Important Highlights of FCOI Regulatory Requirements for Foreign Institutions

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Information for NIH Applicants and Recipients of NIH Funding" data-drupal-link-system-path="node/793"> Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding <i class="bi bi-caret-right me-24"></i> </a> <div class="d-none"> <ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush ps-3"> <li class="level-4 py-0 px-0 border-0 list-inline"> <a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus/history-update" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Applicant/Recipient COVID-19 Update History" data-drupal-link-system-path="node/858">Applicant/Recipient COVID-19 Update History</a> <div class="d-none"> </div> </li> <li class="level-4 py-0 px-0 border-0 list-inline"> <a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus/funding-opportunities" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Funding Opportunities Specific to COVID-19" data-drupal-link-system-path="policy-and-compliance/policy-topics/natural-disasters/corona-virus/funding-opportunities">Funding Opportunities Specific to COVID-19</a> <div class="d-none"> </div> </li> <li class="level-4 py-0 px-0 border-0 list-inline"> <a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus/nih-omb-memo" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Implementation of OMB Memorandum M-20-26 “Extension of Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations” dated June 18, 2020" data-drupal-link-system-path="node/747">NIH Implementation of OMB Memorandum M-20-26 “Extension of Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations” dated June 18, 2020</a> <div 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role="button" title="Expand menu Peer Review Policies and Practices" data-drupal-link-system-path="node/744"> Peer Review Policies and Practices <i class="bi bi-caret-right me-24"></i> </a> <div class="d-none"> <ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush ps-3"> <li class="level-3 py-0 px-0 border-0 dropdown list-inline"> <a href="/policy-and-compliance/policy-topics/peer-review/simplifying-review" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Simplifying Review of Research Project Grant Applications" data-drupal-link-system-path="node/482"> Simplifying Review of Research Project Grant Applications <i class="bi bi-caret-right me-24"></i> </a> <div class="d-none"> <ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush ps-3"> <li class="level-4 py-0 px-0 border-0 list-inline"> <a 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data-drupal-link-system-path="node/848">Applicant Guidance for Simplifying the Review Framework for Most Research Project Grants</a> <div class="d-none"> </div> </li> <li class="level-4 py-0 px-0 border-0 list-inline"> <a href="/policy-and-compliance/policy-topics/peer-review/simplifying-review/notices" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Notices, Statements and Reports" data-drupal-link-system-path="node/110">Notices, Statements and Reports</a> <div class="d-none"> </div> </li> </ul> </div> </li> <li class="level-3 py-0 px-0 border-0 dropdown list-inline"> <a href="/policy-and-compliance/policy-topics/peer-review/revisions-nih-fellowship-application-review-process" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Revisions to the NIH Fellowship Application and Review Process" data-drupal-link-system-path="node/499"> Revisions to the NIH Fellowship Application and Review 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Harassment on an NIH-Funded Project at a Recipient Institution" data-drupal-link-system-path="node/114">NIH Process for Handling Allegations of Harassment on an NIH-Funded Project at a Recipient Institution</a> <div class="d-none"> </div> </li> </ul> </div> </li> <li class="level-3 py-0 px-0 border-0 dropdown list-inline"> <a href="/policy-and-compliance/policy-topics/harassment/find-help" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Find Help" data-drupal-link-system-path="node/569"> Find Help <i class="bi bi-caret-right me-24"></i> </a> <div class="d-none"> <ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush ps-3"> <li