An Investigator is any person (including subrecipients, subgrantees and collaborators) who is responsible for the design, conduct or reporting of research funded by PHS. This term includes both the principal investigator and the key personnel on each grant or contract.
ISurTec personnel who conduct research on federally funded grants and contracts are required to complete training related to Financial Conflict of Interest (FCOI). The training must be performed prior to the application for a federal grant or contract and updated no-less than every four years or as designated based on grant or role circumstances. Training should be performed for every new investigator, whenever ISurTec revises its FCOI policy, and repeated if an investigator is not in compliance with the policy or its management plan within 120 days.
Significant Financial Interest (SFI)
Significant Financial Interest is defined by the regulations as:
- 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 reasonable 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.
Disclosure and Review Requirements
Every investigator must disclose their significant financial interests as defined above prior to the application for PHS-funded research. Additionally, investigators must re-certify the form annually on the first of the year. If the investigator has disclosed their significant financial interests within one year of a new grant application, no new form is required. Investigators must disclose any new significant financial interests within 30 days of discovery regardless of the date of their prior reporting.
ISurTec will designate an FCOI officer to review all significant financial interest disclosure forms. Unless otherwise specified, the FCOI officer will be the signing officer for the company. If the signing officer is an investigator, an alternate non-investigator FCOI officer will be named. Prior to application for a federal grant or contract, the FCOI officer will collect significant financial interest disclosure forms from the relevant personnel and review them. Similarly, after the first of every year, when new investigators begin, or when new significant financial interests are discovered, the FCOI officer will collect and review all significant financial interest disclosure forms. The officer will determine if a Financial Conflict of Interest exists, initiate reporting to the NIH, prepare the FCOI management plan and monitor its implementation.
Financial Conflict of Interest (FCOI)
A Financial conflict of interest exists when ISurTec reasonably determines that a Significant Financial Interest (defined above) could directly and significantly affect the design, conduct or reporting of NIH-funded research.
ISurTec shall determine that a FCOI exists when:
- a) There is a significant financial interest for one or more of the investigators
- b) The significant financial interest is directly related to the PHS-funded research
- c) The significant financial interest is determined by ISurTec to be a financial conflict of interest.
If an FCOI is determined to be present, the FCOI officer will initiate a Financial Conflict of Interest report to the NIH through the eRA commons module. This reporting must be done prior to the expenditure of any funds on new federal grants or contracts. For new investigators or newly discovered FCOIs, the FCOI report must be filed within 60 days. The Financial Conflict of Interest report will include: the grant/contract number, PI and/or co-PI, name of the investigator with a FCOI, name of the legal entity with which the investigator has the FCOI, nature of the financial interest, a description of how the significant financial interest could influence the conduct, design or reporting of PHS-funded research, and a description of the management plan for the FCOI including roles and principal duties of the conflicted personnel, conditions of the management plan, monitoring plans, and a description of how the management plan is designed to safeguard objectivity of the research. Annual updates on the FCOI at the time of progress reports must be submitted throughout the grant or contract period until completion of the project. A retrospective review may be used to update previously submitted FCOI reports if appropriate.
If ISurTec determines that bias has been found with the design, conduct or reporting of NIH-funded research, ISurTec will notify the relevant program officer within 30 days and submit a Mitigation Report in accordance with 42 CFR 50.605a3iii. Similarly, if ISurTec determines that an investigator has failed to comply with the FCOI policy or that an FCOI management plan appears to have biased the design, conduct or reporting of NIH-funded research, ISurTec will notify the relevant program officer and update the FCOI report through the eRA commons. Corrective actions will be taken following discussion with the NIH.
Management and Monitoring of a FCOI
Means taking action to address a FCOI, which can include reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias. Management plans may include reassignment of investigator personnel and roles within the project, disqualification of the investigator from part or all of the proposed research, assignment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the PSH-sponsored research, or divestment of the significant financial interest. Public disclosure of the financial conflict of interest on scientific publications may be necessary. Management plans must be initiated within 60 days of disclosure or discovery of a FCOI. Monitoring of FCOI management must be continued throughout the federal grant or contract period with updated annual reports to the NIH.
PHS Awarding Component
The PHS awarding component is any sub-agency of the Public Health Service or Department of Health and Human Services.
The records of all financial disclosures and all actions taken by ISurTec will be maintained for at least three years from the date of submission of the final expenditures report.
PHS-sponsored research is any project governed by PHS regulation excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Compliance and Penalties for Non-Performance
If an investigator fails to comply with ISurTec’s FCOI policy within 120 days, ISurTec shall complete a retrospective review of the Investigator’s activities to determine bias. If a bias is found, ISurTec shall submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions it has taken to mitigate the bias. ISurTec will work with the Investigator to set up an FCOI management plan to mitigate the situation. In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution as required by this Policy, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations. In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future NIH funding.
Subrecipients on federal grants and contracts should be contacted prior to application for the grant if possible, and at least prior to expenditure of funds for their research, and informed of ISurTecs FCOI policy. If possible, the subrecipient will certify that they will follow ISurTec’s FCOI policy in writing. If applicable, the subrecipient should disclose significant financial interests on the same timetable as ISurTec investigators to allow timely reporting of FCOI to the NIH. The subrecipient may either determine FCOIs itself, or allow ISurTec to review their significant financial interest disclosures and determine if FCOI exist.
ISurTec will make its FCOI policy publicly available on its website. In addition, information on identified FCOIs will be publicly available within 5 calendar days of a written request with updated information.