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class="breadcrumbCurrent">Human Subjects Research Policies</span></span> <span class="print"> <a href="javascript:window.print();" title="Print this page">Print</a> </span> </div> <div id="DeltaPlaceHolderMain"> <div class="fic-fixed-wrap no-pad-mobile"> <div class="fic-main-wrap fic-columns"> <nav aria-label="Section" class="fic-left-nav fic-rail s4-notdlg noindex"> <div class="noindex"> <ul><li><a href="/Grants/Search/Pages/search-grants.aspx">Search Current and Recent Grants</a></li><li><a href="/Grants/Pages/Frequently-Asked-Questions.aspx">Grants FAQs</a></li><li><a href="/Grants/Pages/Apply.aspx">Apply for a Grant</a></li><li><a href="/Grants/Pages/Manage.aspx">Manage a Grant</a></li><li class="current"><a href="/Grants/Pages/human-subjects-research.aspx">Human Subjects Research<span class="sr-only"> (current section)</span></a></li><li><a href="/Grants/Pages/progress-reports.aspx">Progress Reports</a></li><li><a href="/Grants/Pages/administrative-supplements.aspx">Administrative Supplements</a></li><li><a href="/Global/Pages/nih-grantees.aspx">NIH Grants and Grantees</a></li><li><a href="/Grants/Pages/Foreign.aspx">Foreign NIH Grant Applicants</a></li><li><a href="/Grants/Pages/acknowledging-fogarty-funding.aspx">Communicating and Acknowledging Fogarty Funding</a></li></ul> </div> </nav> <main id="mainContent" tabindex="-1" class="fic-column-main no-pad-right"> <h1> Human Subjects Research Policies </h1> <div class="fic-columns no-stretch"> <div class="fic-column-main fic-content no-pad"> <p>These NIH policies, regulations, training and resources can help when proposing or conducting NIH extramural research involving human subjects.<br></p><ul><li> <a href="https://grants.nih.gov/policy/humansubjects.htm" target="_blank">Research involving human subjects</a>: Useful information about proposing and conducting NIH extramural research involving human subjects, including policies, regulations, training, and resources.</li><li> <a href="https://grants.nih.gov/policy/humansubjects/hs-decision.htm" target="_blank">Decision Tool: Am I Doing Human Subjects Research?</a>: A quick decision tool to assist you with determining if your research involves human subjects.</li><li> <a href="https://grants.nih.gov/grants/how-to-apply-application-guide/resources/annotated-form-sets.htm">Annotated NIH grant application forms</a>, including the "PHS Human Subjects and Clinical Trials Information" form.<br></li><li> <a href="https://grants.nih.gov/grants/funding/lifespan/lifespan.htm">Inclusion across the lifespan in NIH applications and proposals involving human subjects research</a>: Overview of the NIH Inclusion Across the Lifespan Policy.</li></ul><h2>Clinical Trials</h2><p>Studies involving human subjects may meet the NIH definition of a clinical trial.</p><ul><li> <a href="https://grants.nih.gov/policy/clinical-trials.htm" target="_blank">Clinical trial requirements for NIH grants and contracts</a>: Includes the NIH definition of a clinical trial, clinical trial-specific review criteria, and other resources.</li><li> <a href="https://grants.nih.gov/policy/clinical-trials/case-studies.htm#collapseS2_NIDDK_8" target="_blank">Clinical trial case studies</a> designed to help you identify whether your study would be considered by NIH to be a clinical trial.</li><li> <a href="https://grants.nih.gov/grants/Comparison-of-FOA-Types-Clinical-Trials.pdf" target="_blank">Comparison chart of funding opportunity announcement types [PDF]</a>: Use this table to help determine which funding opportunity announcement (FOA) to use if you are including a clinical trial.</li><li> <a href="https://clinicaltrials.gov/ct2/help/for-researcher" target="_blank">Information about ClinicalTrials.gov for researchers</a> provides an overview of how and why you should register your trial.</li></ul><h2>Training</h2><ul><li> <a href="https://www.hhs.gov/ohrp/education-and-outreach/online-education/human-research-protection-training/index.html">Training in human research protections</a> from the U.S. Department of Health and Human Services (HHS)</li><li> <a href="https://grants.nih.gov/policy/clinical-trials/training-resources.htm">Training opportunities and resources for NIH clinical trial policies</a></li><li> <a href="https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm">Good Clinical Practice training policy </a></li></ul><h2>NIH Human Subjects System (HSS)</h2><p>NIH grantees are required to submit information on research and trainee research projects that include human subjects to the NIH Human Subjects System.