GAP 200.440, Administering Commercially-Sponsored Projects and Gifts

  1. Purpose
  2. Definitions
  3. Procedures
  4. Resources

I. PURPOSE

The purpose of this GAP is to establish guidelines for distinguishing and administering commercially-sponsored projects and gifts. Interactions with Industry occur in many contexts and provide positive contributions to the University’s academic missions. However, these collaborations cannot be permitted to create conflicts of interest that could undermine the integrity of these missions. In particular, commercially sponsored projects and gifts cannot serve as inducements to Duke University to enter into separate commercial transactions with the funding company (e.g., the purchase of the funding company’s equipment, drugs or services) or otherwise affect the terms of any such separate commercial transaction (whether past, current, or proposed). Accordingly, this policy is intended as guidance to assist Duke University personnel in navigating financial interactions with commercial sponsors.

II. DEFINITIONS

Gifts. Gifts can come in two forms: unrestricted and restricted.

  • Unrestricted Gifts: These gifts are given without any expectation of, or the appearance of, reciprocal obligations between the donor and the recipient. The donor expects nothing of value in return for the gift, other than recognition. The University has broad discretion in how it can use the funds.
  • Restricted Gifts: These gifts have limitations regarding the use of the donated funds, but the limitations do not meet the definition of a “Sponsored Project” as set forth below. The University generally retains broad discretion in how it can use the funds as long as the use is consistent with the donor’s restrictions.

For both types of gifts, the following circumstances should be considered to avoid potential or actual conflicts of interest:

  • Whether the gift is so significant that even when placed in a general account or endowment it could influence, or give the appearance of influencing, the integrity of the University’s educational, clinical, or research missions; or
  • Whether the gift is restricted in such a manner that it will only benefit the department or unit where a substantial portion of the project is carried out; or
  • Whether a University faculty member or official who is able to influence or reasonably appear to influence key aspects of the project has also been actively involved in procuring the gift, or managing it once received by the University; or
  • Whether the gift appears to create unwritten expectations or a quid pro quo.

Faculty and staff who are offered gifts also must adhere to the DUHS Gifts and Courtesies Policy and applicable University policies and procedures.

Note: Monetary contributions of faculty members to their discretionary WBSE or any other cost element the faculty member controls are not charitable gifts and are not eligible for a gift receipt.

Sponsored projects. For the purposes of this policy, the term “Sponsored Project” refers to an endeavor for which funding is received from a commercial or for-profit entity, including funds for defined research projects, education, and fellowships. Sponsored projects generally involve the business interests or mission of the donor and impose greater obligations on Duke or have greater restrictions than gifts. Any project funded by a commercial or for-profit entity is a "Sponsored Project" if it meets any of the following criteria:

  • The project commits the recipient to delineated milestones, deliverables, or personnel work effort; or
  • The activities adhere to a budget, and the recipient is obligated to produce fiscal reports and/or invoices;
  • The donor via an agreement (formal or informal) requires that unused funds are returned to the sponsor when the project period is over;
  • The donor via an agreement (formal or informal) specifies the disposition of tangible or intangible property, including intellectual property, which may come out of the project;
  • The donor specifies a period of performance as a condition of the award; or
  • The funds are given to support non-CME-accredited educational activities or fellowships.

If the sponsored project involves human subjects, animals, use of radioactive materials, biohazardous materials or the potential for exporting, it must be reviewed by the appropriate Unviersity committees or Units for compliance with federal regulations and University policies.

III. PROCEDURES

Determination of Funding Type: If there is a question as to whether proposed funding should be handled as a gift or sponsored project under this policy, the representatives of the departments or units involved in procuring the gift will consult with the Vice Provost for Research and or the Executive Vice Dean for the School of Medicine as appropriate to make the determination. 

Non-CME-accredited educational activities or fellowships will be reviewed by Office of Research Contracting or the Office of Research Support to determine if they are gifts or a sponsored project pursuant to this policy.

Approval and Administration of Sponsored Projects

  1. Review and approval: No industry-sponsored project for research or non-GME education related activities may proceed without review and approval from the Office of Research Contracting ("ORC") or the Office of Research Support (“ORA”) as appropriate. ORC and ORA will follow their established policies for reviewing and approving agreements for sponsored projects that are consistent with the University’s non-profit missions and the principles expressed in this policy.

    • No industry-sponsored project for GME-related education and activities may proceed without review and approval from the DUHS Clinical Contract Services Office.  The Clinical Contract Services Office will follow its established policies for reviewing and approving agreements that are consistent with the ACGME requirements. 
  2. Principles: All industry-sponsored projects shall be assessed and administered in a manner consistent with the following principles:

    • Funding for sponsored research, educational activities and fellowships will be awarded to the University, Department, Division, Center, or Institute and not to a specific individual. For industry-sponsored support of ACGME accredited activities for residencies and fellowships, reference should be made to ACGME guidance relating to the conduct of such projects;
    • There will be no express or implied quid pro quo unrelated to the approved educational, fellowship or research-related purposes of the project funding;
    • The Department will determine the recipients, activities, and initiatives consistent with the sponsored project educational or fellowship agreement; and
    • The sponsor may be acknowledged in appropriate settings.

Receipt and Administration of Gifts: All gifts are received and processed by the Office of Treasury & Cash Management in accordance with the terms of this policy, and the Office of Research Integrity is responsible for reviewing restricted gifts to verify the absence of any express or implied quid pro quo or any actual or potential conflicts of interest. The Management Center for the recipient of the gift is responsible for monitoring compliance with the specific conditions associated with a restricted gift.

IV. RESOURCES