Conflict of Interest Policy

Beginning October 1, 1995, new federal regulations require that the University manage, reduce, or eliminate actual or potential conflicts of interest with financial interests of a principal investigator (PI), project director, or others of a project sponsored by PHS or NSF. Accordingly, the University must require that investigators/project directors disclose any significant financial interest that creates an actual or potential conflict of interest in relation to a sponsored project from these agencies. These new federal regulations also require that such disclosure occur prior to the submission of a sponsored project proposal, or, if a significant financial interest develops subsequent to proposal submission or issuance of award, as such significant financial interests arise.

In order to comply with these new federal requirements, the University requires Certification of Compliance which is a form attached to this Policy.

The new Federal requirements relate only to sponsored project proposals for PHS and NSF. The University's Conflict of Interest (3.20.060) and Faculty Professional Service Activities and Conflict of Interest (3.01.005) Policies continue to apply to all University personnel under all circumstances.

Definition of Significant Financial Interests

"Significant financial interests" means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights, and royalties from such rights). The term does not include:

(1) Salary, royalties, or other remuneration from the University as an employee;
(2) Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
(3) Income from service on advisory committees or review panels for public or nonprofit entities; or
(4) Financial interests in business enterprises or entities if the value of such interests does not exceed $ 10,000 (or $ 10,000 per annum if such interests represent salary, fees or other continuing payments) or represent more than 5% ownership interest for any one enterprise or entity when aggregated for the investigator, the investigator's spouse, and dependent children.

Certification Procedures for PHS and NSF Applications and Grants

1. Disclosure by the investigator (PI's, Co-PI's and others who are responsible for the design, conduct, or reporting of research) of any significant financial interest is required prior to the submission of a sponsored project proposal. Others include any employee or student of DU, or subcontractor, consultant, or collaborator, who have key responsibility for the design, conduct, or reporting of research. The PI is responsible for determining those individuals who have key responsibility on their grant. PI's are also responsible for obtaining disclosures from individuals identified as having key responsibility.

2. The Office of Research and Sponsored Programs will obtain such disclosures from the PI as part of the normal sponsored project proposal review and routing process.

3. The Office of Research and Sponsored Programs will use the two-page Certification of Compliance Summary form to document the University's compliance with federal regulations.

4. All financial disclosures must be updated either on an annual basis or as new reportable significant financial interests occur. Certification is also required from individuals who are added to a project after a grant is awarded if the individual has key responsibility for the design, conduct, or reporting of research.

5. To the extent permitted by University policy and State and Federal laws, all records of financial interest will remain confidential.

6. The Office of Research and Sponsored Programs must report all significant financial interest disclosures to PHS or NSF prior to the issuance of an award.

7. The sponsoring agency has the right to obtain from the University all information related to the disclosures or any other information and/or action relating to how the University has handled the disclosure.

8. The Office of Research and Sponsored Programs will maintain records of all financial disclosures and all actions taken by the University for at least three years beyond the award termination date or until resolution of any action by the sponsoring agency involving the records, whichever is longer.

9. The Office of Research and Sponsored Programs will obtain assurances from subgrantees (subcontractors, consultants, and collaborators) that they are in compliance with the current Conflict of Interest regulations. Individual consultants will be required to comply with this policy and to submit the Certification of Compliance.

References

For further information about the University of Denver policies relevant to issues of conflict of interest, please refer to the following policy documents contained in the University's policy manual:

*Policy on Faculty Professional Service Activities and Conflict of Interest, 3.01.005
*Policy on Conflicts of Interest, 3.20.060
*Policy on Patents, 2.40.010
*Policy on Copyrightable Materials, 2.40.020

Conflict of Interest Certification Form

Conflict of Interest Certification Form (PDF)