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).
Duke’s Office of Research Support (ORS*) provides services to Campus-based faculty and scholars who have a primary appointment in one of the following:
Generally, an individual qualifies as a faculty or a scholar if she/he meets at least one of the following criteria:
Campus-based faculty and scholars are required to submit and annual conflict of interest disclosure form, and update it within 30 days of acquiring days of discovering or acquiring a new and reportable financial interest. This is required under federal regulations and Duke’s FCOI policy.
ORS* 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. A 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:
The term SFI does not include:
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:
Each management plan is reviewed by the Campus COI* Committee, either by consent agenda or full review. If approved, the individual, signs the plan and ORS* 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 the following link: https://radapps.duke.edu/phs_travel
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.
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.
Please contact ORS* at firstname.lastname@example.org or 919 684-3030.
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