The Head of Department must review all Significant Financial Interest (SFI) disclosed by Investigators to determine whether any are related to research funded through a U.S. Public Health Service funder and if so, whether they constitute a Financial Conflict of Interest.
If an SFI is determined to be an FCOI, the Head of Department together with the Departmental Administrator will set out a plan to manage, reduce or eliminate the conflict.
Management plan
The management plan could include the following actions:
- Public disclosure of financial conflicts of interests (e.g. when presenting or publishing the research; to staff members working on the project, to relevant ethics committees)
- For research projects involving human subjects, disclosure of financial conflicts of interest directly to participants
- 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
- Modification of the research plan
- Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research
- Reduction or elimination of the financial interest (e.g., sale of an equity interest)
- Severance of relationships that create financial conflicts
The management plan should also include the following details:
- The role and principal duties of the conflicted Investigator in the research project
- Conditions of the management plan
- How the management plan is designed to safeguard objectivity in the research project
- Confirmation of the Investigator's agreement to the management plan
- How the management plan will be monitored to ensure Investigator compliance
- Other information as needed
Submission of reports
Unless the conflict is eliminable, the plan must be submitted to the PHS funder; in the case of the NIH this will be via the electronic Research Administration (eRA) Commons FCOI Module. The Head of Department and Departmental Administrator are responsible for ensuring that reports are submitted on time (via the ROO) as and when required.
Updated or annual FCOI reports must include the status of the management plan (i.e. whether the financial conflict is still being managed or an explanation of why the financial conflict no longer exists) and a description of any changes to the management plan since the last FCOI report was submitted.
Reports must be submitted prior to any expenditure of funds under a PHS-funded project. Note that reports need only be made if the Head of Department determines that an SFI constitutes an FCOI. But reports must also be submitted if an Investigator does not disclose an SFI in the timeframe required or the University does not review a disclosure but later determines that an FCOI exists.
For new Investigators who join the project, for any SFI disclosed which is judged to be an FCOI, the FCOI report must be submitted within 60 days.
For a new SFI that is deemed to be an FCOI, an FCOI report must be submitted within 60 days of disclosure.
For any FCOI previously reported, the University must provide an annual FCOI report to address the status of the financial interest and any changes to the management plan. The plan must specify whether the FCOI is still being managed or explain why the FCOI no longer exists. Annual reports must be submitted via eRA Commons for the duration of the project period (including extensions with or without funds) at the same time as submitting the annual progress report.
All FCOI reports must include sufficient information to enable the PHS-funder to understand the nature and extent of the FCOI and to assess the appropriateness of the management plan. The regulation provides key elements that must be included in the FCOI report to NIH. These include but are not necessarily limited to the following:
- Project number
- Programme Director (PD)/PI or Contact PD/PI if a multiple PD/PI model is used
- Name of the Investigator with the Financial Conflict of Interest
- Name of the entity with which the Investigator has a Financial Conflict of Interest
- Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium)
- Value of the financial interest (dollar ranges are permissible: $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
- A description of how the financial interest relates to the NIH-funded research and why the Institution determined that the financial interest conflicts with such research
NOTE THAT THERE IS NO REQUIREMENT TO SUBMIT A REPORT IF THE UNIVERSITY DETERMINES THAT NO DISCLOSURE OF AN SFI CONSTITUTES AN FCOI.
Retention of information
All records of all Investigator disclosures of financial interests and the University's review, or response to, such disclosure (whether or not a disclosure resulted in determination of an FCOI), and all actions under our own policies or retrospective review, must be retained for at least 3 years from the date of submission of the final expenditures report (or other dates as specified in the regulations (see NIH Grants and Funding FAQs, Section A, 9).
Failure to comply
If an Investigator fails to comply with the policy or a management plan subsequently put in place, the University must, within 120 days, undertake a retrospective review of the research project to determine if any bias in the design, conduct or reporting of the research. If a bias is found, the PHS funder must be notified and provided with a mitigation plan and thereafter report annually as normal, unless the University decides further interim measures are necessary. The funder is entitled to suspend or terminate the award.