Yes, effective June 1, 2020, Duke University will implement a revised Policy on Faculty Conflicts of Interest and Conflict of Commitment in Research (formerly the Individual Conflict of Interest Policy).
The revised policy will encompass the Institution’s positions and guidelines for community members engaged in research and outside activities, including start-up companies and relationships with non-faculty individuals. Individuals who are required to complete the Conflict of Interest Disclosures should review the revised policy to ensure awareness and compliance with updated Institutional directives.
The following is a summary of changes which may affect the reporting and management of outside activities for individuals required to complete annual financial conflict of interest disclosures:
Conflict of Commitment: The policy includes definitions, expectations and processes for regular and non-regular rank faculty to meet standards set in the Faculty Handbook, 220.127.116.11 Conflict of Commitment. Individuals should review to determine what and how to disclose, discuss and manage potential conflicts of commitments with their supervisors.
Conflict of Interest for Faculty involved in Start-Ups: Appendix A formalizes Institutional guidance on managing faculty’s involvement with and actions on behalf of start-ups with which they may be involved.
Relationships with non-faculty members: Appendix B formalizes Institutional guidance of relationships between faculty and non-faculty members in outside activities.
Dispute Resolution: Defining pathways for dispute resolution of Conflict of Interest management plans and potential violations of management plans and/or the Policy. Includes potential outcomes and steps the Institution may take in response to inquiries and/or violations.
The newly revised policy does not change the requirements for individuals to annually disclose conflicts of interest, or to amend their disclosure within 30 days of a change. Additionally, it reaffirms the Institution’s commitment to management of potential conflicts of interest and adherence with relevant sponsor policies.
To maintain the integrity of Duke University, its personnel, and the public’s interest as it relates to conflicts of interest and conflicts of commitment in research.
The policy applies to regular-rank tenure and non-tenure track faculty members. These faculty members will hold one of the following titles: unmodified professor, associate professor and assistant professor; unique named titles associated with named chairs; and approved non-tenure track titles including professor of the practice, clinical professor, research professor, lecturer and medical instructor (and associate/assistant professors of the same categories).
Furthermore, the policy also applies to: 1) individuals granted Principal Investigator status and 2) those individuals employed by the University and providing material benefits to externally funded research projects. This will be indicated by being named a key personnel or receiving salary from effort on a U.S. federal, state or local government funded project that had financial activity within the preceding twelve months.
- Using University resources in activities that may lead to financial gain for the faculty member (or their immediate family).
- Using University resources to benefit an external entity
- Using the name of the University in promoting activities that may lead to financial gain for the faculty member (or their immediate family).
- Interacting with students in external as well as internal roles. e.g., seeing students as clients or patients, employing students for non-University work.
- Engaging in research in which a faculty member (or their immediate family) has a financial interest, including interests in a start-up company and/or interests related to licensed intellectual property.
- Having a relationship or affiliation between the faculty and the source of information or materials.
- Competing with the University for clients, contracts, etc.
- Financial involvement of a faculty member (or their immediate family) with an outside organization, or holding a position in an outside organization.
- Having an external interest that could be implicated in internal University decisions. e.g., contracts, hiring, research, or in giving advice.
Payments from outside entities or stock interests greater than $5,000.
- Payments for services (consulting, lectures, advisory board payments, or honoraria);
- Equity interests, i.e. stocks, stock options, and other ownership interests;
- Intellectual property rights (e.g., licenses and royalties);
- Donations (monetary, unrestricted funds, in-kind designated for research)
- Relationships and activities with foreign institutions and funding agencies
- All external professional activities.
Federally funded Individuals are also required to disclose items such as sponsored or reimbursed travel and/or gifts and gratuities. These disclosures should be made using appropriate mechanisms and in accordance with relevant university policies.
- Ownership of a share in a mutual fund
- Salary or other remuneration from Duke or another accredited U.S. institution of higher education
- Salary or other remuneration from the U.S. Department of Veterans Affairs or another U.S. federal, state, or local government entity
- A distribution from Private Diagnostic Clinic, PLLC or the Duke University Health System
- Book Royalties
A conflict of interest may arise when a faculty member’s relationship with an outside entity might appear to bias that individual’s judgment in performing his or her professional responsibilities at the University. A conflict of commitment may arise when a faculty member engages in external activities or assumes external commitments that might appear to compromise their ability to fulfill the responsibilities of their University obligations.
At no time should any outside activity, with or without compensation, exceed the four (4) days per month standard, for full-time faculty, averaged over an annual period of service based on term of appointment. Exceptions to this policy may be granted by the dean, director or designee where conditions such as reduced effort allow for increased outside activity without creating a conflict of commitment. The University has established four days per month as the outer limit for faculty members’ outside activity.
No, outside activities may not involve the use of University facilities, materials, services, personnel, or information without prior University approval and a written agreement between all parties.
No, faculty member should not include Duke as a party for their personal contracts. Negotiation of the terms of the contract or agreement is the responsibility of the faculty member. The faculty member should ensure the terms of any such agreement, including confidentiality and intellectual property terms, are consistent with his/her obligations under applicable Duke policies. Research in Duke facilities must not be conducted under such personal contracts or agreements.
Management plans are intended to mitigate the potential bias of an apparent or potential conflict to preserve the integrity of the research.
- Disclosing the potential conflict to appropriate sources inside and/or outside the University;
- Modifying or limiting the faculty member’s duties to minimize or eliminate the conflict;
- Reducing the faculty member’s appointment to accommodate the outside interest or activity;
- Securing the faculty member’s agreement to modify or suspend outside activity, use of University resources, or other activities that create the potential conflict;
- Prohibiting certain outside activity as inconsistent with the faculty member’s obligations to the University;
- Initiating an oversight plan to mitigate potential bias;
- Other actions or steps, as appropriate
Cautionary Memos are advisory in nature. They contain a list of reminders that one should be mindful of when maintaining outside relationships. Management plans, on the other hand contain action items that must be adhered to in order to remain in compliance with the COI/COC policy and federal regulations.
Yes, Faculty members may dispute decisions made in response to the disclosure or non-disclosure of a potential conflict of interest or commitment. The recourse for such a dispute is to make a request in writing to the Conflict of Interest Committee at email@example.com. Once a request is received, the DOSI-COI office will issue an email notifying the individual that their case is under review.
Payments from subsidiary companies or contractors should be reported as coming from the parent company. For example, if "Company A" hires a contractor to run a conference, and the honorarium check comes from the meeting organizers, the money should still be attributed to the "Company A" and should be included on the COI reporting form. In some cases, meetings may have multiple sponsors, each of whom makes contributions that not easily distinguishable. In those cases, if the meeting meets the standard for independence (for example, in medicine, continuing medical education certification), the honorarium need not be reported, otherwise payments should be reported as coming from the parent company.
In general, companies that are owned by larger companies (for example, Janssen and Ortho Biotech are owned by Johnson & Johnson) will be treated as one entity (the overarching company - Johnson & Johnson in this case), unless the COI Office specifically concurs that the subsidiary truly operates independently of the holding company.
Because it may be difficult to determine fair market value for privately-traded companies, all related equity holdings in privately-traded companies must be reported in the annual COI reporting process. In most cases, any equity in a non-publically traded company is treated as if it exceeds all thresholds and is managed accordingly if there is an identified research overlap.