Funded Conflict of Interest Policies & Forms

Before completing the forms, please read the following policy on funded conflict of interest. This policy applies to research, educational, or service projects funded by the National Science Foundation (NSF) either directly to ʯÁñÖ±²¥ (ʯÁñÖ±²¥) or through another institution or organization by a subaward. It outlines the definitions, procedures, and disclosure requirements to manage and mitigate any significant financial interests that could potentially bias the design, conduct, or reporting of NSF-funded activities. The goal is to ensure transparency and integrity in the administration of federally-funded projects at ʯÁñÖ±²¥.

Again, please read the policy below BEFORE completing the forms.

  • This policy and the implementation procedures apply to research, educational, or service projects funded by the National Science Foundation either directly to the Kennesaw State University Research and Service Foundation or through another institution or organization by a subaward.

    Definitions

    1. Conflict of Interest â€“ A conflict of interest exists when the university reviewer(s) reasonably determines that a significant financial interest could directly and significantly bias the design, conduct, or reporting of the federally-funded research, educational, or service activities.

    2. Investigator â€“ Investigator means the Principal Investigator, Co-Principal Investigators(s), co-project directors, and any other person(s) responsible for the design, conduct, or reporting of research, educational, or service activities funded, or proposed for funding. Interests of the investigator that would constitute a conflict of interest include interests of the investigator’s spouse and dependent children.

    3. Institution â€“ Any domestic or foreign, public or private, entity or organization (excluding a Federal agency).

    4. Research â€“ A systematic investigation designed to develop or contribute to knowledge. The term encompasses basic and applied research and product development.

    5. Significant Financial Interest â€“ Significant financial interest means anything of monetary value, including but not limited to:
      • Salary or other payments for services (e.g., consulting fees or honoraria), or income generated by the manufacture or sale of products;
      • Equity interests (e.g., stocks, stock options or other ownership interests); or
      • Intellectual property rights (e.g., patents, copyrights and royalties from such rights).

    The term does not include:

    • Salary, royalties, or other remuneration from the applicant institution;
    • Any ownership interests in the institution, if the institution is an applicant under the Small Business Innovation in Research program;
    • Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
    • Income from service on advisory committees or review panels for public or nonprofit entities;
    • An equity interest that when aggregated for the investigator and the investigator’s spouse and dependent children,
      1. does not exceed $10,000 in value, as determined through reference to public prices or other reasonable measures of fair market value, and
      2. does not represent more than a five percent ownership interest in any single entity (both conditions must be met); or
    • Salary, royalties, or other payments that, when aggregated for the investor and the investigator’s spouse and dependent children over the next 12 months, are not expected to exceed $10,000.
  • Compliance with the federal regulations requires that investigators disclose a listing of significant financial interests (and those of his/her spouse and dependent children) that would reasonably appear to affect the research or educational activity funded, or proposed for funding, or in entities whose financial interests would reasonably appear to affect such activities.

    • Disclosures â€“ Disclosures must be made to the designated university official prior to the submission of a proposal for funding. This official will review the disclosures and determine which, if any, financial interests could directly and significantly affect the design, conduct, or reporting of the research. The institution must, prior to any expenditure of awarded funds, comply with the conflict of interests reporting requirements of the funding agency.

    • Disclosures Process â€“ Financial disclosures must be updated at least annually during the award period and more frequently as new reportable significant financial interests are obtained.

    The procedural steps for this policy are as follows:

    1. Investigators are required to complete the . If the investigator does have activities to report that may constitute a conflict of interest, the  must also be submitted in a sealed envelope marked CONFIDENTIAL. Forms should be forwarded to the Office of Research at the same time the proposal is submitted for the administrative review process.

    2. The Director of Proposal Development will review the proposal and disclosure questionnaire only and forward the questionnaire and the sealed envelope containing the Statement of Significant Financial Interest to the Vice President for Research, the designated university official. Disclosure questionnaires will be retained within the investigator’s proposal file in the Office of Research.

