator must assess the work to be performed by the collaborator and complete the Independent Contractor Checklist to make the determination.  If it is determined that the individual is to be compensated as an independent contractor or via a subaward, a separate, distinct, and detailed scope of work must be provided to the grant administrator.

ORA/ORS may request additional information regarding the activities and work to be performed, including the Independent Contractor Checklist used for making the determination, to ensure Duke University is complying with Uniform Guidance requirements (see § 200.331 Subrecipient and contractor determinations).

Short Answer: Yes.  Duke values collaborations with external investigators and understands that these collaborations are vital to advancing research and education.

The Details: The Duke Office for Research and Innovation provides guidance specifically on visiting scholars engaged in research (requires NetID login).  The guidance outlines the processes and guidelines for a Visiting Research Scholar’s participation in research at Duke University, including registering their participation in Duke research, ensuring a safe and inclusive environment, appropriate management of data and intellectual property, and facility/equipment access and use. This guidance is applicable to activities that occur on campus and remotely. Visiting Research Scholars must not engage in research until this process is completed.

Additionally, Visiting Research Scholars participating in federally-sponsored research must be appropriately disclosed to the sponsor. Access guidance on appropriate disclosure. 

Short Answer: The type and level of information needed to appropriately compensate a collaborator depends on how the collaborator will be engaged (employee, independent contractor/consultant, subaward or vendor).

The Details:

Employees.  When a portion of the scope of work will be performed by multiple investigators within Duke, no formal agreement is necessary.  However, when the National Institutes of Health is the sponsor and there will be multi-PIs, a multi-PI plan is required between the Duke investigators. This is true also for multi-PIs at other institutions when there is a subaward agreement in place.  See NIH Guidance on Multiple Principal Investigators for more information.

Subawards. When a portion of the scope of work on a sponsored project will be performed by another organization (the subrecipient), a subaward agreement must be established and managed throughout the award period. Special considerations must be made when the other organization is the Durham Veterans Administration Medical Center. 

Note: Subawards differ in mechanism of payment from vendors or consultants.  For help in making the appropriate determination, please see this tool.

Sponsor guidelines should be followed to ensure the appropriate documents are requested and collected from the proposed subrecipient. All subrecipient documents will need to be attached to the SPS Internal Documents section of SPS for review.

Generally, the documents needed to establish a new subaward are:

• Detailed (separate and distinct from Duke) Scope of Work
• First Year Detailed Budget or SF424 RA& Subagreement Budget
• Budget Justification
• Letter of Commitment signed by an AOR of the subcontracting institution

Other elements may be required depending on the sponsor and award mechanism, including:

• Biosketch for Key Personnel
• Current & Pending or Other Support for Key Personnel
• Facilities and Other Resources
• Equipment
• Letters of Support
• Representations and Certifications
• Small Business Subcontracting Plan
• PHS 398 Face Page
• PHS 398 Checklist

Learn more about how to Establish and Maintain Outgoing Subaward Agreements.

Independent Contractor/Consultant. If an individual is hired to perform services, you must first determine if the relationship is that of an independent contractor or an employee-employer. The Independent Contractor Checklist is the established tool to make this determination. 

If the individual is already a Duke employee, he or she must also be treated as an employee for contractor/consultant services and paid through Duke’s payroll system. Otherwise, whether an employer-employee relationship exists generally depends on a single factor: the degree to which the University or Health System has a right to direct and control the work of the individual, not only as to the result to be accomplished, but also as to the details and means by which that result is to be achieved.

See detailed guidance and process overview for engaging and making payments to independent contractors/consultants in Duke Gap 200.134 All Other Payments to Individuals for Services.

Vendor. Procedures for procuring goods, services, and other materials from sources external to Duke University can be found in Duke GAP 200.372 Purchasing Goods on Sponsored Funds.  For payments to foreign vendors, see Duke GAP 200.137 for Documentation Requirements for Payments to Foreign Vendors.

Collaborations with entities and individuals outside of Duke may require formal agreements around ownership and confidentiality of research-related data and materials. The Office of Research Contracts (Schools of Medicine & Nursing) and the Office of Research Support (other Duke schools) assist researchers in establishing appropriate documentation for exchanges of research materials, confidential information, data, technical know-how, and equipment in support of research across the University.

When the National Institutes of Health is the sponsor and there will be multi-PIs (at Duke or at other collaborating organizations), a multi-PI plan is required between the investigators.  See NIH Guidance on Multiple Principal Investigators for more information.

Note: Only authorized organizational representatives with delegated signature authority are authorized to sign research-related agreements on behalf of Duke University.

Access the Navigate contracts and agreements page to determine what contracts may be needed for your project and who to contact for assistance.

International research collaborations are vital to Duke’s mission to advance healthcare and innovation globally. To accomplish this, there are special considerations to understand prior to engaging with international collaborators. These include:

• International visitors and scholars
• Travel to sanctioned countries
• Sponsor disclosure requirements
• International shipping of research materials or technologies

Foreign Components.  The performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended requires prior sponsor approval BEFORE the activity may occur.

Activities that would meet this definition include: (1) the involvement of human subjects or animals, (2) extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities, or (3) any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country. Examples of other grant-related activities that may be significant are:

• collaborations with investigators at a foreign site anticipated to result in co-authorship;
• use of facilities or instrumentation at a foreign site; or
• receipt of financial support or resources from a foreign entity.

Contact your grant administrator for guidance on seeking prior approval to include a foreign component in your research.

Access the international activities guidance or the Resource Guide to Support International Research for more information about potential international collaborations.  For information regarding paying international partners, reference this checklist for Payment to Foreign Vendors and the related Duke GAP 200.137 for Documentation Requirements for Payments to Foreign Vendors.

As of July 1, 2024, investigators with international subrecipients are required to ensure that all data, lab notebooks, and supporting documentation from their international subrecipients has been shared with Duke and is therefore easily accessible upon request by the NIH. To that end, investigators must store the data on a Duke-provided system that allows for central access to the data. 

In order to meet this requirement, the ASIST office recommends that investigators with international subrecipients set up a notebook in LabArchives where each subrecipients can upload the required materials and data. 

More information, including steps to active your LabArchives account can be found here. 

Please reach out to internationalsubdata@duke.edu with any questions or to request a consult. 

NIH Final Updated Policy Guidance for Subaward/Consortium Written Agreements

Frequently Asked Questions.