Financial Conflict of Interest in Research Policy

Responsible Office or Person: Provost Office
Related Law & Policy: 42 CFR Part 50, Subpart F

Purpose

To promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of sponsored research will be biased by any conflicting financial interest of an investigator.

Federal regulations (42 CFR Part 50, Subpart F) require investigators to disclose any financial interest that may present an actual or potential conflict of interest in relationship to externally sponsored projects prior to the submission of a proposal for funding. Institutions must develop specific mechanisms by which conflicts of interest will be satisfactorily managed, reduced or eliminated prior to the expenditure of any funds on an award. Should a new reportable significant conflict of interest arise at any time, the investigator must disclose this interest.

Policy

The principal investigator, project director, co-principal investigators, and any other person conducting research at Carroll University who is responsible for the design, conduct, or reporting of research that is being funded or proposed for funding by an external sponsor must disclose whether they (including their spouse, domestic partner, children, and dependents) have significant financial interests related to the work being conducted under the sponsored project.
Financial Interests – Anything of monetary value received within the preceding 12 months, including but not limited to:

Salary or other payments for services (e.g., consulting fees or honoraria) received from for-profit entities
Equity interests (e.g. stocks, stock options or other ownership interests, excluding mutual funds or other retirement accounts*) or
Intellectual property rights (e.g. patents, copyrights, trademarks, licensing agreements, and royalties from such rights)

*For a complete description of exclusions, see 42 CFR Part 50, Subpart F

Procedure

At the time a grant application is made and submitted to the Director of Grant Programs, the principal investigator is required to fill out the “Disclosure of Financial Interests Related to Sponsored Research Proposals” form. The PI is responsible for ensuring that all appropriate personnel complete the document and return it to the Director of Grant Programs. If a conflict of interest should arise during the course of the project, the investigator must immediately disclose the interest to the Business Office.

If the investigator indicates that a financial interest exists, the Director of Grant Programs will notify the Business Office for further review. If the Business Office determines that there is a potential conflict of interest, the CFO and Provost will conduct additional evaluation of the information. If it is determined there is a financial conflict of interest, the Business Office will work with the investigator to develop a resolution to manage, reduce or eliminate the conflict. The resolution will be incorporated into a management plan. This document will be executed prior to the expenditure of funds and kept on file in the Business Office.

In accordance with 42 CFR § 50.604(2), “Prior to the institution’s expenditure of any funds under the award, the institution will report to the PHS Awarding Component, the existence of a conflicting interest (but not the nature of the interest or other details) found by the institution and assure that the interest has been managed, reduced or eliminated in accordance with this subpart; and, for any interest that the institution identifies as conflicting subsequent to the institution’s initial report under the award, the report will be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within sixty days of that identification.”

Upon request, Carroll University agrees to make information available to the sponsoring agency regarding all conflicting interests and how these interests have been managed, reduced, or eliminated.

When the project is submitted to the Business Office for annual renewal, the investigators will be required to update their financial disclosures.
All investigators outside of the institution, whether through subcontracts, consulting agreements, etc. will also be required to submit financial disclosures to Carroll University on an annual basis as required by federal regulation.
Records of all financial disclosures and all actions taken by the institution will be maintained for three years from the date of submission of the final expenditure report.

Public Accessibility

Information concerning identified financial conflict of interests held by senior/key personnel will be provided within five business days upon written request to the Business Office.

Training

Each investigator will complete either in-person FCOI training with the Post-Award Administrator, or complete individual training via an online computerized module prior to engaging in research related to any government funded grant or contract and at least every four years, and immediately under the designated circumstances:

Institutional FCOI policies change in a manner that affects investigator requirements
An investigator is new to the institution
The institution finds an investigator noncompliant with Carroll’s FCOI policy or management plan.

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