Financial Conflicts of Interest Related to Research and Sponsored Programs

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Lehigh University is committed to the conduct of research and sponsored programs in a manner that is consistent with its academic mission, maintains the trust of its sponsors and the public, and promotes compliance with applicable federal and state laws, regulations, and policies regarding conflicts of interest.

These commitments require the university to identify and manage any real or apparent financial conflicts of interest (fCOI) related to research and sponsored programs.

What is essential?

A financial conflict of interest (fCOI) exists when the university reasonably determines, pursuant to its established policy on Financial Conflicts of Interest Related to Research and Sponsored Programs, that an individual’s significant financial interest is related to their university research or sponsored program, and could directly and significantly affect the design, conduct, or reporting of the research or sponsored program.

When it is determined that an fCOI exists, the university Conflict of Interest Review Committee (CIRC) determines if a project activity can proceed, and if so, works collaboratively with the investigator to construct appropriate management plans to arrive at practical and effective solutions to mitigate the impact of the investigator’s financial interests on the conduct of their research.

Transparency and accurate disclosures about financial interests external to the University is critical to ensuring that fCOIs are properly disclosed, managed, and mitigated.

Why it’s Important

A significant financial interest in an entity external to the University has the potential to create a real or perceived conflict of interest when it is related to an investigator’s research or sponsored program. University faculty and staff are obligated to make the University aware when these external interests exist, so that the conflict of interest is eliminated or adequately managed and the University and investigator can collaborate to ensure that academic and research integrity is prioritized.

Failure to disclose conflicts of interest can jeopardize the University’s tax-exempt status and can result in violation of the Federal False Claims Act, which carries the risk of substantial financial penalties and criminal charges with penalties that can include imprisonment.

How to Comply

University faculty and staff responsible for the design, conducting, reporting, or direct administration of research must disclose their Significant Financial Interests that are Related to their University and/or Sponsored Programs at the following intervals:

  • With each Sponsored Program proposal submission through ORSP. ORSP will ask each member of the research team to submit a disclosure form. The forms are required whether or not the individual has a Related SFI to disclose.
  • Prior to acceptance of an award from research investment programs run by the OVPR. OVPR will ask each member of the research team to submit a disclosure form. The forms are required whether or not the individual has a Related SFI to disclose.
  • Prior to engaging in University Research, which is how we refer to any research activity supported by University funds, regardless of source. This will commonly include research supported by department funds or other sources that are not administered through OVPR or ORSP. In this instance, individual staff and faculty planning to engage in University Research are responsible for proactively disclosing any Related SFIs. Individual staff and faculty should understand the disclosure requirements, and notify their Department Chair or direct supervisor if they have SFIs Related to the University Research that are required to be disclosed, prior to engaging in the research. The Department Chair or direct supervisor must then contact Research Integrity to initiate the disclosure process. Disclosures are not required for University Research when individual faculty and staff do not have Related SFIs.
  • Disclosures must be amended within 30 days of material changes to circumstances that affect existing disclosures. For example, if at the proposal stage, you did not have any Related SFIs to disclose, but during the course of the award, you acquired an equity interests totaling $5,001 in value in an external entity that is supplying research materials for the award, then you would need to submit a disclosure within 30 days of that acquisition. If you are uncertain about your disclosure responsibilities or have questions, seek help.
  • Disclosures must be updated annually.