Management plans manage, reduce, or eliminate actual or potential conflicts of interest in research. The plan is designed to promote transparency and objectivity in the design, conduct, and reporting of the research. Management plans are subject to public records requests, and sponsors may require the UO to report management plan steps to them.
When COI staff identify and the Conflict of Interest in Research Committee (COIRC) confirms an actual or potential conflict, a management plan must be in place within 60 days and before funding is released or work begins. This restriction is a condition of 42 CFR Part 50 Subpart F and the UO's Financial Conflict of Interest in Research Policy.
Common Management Plan Steps
42 CFR Part 50 Subpart F includes recommendations for managing financial conflicts of interest in research. At the UO, management plan steps may include, but are not limited to, requirements to:
Common management plan steps include requirements to:
- Disclose the conflict in publications and presentations related to the research
- Disclose the conflict directly to human subjects research participants
- Modify the research plan
- Recuse oneself from the informed consent process for human subjects research (if applicable)
- Recuse oneself from data analysis, using double-blind methods, or an open science framework (if applicable)
- Reduce or eliminate the financial interest
Management Plan Process
The Conflict of Interest in Research Committee (COIRC), comprised of research faculty and administrators (rotating every 3 years), develops management plans by collaborating with:
- The conflicted investigator
- The principal investigator, if different from the conflicted investigator
- The department head
- Industry, Innovation, and Translation (IIT)
For AY2024-25, the COIRC meets on the fourth Wednesday of every month.
If a plan is needed,
- COI staff and the COIRC draft or update a plan for the investigator, working with other relevant departments as needed.
- Industry, Innovation, and Translation may review the plan to ensure proper handling of intellectual property.
- The investigator, the PI (if different from the conflicted investigator), and the investigator's supervisor or department leadership review the plan and ask questions.
- COI staff route the management plan for formal approvals in the Research Administration Portal (Duck ID required), and the investigator accepts the plan.
- If required, COI staff report the conflict and how the institution will manage the conflict to the sponsor.
If the investigator already has a management plan in place, the existing plan may adequately manage the conflict in the research and no additional steps may be necessary.
If the COIRC cannot agree to the terms of a management plan or believes a conflict cannot be managed or mitigated, the UO has the responsibility to determine the disposition of the application or award, including reassigning an investigator's responsibility on the award or not accepting the award.
Management Plan Compliance
Those with existing management plans must:
- Annually submit a disclosure
- Report changes in their outside activities or interests within 30 days
- Fully comply with the steps in their management plan
Management plans remain effective through the duration of the sponsored award or when the source of the conflict no longer exists, such as when the investigator's UO job duties change or their outside activities changes.
Failure to comply with a management plan may subject the investigator to discipline, up to and including termination, consistent with applicable UO policies and collective bargaining agreements.