Financial Conflicts of Interest (FCOI)

This website outlines the policy and procedures for identifying and resolving actual and potential financial conflicts of interest (FCOIs) in relation to all federal sponsored projects, including subawards and projects supported by federal flow-through funding. The policy also applies to non-federal sponsors with FCOI requirements (e.g., Alliance for Lupus Research, American Cancer Society, American Heart Association, Arthritis Foundation, Juvenile Diabetes Research Foundation, Lupus Foundation of America, Susan G. Komen for the Cure). The policy applies to all types of extramural funding mechanisms, including but not limited to grants, cooperative agreements, and sponsored research contracts.

FCOI Basics: Overview of Policy & Requirements

UW-La Crosse FCOI Policy Webpage

Forms expanding section
Resources expanding section

FAQs

What are the primary requirements of the FCOI policy? expanding section

All investigators at UWL and collaborating institutions are responsible for completing the following items before a federal proposal can be submitted:

  1. For proposals to any federal agency: Complete a Significant Financial Interest (SFI) Disclosure Form.
    • Fill out the online UWL SFI Disclosure Form. Report all of your SFIs and those of your immediate family. SFIs should be related to your institutional responsibilities, field of professional interest, and/or the sponsored project.
    • Each investigator must complete a separate SFI Disclosure Form for each proposal in which they are involved.
    • If an award is funded, an updated SFI Disclosure Form must be completed annually by June 30 and within 30 days of when new SFIs are obtained or discovered.
  1. Additional requirement for proposals to PHS agencies and other agencies following PHS FCOI regulations*: Complete FCOI training and assessment.
    • Contact ORSP (grants@uwlax.edu, 608.785.8007) to be added to the FCOI course in Canvas.
    • Access the course as a student.
    • View the training presentation.
    • Complete the 10-question assessment. You must score at least 80% to pass but can take it as many times as needed.
    • The training and assessment needs to be re-completed once every four years if you have an active PHS award or are applying to a PHS agency (or any agency following PHS FCOI regulations).

* Examples of PHS agencies include the CDC, FDA, HRSA, NIH, and SAMHSA. For a comprehensive list of PHS agencies, see https://www.usphs.gov/aboutus/agencies/hhs.aspx. Several non-PHS agencies also follow the PHS regulations, such as the American Heart Association and American Cancer Society.

Which people are subject to the policy? expanding section

The policy applies to anyone who qualifies as a project investigator – i.e., any individual responsible for the design, conduct, or reporting of research. This always includes all PIs/PDs, co-investigators, and senior/key personnel from all participating institutions. It may also include graduate students, undergraduate students, and other collaborators. See the Identifying Investigators table for assistance.

If a project involves external collaborators who qualify as investigators, they are also subject to FCOI requirements at UWL and their home institution. Before a proposal can be submitted, these requirements include, at minimum, the completion of an FCOI policy certification and SFI disclosure form. It may also require the completion of FCOI training and assessment prior to submission. Plan ahead and contact ORSP early to meet these requirements.

Who is considered an investigator? expanding section

An investigator is any individual responsible for the design, conduct, or reporting of research. This always includes all PIs/PDs, co-investigators, and senior/key personnel from all participating institutions. It may also include graduate students, undergraduate students, and other collaborators. See the Identifying Investigators table for assistance.

What is (and is not) a significant financial interest (SFI)? expanding section

Items that are not considered SFIs, and thus do not need to be reported, include:

  1. Payments or equity interests not related to the investigator’s university responsibilities, field of professional interest, or the sponsored project
  2. Salary, royalties, or other payments from the investigator’s university
  3. Income from seminars, lectures, or teaching engagements sponsored by US public or non-profit organizations
  4. Income from service on advisory committees or review panels for US public or non-profit organizations
  5. Any equity interests in an organization that is applying to an SBIR or STTR program (if the investigator is disclosing SFIs for the same proposal)

 

Items that are considered SFIs, and thus need to be reported, include payments received by or equity interests owned by the investigator (and/or their immediate family members) that are listed in the table below and are related to the investigator’s institutional responsibilities (e.g., consulting, research, teaching, writing), field of professional interest, or the sponsored project. In determining value of SFIs, investigators should aggregate the values of payments received or equity held by themselves as individuals in addition to those received or held by their immediate family members.

SFI Overview

Type of Entity

Type of Financial Interest

Value

Publicly traded US entity

Any payments, including but not limited to salary or other payments for services (e.g., consulting fees, honoraria, paid authorship)

Totaling $5,000 or more in the preceding 12 months alone or in aggregate with equity interests in the entity

Equity interests (e.g., stocks, stock options, convertible bonds, other ownership interests)

Totaling $5,000 or more (as determined through reference to public prices or other reasonable measures of fair market value) alone or in aggregate with other payments received from the entity; or representing 5% or more ownership interest in any single entity

Non-publicly traded US entity

Any payments, including but not limited to salary or other payments for services (e.g., consulting fees, honoraria, paid authorship)

Totaling $5,000 or more in the preceding 12 months

Equity interests (e.g., stocks, stock options, convertible bonds, other ownership interests)

Any amount

N/A

Intellectual property rights and interests (e.g., patents, copyrights, royalties from such rights)

Any amount already paid or expected to be paid for the preceding 12 months

Any US entity that is not a federal, state, or local government agency; institution of higher education (IHE); academic teaching hospital; medical center; or research institute affiliated with an IHE

Reimbursed or sponsored travel (i.e., travel paid on behalf of the investigator and not reimbursed to them so that the exact monetary value may not be readily available)

Any amount

Any foreign entity

(inclusive of institutions of higher education, government entities, and non-profit organizations)

Any financial interests (including but not limited to payments of all types, honoraria, consulting fees, paid authorship, investments, equity interests, intellectual property rights and interests, royalties, reimbursements, and/or sponsorships)

Any amount

How should the value of financial interests be determined? expanding section

To determine the value of financial interests, investigators should aggregate the values of payments received or equity held by themselves as individuals in addition to those received or held by their immediate family members. Investigators should use standard financial documents to establish the present market value or estimated value in US dollars (USD) of financial interests in determining which interests need to be disclosed and the values to be reported. For example, this may include recent account statements, pay statements, W-2s, 1099s, reimbursement documentation, service contracts, equity documents, stock certificates, purchase agreements, articles of incorporation, balance sheets, income statements, cash flow statements, tax returns, and license agreements. Investigators may be asked to provide copies of such documents to ORSP and the UWL FCOI Committee to substantiate valuations and aid the review process.

To calculate the values of financial interests involving foreign entities, investigators should use the OANDA currency converter to establish the values in USD: https://www1.oanda.com/currency/converter/. Use the exchange rate for a date within two weeks of the SFI Disclosure Form submission date.

What is a financial conflict of interest (FCOI)? expanding section

A financial conflict of interest (FCOI) is a significant financial interest (SFI) of any investigator that could directly and significantly affect the design, conduct, or reporting of funded research. Not all SFIs are considered FCOIs, but all SFIs that meet the definition of the FCOI policy must be disclosed. UWL has established an institutional process to review SFIs and determine whether they may or may not constitute an FCOI. If an investigator is determined to have an FCOI, UWL has a process for working with the investigator to develop an FCOI Management Plan to eliminate, manage, or mitigate the associated risk while they work on a project.