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Minneapolis VA Health Care System Research Service

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Financial Conflict of Interest (fCOI) Statements

Why must VA investigators file fCOI statements?

Federal regulations under VHA Handbook 1200.13, 18 USC Chapter 11, and the Executive Branch Standards of Conduct (5 CFR Part 2635) require VA investigators to disclose all potential financial conflicts of interest that may affect their work. The Office of Government Ethics states that a financial conflict of interest occurs "when any financial arrangement, situation or action affects or is perceived to exert inappropriate influence on the design, review, conduct, results, or reporting of research activities or findings." Failure to disclose fCOIs may result in termination of the research protocol, removal of the investigator from a research project, or revocation of the right to conduct research within VA, in addition to other potential civil and criminal penalties.

When is a fCOI statement required?

Submission of the fCOI form (OGE Form 450 ALT) is required for all personnel listed with an investigative Role (e.g. Principal Investigator (PI), Co-PI, Co-Investigator, Sub-Investigator, etc.) on a VA-approved research protocol. A separate fCOI form is required for each separate protocol for which the individual is listed in an investigative role. Submission of this form is required:

  1. Initially, upon new project submission;
  2. Upon being added to an ongoing project;
  3. Upon Continuing Review for the research oversight committee of record;
    4. and
  4. Whenever their personal or financial situation changes that may impact their fCOI

How do I create my fCOI statement?

fCOI statements are created and submitted using the IRBNet platform. Each investigator must have an IRBNet account to submit their fCOI statement. If you are an investigator and do not have an IRBNet account, you can self-register for an account here.

For instructions on creating your fCOI statements, refer to the PowerPoint presentation Creating Financial COI Statements.

How do I submit fCOI statements?

One person (the PI or a delegate such as a Study Coordinator) will manage submission of fCOI forms created by the investigator(s). Any person who has Full Access rights to the project in IRBNet can create a package, link all applicable forms, and submit.

For each protocol submission in IRBNet that must include new or updated fCOI statements (new projects, continuing reviews, and amendments that add new investigators), our fCOI Administrator requires you to submit two packages in IRBNet:

  • The first package must contain all of the the applicable linked fCOI disclosures.
  • The second package must contain all other applicable documents required by the research oversight committee(s) of record.

fCOI forms must be current for accurate evaluation. fCOI disclosure forms linked to an IRBNet package should be created or updated no earlier than 120 days prior to submission in IRBNet.

fCOI disclosure packages should be submitted just before the corresponding new project, continuing review, or amendment package.

fCOI packages containing linked fCOI disclosure forms must be submitted to the Conflict of Interest Review Board in IRBNet. Do not submit fCOI packages to any other IRBNet review board.

For instructions on submitting fCOI disclosure packages, refer to the PowerPoint presentation Submitting Financial COI Statements.

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