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.
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.
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:
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:
Once you have completed module 15070, module 15072 will become available. Please print your certificate to a PDF and email to firstname.lastname@example.org.
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.
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.
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:
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:
Revision Date: 22 August 2012