{"id":41,"date":"2014-06-12T16:30:47","date_gmt":"2014-06-12T16:30:47","guid":{"rendered":"https:\/\/research.uga.edu\/compliance\/?page_id=41"},"modified":"2025-08-08T13:18:28","modified_gmt":"2025-08-08T13:18:28","slug":"fcoi","status":"publish","type":"page","link":"https:\/\/research.uga.edu\/integrity-support\/fcoi\/","title":{"rendered":"Financial Conflict of Interest (FCOI) Training"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row][vc_column][vc_column_text css=&#8221;&#8221;]\n<blockquote>\n<p><a href=\"https:\/\/research.uga.edu\/documents\/conflicts-of-interest\">UGA Policy on Conflicts of Interest in Sponsored Programs<\/a> complies with U.S. Department of Health and Human Services (DHHS) regulations for all Public Health Services (PHS) units, including the NIH, CDC, FDA, Indian Health Service (IHS), Health Resources and Services Administration (HRSA), and the Agency for Healthcare Research and Quality (AHRQ).<\/p>\n<\/blockquote>\n<p>Additional details on the Policy on Conflicts of Interest in Sponsored Programs is available at the Research Conflicts of Interest&nbsp;<a href=\"https:\/\/research.uga.edu\/compliance\/research-conflicts-of-interest\/\" target=\"_blank\" rel=\"noopener noreferrer\" data-auth=\"NotApplicable\">webpage<\/a>.<\/p>\n<h3 id=\"training\" class=\"a-dst\">Training<\/h3>\n<p><strong>Conflict of Interest training\/education is required for all investigators on PHS and DOE grant and cooperative agreement proposals.<\/strong> Training for UGA Investigators is provided via the <a href=\"https:\/\/pep.uga.edu\">Professional Education Portal<\/a>. The appropriate training is titled \u201c<a href=\"https:\/\/uga.csod.com\/samldefault.aspx?returnurl=%252fDeepLink%252fProcessRedirect.aspx%253fmodule%253dlodetails%2526lo%253d3dc3d2d0-4758-4748-9d25-2850f247f0fc\">University of Georgia: Conflict of Interest<\/a>\u201d and can be located by using the search feature in PEP.<\/p>\n<p>This COI course discusses University Policies and federal requirements on financial conflicts of interest and an investigator\u2019s responsibilities relating to the disclosure of \u201cSignificant Financial Interests.\u201d It is designed to help learners satisfy training requirements associated with University Policies and federal requirements on financial conflicts of interest.<\/p>\n<p><strong>Training must be completed prior to an expense being recorded in UGA\u2019s official records<\/strong> (i.e., training is not required at proposal time but must have been completed by award time). Refresher courses are required every four (4) years. In addition, training is required immediately when a) the Policy on Conflicts of Interest in Sponsored Programs is revised in a manner that changes researcher requirements and b) a researcher is noncompliant with financial conflict of interest policies and procedures.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]\n<h3>FCOI FAQs<\/h3>\n[\/vc_column_text][vc_tta_accordion shape=&#8221;square&#8221; spacing=&#8221;5&#8243; gap=&#8221;5&#8243; active_section=&#8221;999&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221; el_class=&#8221;accordionResearch&#8221;][vc_tta_section title=&#8221;What are UGA\u2019s obligations regarding Disclosure?&#8221; tab_id=&#8221;1496338507974-b768979f-a0dd&#8221;][vc_column_text]\n<ul>\n<li>UGA (not the employee) must decide whether Significant Financial Interests (SFIs) are sufficiently related to a particular proposed or funded PHS project such that they could directly and significantly affect the project\u2019s design, conduct, or reporting.<\/li>\n<li>If UGA determines that a disclosed SFI is sufficiently related to the proposed or funded project, then a Financial Conflict of Interest (FCOI) exists and it must be managed, mitigated, or eliminated. UGA is required to report each FCOI to the PHS funding entity.<\/li>\n<li>To manage or mitigate a FCOI, UGA and the project personnel must implement a documented Management Plan to safeguard objectivity of the research project.<\/li>\n<\/ul>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Who will see my Disclosure?&#8221; tab_id=&#8221;1496338684590-91ffc0e3-a276&#8243;][vc_column_text]UGA is required to review Disclosures and determine the relatedness of the disclosed Significant Financial Interests (SFIs) to proposed\/funded NIH projects. Relatedness is defined as \u201ca reasonable determination by UGA\u2019s designated official(s) that a SFI could be affected by the PHS-funded research or the SFI is in an entity whose financial interest could be affected by the research.\u201d Disclosures will be reviewed by UGA\u2019s Institutional Integrity Officer, who will make the necessary determinations.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;What is Financial Conflict of Interest (FCOI)?&#8221; tab_id=&#8221;1496338508040-f3fd945d-bf53&#8243;][vc_column_text]FCOIs are defined as Significant Financial Interests (SFIs) that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. They arise when a secondary objective could affect the performance of a person\u2019s primary mission. Conflicts of interest are not inherently wrong; they are a normal part of our existence. They must be managed so that objectivity in research is maintained.[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;What happens if I have a Financial Conflict of Interest (FCOI)?&#8221; tab_id=&#8221;1496338727683-5e3d11e4-1d3b&#8221;][vc_column_text]\n<p class=\"p1\">The Institutional Integrity Officer will determine whether an Investigator\u2019s disclosed Significant Financial Interests (SFIs) are related to the proposed or on-going research. Determining \u201crelatedness\u201d likely involves communication between the Investigator and the Integrity Officer, as the Officer will need the Investigator\u2019s help in understanding the proposed project in order to determine \u201crelatedness.