class="level-4 py-0 px-0 border-0 list-inline"> <a href="/policy-and-compliance/policy-topics/harassment/notify" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu What to Expect When Notifying NIH" data-drupal-link-system-path="node/661">What to Expect When Notifying NIH</a> <div class="d-none"> </div> </li> </ul> </div> </li> <li class="level-3 py-0 px-0 border-0 list-inline"> <a href="/policy-and-compliance/policy-topics/harassment/institutional-reporting" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Institutional Reporting" data-drupal-link-system-path="node/746">Institutional Reporting</a> <div class="d-none"> </div> </li> <li class="level-3 py-0 px-0 border-0 list-inline"> <a href="/policy-and-compliance/policy-topics/harassment/definitions" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Definitions" data-drupal-link-system-path="node/779">Definitions</a> <div class="d-none"> </div> </li> <li class="level-3 py-0 px-0 border-0 list-inline"> <a href="/policy-and-compliance/policy-topics/harassment/data" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Data - Harassment and Discrimination Concerns" data-drupal-link-system-path="node/757">Data - Harassment and Discrimination Concerns</a> <div class="d-none"> </div> </li> <li class="level-3 py-0 px-0 border-0 list-inline"> <a href="https://hr.nih.gov/workforce/workplace-civility-and-equity-survey" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Resources to Evaluate Workplace Climate">Resources to Evaluate Workplace Climate</a> <div class="d-none"> </div> </li> <li class="level-3 py-0 px-0 border-0 list-inline"> <a href="/policy-and-compliance/policy-topics/harassment/related-statements" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Related Statements" data-drupal-link-system-path="node/343">Related Statements</a> <div class="d-none"> </div> </li> <li class="level-3 py-0 px-0 border-0 list-inline"> <a href="https://www.nih.gov/anti-sexual-harassment/nih-staff" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Anti-Sexual Harassment Policies and Resources for NIH Staff">Anti-Sexual Harassment Policies and Resources for NIH Staff</a> <div class="d-none"> </div> </li> </ul> </div> </li> </ul> </div> </li> </ul> </div> </li> </ul> </nav> </div> </div> <div class="order-1 order-lg-2 syndicate col-12 col-lg-9 ps-0 ps-lg-5"> <div class="region region-content"> <div data-drupal-messages-fallback class="hidden"></div> <div id="block-nihod5-subtheme-page-title" class="block block-core block-page-title-block"> <h1><strong><span class="field field--name-title field--type-string field--label-hidden">Important Highlights of FCOI Regulatory Requirements for Foreign Institutions</span> </strong></h1> </div> <div id="block-nihod5-subtheme-content" class="block block-system block-system-main-block"> <article class="node node--type-page node--view-mode-full"> <div class="node__content"> <div class="layout layout--onecol"> <div class="layout__region layout__region--content"> <div class="block block-layout-builder block-field-block-node-page-field-scope-note"> <div class="clearfix text-formatted field field--name-field-scope-note field--type-text-long field--label-visually_hidden"> <div class="field__label visually-hidden">Scope Note</div> <div class="field__item"><p>NIH requires foreign <a href="/faqs#/financial-conflict-of-interest.htm?anchor=52851">institutions </a>and their investigators to fully comply with all the requirements of the FCOI regulation.  If a foreign Institution carries out NIH-funded research through a subrecipient (e.g., subcontractors or consortium members), the foreign Institution must take reasonable steps to ensure that any subrecipient Investigator complies with FCOI requirements. </p></div> </div> </div> <div class="block block-layout-builder block-field-block-node-page-body"> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><p>An <a href="https://www.ecfr.gov/current/title-42/part-50/subpart-F#p-50.603(Investigator)" target="_blank">Investigator</a> is: </p><ul><li>the PD/PI and any other person, regardless of title or position who is responsible for the design, conduct, or reporting of NIH-funded research, or proposed for such funding, and