Financial Conflict of Interest (FCOI) Policy
In accordance with the Code of Federal Regulation (42 CFR Part 50, Subpart F)
Gismo Therapeutics Inc. is committed to protecting the integrity and objectivity of its research activities by ensuring that the design, conduct, and reporting of research will not be biased or appear to be biased by a personal financial conflict of interest.
This policy is to ensure that all Gismo Therapeutics’ personnel, responsible for the design, conduct or reporting of research funded by or proposed for funding by the PHS, as well as any subcontractors and sub awardees, follow standards to promote objectivity in research, in order that the funded research is free from bias resulting from an investigator’s (or spouse or dependent children’s) financial conflict of interest.
The company policies and procedures are to comply with Responsibility of Applicants for Promoting Objectivity in Research, Title 42 CFR, Part 50, Subpart F, and are outlined below.
For purposes of this policy, the following definitions shall apply:
Investigator means any 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, including collaborators, sub-awardees, or consultants.
Immediate family refers to an Investigator’s spouse and dependent children.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
Equity interest includes any stock, stock option, or other ownership interest, and its value may be determined through reference to public prices or other reasonable measures of fair market value.
Designated Official is the individual designated by Gismo Therapeutics Inc. to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests.
Remuneration includes, for example, salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship).
Financial Conflict of Interest (FCOI): A Significant Financial Interest (SFI) related to a research program or project that could directly and significantly affect the design, conduct or reporting of research.
Significant Financial Interest (SFI):
A financial interest consisting of one or more of the following interests of the Investigator (and/or of the Investigator’s immediate family) that reasonably appears to be related to the Investigator’s 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 the disclosure, when aggregated, exceeds $5,000. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship). Equity interests includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
- Regarding 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 (and/or the Investigator’s spouse and/or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- For PHS-funded investigators, any reimbursed or sponsored travel related to an Investigator’s institutional responsibilities, including that which is paid on behalf of the investigator so that the exact monetary value may not be readily available. This 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 term Significant Financial Interest does not include the following types of financial interests:
- salaries, royalties or other remuneration paid by Gismo Therapeutics Inc. to the Investigator if the Investigator is currently employed or otherwise appointed by the company, including intellectual property rights and agreements to share in royalties related to such rights. ** Note exclusion from disclosure (i.e., not considered an SFI) only applies in those cases where Gismo Therapeutics is the Institution that is applying for, or that receives, NIH research funding. If a university is the applicant/recipient and the Investigator is supported by an NIH grant awarded to a University, the Investigator must disclose his/her Significant Financial Interest (SFI) (e.g., ownership interest or equity interest in a for-profit company) to the University if the SFI is related to the Investigator’s institutional responsibilities.
- 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
- 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.
Financial Conflict of Interest Policy Reporting
Gismo Therapeutics will maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with the FCOI regulation.
This policy will be available via Gismo Therapeutics Inc. publicly accessible website (www.gismotherapeutics.com).
The FCOI policy will be submitted to NIH via the eRA Commons Institution Profile Module (IPF) under the “Policy Documents” tab.
All Investigators involved in Gismo Therapeutics’ PHS funded research will receive a copy of this policy.
The Designated FCOI Official’s Responsibilities
1) Ensures that all investigators working on NIH funded projects know their FCOI obligations and are up to date with SFI documentation
2) Ensures Gismo Therapeutics policies, training requirements and records are up-do-date.
3) At the time of a grant application, certifies that the company has an FCOI policy and is in compliance with PHS FCOI requirements (as per AOR signature).
4) Submits required documents to era Commons site: FCOI Policy, Annual FCOI report, New FCOI report, Revised FCOI report, Mitigation report.
4) Solicits SFIs prior to the submission of grant application, annually, and whenever a new SFI is identified.
5) Reviews all SFIs for FCOI and determine if FCOIs exist.
6) Manages identified FCOIs as required including FCOIs of subrecipients including reporting as required to the NIH.
7) After an award is granted, prior to Institution’s expenditure of funds:
- Ensures that SFI disclosures from all investigators including subcontractors are up-to-date and reviewed.
- Determine if any SFIs relate to the PHS/NIH-funded research and if an FCOI exists.
- Submit an initial FCOI (new) Report
- If FCOI is identified, develop and implement a management plan to manage the FCOI(s)
- Submit FCOI reports and management plans for any identified FCOIs to NIH
Investigator Disclosure Responsibilities
Any Gismo Therapeutics’ personnel involved in the design, conduct or execution of NIH funded research through Gismo Therapeutics must provide a disclosure of all Significant Financial Interests (as defined above) for themselves, their spouse and for their dependents. An SFI disclosure must be submitted to the FCOI officer at these times:
1) Annually, whether there is any financial interest to report.
2) At the time a research proposal is submitted to the NIH.
3) Within 30 days after an investigator becomes aware of any new SFI.
4) If a FCOI has been identified and managed, after the FCOI has been eliminated.
Additionally, if acting as the PI/PD, the investigator must provide a list of individuals who meet the definition of“investigator” at the time a grant is awarded.
Review of Investigator SFI/FCOIs
Gismo Therapeutics’ FCOI officer will review all SFI disclosures. If necessary, the FCOI officer will obtain additional information from the investigator and other individuals to help determine whether the SFI disclosed is related to a proposed or existing sponsored project or program. The FCOI officer will formally identify cases that require further review by management.
Management of FCOIs
Any FCOI identified for any investigator, including sub awardees and subcontractors, will be reported to the NIH awarding Institute or Center through the submission of an initial FCOI report via the eRA Commons FCOI Module. The report will address the impact of the bias on the research project, the actions planned to mitigate the bias, and contain other required information outlined in the NIH Grants Policy Statement. Gismo Therapeutics will work with the Investigator to develop an FCOI management plan to mitigate the situation. An annual report will be submitted containing the required information (Status of FCOI and changes to management plan, if applicable) until the FCOI no longer exists. A management plan may include the following, as applicable:
- Public disclosure of FCOI (when presenting or publishing the research, (*and see below)
- Monitoring of research by independent reviewer(s)
- Modification of the research plan
- Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research
- Reduction or elimination of Significant Financial Interests (e.g., sale of an equity interest)
- Severance of relationships that create financial conflicts.
- In extreme cases of bias, the Investigator may lose the right to work on the project or receive any future NIH funding.
*Any current FCOI will be published on Gismo Therapeutics’ website and contain the following information: a) the investigator’s name, title and role with respect to the research project b) The name of the entity in which the SFI is held c) The nature of the SFI (equity interest, consulting fees or honoraria, travel reimbursements, etc) d) The approximate dollar value of the SFI or a statement indicating that fair market value cannot readily be determined.
Investigator Noncompliance: FCOI officer will document noncompliance within 120 days of determination of noncompliance, complete a retrospective review of investigator’s activities to determine bias, list measures to be taken, and submit a mitigation report to the NIH. If noncompliance continues, the investigator may be removed from the project and potentially be prohibited from future NIH funding.
Sub-award and Subcontractor Investigators
Gismo Therapeutics will incorporate as part of a written agreement with subrecipient terms that establish whether the Financial Conflict of Interest policy of the awardee Institution or that of the subrecipient apply to the subrecipient’s Investigators.
If the subrecipient’s Investigators must comply with the subrecipient’s FCOI policy, the subrecipient shall certify as part of the agreement with Gismo Therapeutics that its policy complies with NIH requirements. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the FCOI policy of Gismo Therapeutics for disclosing SFIs that are directly related to the subrecipient’s work for Gismo Therapeutics. The agreement shall specify time period(s) for the subrecipient to report all identified FCOIs to Gismo Therapeutics sufficient to enable Gismo Therapeutics to submit timely FCOI reports, as necessary, to the PHS as required.
If the subrecipient’s Investigators must comply with Gismo Therapeutics’ FCOI policy, Gismo Therapeutics shall specify time period(s) for the subrecipient to submit all Investigator disclosures of SFIs to Gismo Therapeutics in order to enable Gismo Therapeutics to comply with its review, management, and reporting obligations as outlined in the FCOI policy.
Training and Education
Investigators employed by Gismo Therapeutics who are involved in NIH funded research are required to complete the NIH FCOI training webinar posted on the NIH website: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm and provide a current (within four years) certificate of completion or equivalent under these circumstances:
-Prior to engaging in PHS/NIH funded research.
-After four years of previous training.
-If a new investigator engaging in PHS/NIH research
-When the company FCOI policy changes
-If an investigator is found to be out of compliance with FCOI policy or management plan.
All investigators must also review the company FCOI policy and be familiar with requirements for reporting Significant Financial Interests, and understand what constitutes Financial Conflicts of Interest with respect to NIH funded research.
Retention of Records
The records of all SFI disclosures, training certifications, FCOI reports, and management plans will be maintained for at least three years from the date of submission of the final expenditures report by the company FCOI officer.