SMU Research

Financial Conflicts of

Interest (FCOI) Program

Introduction and Justification

The Financial Conflict of Interest (FCOI) Program helps Research Compliance identify and manage any potential or actual conflicts of interest involving Sponsored Project. The requirements of the program are codified in SMU Policy 10.7, Financial Conflicts of Interest in Externally Sponsored Research. The FCOI program was designed to satisfy the requirements of several major Funding entities, including the National Institutes of Health and the National Science Foundation. SMU Researchers cannot receive Funding from many external entities unless an FCOI Program is in place and enforced.

Applicability

The FCOI Program applies to Responsible Parties at SMU, regardless of title. Responsible Parties include:

  • Those who are responsible for the oversight, design, conduct, or reporting of Research at SMU under Grants or Contracts funded by government entities or other external Sponsors;
  • Those who are involved in the negotiation of externally-Sponsored Research Agreements; and
  • Those who are responsible for externally funded educational activities.

Training

All Responsible Parties must complete FCOI Training every 4 years. The training, which is available through CITI, consists of 2 modules, and should take about 30 minutes to complete.

Assistance with logging in to an existing account and adding the appropriate course(s)

Assistance with creating a new account and registering for the appropriate course(s)

Assistance with associating your existing account with your SMU credentials

Training notifications and reminders will occur in several ways:

  • Principal Investigators (PIs) / Project Directors (PDs) will certify that they have completed the training when they sign a Proposal Initiation and Approval Form (PIAF)
  • Research Compliance will send a reminder email if the training is not complete upon proposal of externally funded Research
  • PIs / PDs will certify that they have completed the training when they sign an Award Authorization and Approval Form (AAAF)
  • Research Compliance will send a reminder email if the training is not complete upon awarding of Funding

Please note that awarded Funding, including new and incremental Funding, will NOT be set up until the FCOI training has been completed by the project PI / PD and all Co-PIs.

Disclosure

Responsible Parties must submit a Financial Conflict of Interest Disclosure Form upon proposal of every externally funded Research project. In addition, the FCOI Disclosure process must be completed every year during the duration of an externally funded Research project. Disclosure notifications and reminders will occur in several ways:

  • Grant Management Specialists will request FCOI Disclosures during the Proposal development process
  • PIs / PDs will certify that they have completed the disclosures when they sign a Proposal Initiation and Approval Form (PIAF)
  • Research Compliance will send a reminder email if disclosures is not complete upon proposal of externally funded Research
  • PIs / PDs will certify that they have completed disclosures when they sign an Award Authorization and Approval Form (AAAF)
  • Research Compliance will send a reminder email if disclosures are not complete upon awarding of Funding

The FCOI Disclosure process asks Responsible Parties to divulge any Significant Financial Interest they, or a member of their Immediate Family, may have in a Funding entity, Pass-Through Entity, or other entity involved in a Research project. Responsible Parties will also be asked to certify that they have read and understand the relevant policy. FCOI Disclosure can be completed using either a PDF version of the form or a Qualtrics version of the form.

FCOI Disclosure Form - PDF

FCOI Disclosure Form - Qualtrics

Please note that awarded Funding, including new and incremental Funding, will NOT be set up until the FCOI Disclosure has been completed by the project PI / PD and all Co-PIs.

Management

The existence of a potential or actual Financial Conflict of Interest does not mean that the Research project cannot take place. Instead, a Management Plan can be created by Research Compliance and implemented by the Responsible Party. This can involve, but is not limited to, disclosure of the financial relationship on publications, disclosure to employees and students, review of the project by an outside party. Significant Financial Conflicts of Interest may be referred for review to the Committee on Conflicts of Interest in Research (CCIR), according to Policy 10.7.