Financial Conflict of Interest (FCOI) in Research Policy
The Emmes Company, LLC
Financial Conflict of Interest (FCOI) in Research Policy
The Emmes Company is committed to protecting the credibility and integrity of our staff and to ensure public trust and confidence in Emmes’ research related activities. This policy is designed to meet the requirements of Federal regulations covering conflicts of interest (42 CFR Part 50 Subpart F for grants and cooperative agreements and 45 CFR Part 94 for contracts). The Emmes Company has a responsibility to manage, reduce or eliminate any actual or potential conflicts of interest that may arise because of the financial interests of an Investigator.
This policy promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH contracts, grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.
The Emmes Company requires staff identified as responsible for the design, conduct, or reporting of research (an “Investigator”) to complete an annual FCOI Disclosure. Any Significant Financial Interest (as defined in 42 CFR 50.603) in certain entities of an Emmes Investigator making the disclosure, along with those of his/her spouse and dependent children, requires further disclosure.
Who is covered by this policy?
Investigator means the principal investigator, project director, co-principal investigator, and any other person at Emmes, regardless of their title or position, who is responsible for the design, conduct, or reporting of research funded by the Federal Government (which includes NIH and the DoD), or proposed for such funding. In addition, this may include outside collaborators or consultants. In this context, “Investigator” includes the person’s spouse and dependent children (42 CFR 50.603). All Emmes staff covered under the FCOI requirements shall also be required to comply with training requirements regarding FCOI compliance.
What must be disclosed?
Each Investigator shall disclose all Significant Financial Interests:
- That would reasonably appear to be affected by the research or other activities funded, or proposed for funding; or
- In entities whose financial interest would reasonably appear to be affected by such activities.
What is a Financial Conflict of Interest?
A Financial Conflict of Interest is a situation where there is a divergence between an Investigator’s personal financial interest and that individual’s employment obligations at Emmes, such that an independent observer might reasonably question whether the performance of the employment (Emmes’) obligations are adversely affected (or have the potential to be) by considerations of personal gain, and in the case of research, includes the existence of a significant financial interest of an Investigator that could directly and significantly affect the design, conduct or reporting of the research (42 CFR 50.605). This includes:
- Any significant financial interest of the Investigator that would reasonably appear to be affected by the research or activities funded, or proposed for funding, by an external sponsor; or
- Any significant financial interest of the Investigator in an entity whose financial interest would reasonably appear to be affected by the research or activities funded, or proposed for funding, by an external sponsor.
What is a Significant Financial Interest?
A Significant Financial Interest is defined in 42 CFR 50.603 and means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests in publicly-traded or non-publicly traded entities); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). A Significant Financial Interest includes a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's Emmes responsibilities:
- With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
- With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
What else must be reported?
Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional (Emmes) responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by:
- A Federal, state, or local government agency,
- An Institution of higher education as defined at 20 U.S.C. 1001(a),
- An academic teaching hospital, a medical center, or
- A research institute that is affiliated with an Institution of higher education.
The details of this disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Emmes’ FCOI policy, the Emmes official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
What does a Significant Financial Interest not include?
The term Significant Financial Interest does not include the following types of financial interests:
- Salary, royalties, or other remuneration paid by Emmes to the Investigator, including intellectual property rights and agreements to share in royalties related to such rights;
- Any ownership interest in Emmes held by the Investigator;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
- Income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
Disclosure of both perceived and actual conflict of interest protects one’s reputation from embarrassing or harmful allegations of misconduct. An Emmes Investigator may choose to disclose any financial or related interest, beyond those required by regulation or this policy that could present an actual or perceived conflict of interest.
All Emmes staff whose job duties place them within the definition of an “Investigator” must disclose their Significant Financial Interests utilizing the attached form and attaching all required supporting documentation. The completed form and attachments must be submitted to the Emmes Company’s General Counsel.
The disclosure shall be updated annually, within thirty days of when a Significant Financial Interest or Sponsored Travel occurs or is discovered, and with the submission of a new proposal.
Resolutions to conflicts of interest must be explained in writing and signed by the Investigator(s) and Emmes’ President, to be submitted to the Emmes Company’s General Counsel.
What is the Review Process?
Prior to submitting a proposal that involves a Significant Financial Interest or Sponsored travel, the Investigator should discuss with appropriate Emmes Officers proposed measures that will be taken to manage, reduce, or eliminate any actual or potential conflict of interest presented by a significant financial interest. Such measures could include:
- Public disclosure of significant financial interests;
- Review of research protocol by independent reviewers; and
- Monitoring of research by independent reviewers.
The Emmes President or his or her official designee(s), with the assistance, if necessary, of appropriate members from the Executive Officer Group, shall review all financial disclosures to determine whether a conflict of interest exists. If they determine that there is a potential for conflict of interest covered by this policy, then the Emmes President may impose additional conditions or restrictions other than those listed in #1 above, including the following:
- Modification of the research plan;
- Disqualification from participation in all or a portion of the research funded;
- Divestiture of significant financial interests; or
- Severance of relationships that create the actual or potential conflicts
The Emmes President may require that a plan for reducing or eliminating conflicts of interest be incorporated into a Memo of Understanding between Emmes and the Investigator.
If Emmes’ President determines that imposing the conditions or restrictions would be ineffective or inequitable, or that the detrimental effects that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the President may decide that, to the extent permitted by Federal regulations, the research go forward without imposing such conditions or restrictions. In these cases, the President shall make the final decision regarding resolution.
How will Emmes manage Conflicts of Interest?
Actual or potential conflicts of interest will be satisfactorily managed, reduced, or eliminated in accordance with these guidelines and all required reports regarding the conflict of interest submitted to the sponsor prior to expenditure of any funds under an award.
Where any conflicts of interest exists with regard to a federally-funded research project, Emmes will develop and implement a management plan that specifies the actions taken, and/or to be taken to manage the conflict of interest, and Emmes will make any reports or disclosures of the conflict of interest that are required or that Emmes deems to be appropriate.
All collaborators/sub-recipients/subcontractors from other organizations must either comply with this policy or provide a certification that their organizations are in compliance with Federal policies regarding Investigator significant financial interest disclosure and that their portion of the project is in compliance with their institutional policies.
What happens if there is a violation of this Policy?
Whenever an Investigator has violated this policy or the terms of any resolution plan required by the Emmes President (including failure to file or knowingly filing incomplete, erroneous, or misleading disclosure forms), the President shall notify the other Executive Officers and the Chief Human Resources Officer, who will impose sanctions or institute disciplinary proceedings against the Investigator.
In addition, Emmes shall follow Federal regulations regarding the notification of the sponsoring agency in the event an Investigator has failed to comply with this policy. The sponsor may take its own action as it deems appropriate, including the suspension of funding for the Investigator until the matter is resolved.
Any questions regarding this policy should be addressed to one or all of the following:
Emmes General Counsel:
Emmes Chief Human Resources Officer: