Prior to expending any funds under a PHS-funded research project, RFMH will provide the PHS Awarding Component with a FCOI report regarding any Investigator’s SFI that is found to be a FCOI and ensure that a management plan has been implemented. If an identified FCOI has been eliminated prior to expenditure of PHS funds reporting is not required.

If a FCOI is identified subsequent to RFMH’s initial report to PHS for an ongoing project, e.g., when a new investigator joins a project, RFMH will report to the PHS Awarding Component within 60 days and ensure that a management plan has been implemented.

If a FCOI report involves a SFI that was not disclosed timely by the Investigator or, for whatever reason, was not previously reviewed or managed by RFMH (e.g., was not timely reviewed or reported by a subrecipient), RFMH will conduct a retrospective review as described above (See Section : FAILURE TO TIMELY DISCLOSE OR REVIEW FCOI, OR FINDING OF NON COMPLIANCE WITH A FCOI MANAGEMENT PLAN.) If bias is found, RFMH shall promptly notify the PHS Awarding Component and submit a mitigation report to the PHS Awarding Component.

Any FCOI report will include sufficient information to enable the PHS Awarding Component to understand the nature, and extent of the financial conflict, and to assess the appropriateness of RFMH’s management plan. The report must include:

1. Project Number;
2. Principal Investigator (PI)/ Project Director (PD) or Contact PD/PI name if a multiple PD/PI model is used;
3. Name of the Investigator with the FCOI;
4. Name of the entity with which the Investigator has a FCOI;
5. Nature of the Financial Interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
6. Value of the Financial Interest Reports of dollar values may be made in ranges ($0 – $4,999, $5,000 - $9,999, $10,000 - $19,999, amounts between $20,000- $100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
7. A description of how the Financial Interest relates to the PHS-funded research and the basis for RFMH’s determination that the Financial Interest conflicts with the research;
8. A description of the key element of the management plan, including:
   1. Role and principal duties of the conflicted Investigator in the research project;
   2. Conditions of the management plan;
   3. How the management plan is designed to safeguard objectivity in the research project;
   4. Confirmation of the Investigator’s agreement with the management plan;
   5. How the management plan will be monitored to ensure Investigator compliance; and
   6. Other information as needed