    3. After a grant application has been submitted, and prior to the acceptance of an award, the Vice President for Research will review all financial disclosures, determine whether a conflict of interest exists, and if so, determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce, or eliminate such conflicts.

    4. Concurrent with the foregoing process, the investigator, in cooperation with the investigator’s department chair and dean, shall develop and present to the Vice President for Research a resolution plan that details proposed steps that could be taken to manage, reduce, or eliminate any actual or potential conflict of interest presented by a significant financial interest. This plan will be seriously considered in the determination of appropriate action. Examples of conditions or restrictions that might be imposed include, but are not limited to:
      • Public disclosure of significant financial interests;
      • Monitoring of the research or project by independent reviewers;
      • Modification of the research or educational plan;
      • Disqualification from participation in all or a portion of the research or educational activity;
      • Divestiture of significant financial interests; or
      • Severance of relationships that create actual or potential conflicts.

    5. Should the investigator disagree with the proposed conditions or restrictions, he/she may appeal the decision. The Vice President for Research will convene a review committee comprised of three to four faculty representing a cross section of disciplines and a research administrator to hear the appeal. The committee will review the disclosed potential conflicts and either concur with the previous resolution plan or suggest amendments based upon supporting documentation and agency regulations. Final resolution of conflict of interest questions will rest with the President of ʯÁñÖ±²¥.

    6. The approved resolution plan shall be incorporated into a memorandum of understanding (MOU) between ʯÁñÖ±²¥ and the investigator that details the conditions or restrictions imposed upon the investigator in the conduct of the project or in the relationship with the business enterprise or entity. The MOU shall be signed by the investigator, the department chair/unit head, the dean, and the Vice President for Research.

    7. If the Vice President for Research determines that imposing the conditions or restrictions would be either ineffective or inequitable and that the potential negative impacts that might arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then he/she may recommend that, to the extent permitted by federal regulations, the research go forward without imposing such conditions or restrictions.

    8. Prior to expenditure of any funds under an award, the university will comply with reporting requirements of the sponsoring agency concerning the existence of a conflict of interest. The investigator will update any financial disclosures at least annually throughout the period of the award or more frequently as new reportable significant financial interest is obtained.

    9. For any interest that the institution identifies as conflicting subsequent to the institution’s initial report under the award, the report will be made and the conflicting interest managed, reduced, or eliminated, at least on an interim basis, within 60 days of that identification.

    10. Records of investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest shall be retained by the Vice President for Research for at least three years beyond the completion of the grant or longer if required by the agency.

    11. The university agrees to make information available, upon request, to the sponsoring agency regarding all conflicts of interest for the specified PI identified by the institution and outlining how those interests have been managed, reduced, or eliminated to protect the project from bias.

    12. If an investigator violates this policy or the terms of the MOU, the Vice President for Research will recommend appropriate sanctions to the President of the university. If failure to comply has biased the design, conduct, or reporting of the funded research or educational activity, the institution will promptly notify the awarding agency of the corrective action taken or to be taken. The awarding agency may take action or refer the matter to the institution for further action.

    13. Collaborators/sub-recipients/subcontractors from other academic/not-for-profit institutions must either comply with this policy or provide a certification from their institutions that they are in compliance with federal policies regarding investigator significant financial interest disclosure and that their portion of the project is in compliance with their institutional policies.

 

Form A

Disclosure Questionnaire for Significant Financial Interests - is required. 

Download

 

Form B

State of Significant Financial Interest should be completed if applicable.

Download

 

Policy for Public Health Service and National Institute of Justice Proposals

The following outlines ʯÁñÖ±²¥â€™s policy and procedures regarding conflicts of interest in relation to research, educational, or service projects directly funded by

Please read the policy below before completing the Financial Conflict of Interest Disclosure Form for PHS and NIJ Proposals.

  • ʯÁñÖ±²¥â€™s policy on financial conflict of interest (hereinafter, the FCOI Policy) conforms to the 2011 revised FCOI regulation, . The revised regulation and the FCOI Policy promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded by PHS agencies will be free from bias resulting from Investigator financial conflicts of interest.

