Management Plan

What is a Management Plan?

If circumstances are such that an external financial relationship is found to exist in conflict of interest, you may be required to file a management plan to ensure optimal objectivity in carrying out your WCU duties.  A management plan is derived from and included in your COI disclosure.  The plan should detail the actions and safeguards that will be undertaken to ensure objectivity in research is maintained.

Examples of conditions/restrictions that may be imposed on the Conflict of Interest include:

  • Public disclosure (when presenting/publishing; to staff members; to the IRB)
  • Directly disclose to human subjects involved in research
  • Appointment of an independent monitor capable to taking measures to protect the design, conduct, and reporting of the research against biases resulting from the COI
  • Modification of the research plan
  • Change in personnel or personnel responsibilities; disqualification from participation in all or part of the research.
  • Reduction or elimination of financial interest

Critical Components of a Management Plan

The management plan should be developed in concert with your department chair/director.  The following critical components should be included:

Critical components of a management plan

  • The role and principal duties of the conflicted Investigator in the research project
  • Conditions of the management plan
  • How the plan is designed to safeguard objectivity in the research project
  • How the management plan will be monitored to ensure Investigator compliance
  • Other information as needed

The plan must be updated at least annually or as the status of the management plan changes.

 

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