Management Plan Non-Compliance

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In order to ensure that Investigators are in compliance with all provisions of the Management Plan, the Investigators’ Department Head, Research Center/Institute Director (if any) and Dean are responsible for the ongoing monitoring and oversight of Investigator activities. The responsible party will report any discovered or reported non-compliance to the Designated Institutional Official. Non-compliance includes failure to declare an SFI, failure to declare an SFI in the required time period, and failure to adhere to any elements of a Management Plan.

Issues pertaining to non-compliance will be referred to the COIR Committee for review.  The COIR Committee will review the matter within the next 120 days and complete a retrospective review of the Investigator’s sponsored project and institutional activities to make a recommendation regarding whether any sponsored activity conducted during the time period of the non-compliance was biased in its design, conduct, or reporting.  The retrospective review will be conducted, managed and documented by Research Compliance Services, under the direction of the Designated Institutional Official. 

After the retrospective review is complete, the COIR Committee will review the findings and make a recommendation whether there is sufficient evidence to conclude that bias existed;the Designated Institutional Official makes the final determination. The Investigator will be notified when potential non-compliance has been identified and will have an opportunity to attend the portion of the COIR Committee meeting(s) during which the matter will be reviewed and retrospective review conducted.  The COIR Committee will consider the Investigator’s input.  The final recommendations regarding non-compliance and existence of bias will be determined solely at the discretion of the COIR Committee.

If an affirmative recommendation regarding non-compliance and bias is made, the Conflict of Interest in Research Committee will: 1) recommend a corrective action plan to mitigate the bias, 2) recommend Investigator sanctions and 3) comply with all additional sponsor requirements to address instances of non-compliance, including initiation of sponsor reporting by Sponsored Project Services.

Depending on the nature of non-compliance, the Conflict of Interest in Research Committee and the Designated Institutional Official may implement interim measures that are deemed necessary to safeguard against bias with regard to the Investigator’s participation in sponsored research between the date that the noncompliance is discovered and the completion of the retrospective review.  If the nature of non-compliance requires immediate intervention, such as a risk presented to human subjects participating in the Investigator’s research, the Designated Institutional Official has authority to impose immediate mitigation steps.

The COIR Committee’s recommendations for Investigator sanctions will always include required additional training for the Investigator and may include the suspension of an ongoing sponsored project. 

The Designated Institutional Official will make a final determination and notify the Investigator by certified mail. 

If the Investigator wishes to appeal the determination, corrective action plan and recommended sanctions, the Investigator can issue a letter of appeal, specifically stating the reasons and justification for the appeal to the Vice President for Research & Innovation.  Final determinations regarding an appeal will be made at the sole discretion of the Vice President for Research & Innovation.