The Conflict of Interest Office is pleased to share that it is transitioning to an annual disclosure model.
Here are some Frequently Asked Questions:
How are COI Disclosures changing?
Currently, investigators submit new COI disclosures at several points on the lifecycle of a sponsored project and of a protocol.
In our new model, investigators must:
- Update and Certify their COI disclosure once per year and
- Update their COI disclosure within 30 days of a change to their financial interests.
When will I complete my annual COI Disclosure?
Investigators will be notified to update and certify their Conflict of Interest Disclosure annually in February. This aligns with the tax year, which may simplify recordkeeping.
When will I need to update my COI Disclosure?
Update your disclosure form if your financial interests change.
For example, if:
- You gain a new financial interest (i.e., receiving travel renumeration)
- You lose a financial interest (i.e., selling ownership in a company)
- Your financial interest changes in number. (i.e., buying additional shares)
- Your financial interest changes in type (i.e. one of your financial interests is bought out)
- You take on a new EPAP activity that overlaps with your university duties and responsibilities (e.g., external consulting relationship)
Investigators can always contact the COI Office at [email protected] with questions about disclosure updates.
Why is the COI Program moving to an annual disclosure model?
The Conflict of Interest seeks to simplify the administrative burden of COI disclosures. We anticipate a twelve-fold reduction in the number of disclosures submitted each year.
Further, research (Young et. al 2023) suggests that administrative simplification may facilitate greater accuracy, management, and compliance. By moving towards an annual disclosure model, the University aims to manage interests more accurately and efficiently.
How will I complete my COI Disclosure?
Researchers will log into the Activities, Interests, and Relationships (AIR) system to complete their disclosure. Stay tuned for future resources.
How will COI Training be managed?
COI Training will be fully incorporated into the disclosure workflow. In other words, by certifying investigators will inherently complete training by nature of completing their disclosure.
In addition to the PHS-mandated COI Training, the Research Compliance Services will support Question and Answer sessions, will provide updates at Research Administration events (i.e., Symposium, Research Administration Peer-to-Peer), redevelop the Conflict of Interest website, and provide additional materials on what Conflicts of Interest are, under the PHS regulations, COI management, and best practices.
Have there been any major changes to Conflict of Interest regulations?
No. Financial Conflicts of Interest are defined in PHS regulations as Significant Financial Interests which influence or appear to influence, the design, conduct, or reporting of research.
Significant financial interests include:
A financial interest of the COI investigator (and those of the COI investigator’s immediate family) that reasonably appears to be related to the COI investigator’s institutional responsibilities. These include:
- Publicly traded companies: The combined value of any remuneration received in the 12 months before disclosure and equity interest held as of the disclosure date exceeds $5,000.
- Remuneration includes salary, consulting fees, honoraria, and paid authorship.
- Equity interest includes stock, stock options, or other ownership interests.
- Non-publicly traded (private) companies:
- Any equity interest (e.g., stock, stock options, ownership in a start-up), regardless of value, and/or
- Remuneration exceeding $5,000 received in the 12 months before disclosure.
- Intellectual property (IP): Any income received from IP rights (e.g., patents, copyrights) paid by a source other than the University.
- Sponsored or reimbursed travel: Any travel related to institutional responsibilities that is paid for or reimbursed by a third party, unless sponsored by:
- a federal, state, or local government agency,
- a U.S. institution of higher education,
- an academic medical center, or
- a research institute affiliated with a U.S. university.
The Conflict of Interest office continues to manage these interests when identified at the University.
How will management plans be affected?
Management plans will be focused on addressing Financial Conflicts of Interest as defined by Public Health Service (PHS) regulations. As a result, we expect the total number of management plans to decrease.
When will these changes take place?
Research Compliance Services and the Office of Research Information Services are redeveloping the AIR system to support these changes. We anticipate a release in early 2026.
How do I express feedback or receive further information?
The Conflict of Interest program will host fora, release training, and provide announcements on progress under the program release. Follow Research Compliance Service’s news feed for further information and contact [email protected] for any questions.