    The FCOI Policy applies to each Investigator who is planning to participate in or is participating in Public Health Service (PHS) funded research (SBIR/STTR Phase I applicants are exempt). PHS agencies include the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Food and Drug Administration (FDA), and the Agency for Healthcare Research and Quality (AHRQ).

    The FCOI Policy also applies to Investigators planning to participate in or participating in research funded by the National Institute of Justice (NIJ). For the purposes of this policy, PHS includes the NIJ.

    For ongoing research, the FCOI Policy applies to each project with a Notice of Award issue date on or after August 24, 2012. Investigators participating in PHS-funded research awarded prior to August 24, 2012 are strongly encouraged, but not required, to complete the mandatory training.

    1. 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 PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

    2. Investigator’s Institutional Responsibilities means an Investigator's professional responsibilities on behalf of ʯÁñÖ±²¥, including teaching, research, and service, and as outlined in the faculty member’s Faculty Performance Agreement (FPA).

    3. Significant Financial Interest (SFI) means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse or domestic partner and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:

      1. 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;

      2. 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

      3. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

      4. Investigators also must disclose any reimbursed travel or travel paid on behalf of the Investigator (i.e., not reimbursed to the Investigator), related to their ʯÁñÖ±²¥ responsibilities. 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 USC 1001(a); an academic teaching hospital; a medical center; or a research institute affiliated with an institution of higher education.

      5. The following are excluded from the definition of SFI:
        • Salary royalties, or other remuneration paid by ʯÁñÖ±²¥ to the Investigator if the Investigator is currently employed or otherwise appointed by ʯÁñÖ±²¥;
        • Intellectual Property Rights assigned to ʯÁñÖ±²¥ and agreements to share in royalties related to such rights;
        • 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, 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.

    4. Financial Conflict of Interest (FCOI) means an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
  • Each investigator must complete FCOI training prior to engaging in research related to any PHS-funded grant and at least every four years, and immediately under the following circumstances:

    • ʯÁñÖ±²¥ FCOI policies change in a manner that affects Investigator requirements
    • An Investigator is new to ʯÁñÖ±²¥
    • ʯÁñÖ±²¥ finds an Investigator noncompliant with its FCOI policy or management plan

    Investigators must complete the  and forward proof of completion to the Office of Research. The link will take you to the CITI Program home page, , where you will register for an account or log in. When you register, select "Conflict of Interest." There are two modules:

    • Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules (15070)
    • Institutional Responsibilities as They Affect Investigators (15072)

    Once you have completed module 15070, module 15072 will become available. Please print your certificate to a PDF and email to sponprog2@kennesaw.edu.

  • At Time of Application
    • Each Investigator, including subrecipient Investigators, if applicable, planning to participate in PHS-funded research must submit a  to the Vice President for Research at time of application.

    Updates

    • Annual: Each Investigator, including subrecipient Investigators, if applicable, must submit an updated disclosure of SFI at least annually, during the period of the award, beginning with the anniversary date of the award.
    • Within 30 days: Each Investigator, including subrecipient Investigators, if applicable, must submit an updated disclosure of SFI within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.
  • The Vice President for Research (VPR) will review all PHS disclosure forms and determine whether an Investigator’s SFI is related to the PHS-funded research, i.e. whether the SFI could be affected by the PHS-funded research or is in an entity whose financial interest could be affected by the research. If not, there is no financial conflict of interest. The VPR may decide to refer the matter to the Financial Conflict of Interest Committee. If it appears that the SFI is related to the PHS-funded research, the VPR or FCOI Committee will determine whether a financial conflict of interest exists.
    1. Where an FCOI has been identified, the VPR or FCOI Committee will work with the employee to develop a resolution plan to manage, reduce, or eliminate any actual or potential financial conflict of interest presented by a significant financial interest. Possible approaches include, but are not limited to the following:
      • Public disclosure of significant financial interests;
      • Appointment of independent monitor(s) capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
      • Modification of the research plan;
      • Change of personnel or personnel responsibilities or disqualification of personnel from participation in all or a portion of the related project or research;
      • Reduction or elimination of the significant financial interest (e.g., sale of an equity interest); or
      • Severance of relationships that create actual or potential financial conflicts.

