Conflict of Interest
The University of Denver has an obligation to the public to conduct its activities transparently and with integrity. DU is committed to avoiding financial conflicts of interest that may compromise or appear to compromise the integrity and objectivity of research and the safety of human research subjects.
What is a conflict of interest?
An individual conflict of interest related to research arises when financial or other personal considerations compromise, or have the appearance of compromising, an individual's professional judgment in proposing, conducting, supervising or reporting research. University researchers (faculty, staff and students) have an obligation to disclose outside activities when they maintain an interest (equity interest, management role or consulting income in excess of $5,000 per year) in a sponsoring entity, or in an outside entity whose product (drug, device, equipment, supplies, etc.) is under study, regardless of the sponsoring entity.
Who must complete a conflict of interest (COI) disclosure?
Researchers who are proposing or have received federal funding support (NIH, NSF) or who have received an external funding award must make an annual disclosure of all financial interests related to their institutional responsibilities to DU, regardless of whether any of these interests give rise to a conflict of interest related to their research. The annual disclosure must be completed before a proposal is submitted, and any identified conflicts must be managed before an account can be established.
The COI disclosure must be submitted if a DU investigator:
- Receives external funding to conduct research;
- Receives a federally-funded research award (e.g., NIH, NSF);
- Is awarded a sub-contractor is a sub-grantee and the prime award is federally-funded
- Has a change that occurs during the year that potentially affects an investigator's COI associated with any research project;
- Becomes involved in a research project that may involve a potential COI, regardless of funding source.
What conflict of interest training is required for researchers?
In addition to submitting an annual disclosure form, all DU investigators who are federally funded must complete COI training within four years prior to commencing or engaging in any federally funded research activity and must renew their training at least every four years. When funding is awarded, the PI must complete the Conflict of Interest curriculum through the Collaborative Institutional Training Initiative (CITI) Program. For more information on the online CITI training, please click here.
Conflict of Interest Disclosure
DU policy requires all investigators who receive externally funded awards to complete an annual Conflict of Interest Disclosure (COI) Form, complete a separate disclosure for any newly funded projects during the calendar year, and update a disclosure during the year if a potential conflict occurs or changes. All COI disclosures must be submitted electronically, utilizing the InfoEd system.
How do I complete disclosure for the first time?
All COI disclosures must be completed the electronic form produced by InfoEd, click here.
How do I update my current disclosure?
If an investigator's conflict of interest changes throughout the year related to a proposed new project or current project, a new COI Disclosure must be completed using the electronic system.
Who must disclose?
- Any University employee that serves as a project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by any federal agency, or who has submitted a proposal for such funding, which may include, for example, collaborators or consultants, must complete an annual disclosure form.
- Investigators also include any other individual (internal or external to DU) who are independently responsible for research design, conduct, or reporting (i.e. individual(s) who have the authority to make independent decisions about the direction of the research and the subsequent conclusions about the results and/or likely to be authors on manuscripts or to present research findings).
- Investigators who receive federally-funded awards, either as prime or pass-through awardee, must complete the annual disclosure and fulfill the required conflicts of interest training (Research Conflicts of Interest module) through the CITI program.
What must be disclosed?
Any Significant Financial Interests (SFI), which means an external financial interest consisting of one or more of the following interests of an investigator (and those of the Investigator's spouse and dependent children) related to one's DU institutional responsibilities, when combined for the twelve (12) months preceding the disclosure date, from a single entity.
When must a disclosure be submitted?
Timing Disclosure Timeframe Initial disclosure All investigators must electronically submit the COI disclosure prior to engaging in research funded by the federal government of as required by the ORSP Research Conflicts of Interest Policy. Within 30 days of a new SFI Investigators must update their disclosure within 30 days of acquiring a new significant financial interest (SFI) meeting disclosure requirements. Annually Investigators must update their disclosure at least annually, even if acknowledging no change.