</p><ul><li> <a href="https://era.nih.gov/about-era/services-for-grant-applicant-grantee/reports/overview-hss.htm">Overview of Human Subjects System (HSS)</a></li></ul><p style="margin-bottom:-30px;">The following supplemental guidance on submitting information to the NIH Human Subjects System is specific to Fogarty grantees:</p><div class="accordion"><h3>Supplemental guidance: R25 - Education Projects</h3><p>For Fogarty-supported <strong>R25 "Education Projects"</strong> that support trainees conducting mentored human subject studies:</p><ul><li>Enter each trainee human subjects research project study record separately.</li><li>Enter whether the study is exempt. Determine if the study is exempt using the <a href="https://grants.nih.gov/policy/humansubjects/research.htm">Exempt Human Subjects Research Infographic</a>.</li><li>Respond to the clinical trial questions.</li><li>Respond “No” to the Phase III clinical trial question.</li><li>Respond “No” to the <a href="https://clinicaltrials.gov/ct2/manage-recs/fdaaa">Food and Drug Administration Amendments Act FDAAA</a> question.</li><li>Add or upload an inclusion enrollment report for each study record.</li></ul><h3>Supplemental guidance: D43 - International Research Training Grants and U2R - International Research Training Cooperative Agreements</h3><p>For Fogarty-supported <strong> D43 "International Research Training Grants"</strong> and <strong>U2R “International Research Training Cooperative Agreements"</strong> that support trainees conducting human subject (HS) studies:</p><ul><li>Enter at least one study record for the non-clinical trial studies for the training program:</li><ul><li>Inclusion Enrollment Records (IERs) are not required for non-clinical trial trainee studies.</li><li>Phase III questions must be marked “No.”</li><li> <a href="https://clinicaltrials.gov/ct2/manage-recs/fdaaa">Food and Drug Administration Amendments Act (FDAAA)</a> question must be marked “No.”</li></ul><li>If a trainee is conducting an independent clinical trial, a separate individual record must be created for this study:</li><ul><li>All the required information must be completed.</li><li>An Inclusion Enrollment Record (IER) must be uploaded into HSS.</li><li>Phase III question must be answered.</li><li> <a href="https://clinicaltrials.gov/ct2/manage-recs/fdaaa">Food and Drug Administration Amendments Act (FDAAA)</a> question must be answered.</li></ul></ul></div><h2>Phase III Studies</h2><p> NIH-Defined Phase 3 updates: <br> Recipients can navigate to the study record and edit the item in Section 4 as they would edit any other items on their study record.</p><p> <a href="https://www.era.nih.gov/erahelp/HSS_External/#edit_studies.htm?TocPath=_____6">Instructions for editing study records</a> are available in the <a href="https://www.era.nih.gov/erahelp/HSS_External/">HSS Online Help for External Users</a>.<br></p> <p class="endnote">Updated May 10, 2024<br></p> </div> <aside class="fic-rail"> <h2>Related News & Resources</h2><ul><li><a href="https://nexus.od.nih.gov/all/2024/04/25/exploring-the-difference-between-exempt-human-subjects-research-and-expedited-irb-review/">Exploring the Difference Between Exempt Human Subjects Research and Expedited IRB Review</a>, <em>NIH Extramural Nexus</em>, April 25, 2024</li> <li> <a href="https://clinregs.niaid.nih.gov/">NIH ClinRegs database</a>: Online database of country-specific clinical research regulatory information designed to assist in planning and implementing international clinical research</li><li> <a href="https://grants.nih.gov/policy/clinical-trials/definition.htm">NIH Definition of "Clinical Trial" </a></li></ul><br> <span class="ms-rtestate-read ms-reusableTextView" contenteditable="false" id="__publishingReusableFragment" fragmentid="/ReusableContent/11_.000"><h2 id="sidebar-h2-optional">Grant News and Information</h2><ul><li> <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-24-115.html">Publication