    2. Whenever ʯÁñÖ±²¥ identifies a significant financial interest that was not disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed by the University, within 60 days the VPR or FCOI Committee will: review the significant financial interest; determine whether it is related to the Investigator’s institutional responsibilities; determine whether a financial conflict of interest exists; and, if so:

      1. Implement, on at least an interim basis, a management plan that specifies the actions that have been, and will be, taken to manage such financial conflict of interest going forward;

      2. Within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator’s activities to determine whether any research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research. If necessary, ʯÁñÖ±²¥ will update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, ʯÁñÖ±²¥ is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. ʯÁñÖ±²¥ may determine that additional interim measures are necessary.
  • Any dispute, controversy, sanction or appeal in relation to disclosure, management or elimination of financial conflicts of interest shall be resolved by the Vice President for Research or the Financial Conflict of Interest Committee. The VPR/Committee’s decision shall be considered final subject to review and modification by the VPAA/Provost, President and the University System of Georgia Board of Regents.
    1. Prior to the University’s expenditure of any funds under a PHS-funded research project, the University is required to provide to the PHS Awarding Component an FCOI report regarding any Investigator's significant financial interest found by the University to be conflicting and ensure that ʯÁñÖ±²¥ has implemented a management plan in accordance with the FCOI policy. If ʯÁñÖ±²¥ identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, the University is not required to submit an FCOI report to the PHS Awarding Component.

    2. For any significant financial interest that ʯÁñÖ±²¥ identifies as conflicting subsequent to its initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), within sixty days ʯÁñÖ±²¥ must provide to the PHS Awarding Component an FCOI report regarding the financial conflict of interest and ensure that ʯÁñÖ±²¥ has implemented an FCOI management plan. If the FCOI report involves a significant financial interest that was not disclosed in a timely manner by an Investigator or, for whatever reason, was not previously reviewed or managed by the University, ʯÁñÖ±²¥ must complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research. If bias is found, ʯÁñÖ±²¥ is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

    3. FCOI reports will be submitted to the PHS Awarding Component according to PHS regulations.

    4. For any FCOI previously reported by ʯÁñÖ±²¥ with regard to an ongoing PHS-funded research project, the University shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report will specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. ʯÁñÖ±²¥ must provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.
  • When ʯÁñÖ±²¥ carries out any PHS-funded research through a subrecipient, the University will take reasonable steps to ensure that any subrecipient Investigator complies with PHS FCOI regulations by:

    1. Incorporating terms as part of a written agreement with the subrecipient that establish whether ʯÁñÖ±²¥â€™s FCOI policy or the subrecipient’s policy will apply to the subrecipient's Investigators.

    2. If the subrecipient's Investigators are to comply with the subrecipient's FCOI policy, the subrecipient must certify that its policy complies with the PHS FCOI regulations and the agreement will specify the time period(s) for the subrecipient to report all identified FCOIs to ʯÁñÖ±²¥. If the subrecipient cannot provide such certification, its Investigators must comply with ʯÁñÖ±²¥â€™s FCOI policy.

    3. If the subrecipient’s Investigators are to comply with ʯÁñÖ±²¥â€™s FCOI policy, the agreement will specify the time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to ʯÁñÖ±²¥.
  • Pursuant to PHS FCOI regulations, prior to spending any funds under a PHS-funded research project, ʯÁñÖ±²¥ will ensure public accessibility, via a publicly accessible Web site or written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to the University that meets the following three criteria:

    1. The significant financial interest was disclosed and is still held by the senior/key personnel;

    2. ʯÁñÖ±²¥ determines that the significant financial interest is related to the PHS-funded research; 

    3. and ʯÁñÖ±²¥ determines that the significant financial interest is a financial conflict of interest.