Financial Conflict of Interest

Policies, Procedures, and Guidance | Disclosure Process | Disclosure of a Significant Financial Interest | Training | Federal Regulations

On August 24, 2012, the Department of Health and Human Services under 42 CFR Part 50 and Part 94 required all investigators who are involved in the design, conduct or reporting of research to adhere to revised disclosure requirements. http://grants.nih.gov/grants/policy/coi/coi_faqs.htm.  FAU responded with implementation of the required policy and disclosure forms including offering of the NIH online tutorial to satisfy the training requirements.

The revised key areas included: the expanded definition of a Significant Financial Interest which includes:

  • lowering the disclosure threshold to $5,000,
  • expanding the extent of investigators’ disclosure of information to institutions regarding their Significant Financial Interests, and
  • broadening an institution’s management of identified Financial Conflicts of Interest.

Florida Atlantic University’s Financial Conflicts of Interest in Research policy provides guidelines to promote objectivity in research while establishing standards to ensure that the design, conduct, and reporting of research funded by extramural sponsors will not be biased by any conflicting financial interest of an Investigator.

The following information is provided to you, our researchers, to guide you in the requirements of the federal requirements to disclose your significant financial interests.

Policies, Procedures, and Guidance

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

Disclosure Process

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. 

Disclosure of a Significant Financial Interest

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 FAU 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.

Form required for assessment of Conflict of Interest:

Division of Research “Disclosure of Significant Financial Interest Form”

Training

The Federal regulations require mandatory training and the Division of Research requires such training within 30 days of a proposal submission, and at least, every three years thereafter. FAU has recently adopted the Collaborative Institutional Training Initiative (CITI) Conflict of Interest training module to fulfill this mandatory requirement. 

Please be advised that effective immediately all investigators are strongly encouraged to complete this training requirement.  After July 1, 2015 all investigators are required to complete the training within 30 days of their grant submissions with the understanding that after December 31, 2015 all FAU investigators will be required to complete this training prior to grant submission. Division of Research policy will state that account set up will not proceed without completion of the required training component.

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

Once you are registered and have access to your CITI account, complete the following steps to locate the training:

 — Log in to CITI.org;

— Click ‘Add a Course or Update Your Learner Groups';

— Scroll down to Question 4 ‘Conflicts of Interest’ and check “Yes”;

— Click ‘continue';

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.

Federal Regulations

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: http://grants.nih.gov/grants/policy/coi/

Department of Health and Human Services Final Rule 42 CFR Part 50 and Part 90

Summary of major changes to the 1995 Regulations

Questions can be directed to Elisa Gaucher, Director, Research Integrity, egaucher@fau.edu, or Camille Coley, Interim Director Sponsored Programs, ccoley@fau.edu



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