of the Revised NIH Grants Policy Statement (Rev. April 2024) for Fiscal Year 2024</a> (NOT-OD-24-115), May 2, 2024</li><li> <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-24-086.html" target="_blank">New NIH "FORMS-I" Grant Application Forms and Instructions Coming</a> for Due Dates on or after January 25, 2025 (NOT-OD-24-086), April 4, 2024</li><li> <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-24-061.html" target="_blank">NIH Guidance on Marking Changes in Resubmission Applications</a> (NOT-OD-24-061), February 13, 2024<br></li><li> <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-24-042.html" target="_blank">Reminder of eRA Commons ID Requirement for All Personnel on the R&R Senior/Key Person Profile Form</a> (NOT-OD-24-042), December 21, 2023</li> <li> <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-24-010.html" target="_blank">Simplified Review Framework for NIH Research Project Grant Applications</a> for due dates on or after January 25, 2025 (NOT-OD-24-010), October 19, 2023</li></ul></span><br><br> </aside> </div> </main> </div> </div> <div style='display:none' id='hidZone'><menu class="ms-hide"> <ie:menuitem id="MSOMenu_Help" iconsrc="/_layouts/15/images/HelpIcon.gif" onmenuclick="MSOWebPartPage_SetNewWindowLocation(MenuWebPart.getAttribute('helpLink'), MenuWebPart.getAttribute('helpMode'))" text="Help" type="option" style="display:none"> </ie:menuitem> </menu></div> </div> </div> <footer class="fic-site-footer s4-notdlg ms-dialogHidden"> <div class="fic-footer-wrap noindex"> <div class="fic-footer-detail noindex"> <ul> <li><a href="/Pages/Accessibility.aspx">Accessibility</a></li> <li><a href="/Pages/FOIA.aspx">FOIA</a></li> <li><a href="/Pages/PrivacyPolicy.aspx">Privacy Notice</a></li> <li><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" class="no-disclaimer" title="HHS Vulnerability Disclosure" target="_blank">HHS Vulnerability Disclosure</a></li> <li><a href="/Pages/Disclaimer.aspx">Disclaimer</a></li> <li><a href="/Pages/sitemap.aspx">Site Map</a></li> <li><a href="/Pages/ContactUs.aspx">Contact Us</a></li> </ul> <ul> <li> <a href="https://www.nih.gov" target="_blank">National Institutes of Health</a> </li> <li> <a href="https://www.hhs.gov" target="_blank">U.S. Department of Health & Human Services</a> </li> <li> <a href="https://www.usa.gov" target="_blank">USA.gov</a> </li> </ul> <ul> <li><a href="https://www.linkedin.com/company/john-e-fogarty-international-center-for-advanced-study-in-the-health-sciences-fic" class="no-disclaimer" title="Connect with us on LinkedIn" target="_blank">LinkedIn</a></li> <li> <a href="https://www.facebook.com/fogarty.nih" class="no-disclaimer" title="Like Fogarty on Facebook" target="_blank">Facebook</a> </li> <li><a href="https://flickr.com/photos/fogartynih/" class="no-disclaimer" title="Follow Fogarty on Flickr" target="_blank">Flickr</a></li> <li><a href="https://www.instagram.com/fogarty_nih/" class="no-disclaimer" title="Follow Fogarty on Instagram" target="_blank">Instagram</a></li> <li><a href="https://x.com/fogarty_nih" class="no-disclaimer" title="Follow Fogarty on X" target="_blank">X</a></li> <li><a href="https://www.youtube.com/user/FogartyNIH" class="no-disclaimer" title="Subscribe to our YouTube channel" target="_blank">YouTube</a></li> <li><a href="https://public.govdelivery.com/accounts/USNIHFIC/subscriber/new" class="no-disclaimer" title="Subscribe to Fogarty email updates" target="_blank">Subscribe</a></li> <li><a href="/Pages/rss-news.aspx" title="Subscribe to Fogarty News via RSS" target="_blank">RSS</a> </li> </ul> <address> <div class="name"><a href="/Pages/Default.aspx">Fogarty International Center</a></div> <div class="agency">at the National Institutes of Health</div> <div class="address">31 Center Drive, MSC 2220<span class="full">, </span><br class="mobile" />Bethesda, MD 20892-2220 USA</div> </address> <div class="fic-tagline noindex">NIH...Turning Discovery Into Health<sup>®</sup></div> </div> </div> </footer> </div> </div> </div> <div class="ms-tableCell ms-verticalAlignTop"> <div id="DeltaFormDigest"> <script type="text/javascript">//<![CDATA[ var formDigestElement = document.getElementsByName('__REQUESTDIGEST')[0]; 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