Financial Conflict of Interest in Research

The Division of Research recognizes that actual or perceived conflicts of interest may occur in the normal conduct of research and other activities and therefore it is essential that investigators disclose their and their family members' financial interest related to research that they are involved in. Only after disclosure of a significant financial interest can the University make an informed judgment about a particular activity and require the appropriate oversight, limitations or prohibitions in accordance with applicable federal, state or university regulations.

• Division of Research Conflict of Interest Review Process (Flow Chart)
• Financial Conflict of Interest (FCOI) Policy

The Division of Research requires that all principal investigators, co-PIs and key personnel follow federal regulations, and complete a disclosure of significant financial interests (SFI):

• Proposal-Related Disclosures: Prior to submitting proposals for internal or external funding. The significant financial interest (SFI) disclosure forms should be completed and signed by all key personnel and uploaded into grantsERA as part of the complete proposal package.
• Ad Hoc Disclosures: Within 30 days of joining a research project already in progress or within 30 days of acquiring a new SFI. The significant financial interest (SFI) disclosure forms should be completed, scanned, and e-mailed to the Proposal and Contract Administrator assigned to the lead PI's college.
• Travel Disclosures: Within 30 days of any reimbursed or sponsored travel undertaken by the Investigator related to his or her Institutional Responsibilities (over $5,000)
• Annual Disclosures: Annually, significant financial interest (SFI) disclosure forms should be completed, scanned, and e-mailed to the Proposal and Contract Administrator prior to the issuing of continuing funds.

This form is required for assessment of Conflict of Interest, please read information below:

*Use the Novelution website: http://fau.novelution.com/ to complete your disclosure for the FCOI

A disclosure for Significant Financial Interest will be filed by each investigator (PI, co-PI and key personnel) upon submission of a funding proposal to Sponsored Programs. Upon notice of award, any positive disclosure for Significant Financial Interest will be forwarded with all applicable information, i.e. disclosure, abstract, scope of work, research strategy, to the Financial Conflict of Interest (FCOI) Committee. The Division of Research facilitates the FCOI faculty committee charged with ensuring that significant financial interests of Florida Atlantic researchers (PIs, Co-PIs and key personnel) do not compromise their objectivity in:

a) Defining, conducting or reporting research activities; b) Protecting the welfare of research participants; or c) Developing intellectual property. The FCOI committee will determine whether a financial interest with an external entity (or travel sponsored by an external entity if travel disclosure is required) is related to the particular research project on a case-by-case basis.

If the FCOI committee determines that a significant financial interest (or travel sponsored by an external entity when travel disclosure is required) is reasonably related to an investigator's research-related responsibilities (design, conduct or reporting of such research) it will next determine whether the Investigator will be required to eliminate or manage the Financial Conflict of Interest, as appropriate.

A Financial Conflict of Interest may be eliminated by divestiture of Equity Interests; termination of the relationship that gives rise to the Significant Financial Interest (such as consulting); abandoning the proposal; terminating the sponsored project; or other similar measures.

If the Investigator does not want to eliminate a Financial Conflict of Interest or the appearance of a Financial Conflict of Interest and FCOI committee determines that it can be managed, the Investigator will work with the FCOI committee to develop a written management plan. This management plan will remain in place for as long as the grant award is active or until there is a change in the investigators SFI disclosure status.

Novelution is a Research Management System which connects the Sponsored Programs Research Proposal process directly with the Financial Conflict of Interest disclosure requirements. This web-based platform allows users to complete their disclosures in a text fillable virtual form that can be updated annually or as changes occur rather than requiring a new form to be completed each time.

The SFI Disclosure will be completed at the time of proposal submission which includes a general overview of the researcher’s outside entities. At the time of award, a project-specific disclosure will be submitted to the system to describe how the work being done within Florida Atlantic does or does not relate to work being done outside of Florida Atlantic.

View a presentation demo by clicking here.

The Office of Research Integrity and the Office of Sponsored Programs (OSP) work closely together using the Novelution system. For additional information visit the OSP Novelution website which includes further resources about the FCOI module as well as the OSP module.

The Federal regulations require mandatory training, and the Division of Research requests that such training be completed within 30 days of a proposal submission. Effective January 1, 2016, account set up for all funded awards, regardless of funding source, will not proceed without completion of the required training component.

Florida Atlantic adopted the Collaborative Institutional Training Initiative (CITI) Conflict of Interest training module to fulfill this mandatory training requirement. This training, once completed, will remain current for three years and will require a refresher course thereafter.

Access to the training module is available on: http://www.citiprogram.org

Once you are registered access your CITI account and follow steps to locate training:

• Log in to CITIprogram.org
• Click Main Menu / My Courses and select Add a Course
• Scroll down to Question 4 'Conflicts of Interest' and check "Yes"
• Note that Question 6 is mandatory so you must answer that to continue
• Click 'Submit'
• The Conflict of Interest course Stage 1 is now added to your account
• If you had already completed your Conflict of Interest Stage 1 and it has or is within the 90-day window to expire, these steps will provide you the Stage 2 Refresher course

Note: If you do not already have a CITI account, you first need to create an account and select Florida Atlantic University as your participating institution.

The federal requirements are intended to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of sponsored research will be free from bias resulting from Investigator financial conflicts of interest.

For more information see:

• NIH Grants & Funding
• Department of Health and Human Services Final Rule 42 CFR Part 50 and Part 90
• Summary of major changes to the 1995 Regulations