Lehigh University is committed to conduct of research and sponsored programs in a manner that
- is consistent with our academic mission;
- maintains the trust of our sponsors and the public, and;
- promotes compliance with applicable federal and state laws, regulations, and policies regarding financial conflicts of interest.
These commitments require the university to identify and manage any real or apparent financial conflicts of interest (fCOIs) related to research and sponsored programs.
The information on this page helps to summarize the requirements in the Lehigh University fCOI Related to Research and Sponsored Programs Policy. Here you will find guidance on
- to whom the policy applies;
- what Lehigh activities are covered by the policy;
- what you should consider when determining what you need to disclose, and;
- specific circumstances related to conflicts of interest and COI management.
Email your questions to: incoi@lehigh.edu
What is a financial conflict of interest (fCOI)?
In common language, a financial conflict of interest, or an fCOI, exists when there is reasonable concern that an outside financial interest, role, or obligation could, or could appear to, compromise a person's objectivity in carrying out their academic research.
The university policy on Financial Conflicts of Interest Related to Research and Sponsored Programs formally defines an fCOI as follows:
"An fCOI exists when the university reasonably determines that an individual's Significant Financial Interest is Related to University Research or Sponsored Programs and could directly and significantly affect the design, conduct, or reporting of the University Research or Sponsored Program."
Financial conflicts of interest can be real or apparent. Situations occur in which decisions made in designing or conducting a study, or in reporting results, could have a direct and significant effect on the value of a financial interest or on a person’s ability to follow through on obligations they’ve made to an entity outside the university, whereby the person’s judgment in carrying out the academic work could be compromised. Situations can also occur in which such effect is technically unlikely, yet considering the circumstances others - colleagues, students, sponsors, the public - would reasonably be concerned.
Identifying and managing fCOI begins with the individual’s good faith determination of any Significant Financial Interests (SFIs) that may present real or apparent financial conflicts of interest. The policy specifically identifies SFIs that are to be considered. This is followed by collection of information necessary for the university to confirm the existence of an fCOI and, working with the individual, take the steps necessary to maintain confidence in the integrity of university programs. Such steps include management of conflicts of interest that are amenable to management, and avoidance of circumstances that would make management difficult or unreliable.
Procedures for each type of disclosure:
SFI disclosure type: | Required by: | Required to disclose: | Disclose via: | Disclosure assessment completed by: | Timing of disclosure: |
|---|---|---|---|---|---|
| Annual |
| SFIs in External Entities that are Related to University Research and Sponsored Programs | LIRA | CIRC Administrator | Annually by the deadline established by the CIRC Administrator |
| Sponsored Program | All Project Personnel on a proposal. | SFIs in External Entities that are Related to the Sponsored Program | LIRA | CIRC Administrator | After funding is offered, and before resulting award is distributed. |
| University Research | Faculty and staff who wish to engage in the design, conduct, reporting or direct administration of University Research not supported by a Sponsored Program. | SFIs in External Entities that are Related to the University Research | Department Chair/supervisor, who then notifies the CIRC Administrator | CIRC Administrator | Prior to engaging in the design, conduct, reporting, or direct administration of University Research |
| Human Subjects Research | Faculty and staff Project Personnel on an IRB protocol application. Undergraduate students, graduate students, and Ph.D. candidates listed on IRB protocol applications are not required to submit a disclosure. | SFIs in External Entities that are Related to the research | Research Integrity via IRB protocol application in IRBNet | CIRC Administrator | With submission of an IRB protocol application in IRBNet |
| Amending Existing Disclosures | All individuals as described above, for each disclosure type | Amending any of the above disclosure types | Update Discloser Profile in LIRA | CIRC Administrator | Within 30 days of material changes to the Related external SFI |
For additional information: