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Conflicts of Interest (COI) in Research

What is a COI in Research?

A conflict of interest (COI) is a situation in which an individual's financial, professional or other personal interest outside of the University affects, appears to affect or has the potential to compromise the individual's professional judgement or objectivity. An apparent conflict of interest is one in which a reasonable person would think that the individual's judgment or objectivity is likely to be compromised. A conflict of interest exists whether or not decisions are actually affected by a personal interest; a conflict of interest implies only the potential for bias, not a likelihood.

The term “conflict of interest (COI) in research” refers to situations in which such interests may compromise—or have the appearance of compromising—a researcher’s professional judgment or objectivity such that the design, conduct or reporting of their research is directly and significantly affected. A COI depends on the situation, not on the actions or character of the researcher.

COI and Human Research

The University and its researchers have specific ethical and federal legal obligations to honor the rights and to protect the safety and well-being of human subjects in research. Researchers' financial, professional or other personal interests may compromise or appear to compromise these obligations as well as the integrity of their research. Accordingly, there is a strong presumption against permitting researchers with such interests to be involved in the design, conduct or reporting of research.

So that researchers do not have or appear to have a conflicts of interest that may compromise their professional judgment or objectivity, federal regulations and University policy 7A-21 require that researchers report their financial and other personal interests, including at the time that a human research study is submitted for IRB review or whenever such interests arise. When these interests are disclosed, a researcher's interest is reviewed by an independent (non-IRB) reviewer(s) and a determination may be made as to whether a COI exists and if so, how the COI needs to be managed (through a management plan) so as to mitigate the affect of such conflict upon a study's design, conduct or reporting. This may include, for human research, direct and specific disclosure to human subjects about such conflicts through the consent process; in this case, both the management plan and the disclosure to human subjects will be reviewed by the FSU IRB. The IRB has authority under federal law to approve, require modifications in (to secure approval), or disapprove human research activities that are subject to IRB review, including informed consent and research in which conflicts of interest are deemed to exist.

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Select from among the resources below to obtain additional information about conflicts of interest

IRB Application Procedures

A researcher's application submitted in RAMP IRB will automatically cross-reference the University's Conflict Administration Management System (CAMS) to identify for IRB review purposes the status of COI disclosures for all members of study team listed on the researcher's RAMP IRB application. If a COI reviewer or COI committee determines and documents that the researcher or other study team has a conflict of interest, then direct and specific disclosure to human subjects about such interests IS REQUIRED. Such interests may include, for example:

  • Funding or sponsorship of the study (agencies or institutions, cooperative groups, foundations, industry or other commercial sponsors that provide, e.g., funding, study drugs or equipment for the study),
  • A researcher has a patent on a product or item being used in the study,
  • A member of the study team has stock or other financial investments in a entity that is funding or sponsoring the study or,
  • A researcher is a member of a Scientific Advisory Board of the research sponsor.

Template Consent Form Language

A conflict of interest should be described for human subjects, depending upon the consent form template utilized, as follows:

  • In the first paragraph in the “What else do I need to know” section of the HRP-502 consent form,
  • After the first paragraph in the “What is this study about” section of the HRP-502a or HRP-502c consent forms, or
  • At the end of the first paragraph in the HRP-502i Information Sheet template.
  • All of the templates referred to above are accessible in RAMP IRB; locate the consent templates by clicking on the IRB tab in RAMP IRB (top row), clicking on the Library tab (second row), then clicking on the Templates tab (third row), and selecting HRP-502, 502a, 502c or 502i as applicable. The templates may also be accessed from the OHSP Templates & Required Forms web page; scroll down to the Consent-related Templates section.
  • USE the HRP-502COI – TEMPLATE COI Consent Language Template to add to your consent form a description of different types of interests (available here in RAMP IRB or here on the OHSP Templates & Required Forms web page; scroll down to the Consent-related Templates section and look for the Conflicts of Interest Consent Language Template). 
  • Any consent forms missing such language, when applicable, will be returned to the study team for correction.

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Key Tips

  • COI processes and workflow have transitioned from a paper to automated format (see January 5, 2022 FSU Important Announcement)
  • All study team members must complete their CAMS disclosure profile and complete any required actions, such as training and CAMS clarification requests
  • In your RAMP IRB submission, refer to the COI tab's "Status" column to check for any incomplete CAMS reporting or reviews
  • CAMS may be accessed at https://cams.fsu.edu or by clicking on the CAMS icon on the myFSU Portal
  • Keep all CAMS disclosures updated; submit a RAMP IRB study modification for changed study funding
  • Use our COI consent language template to disclose conflicts of interest
  • See our FAQ #9 under Specific Questions for key references, instructions and helpful graphics

Questions? Click for FAQs!