Financial Conflict of Interest (FCOI) Policy
- Training Requirement
- Management and Reporting of Financial Conflicts of Interest
- Records Management
- Compliance and Penalties for Non-Performance
- Publicly Available Financial Conflict of Interest (FCOI) Information
- Additional Resources
- d'Vinci Interactive FCOI Point of Contact
Conducting fair and objective research is of the highest priority for d'Vinci Interactive. The aim of this policy is to provide transparency, honesty and trust in meeting educational, scientific, and research goals of all Public Health Service Awarding Components. The following policy provides means to address a Financial Conflict of Interest (FCOI), which can include reducing or eliminating the conflict to ensure that the design, conduct, and reporting of research will be free from bias. d'Vinci Interactive understands that the US Department of Health and Human Services (HHS) has published clear rules on financial conflict of interest (42 CFR Part 50, 45 CFR Part 94 - http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf
According to this policy, d'Vinci Interactive requires all investigators, sub-recipients, sub-grantees, collaborators and affiliates comply with 42 CFR Part 50, Subpart F for grants and cooperative agreements (and 45 CFR Part 94 for contracts). d'Vinci Interactive will inform each Investigator of this company policy on financial conflicts of interest, the Investigator's responsibilities regarding disclosure of significant financial interests, and of all other relevant regulations. d'Vinci Interactive will regularly review and revise this financial conflict of interest policy based on new requirements, new Investigators and any issues of non-compliance that may arise. d'Vinci Interactive believes we have comprehensively addressed all requirements of Public Health Service policy via this document.
Significant Financial Interest
A Significant Financial Interest is defined by regulation as the following:
A financial interest that contains one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that appears to be related to the Investigators institutional 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 the 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 in stock, stock options or other ownership interest, as determined through reference to public prices and 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 remunerations 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 interests (e.g. stock, stock options, or other ownership interest) or
Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.
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 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, medical center, or research institute that is affiliated with an Institution of higher education. The Institution's FCOI policy will specify the details of this disclosure, which 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 Institution's FCOI policy, the institutional 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 a FCOI with the PHS-funded research.
The term significant financial interest does not include the following types of financial interests: salaries, royalties or other remuneration paid by the institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the investigator, if the Institution is a commercial or for profit organization; income from investment vehicles, such as mutual funds and retirements 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, 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.
The Public Health Service
The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
PHS Awarding Component
The organizational unit of the Public Health Service (PHS) that funds the research activities related to this policy.
PHS research is any project governed by PHS regulation, but excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Investigators are any persons who is responsible for the design, conduct or reporting of research funded by a Federal source.
d'Vinci Interactive will require each Investigator to complete training regarding the same prior to engaging in research related to any NIH-funded grant and at least every four years, and immediately when any of the following circumstances apply:
- d'Vinci Interactive revises this Financial Conflict of Interest policy in a way that affects requirements of Investigators;
- A new Investigator joins research activities affiliated with d'Vinci interactive;
- Any Investigator is found not in compliance with this policy or management plan
d'Vinci Interactive will require each Investigator, partner and vendor to complete Financial Conflict of Interest (FCOI) training and insure that training is updated at a minimum of every four years or sooner if indicated by role. d'Vinci will provide resources and training that can be accessed through the NIH website, including at https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html. When possible, the Financial Conflict of Interest requirements consistent with this policy will be documented in the official teaming agreements established between individuals and organizations.
Management and Reporting of Financial Conflicts of Interest
Prior to the d'Vinci Interactive's expenditure of any grant funding, the designated d'Vinci Signing Official will review all disclosures of significant financial interests from all grant participating investigators, subrecipients and vendors. After review, d'Vinci will determine whether any significant conflicts exist with NIH-funded research requirements. If no financial conflict of interest is found the “disclosure forms” will be filed in the SFI binder. If a financial conflict of interest is identified it will be put on the financial conflict of interest report through the eRA Commons FCOI module prior to usage of any funds. If any interests are identified as conflicting subsequent to the initial report they must be reported to d'Vinci Interactive within 30 days. d'Vinci will then report it to the PHS awarding component that has issued the award within 60 days.
Each Investigator must submit an updated disclosure of a significant financial interest no less than annually. In addition, any new Investigator who is participating in the research project discloses a significant financial interest, the Signing Official will review the disclosure of the significant financial interest within sixty days. In both examples above, if a financial conflict of interest is determined to exist, d'Vinci will implement a management plan to remediate and manage the financial conflict of interest.
If a financial conflict of interest is not identified or managed in a timely manner from negligence of an Investigator or oversight, d'Vinci Interactive will within 120 days of the determination date of noncompliance, complete a retrospective review of the Investigator's activities and the NIH-funded research to determine if any portion of the research during the time of noncompliance was biased. The retrospective review will be documented in the following key format:
- Project number
- Project title;
- PD/PI or contact PD/PI if a multiple PD/PI model is used;
- Name of the Investigator with the FCOI;
- Name of the entity with which the Investigator has a financial conflict of interest;
- Reason(s) for the retrospective review;
- Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
- Findings and conclusions of the review
Based on the results of the retrospective review, d'Vinci Interactive will update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward, as well as submit a mitigation report to the NIH-funding institution.
d'Vinci Interactive will maintain records relating to all Investigator disclosures of financial interests and review of, and response to these disclosures as well as all actions under this policy or retrospective review, as well as all financial disclosures and all financial conflict of interest compliance actions taken by d'Vinci Interactive, sub-awardees and vendors. These records will be stored and preserved for a minimum of five years from the final date of submission of grant closeout reports.
Compliance and Penalties for Non-Performance
d'Vinci Interactive will ensure that all Investigators, including sub-recipients, sub-grantees and collaborators affiliated with d'Vinci Interactive where applicable, establish a written agreement that states they will follow the financial conflict of interest policy of the awardee Institution and d'Vinci Interactive (this policy). If an Investigator fails to comply with this Financial Conflict of Interest policy, d'Vinci Interactive shall complete a retrospective review of the Investigator's activities in no less than 120 days to determine bias. If a bias is found, d'Vinci Interactive will immediately submit a mitigation report to the PHS Awarding Component that shall address the consequences of the bias on the funded research project and the actions taken to mitigate that bias. d'Vinci Interactive will work with the Investigator to set up a Financial Conflict of Interest management plan to mitigate the situation. If extreme cases of bias are found, the Investigator may lose the right to participate in the project or receive any future funding from the PHS Awarding Component. d'Vinci Interactive as a company is required to mandate the Investigator disclose the Financial Conflict of Interest in each public presentation with research results if it was not reported at the beginning.
Publicly Available Financial Conflict of Interest (FCOI) Information
This policy and all FCOI d'Vinci Interactive guidance are published and available at https://www.dvinci.com/fcoi-policy to provide access to all relevant parties and the public. d'Vinci Interactive has established this policy guidance for principal or program Investigators, sub-recipients, sub-grantees and collaborators affiliated with d'Vinci Interactive. Any reported Financial Conflicts of Issue will be reported on this web page annually and within 60 days of d'Vinci Interactive's identification of a new conflict of interest. As of November 1, 2020, d'Vinci Interactive has not received any allegations or conducted any inquires that fall under the definition of research misconduct that involve NIH funded grants. In addition, a written report on all Financial Conflict of Interest activities can be provided the written version of this policy within five business days of a request. All Financial Conflict of Interest information will be published for no less than three years from the date that the information was last updated.