Dynocardia - Financial Conflict of Interest (FCOI) Policy
Management of a FCOI
The section provides examples of when a management plan would be imposed and what a plan would entail.
Whenever the Institution implements a management plan it will monitor Covered Individual compliance with the management plan on an ongoing basis until the completion of the federally-funded research project.
Prior to the expenditure of any funds for a PHS Funded Research, the Controller will, as the process above describes, review all disclosures of SFI; determine whether any SFI relate to the PHS Funded Research; determine whether a FCOI exists; and, if so, develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such FCOI.
Examples of conditions or restrictions that might be imposed to manage a FCOI include, but are not limited to:
Public disclosure of FCOI (e.g., when presenting or publishing the research);
taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;
Modification of the PHS Funded Research plan;
Change of Covered Individual responsibilities, or disqualification of Covered Individual from participation in all or a portion of the PHS Funded Research;
Reduction or elimination of the Financial Interest (e.g., sale of an equity interest); or
Severance of relationships that create FCOI.
Once a management plan is in place it is reviewed annually, and the Covered Individual is required to inform the Controller of any changes in the FCOI.
Reporting of a FCOI
Reporting FCOIs is specific to PHS Funded Research where reporting FCOIs is a federal requirement. This section explains the process and reporting requirements.
Prior to spending any funds, the Institution will report to the PHS Awarding Component the existence of a FCOI. In these cases, Institution will ensure the FCOI has been managed, reduced, or eliminated in accordance with the PHS Regulation.
For any SFI that Institution identifies as conflicting subsequent to its initial FCOI report during an ongoing PHS Funded Research, the Institution will provide to the PHS Awarding Component, within sixty days, an FCOI report regarding the FCOI and ensure that Institution has implemented a management plan in accordance with the PHS Regulation. Where such a FCOI report involves a SFI that was not disclosed timely by an Covered Individual or, for whatever reason, was not previously reviewed or managed by the Institution (e.g., was not timely reviewed or reported by a subrecipient), the Institution is also required to complete a retrospective review to determine whether any PHS Funded Research, or portion thereof, conducted prior to the identification and management of the FCOI was biased in the design, conduct, or reporting of such research. Additionally, if bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.
Annual FCOI Report to the PHS Awarding Component: For any FCOI previously reported by the Institution with regard to an ongoing PHS Funded Research, Institution will provide to the PHS Awarding Component an annual FCOI report that addresses the status of the FCOI and any changes to the management plan for the duration of the PHS Funded Research. The annual FCOI report will specify whether the FCOI is still being managed or explain why the FCOI no longer exists. The Institution will provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.
PHS/NIH Mitigation Report if Bias is Found During Retrospective Review: Based on the results of the retrospective review, if appropriate, the Institution will update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI going forward. If bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the PHS Funded Research and the Institution’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). Thereafter, the Institution will submit FCOI reports annually. Depending on the nature of the FCOI, the Institution may determine that additional interim measures are necessary with regard to the Covered Individual’s participation in the PHS Funded Research between the date that the FCOI or the Covered Individual’s noncompliance is determined and the completion of the Institution’s retrospective review.