Non-Compliance with FCOI Policy or FCOI Management Plan

UO sponsored researchers are responsible for fully complying with the UO's Financial Conflict of Interest in Research Policy and sponsor regulations.

Compliance includes disclosing outside activities and interests and following management plans. Signatories on management plans, such as supervisors, principal investigators, and unit heads, play a vital role in monitoring researchers' compliance with UO policies and with management plans.

Non-compliance may subject the employee to discipline, up to and including termination, consistent with applicable UO policies and collective bargaining agreements. Non-compliance can be reported to the UO Ethics hotline.

Report a Non-compliance Concern

Non-compliance Procedures

Within 60 days of receiving information relating to an investigator’s potential non-compliance with the Financial Conflict of Interest in Research Policy, the Associate Director of Conflicts of Interest and Export Controls works with the Conflict of Interest in Research Committee (COIRC) to gather necessary information to make a non-compliance determination. If, based on the information gathered, the COIRC determines non-compliance did occur, the Associate Director notifies the investigator.

Identification of non-compliance can happen through various channels, such as a self-report, report by a supervisor or unit leadership, report received by the ethics hotline, or report received by Employee and Labor Relations.

Gathering necessary information to determine non-compliance may include conferring with Employee and Labor Relations, Office of the General Counsel, the investigator, the investigator’s supervisor, the investigator’s unit leadership, and/or others who may have relevant information.

The investigator has 14 days from receipt of the notification of non-compliance to submit an appeal.

If no appeal is received, the COIRC completes a retrospective review and shares it with the investigator, the investigator’s supervisor, and/or the investigator’s unit leadership. This step is not subject to appeal, but revisions can be requested within 5 days of receipt.

Whenever a financial conflict of interest in research is not identified or managed in a timely manner, including failure by the investigator to disclose a significant financial interest that is determined by the UO to constitute a financial conflict of interest, failure by the UO to review or manage such a financial conflict of interest in research, or failure by the investigator to comply with a management plan, federal regulations 42 CFR 50.605(a)(2) require the UO to report to a sponsor within 120 days of a determination of non-compliance and complete a retrospective review.

The retrospective review must be fully documented and must include:

  • Project number
  • Project title
  • PI
  • Name of the investigator with the FCOI
  • Reason(s) for the review
  • Detailed methodology used for the review
  • Findings and conclusions of the review

After 5 days, the COIRC makes revisions, if agreed upon, to the retrospective review and notifies the sponsor as required. 

If the retrospective review identifies bias has occurred as a result of the non-compliance, the COIRC completes a mitigation report. The mitigation report specifies in what ways the sponsored activity was bias because of the non-compliance. As required by UO’s FCOI Policy and federal sponsor regulations, the mitigation report should include:

  • Key elements documented in the retrospective review
  • Description of the impact of the bias on the research project
  • Plan of action(s) to eliminate or mitigate the effect of the bias