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Scientific Integrity
Topic

Conflict of interest

Need assistance with conflict of interest?

Duke Office of Scientific Integrity-Conflict of Interest (DOSI-COI) collaborates with faculty, staff, internal Duke offices, and external organizations to ensure quality review, management, and reporting of conflicts of interest (COI) and conflicts of commitment (COC) related to research at Duke University.

Individuals whose role at Duke work requires them to disclose their outside activities are responsible for maintaining a current and accurate disclosure form in myRESEARCHhome. Disclosure forms must be updated within 30 calendar days of discovering, acquiring, or establishing any new outside activity, or changes in any existing outside activity that might reasonably be related to their Duke responsibilities.

Failure to fully and accurately disclose outside activities, to maintain a current accurate disclosure form or to follow federal, sponsor, or institutional requirements related to COI may result in disciplinary action

If you would like to request information on identified Financial Conflicts of Interest (FCOI) for PHS-funded research, access instructions on submitting a request to the DOSI-COI Office. 

Guidance on Conflict of Interest

Research Conflict of Interest

Duke University researchers have an obligation to disclose outside activities to University officials so that potential conflicts of interest or commitment can be evaluated and managed by the Duke Office of Scientific Integrity – Conflict of Interest Office (DOSI-COI). University officials may be engaged if the need for eliminating the conflict arises. The management and/or elimination of conflicts of interest and conflicts of commitment allows the University to maintain the integrity of the institution, its personnel, and the public’s interest.

This 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 as key personnel or receiving salary from effort on an externally funded research project that had financial activity within the preceding twelve months.

For guidance on public disclosure of outside interests when required in the management plan approved by the Duke Conflict of Interest Committee (COIC) see Public disclosure of potential COI in research page

Important Points

  • An annual disclosure form is required from faculty and non-faculty who participate in research at Duke.
  • In addition to the annual review and reporting, the office also performs an event-based review as grants are awarded to the institution (or preferably at “Just in Time” notification).
  • Disclosure forms are analyzed by staff to determine if disclosed relationships are related to the disclosing individual’s research and/or administrative responsibilities.
  • DOSI-COI manages COI in a manner compliant with federal policies, particularly those of PHS.
  • Management plans are acknowledged by the individual, tracked over time, and monitored.
  • We report managed overlap relating to PHS funding in accordance with PHS regulations.
  • All management plans are reviewed with the COI Committee by consent agenda and/or full review.
  • Individuals are responsible for maintaining a current, accurate disclosure form with DOSI-COI. Individuals must update their COI disclosure form within 30 calendar days of discovering, acquiring or establishing any new outside activity, or changes in any existing outside activity that might reasonably be related to their Duke responsibilities.
  • COI training must be completed prior to engaging in research related to any PHS-funded project and updated as required by the institution.
  • Failure to fully and accurately disclose financial interests, to maintain a current accurate disclosure form or to follow federal or other sponsor or institutional requirements related to COI may result in disciplinary action.

Note: COI/COC Policy revised effective March 10, 2023. The review of this policy was undertaken to ensure consistency with the PHS FCOI regulations Title 42, Code of Federal Regulations (CFR), Part 50 Subpart F, “Promoting Objectivity in Research.”  The revisions to the policy are non-material in nature.

Faculty COI and COC in Research

Institutional Conflict of Interest

An institutional conflict of interest ("Institutional COI") describes a situation in which the financial interests of an institution or an institutional official, acting within his or her authority on behalf of the institution, may affect or appear to affect the research, education, clinical care, business transactions, or other activities of the institution. Institutional conflicts of interest in research are reviewed and managed by the Duke Institutional Conflict of Interest Committee.

  • DOSI-COI staff perform an administrative review of potential institutional COI and manages identified cases in collaboration with the COI Committee Chair, and Duke Conflict of Interest Committee.
  • All management plans are reviewed with the Institutional COI Committee by consent agenda and/or full review.

Institutional Conflict of Interest Policy

For instances when Duke University has the potential for conflicts of interest, the institution is governed by the Institutional Conflict of Interest Policy which approved by the Duke University Board of Trustees.

Outside activity reporting form

Annually, faculty members and certain staff members are required to submit an outside activity disclosure form electronically. The link below will provide access to submit the form or update your current year form when a change of status has occurred.

Outside activity reporting form 

Login using your NetID and NetID password. If you are unsure of your NetID or NetID password, contact the DHTS Help Desk at (919) 684-2243 or the OIT Help Desk at (919) 684-2200. Follow this link for other technical assistance.

Additional Conflict of Interest resources

Best practices for managing Conflicts of Interest

Provided below is a general summary to provide some guidance on the do’s and don’ts if you have a relationship with or work for a company outside of your institutional responsibilities for Duke. 

Generally, you should maintain separation between your Duke responsibilities for research and education and your work with external companies in which you hold equity or from which you receive direct or indirect financial remuneration.

Do

  • Separate and distinguish the focus of your ongoing university research and educational responsibilities from your involvement in any effort being conducted for the company.
  • Limit consulting time for the company to the maximum allowed by the Research Policy Manual.
  • You may wish to seek a leave of absence when engaged in a management role at the company.
  • Disclose your outside financial interest in publications, as applicable, notably where the journal application requires disclosure and where you feel the objectivity of your research may be called into question if you do not volunteer the information.
  • Disclose your outside interest whenever you discuss competitors of the entity in a publication or other statement to the public (e.g. a presentation).
  • Ensure that the company has a physical and virtual presence that is not affiliated with Duke.
  • Ensure that your consulting agreement acknowledges that the company’s IP rights are subject to the university’s rights as your employer.
  • Avoid situations where you seek to be the lead PI for an outside company and the lead PI for Duke on a research agreement between Duke and the outside company.
  • Duke policy requires that Outside Activity reporting form be updated within 30 days of a relationship change or a newly acquired relationship.
  • Duke researchers with PHS funding (usually NIH) are required by the regulations to disclose the occurrence of certain types of reimbursed or sponsored travel related to the Investigator’s Institutional Responsibilities (more information here).
  • For additional guidance see the COI FAQ page

Don't

  • Negotiate with the university on behalf of the company.
  • Influence decisions by the university to enter into commerce with the company.
  • Involve company personnel in Duke Research except where there is a valid subcontract or other agreement negotiated at arms-length that reflects market rates, and you have recused yourself from the negotiation process.
  • Use university facilities for company purposes, other than the incidental use of the faculty/staff member’s office and use of university library resources.  If access to university facilities is provided, ensure that the use is negotiated at arms-length with university administration, reflects market rates, and that you have recused yourself from the negotiation process.
  • Involve university students over whom you have oversight or supervisory responsibility in professional activities at or for the company, except where the student has an opportunity to meet with a representative of the COI Committee to better understand the issues involved, and has signed an acknowledgement that he/she understands those issues.
  • Disclose confidential information obtained through your efforts on behalf Duke to the company before is publicly disclosed when the confidential information does not further the work on a bona fide sponsored research agreement with the company.
  • For additional guidance see the COI FAQ page