The appropriate Institutional Official shall take actions as necessary to manage or eliminate Financial Conflicts of Interest, including any subrecipient Investigator Financial Conflict of Interest when the subrecipient must comply with RFMH’s financial conflicts of interest policy rather than the subrecipient’s policy.

Management of an identified Financial Conflict of Interest requires the development  and implementation of a management plan and, if necessary a retroactive review and a mitigation report. Adequate enforcement mechanisms, including sanctions, to ensure Investigator compliance shall be included in the plan. Management plans must be developed and implemented before any expenditure of PHS funds on the project.

Management plans may include, but are not limited to:

1. Public disclosure of FCOI, e.g. when presenting or publishing  the research ;
2. For research involving human subjects, direct disclosure to research participants;
3. Appointment of an independent  monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;
4. Modification of the research plan;
5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
6. Reduction or elimination of the Financial Interest (e.g., sale of an equity interest); or
7. Severance of relationships that create financial conflicts.

Investigator compliance with monitoring plans must be monitored on an ongoing basis until the completion of the research.