which may include for example, collaborators or consultants </li><li>someone who plans to participate in or who participates in NIH-funded research</li></ul><h3>Highlights of the FCOI Regulation </h3><p>When submitting a grant application or receiving a grant as a result of an application, the signature of the <a href="/grants/glossary.htm#AuthorizedOrganizationRepresentative(AOR)">Authorized Organization Representative (AOR)</a> certifies the applicant institution's full compliance with all of the requirements of the FCOI regulation, including:</p><p>1. <strong>Existence of institutional policy and process</strong>. There is in effect at the Institution an up-to-date, written and enforced administrative process and policy to identify and manage FCOI for all NIH-funded grants and cooperative agreements, excluding Phase I <a href="https://seed.nih.gov/small-business-funding/small-business-program-basics/understanding-sbir-sttr" heap-ignore="true" rel="noreferrer" target="_blank">SBIR/STTR</a> applications and awards.  </p><p>2. <strong>Accessibility of institutional policy and submission to NIH</strong>. Institutions must post their FCOI policy on their publicly accessible Web site and <a href="/grants/policy/nihgps/HTML5/section_4/4.1.10_financial_conflict_of_interest.htm?Highlight=fcoi">must submit their FCOI  policy</a> to the NIH via the <a href="https://www.era.nih.gov/erahelp/Commons/default.htm#Commons/ipf/ipf.htm" target="_blank">eRA Commons Institution Profile (IPF) Module</a>.  </p><p>3. <strong>Institutional training of investigators</strong>. The Institution <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F#p-50.604(b)" target="_blank">must train their Investigators</a> (and ensure subrecipient Investigators are trained) about the FCOI regulation, the Institution’s policy, and the Investigator’s responsibility to fully disclose all domestic and foreign SFIs (and those of their spouse and dependent children) that are related to their <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50#p-50.603(Institutional%20responsibilities)" target="_blank">institutional responsibilities</a>. Refer to NIH’s <a href="/grants/policy/coi/fcoi-training.htm">FCOI Training</a> website for training resources institutions may use to train Institutional officials and Investigators about the FCOI regulation, including other FCOI-related topic areas.</p><p>4. <strong>Investigator disclosures</strong>. Investigators must disclose all domestic and foreign SFIs that are related to the Investigator’s <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50#p-50.603(Institutional%20responsibilities)" target="_blank">institutional responsibilities</a> (i.e., professional responsibilities on behalf of the institution, and as defined by the institution in its FCOI policy, such as research, research consultation, teaching, professional practice, etc.) that are received from and/or held in an entity outside the institution.  Note: institutional policies may provide a threshold for investigator disclosure related to certain types of SFIs (see FAQs <a href="/faqs#/financial-conflict-of-interest.htm?anchor=52866">E.9</a>. and <a href="/faqs#/financial-conflict-of-interest.htm?anchor=53050">E.20.</a>). </p><p><strong>Disclosures of foreign financial interests</strong>. It is important to note that disclosure of foreign financial interests differs from disclosure of domestic financial interests.  Investigators, including subrecipient Investigators, must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed or sponsored travel) received from any foreign entity, including foreign Institutions of higher education or foreign governments (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).   </p><p>5. <strong>Institutions determine FCOIs. </strong>The institution is required to review each Investigator SFI disclosure to determine if a SFI is:</p><ul><li>related to the Investigator’s NIH-funded research.  An SFI is related to NIH-funded research when the SFI could be affected by the research or is in an entity whose financial interest could be affected by the research, and</li><li>a FCOI.  