Duke Conflict of Interest

Duke manages Conflict of Interest (COI) in a manner consistent with NIH policies. The institution requires all faculty members and many staff members to report their external financial interests and relationships each year through an on-line form. These forms are reviewed for their overlap with research projects (found through our grants database, SPS), as well as clinical, purchasing, and educational activities. Those individuals with a potential personal conflict of interest are evaluated, and a management plan is written by the Research Integrity Office staff and approved by the School of Medicine COI Committee. The faculty or staff member with the potential conflict is required to review and sign the management plan. Our key thresholds are $10,000 and $25,000 in external interests (although this will change to $5,000 as of January 1, 2012). Duke requires annual reporting of any external relationships of $600 or more (the same standard as an IRS 1099 form). If an individual has less than $5,000 in external interests, Duke permits them to engage in the full range of activities. They are, however, required to disclose in CME (continuing medical education) certified activities and by some journals, but these are requirements mandated from outside organizations. At $5,000 or more in external financial interests (payments or stock holdings) that overlap with an individual’s research, Duke requires disclosure in all publications, presentations, grant applications, and informed consent documents. When the external relationship involves more than $25,000 in payments or equity, or if the individual has any privately-held equity or any options, the individual is not allowed to be principal investigator on related grants or to obtain consent for human subjects research. Further limitations are considered on a case-by-case basis.

When Duke has an institutional COI (for example, if Duke owns equity in a start-up company) that overlaps with proposed research, the case will be reviewed by Duke University’s Institutional COI Committee. In general, Duke considers the rebuttable presumption that the proposed research be done at a non-Duke site unless there are compelling circumstances to justify doing the work at Duke. If the research is to be done at Duke despite an institutional COI, the ICOI Committee generally requires an independent Data Safety Monitoring Board – Plus, with the usual DSMB functions in addition to evaluation of the project for evidence of bias in the design, conduct, or reporting of the research. Investigators are required to obtain approval from an external, non-Duke IRB, and external monitoring should be in place. The informed consent documents should disclose that Duke has a financial interest.

In addition to the annual reporting and review, Duke also uses an event-based COI review system. The Research Integrity Office evaluates each awarded grant in addition to those grant applications and IRB applications related to the grant. All IRB applications are reviewed by the IRB staff with an eye toward COI questions, and two members of the IRB office attend the School of Medicine COI Committee meetings.

Duke has four committees to formally review COI situations and the management plans. These committees cover School of Medicine/School of Nursing, Campus, Administrative, and Institutional. All are supported by staff whose primary professional responsibility is the evaluation and management of potential conflicts of interest.

Conflict of Interest Liaison by Department