Non-Compliance with FCOI Policy or FCOI Management Plan

Investigators must comply with the UO’s Financial Conflict of Interest in Research Policy, 42 CFR Part 50 Subpart F, and sponsor regulations on financial conflicts of interest in research. Compliance includes: 

  • Completing financial conflict of interest in research training every 3 years
  • Disclosing Significant Financial Interests annually and within 30 days of any changes or new interests
  • Following all management plan requirements 

Non-compliance may result in interim measures to manage the conflict, and disciplinary action, up to and including termination, in accordance with UO policies and collective bargaining agreements. Interim measures are managed by the Conflict of Interest in Research Committee (COIRC).  

Non-compliance can be reported to the UO Ethics hotline.

Report a Non-compliance Concern

Non-compliance Procedures

Within 60 days of receiving information about 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 and the Conflict of Interest in Research Committee (COIRC) gather relevant information to make a determination. 

Non-compliance may be identified via a self-report, unit leadership, the ethics hotline, or Employee and Labor Relations.

The review process may involve input from Employee and Labor Relations, Office of the General Counsel, the investigator, their supervisor, or others with relevant knowledge.

If the Associate Director and the COIRC confirm non-compliance, the Associate Director notifies the investigator. The investigator has 14 days from receipt of this notification to submit an appeal.

If no appeal is submitted, the COIRC conducts a retrospective review.

Retrospective Review

If a financial conflict of interest in research is not disclosed, reviewed, or managed in a timely manner, or if an investigator fails to comply with a management plan, federal regulations (42 CFR 50.605(a)(2)) require the UO to report the issue to a sponsor and complete a retrospective review within 120 days.

The retrospective review must include:

  • Project number (such as EPCS number, UO grant number, or agency grant number)
  • Project title
  • Principal investigator's name
  • Conflicted investigator's name
  • Reason for the review
  • Review methodology
  • Findings and conclusions

The Associate Director shares the retrospective review with the investigator and relevant unit leadership. Although not subject to appeal, revisions to the review may be requested within 5 days. After that period, the COIRC any agreed upon revisions and notifies the sponsor.

If the retrospective review finds that bias has occurred, the COIRC completes a mitigation report.

Mitigation Report

The mitigation report specifies in what ways the sponsored activity was bias because of the non-compliance. It includes:

  • Key elements from the retrospective review
  • Description of the bias and its impact on the research
  • Actions to eliminate or mitigate the bias