Canon Medical Research USA, Inc.
Public Health Service Financial Conflict of Interest (FCOI) Policy
CMRU promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest (FCOI). This document addresses the requirements regarding FCOI as outlined by the National Institutes of Health (NIH), The Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS).
CMRU’s policy requires that each investigator, subcontractor and collaborators affiliated with an NIH award to CMRU or any other applicable grant or contract, be in compliance with 42 CFR Part 50, Subpart F for PHS grants and cooperative agreements (and 45 CFR Part 94 for contracts).
For the purpose of reporting Financial Conflicts of Interest, an “Investigator” means 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 Public Health Service (PHS) (e.g., NIH), or proposed for such funding, which will include, for example, collaborators or consultants.
Significant Financial Interest
Significant Financial Interest is defined by NIH 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 reasonably 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.
Management of FCOI
- CMRU shall take 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.
- CMRU shall maintain records of all Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures (whether or not a disclosure resulted in the CMRU’s determination of FCOI) and all actions under CMRU’s policy or retrospective review, if applicable
- for at least three years from the date of submission of the final expenditures report or, where applicable,
- from other dates specified in 45 C.F.R. Part 75.361 for different situations.
- FCOI information for Senior/key personnel will remain available per the public accessibility requirements.
CMRU will monitor Investigator compliance with a management plan (self-reporting and annual training)
- on an ongoing basis until the completion of the PHS-funded research project.
- FCOI reports will include a confirmation of the Investigator’s agreement to the management plan.
- CMRU will notify NIH promptly (within 60 days) and submit a mitigation report when bias is found (“Revised” FCOI report).
Compliance and Penalties for Non-Performance
If an investigator fails to comply with CMRU’s FCOI policy, within 120 days, CMRU shall complete a retrospective review of the Investigator’s activities to determine bias. If a bias is found, CMRU 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. CMRU will work with the Investigator to set up an FCOI management plan to mitigate the situation. Companywide, CMRU is required to mandate the Investigator disclose the FCOI in each public presentation with research results if it was not reported up front. In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future NIH funding.
CMRU ‘s designated official(s) will review all “disclosures” (1) FCOI form; 2) FCOI report for CMRU; 3) Any changes or new report of significant financial interest (SFI) and evaluate whether they contain any FCOI. If no FCOI is found the “disclosure forms” will be filed in the eRA Commons. If a FCOI is identified it will be put on the FCOI report through the eRA Commons FCOI module prior to expending any funds. If any interests are identified as conflicting subsequent to the initial report they must be reported to CMRU within 30 days. CMRU 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 an SFI not less than annually. If a PHS-funded project is conducted by an investigator or signing official (SO) with a conflict that was not disclosed or managed, CMRU is required to disclose the conflict in each public presentation related to the results of the research.
CMRU shall ensure public accessibility, via our publicly accessible website, of information concerning any Significant Financial Interest disclosed to the Institution that meets the following three criteria:
- The Significant Financial Interest (SFI) was disclosed and is held by Senior Key Personnel for the NIH-funded research project identified by CMRU in the grant application, the progress report, or any other required report submitted to the NIH;
- CMRU determines that the SFI is related to the NIH-funded research; and
- CMRU determines that the SFI is an FCOI.
Investigator disclosure requirements
- Annually: CMRU requires each Investigator to submit an updated disclosure of SFI(s) at least annually, in accordance with the specific time period prescribed by CMRU, during the period of the award. For subrecipient Investigators, CMRU will:
- Require certification that the subrecipient is following, if applicable,
- Within 30 days: Require each Investigator, including subrecipient Investigator, if applicable, who is participating in the NIH-funded research to submit an updated disclosure of SFI(s) within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.
CMRU will Submit FCOI reports on behalf of CMRU and subrecipient institution(s) using the eRA Commons FCOI Module
- CMRU will monitor subrecipient compliance
- CMRU will submit complete, timely and responsive FCOI reports
- CMRU will submit information in response to NIH’s request for additional information through the FCOI Module
CMRU requires that each Investigator complete FCOI training:
- Prior to engaging in research related to any NIH funded project
- At least every four years
- Immediately when any of the following circumstances apply
- CMRU revises its policy in a manner that affects the investigator
- When an investigator is new to the CMRU; or
- When CMRU finds an Investigator is not in compliance with the Institution’s policy or management plan.
- At time of Application
Point of Contact
If you have a conflict of interest or if you have a question to discuss, contact the CMRU FCOI compliance person:
Geri Palmer – email@example.com