Company-wide. This policy covers all projects conducted with government funds that SpikeGadgets is working on and applies to all employees, subrecipients, and consultants.
The purpose of this policy is to identify, manage, minimize, and eliminate financial conflicts of interest in compliance with federal regulators. This policy was written in compliance with NIH’s 4.1.10 Financial Conflict of Interest requirements and 42 CFR Part 50 to ensure that research funded under the Public Health Service (PHS) grants or cooperative agreements will be from bias as a result of Principal Investigator conflicts of interest.
Financial conflict of interest (FCOI) – a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI report – Institution’s report of a financial conflict of interest to a PHS Awarding Component.
Financial interest – anything of monetary value, whether or not the value is readily ascertainable.
Investigator – the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
Significant Financial Interest
Significant Financial Interest (SFI) is defined by the regulations as:
Significant financial interest means:
(1) 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 institutional responsibilities:
(i) 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;
(ii) 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
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) 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, a medical center, or a 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 an FCOI with the PHS-funded research.
(3) The term significant financial interest does not include the following types of financial interests: salary, 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 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.
In compliance with NIH’s requirements each PHS-supported Investigator must complete the FCOI training prior to engaging in engaging in research related to any PHS or NIH-funded grant. After that, training must be completed when one of the following criteria is met:
- Once every four (4) years
- The Institution revises its FCOI policy that affects requirements of Investigators
- An Investigator is new to the Institution
- An investigator is not in compliance with the policy
- The training module can be completed on NIH’s Financial Conflicts of Interest Policy page.
Investigators are required to disclose their SFIs when the following criteria are met:
- No later than the time of application for the PHS/NIH-funded research
- Annually during the period of award
- Within 30 days of discovering or acquiring a new SFI
Any potential SFI should be disclosed to SpikeGadgets’ CEO (Mattias Karlsson, the Principal Investigator of the Research Project) in writing. If a FCOI is newly identified, it will be put an FCOI report on the eRA Commons FCOI module prior to expending funds. If an FCOI is determined SpikeGadgets will make an effort to manage the conflict of interest through such means as a full public disclosure, appointment of an independent monitor, modification of the research plan, etc.
While an NIH research project is ongoing, SpikeGadgets shall submit an FCOI report within 60 days after a newly-identified FCOI. If a FCOI was not disclosed in a timely manner, the Company shall submit a FCOI report to the NIH within 60 days of the discovery, as well as complete a retrospective review within 120 days of discovery of noncompliance following the guidelines specified in Regulatory Citation 42 CFR 50.605(a)(3)(ii)(B).
Annual FCOI report – For any FCOI previously reported to the NIH, the Company shall provide an annual FCOI report addressing the status of the FCOI as well as any changes to its related management plan.
Any subrecipient of the project shall follow SpikeGadgets’ FCOI policy and report any conflicts of interest to the company’s CEO. If the subrecipient already has their own policy in place, they shall submit a certification to the CEO that states their FCOI compliance with the regulation.
Maintenance of Records
The records of all financial disclosures and all actions taken by SpikeGadgets will be maintained for at least three (3) years from the date the final expenditures report is submitted to the PHS (NIH).