|| FAILURE TO TIMELY DISCLOSE OR REVIEW OR FINDING OF NON COMPLIANCE WITH A FCOI MANAGEMENT PLAN
If a Financial Interest was not disclosed timely by an Investigator or was not timely reviewed, the designated Institutional Official must review the Financial Interest within 60 days and make the determinations in “Review of Disclosures” above. If a FCOI is found to exist the designated Institutional Official shall, within the 60 day period, implement, on at least an interim basis, a management plan that specifies the actions that have been taken and will be taken to manage the FCOI going forward.
The following steps must be taken if a FCOI is not identified or managed in a timely manner, including failure of an Investigator to disclose a Financial Interest that is determined to be a FCOI, failure by RFMH to review or manage a FCOI, or failure of the Investigator to comply with a FCOI management plan:
- Within 120 days RFMH shall complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the non-compliance, was biased in the design, conduct or reporting of the research.
- The retrospective review must be documented, including but not limited to:
- 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 a 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; and
- Conclusions of the review.
Based on the results of the retrospective review, if appropriate, RFMH shall update the previously submitted FCOI report and specify any actions that will be taken to manage the FCOI going forward. If bias is found, RFMH will promptly notify the PHS Awarding Component and submit a mitigation report to the PHS Awarding Component. The report must include the documentation elements described above and a description of the impact of the bias on the research project and RFMH’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable).
RFMH may implement interim measures during the period in which the retrospective review is being conducted.