COI: Management Plans
This document discusses the implementation and monitoring of Management Plans for reducing or eliminating Financial Conflicts of Interest (FCOI) at the UW-Madison.
The UW-Madison COI Committee may elect to assign a Management Plan to reduce or eliminate a Financial Conflict of Interest (FCOI) and ensure, to the extent possible, that the design, conduct and reporting of research will be free from bias.
Conditions of a Management Plan may include:
- Disclosure of the existence of the financial conflict of interest to co-investigators, staff, postdocs and students;
- Public disclosure of potential conflicts of interest when presenting or publishing the research;
- For research projects involving human subjects, disclosure of the financial conflict of interest directly to study participants;
- Appointment of an independent monitor capable of taking measures to protect the design, conduct and reporting of the research against bias resulting from the financial conflict of interest;
- Modification of the research plan;
- Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
- Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
- Severance of relationships that create financial conflicts.
If a Management Plan is assigned to you, you are responsible for all its terms, conditions and actions. You must also respond to all requests for information and/or meetings regarding the University's responsibility to monitor compliance with the plan.
Noncompliance with your Management Plan can have serious consequences in the ability to begin or continue spending on federally-funded projects or participation in human subjects research.
If your management plan prohibits you from participating on a human subjects protocol that is either sponsored by or tests a device or technology licensed to the entity, you may work with your Dean's Office to request an exception to your management plan.
In instances where you feel there may have been a possible improper assessment of your significant financial interests or possible incorrect assessment of the relationship between your significant financial interest and your research, you may request reconsideration by the COI Committee within 10 days of receiving notice of the management plan. The request must be in writing and directed to the Graduate School's Associate Vice Chancellor for Research Policy.
When an investigator ends their relationship with an outside entity for which a management plan is in place, they should update their OAR to reflect this change in the relationship. The COI Staff will then present a summary of this information as a request for termination of a Management Plan to the COI Committee. The COI Committee will vote to terminate the Management Plan, and the investigator will be notified.