An SFI is considered a FCOI when that the SFI could directly and significantly (i.e., have a material effect) affect the design, conduct, or reporting of the NIH-funded research.</li></ul><p>6. <strong>Management and reporting of FCOIs</strong>. When the institution determines that an FCOI exits, the Institution must report to the NIH awarding Institute or Center through the submission of an initial (Original) and annual FCOI report using the <a href="https://www.era.nih.gov/recipients/submit-reports/fcoi.htm" target="_blank">eRA Commons FCOI Module</a>. The institution must also manage the identified FCOI.</p><p>7. <strong>Maintenance of records</strong>. The Institution must maintain records of and, when requested, will promptly <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F#p-50.604(h)" target="_blank">make information available</a> to the NIH relating to any Investigator disclosure of financial interests and the Institution’s review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution’s determination of an FCOI.</p></div> </div> <div class="block block-layout-builder block-field-block-node-page-field-body-2"> <div class="clearfix text-formatted field field--name-field-body-2 field--type-text-long field--label-hidden field__item"><div data-ds-id="aas23v54" class="d-flex mb-4"> <div class="d-flex flex-column"> <small class="bg-secondary bi bi-lightbulb-fill d-flex p-1 rounded-circle text-white"></small> <div class="d-flex h-100 justify-content-around mt-1 mx-2"> <div class="bg-secondary h-100" style="width: 3px;"></div> </div> </div> <div class="ps-3"> <strong>Tip</strong> <div>For full FCOI requirements, see the <a href="/grants/policy/nihgps/HTML5/section_4/4.1.10_financial_conflict_of_interest.htm?Highlight=fcoi">NIH Grants Policy Statement</a>, <a href="/grants/policy/nihgps/HTML5/section_4/4.1.10_financial_conflict_of_interest.htm">Section 4.1.10</a>, Financial Conflict of Interest and <a href="https://www.ecfr.gov/current/title-42/part-50/subpart-F" target="_blank">42 CFR 50 Subpart F</a>, Promoting Objectivity in Research.</div> </div> </div></div> </div> <div class="block block-layout-builder block-extra-field-block-node-page-workbench-moderation-control"> </div> </div> </div> </div> </article> </div> <div id="block-grants-learningcenterresources" class="block block-oer-resources-module block-learning-center-resources-block"> <div class="border-2 border-secondary border-top container mb-5" id="general-resource-wrapper"> <div class="row"> <h3 class="border-5 border-secondary border-top col-12 col-md-3 pt-3 text-secondary">Resources</h3> <div class="border-5 border-top border-white col-12 col-md-9 pt-3"> <div class="upcoming-events-block mb-4"> <h4> <strong>Upcoming Events</strong> </h4> <ul id="upcoming-events"></ul> </div> <div class="videos-block mb-4"> <h4> <strong>Videos</strong> </h4> <ul id="videos" class="videos-see-more"></ul> </div> </div> </div> </div> <script> function collapseMore(collapseList, addDiv, btnName) { if (collapseList) { const items = collapseList.querySelectorAll("li"); const maxVisibleItems = 2; if (items.length > maxVisibleItems) { for (let i = maxVisibleItems; i < items.length; i++) { items[i].style.display = "none"; } addDiv.innerHTML = `<a href="#" class="text-decoration-none">See more ${btnName}</a>`; collapseList.after(addDiv); addDiv.addEventListener("click", function (event) { event.preventDefault(); for (let i = maxVisibleItems; i < items.length; i++) { items[i].style.display = ""; } addDiv.style.display = "none"; }); } } } const list = document.querySelector(".general-see-more"); const seeMore = document.createElement("div"); collapseMore(list, seeMore, "General"); let data = {"tags":[{"value":"664bc4e788485d79a20a3211","_attributes":[]}],"project_id":"https:\/\/search.grants.nih.gov\/lc\/api\/resources\/tags","project":"64888cbd5b0ce2db990fc8d3","fqs":[],"query":"OR","see_also":null,"page_contact":null,"general_resources":null,"custom_faq":null,"resources_data":{"success":true,"message":"Resource successfully retrieved.","resources":[{"_id":"66f4608e504251765a041803","type":"standard_event","projectId":"64888cbd5b0ce2db990fc8d3","title":"FCOI and Other Support: NIH and Grantees Working Together","description":"<p>Learn about the Financial Conflict of Interest (FCOI) regulation at 42 CFR Part 50 Subpart F, applicable to NIH grants and cooperative agreements. 