Management Plan Non-Compliance

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Non-compliance includes failure to adhere to all provisions of the University's Financial Conflict of Interest in Research (FCOIR) policy including failure to declare a significant financial interest (SFI), failure to declare an SFI in the required time period, and failure to adhere to any elements of a management plan or directives of the Conflict of Interest in Research Committee (COIRC).  Any discovery, concerns, or questions related to non-compliance should be directed to Research Compliance Services (RCS). 

Investigators are ultimately responsible for full compliance with University policy, including timely disclosures of SFIs and adherence to management plans. Management plans include steps with actionable items to reduce or eliminate investigators conflicts with their research.  RCS monitors investigator compliance with management plans on an ongoing basis by ensuring plan steps include transparent disclosure, third party oversight, and routine follow-up. As a signatory authority on management plans, Department Heads, Research Center/Institute Directors, and Deans play a vital role in the ongoing monitoring and oversight of investigator activities related to managing financial conflicts of interest. RCS and/or the COIRC may determine additional monitoring activities are appropriate to ensure full compliance with management plans.

 If RCS determines non-compliance may have occurred they will refer it to the COIRC for review.  The COIRC will conduct a review to determine whether there has been non-compliance; investigators will be notified of the determination, and if any further action is necessary.  In some cases the COIRC may determine the non-compliance warrants a retrospective review.  Retrospective reviews will be completed within 120 days of the COIRC's determination of non-compliance. The retrospective review includes review of the investigator's activities to determine if there was bias in the design, conduct, or reporting of research during the period of non-compliance.  After the retrospective review is complete, RCS will notify the investigator and any other appropriate parties of the retrospective review outcome.