DUKE’S FINANCIAL CONFLICTS OF INTEREST PROGRAM
Duke University (Duke) is committed to ensuring that its faculty and scholars are provided an open and productive environment in which to teach, conduct research, and carry out other institutional duties. Duke understands that this often requires faculty and scholars to interact with outside institutions and persons, which in turn could lead to a financial conflict of interest (FCOI).
The Duke Office of Scientific Integrity provides services to all faculty and scholars.
Generally, an individual qualifies as a faculty or a scholar if she/he meets at least one of the following criteria:
- have Faculty or Special PI Status;
- are a Postdoctoral Associate/Scholar;
- are listed as Key or Investigator in SPS on an active award; or
- are an Exempt employee who has received salary support from a government source or from a sponsored research project (i.e., WBS Elements 20x, 30x, 31x, 32x, 33x, 34x, 35x, 3x3).
All faculty and scholars are required to submit an annual conflict of interest disclosure form, and update it within 30 days of acquiring or discovering a new and reportable outside financial interest.
DOSI COI reviews forms for compliance with Duke’s policy and laws applicable to requirements for sponsored research awards and contracts. For example, federal agencies that sponsor research at Duke often require a FCOI review before a proposal is submitted, at the time of award, and when the disclosure form is updated. Many contracts require a similar process as well.
Understanding the term Significant Financial Interest” (SFI) is key to considering a FCOI. An SFI is anything of monetary value whether or not the value is readily ascertainable, that reasonably appears to be related to the Individual’s institutional responsibilities, including, but not limited to:
- Payments for services (e.g., consulting fees, lecture payments, paid authorship or honoraria);
- Equity interests (e.g., stocks, stock options, or other ownership interests); and
- Intellectual property rights and interests (e.g., patents, copyrights, and royalties from such rights).
The term SFI does not include:
- Ownership of shares in a mutual fund;
- Salary or other remuneration received from Duke;
- Private Diagnostic Clinic distributions;
- Income from seminars, lectures, or teaching engagements sponsored by Federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
- Income from service on advisory committees or review panels for federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education (e.g., NIH);
- Payments made to Duke by an outside organization; and
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Individual does not directly control the investment decisions made in these vehicles.
A “Financial Conflict of Interest” (FCOI) is a SFI that could directly and significantly affect the design, conduct, or reporting of research, or the performance of duties and responsibilities on behalf of Duke. A FCOI can exist in a variety of situations, including research, teaching and mentoring, procurement, and clinical care.
Where a FCOI exists, e.g., when it could be directly and significantly related to the design, conduct, or reporting of sponsored research, then, depending on the scope of the FCOI, a few different approaches may be considered, including management, reduction, or elimination. Management refers to a conflict management plan.
Management plans are common and recommended by regulators and sponsors. A conflict management plan documents your role at Duke and the fact that the SFI is a FCOI, and the plan contains the terms for managing the FCOI going forward. Provided below is a summary of terms that may be included in a management plan:
- Public disclosure of the financial interest, e.g., when publishing or presenting the results of the research; to Institution’s Institutional Review Board(s) or directly to participants in a clinical trial;
- Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias;
- Changing personnel or responsibilities, or removing personnel from all or some part of the project;
- Reducing or eliminating the financial interest (e.g., sale of an equity interest);
- Severing of relationships that create financial conflicts;
- Confirming the employee’s agreement to the management plan;
- Describing how the plan will be monitored to ensure compliance; and
- Other information, as needed.
Each management plan is reviewed by the COI Committee, either by consent agenda or full review. If approved, the individual, signs the plan and DOSI COI will track compliance with its terms and conditions over time proportionate to the level of risk.
In certain circumstances, ORS will provide information about management plan to a sponsor, i.e., the U.S. Public Health Service’s component agency (e.g.., NIH) that funds the research, or other sponsor that requires such reporting. For NIH, the information is established by regulation, and includes a description of the key elements of the institution’s management plan, including: (a) role and principal duties of the conflicted investigator in the research project; (b) conditions of the management plan; (c) how the management plan is designed to safeguard objectivity in the research project; (d) confirmation of the investigator’s agreement to the management plan; (e) how the management plan will be monitored to ensure investigator compliance; and (f) other information as needed.
Faculty and scholars who are planning to participate in PHS-funded research must disclose their reimbursed or sponsored travel related to their institutional responsibilities over the previous twelve-month period to Duke no later than the time of application for PHS-funded research. They must also submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence. You can report the sponsored or reimbursed travel at this link.
If the FCOI involves a Campus-based faculty or scholar and a clinical trial, then ORS will refer the matter to the School of Medicine’s Research Integrity Office and ORS will represent the faculty member or scholar throughout the process.
FCOI Frequently Asked Questions – These FAQs provide answers to some frequently asked questions about FCOI and other compliance and ethics programs at Duke.
FCOI Disclosure Form - Use this link to submit your annual form through Duke’s electronic interface, and use the link to update your form within 30 days of acquiring days of discovering or acquiring a new and reportable financial interest. Accessing the form requires multifactor authentication (MFA). If you have any MFA-based or other technology-related issues, you can call RAD at (919) 684-2200 or click on the following link: http://www.oit.duke.edu/help/index.php. Additional information is available at http://rad.duke.edu/support/coi-assistance.
FCOI Form User Guide – The guide will assist you with questions regarding the form and how to complete it.
PHS Sponsored/Reimbursed Travel - - If you receive funding through the U.S. Public Health Service (which includes NIH, FDA, CDC, SAMSHA, and more), you must report certain reimbursed or sponsored travel that fits in the criteria noted on the sponsored travel reporting tool. This page provides information to explain this requirement.
Federal and Other FCOI Requirements and Guidelines
Provided below are links to FCOI-specific regulations. By clicking on the sponsor, you will be able to review that sponsor’s requirements.
- Public Health Service
- National Institutes of Health (FAQs)
- National Science Foundation
- Federal Acquisition Regulation – 9.5 – Organizational Conflicts of Interests
Please contact DOSI COIat email@example.com or 919 684-3121 for more information.
If you wish to anonymously report a conflict of interest or any other compliance matter, please call Duke's Fraud and Compliance Hotline: 1-800-849-9793