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} videos_element.appendChild(newLiElement); }); } else { videos_block.style.display = "none"; } const video_list = document.querySelector(".videos-see-more"); const seeMoreVideos = document.createElement("div"); collapseMore(video_list, seeMoreVideos, "Videos"); } </script> </div> </div> <hr class="my-4"> <small class="d-block w-100 text-end mb-5 last-updated-block"> This page last updated on: September 9, 2024<br> For technical issues <a href="/contact-us">E-mail OER Webmaster</a> </small> <div id="embed-survey" class="my-4 position-relative z-1"><div> </div> </div> </div> </main> <footer class="mt-auto "> <div class="container my-0 p-4 px-lg-0"> <div class="row"> <div class="col px-0"> <div class="region region-footer"> <div id="block-nihod5-subtheme-frontendfooter" class="block block-block-content block-block-content-4008fb8e-386e-447e-bfc4-b1cf3d42bf9a"> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="container-fluid pt-1"><div class="row row-cols-1 row-cols-lg-4 gx-5 gy-5"><section><p><img class="mb-3 w-100 pe-lg-5" src="https://github.com/OER-WEB-TEAM/design-system--logos/blob/main/outputs/grants-funding--logo/notagline/grants-funding--logo-white-@3X.png?raw=true" alt="Grants & Funding logo"></p><p>National Institutes of Health<br>Bethesda, MD 20892</p><h4 class="mt-5 pb-2 mb-3 border-bottom me-5">Stay Connected</h4><ul class="stay-connected"><li><div class="d-flex gap-4"><a href="https://x.com/NIHgrants?mx=2" title="X"><i class="bi bi-twitter-x fs-4"></i></a></div></li><li><div class="d-flex gap-4"><a href="https://www.youtube.com/user/nihgrants" title="YouTube"><i class="bi bi-youtube fs-4"></i></a></div></li><li><div class="d-flex gap-4"><a href="http://www.linkedin.com/company/office-of-extramural-research" title="LinkedIn"><i class="bi bi-linkedin fs-4"></i></a></div></li><li><div class="d-flex gap-4"><a href="/news-events/subscribe-follow/email-updates-and-rss-feeds#rss-feeds" title="RSS Feeds"><i class="bi bi-rss-fill fs-4"></i></a></div></li></ul><p><a class="btn btn-light btn-md btn-block ms-0 mt-3" href="/news-events/subscribe-follow/email-updates-and-rss-feeds">Subscribe for Grant News</a></p></section><section><h4 class="pb-2 mb-3 border-bottom">Government Sites</h4><p><a href="https://www.hhs.gov/">Health and Human Services</a></p><p><a href="https://www.nih.gov/">National Institutes of Health</a></p><p><a href="https://www.usa.gov/">USA.gov - Government Made Easy</a></p><p><a class="new-domain" href="https://extramural-intranet.nih.gov/">NIH Staff (Intranet<i class="bi bi-lock-fill"></i>)</a></p></section><section><h4 class="pb-2 mb-3 border-bottom">Web Policies and Notices</h4><p><a href="/web-policies-and-notices/accessibility">Accessibility</a></p><p><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html">HHS Vulnerability Disclosure</a></p><p><a href="https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/freedom-information-act-office">FOIA</a></p><p><a href="/web-policies-and-notices/privacy-notice">Privacy Notice</a></p><p><a href="/web-policies-and-notices/disclaimer">Disclaimer</a></p><p><a class="new-domain" href="#" id="waybackurl" target="_blank">Archive of this Page Since September 24, 2024</a></p><p><a href="/older-versions-of-this-website">Older Versions of this Website</a></p></section><section><h4 class="pb-2 mb-3 border-bottom">Site Map</h4><p><a href="/">Home</a></p><p><a href="/new-to-nih">New To NIH</a></p><p><a href="/funding">Funding</a></p><p><a href="/grants-process">Grants Process</a></p><p><a href="/policy-and-compliance">Policy & Compliance</a></p><p><a href="/news-events">News & Events</a></p><p><a href="/aboutoer">About Us</a></p></section></div></div></div> </div> <div id="block-nihod5-subtheme-frontendmodals" class="block block-block-content block-block-content-69f5da88-85a6-4b07-b3d7-27feac192b3a"> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"></div> </div> </div> </div> </div> </div> </footer> <script> var url = window.location.href; 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