FCOI Policy for PHS and NIJ Proposals
The following outlines KSU’s policy and procedures regarding conflicts of interest in relation to research, educational, or service projects directly funded by the National Institutes of Health, the Health Resources and Services Administration, the Agency for Healthcare Research and Quality, and the National Institute of Justice.Financial Conflict of Interest Disclosure Form for PHS and NIJ Proposals
Kennesaw State University’s policy on financial conflict of interest (hereinafter, the FCOI Policy) conforms to the 2011 revised FCOI regulation, Promoting Objectivity in Research (42 CFR Part 50 Subpart F). 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.
- 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.
- Investigator’s Institutional Responsibilities means an Investigator's professional responsibilities on behalf of Kennesaw State University, including teaching, research, and service, and as outlined in the faculty member’s Faculty Performance Agreement (FPA).
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:
- (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.
- (iv) 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 KSU 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.
- (v) The following are excluded from the definition of SFI:
- Salary royalties, or other remuneration paid by KSU to the Investigator if the Investigator is currently employed or otherwise appointed by KSU;
- Intellectual Property Rights assigned to KSU 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 defied 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 (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:
- KSU FCOI policies change in a manner that affects Investigator requirements
- An Investigator is new to KSU
- KSU finds an Investigator noncompliant with its FCOI policy or management plan
Investigators must complete the CITI Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules module and forward proof of completion to the Office of Research. The link will take you to the CITI Program home page, citiprogram.org, 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 email@example.com.
Disclosure Procedures and Disclosure Form
- At time of Application: Each Investigator, including subrecipient Investigators, if applicable, planning to participate in PHS-funded research must submit a Financial Conflict of Interest Disclosure Form to the Vice President for Research at time of application.
- 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.
Review of Disclosure Forms
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.
Management of FCOIs
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.
Whenever KSU 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:
- (i) 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;
- (ii) 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, KSU 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, KSU is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. KSU may determine that additional interim measures are necessary.
Resolution of FCOI Disputes
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.
Reporting of FCOIs
- 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 KSU has implemented a management plan in accordance with the FOCI policy. If KSU 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.
- For any significant financial interest that KSU 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 KSU must provide to the PHS Awarding Component an FCOI report regarding the financial conflict of interest and ensure that KSU 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, KSU 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, KSU is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.
- FCOI reports will be submitted to the PHS Awarding Component according to PHS regulations.
- For any FCOI previously reported by KSU 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. KSU 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 KSU 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:
- Incorporating terms as part of a written agreement with the subrecipient that establish whether KSU’s FCOI policy or the subrecipient’s policy will apply to the subrecipient's Investigators.
- 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 KSU. If the subrecipient cannot provide such certification, its Investigators must comply with KSU’s FCOI policy.
- If the subrecipient’s Investigators are to comply with KSU’s FCOI policy, the agreement will specify the time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to KSU.
Public Disclosure of PHS-Funded FCOIs
Pursuant to PHS FCOI regulations, prior to spending any funds under a PHS-funded research project, KSU 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:
- The significant financial interest was disclosed and is still held by the senior/key personnel;
- KSU determines that the significant financial interest is related to the PHS-funded research; and
- KSU determines that the significant financial interest is a financial conflict of interest.