Compliance with the Investigator Conflict of Interest Policy (P209) - Additional Actions Required for NIH/PHS Awards

Anniversary Review for Funded Awards

All NIH/PHS awards (grants, cooperative agreements, contracts and subawards) will be reviewed by the DIO to ensure that all Investigators are compliant with both the training and annual certification requirements. In accordance with NIH/PHS policy, no funds may be spent until all Investigators are in compliance with the NIH/PHS regulations. The Office of Sponsored Programs (OSP) will refer all PHS/NIH awards, at the time of their anniversary, to the DIO through a Triggering Event for review of current training and annual certification for all named Investigators. If any Investigator is not in compliance, the DIO will contact the Investigator. The DIO will confirm training and annual certification to OSP.

Retrospective Review

Whenever an FCOI is not identified or managed in a timely manner, including failure by the Investigator to disclose an SFI or comply with a Management Plan, or failure by the University to review or manage an FCOI, the University will, within 120 days of a determination of non- compliance, complete a Retrospective Review of the Investigator's activities and the NIH-funded research project to determine if there was bias in the design, conduct, or reporting of such research.

The Retrospective Review will document the following:

• Project number; • Project title; • PD/PI or contact PD/PI if a multiple PD/PI model is used; • Name of the Investigator with the FCOI; • Name of the entity with which the Investigator has an FCOI; • Reason(s) for the retrospective review; • Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); • Findings and conclusions of the review. • If results of the retrospective review warrant, update previously submitted FCOI report Mitigation Report If bias is found through Retrospective Review, the DIO will notify the NIH Awarding Component promptly (through the eRA Commons) and submit a Mitigation Report.

The Mitigation Report will document the following:

• Key elements documented in retrospective review • Description of the impact of the bias on the research project • Plan of action(s) to eliminate or mitigate the effect of the bias Thereafter, the University will submit FCOI reports annually as described above in the Procedures section.

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