\u201d If the SFI is deemed to be related to the proposed project, the Integrity Officer may refer the matter to the University\u2019s Conflict of Interest Committee (COIC). The COIC comprises senior faculty members selected from the broader University community and appointed by the Vice President for Research. In referral cases, the COIC will make a final determination of relatedness and whether a real or apparent financial conflict of interest (FCOI) exists. The COIC may help develop a Management Plan for any identified FCOI that cannot be eliminated. UGA must report details of any COI Management Plan to the awarding PHS unit.<\/p>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;What happens if a Co-Investigator who isn\u2019t at a university that certifies it is in compliance with the DHHS\/PHS Regulation refuses to disclose his\/her SFIs to UGA?&#8221; tab_id=&#8221;1496338825955-026d3dd5-22c9&#8243;][vc_column_text]\n<p class=\"p1\">No one, not even a member of the wider community (such as a local physician who is helping with a clinical study), can be allowed to perform project activities if he\/she meets the definition of Investigator and has not disclosed SFIs. Solutions include eliminating that Investigator before the proposal is submitted or altering the individual\u2019s role so that he\/she no longer meets the Investigator definition.<\/p>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;How do I get cleared to submit a PHS proposal?&#8221; tab_id=&#8221;1496338858259-b7da0231-5f7f&#8221;][vc_column_text]\n<p class=\"p1\">There is only one clearance required for an Investigator before submitting a PHS proposal. Sponsored Projects grants administrators will check to see that the required Annual Disclosure of Significant Financial Interests has been submitted and is up to date. <b>PHS proposals cannot be submitted until every individual who meets the PHS definition of an Investigator has submitted his\/her <i>Disclosure<\/i>. <\/b><\/p>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;How do I get cleared to start spending a PHS award?&#8221; tab_id=&#8221;1496338892305-c336a8a4-9b51&#8243;][vc_column_text]\n<p class=\"p1\">Two behind-the-scenes clearance steps are required before a sponsored account is established and before an Investigator can spend PHS award funds.<\/p>\n<ol class=\"ol1\">\n<li class=\"li1\">Your Sponsored Projects Administration (SPA) team will check the electronic proposal\/award record to verify that any Investigator with identified FCOIs related to the proposed project has had the required electronic FCOI report submitted to the appropriate PHS funding unit. FCOI reports must be filed before a sponsored account can be established.<\/li>\n<li class=\"li1\">Your SPA team will check online CITI records to ensure that mandated COI training has been completed and is up to date for each Investigator on a PHS project.<\/li>\n<\/ol>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;What FCOI training is required and how long will it take?&#8221; tab_id=&#8221;1496338921217-5c83ed2b-4238&#8243;][vc_column_text css=&#8221;&#8221;]\n<p class=\"p1\">Each Investigator seeking funding from the Department of Health and Human Services, including its agencies, e.g., NIH, CDC, FDA, or from the Department of Energy, must complete a short financial conflicts of interest educational program <b>every four years.<\/b> Training for all Investigators on a given project should be completed no later than 30 days past award start date or Sponsored Projects Administration will freeze the account, preventing further spending until training is complete for all investigators.<\/p>\n<p class=\"p1\">Faculty investigators can fulfill this requirement by completing the &#8220;<a href=\"https:\/\/uga.csod.com\/samldefault.aspx?returnurl=%252fDeepLink%252fProcessRedirect.aspx%253fmodule%253dlodetails%2526lo%253d3dc3d2d0-4758-4748-9d25-2850f247f0fc\">University of Georgia: Conflicts of Interest<\/a>&#8221; training, available through the <a href=\"https:\/\/pep.uga.edu\">Professional Education Portal (PEP)<\/a>. If you have any questions, please contact <a href=\"mailto:coi@uga.edu\">coi@uga.edu<\/a>.<\/p>\n[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Who can I contact with questions?&#8221; tab_id=&#8221;1496338948441-386d8e87-de5b&#8221;][vc_column_text]\n<p class=\"p1\">Researchers with any questions should contact UGA\u2019s Institutional Integrity Officer to discuss the matter. There are situations in which a financial interest may not relate to one\u2019s institutional responsibilities and may not need to be disclosed. The Integrity Officer will work with researchers to determine whether a particular item should be included in the <i>Disclosure of Significant Financial Interests<\/i> or to answer any other questions an individual might have about FCOIs or the required training.<\/p>\n[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text css=&#8221;&#8221;] UGA Policy on Conflicts of Interest in Sponsored Programs complies with U.S. Department of Health and Human Services (DHHS) regulations for all Public Health Services (PHS) units, including the NIH, CDC, FDA, Indian Health Service (IHS), Health Resources and Services Administration (HRSA), and the Agency for Healthcare Research and Quality (AHRQ). Additional details [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":12,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-41","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/research.uga.edu\/integrity-support\/wp-json\/wp\/v2\/pages\/41","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/research.uga.edu\/integrity-support\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/research.uga.edu\/integrity-support\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/research.uga.edu\/integrity-support\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/research.uga.edu\/integrity-support\/wp-json\/wp\/v2\/comments?post=41"}],"version-history":[{"count":0,"href":"https:\/\/research.uga.edu\/integrity-support\/wp-json\/wp\/v2\/pages\/41\/revisions"}],"wp:attachment":[{"href":"https:\/\/research.uga.edu\/integrity-support\/wp-json\/wp\/v2\/media?parent=41"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}