3346 lines
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[AVK] -- TO DO
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Emrul, I removed all the ID attributes as the name attributes are the only things needed to handle a form submission
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but feel free to adjust this snippet with whatever is needed to make it work.
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<p class="d-none d-lg-block">As the largest public funder of biomedical research in the world, NIH supports a variety of programs from grants and contracts to loan repayment. Learn about assistance programs, how to identify a potential funding organization, and past NIH funding.</p>
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<a href="/funding/nih-guide-for-grants-and-contracts" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/45">NIH Guide for Grants and Contracts</a>
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<a href="/funding/find-a-fit-for-your-research-nih-institutes-centers-offices" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/25">Find a Fit for Your Research: NIH Institutes, Centers, and Offices</a>
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|
||
<a href="/funding/explore-data-on-funded-projects" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/24">Explore Who and What NIH Funds</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/grants-process" title="Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#GrantsProcess" aria-expanded="false" data-drupal-link-system-path="node/49"> Grants Process <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="GrantsProcess" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">Grants Process</strong>
|
||
<p class="d-none d-lg-block">Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting.</p>
|
||
<a href="/grants-process" title="Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/49">Explore Grants Process</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/plan-to-apply" title="Plan ahead, assess funding opportunities, and take other early steps. Learn to work with your organization, assess resources and teammates, identify a funding opportunity, check application policies, and lay out your timeline." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1073">Plan to Apply</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/write-application" title="Find the official grant application instructions, preview application forms, get advice on grant writing, check out sample grant applications, and read our tips on specific application attachments and sections." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/670">Write Application</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/submit" title="Learn about the steps you must take after filling out your application forms to complete the submission process, how NIH checks your application for completeness prior to review, and NIH submission policies." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/43">Submit</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/review" title="What happens between the time you submit the application and NIH lets you know you will be funded? Learn more about receipt and referral and NIH’s peer review process." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1082">Review</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/award" title="When NIH awards a grant, we are formalizing our partnership with the recipient to ensure compliance with federal laws, regulations and policies." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1083">Award</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/post-award-monitoring-and-reporting" title="If your organization is the recipient of a grant from the NIH, you will need to pay close attention to the terms of award to be successful stewards of federal funds. Learn about reporting and monitoring requirements." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/349">Post-Award Monitoring and Reporting</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/policy-and-compliance" title="By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block bg-gradient shadow" data-bs-toggle="collapse" data-bs-target="#PolicyCompliance" aria-expanded="false" data-drupal-link-system-path="node/3"> Policy & Compliance <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="PolicyCompliance" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">Policy & Compliance</strong>
|
||
<p class="d-none d-lg-block">By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise.</p>
|
||
<a href="/policy-and-compliance" title="By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/3">Explore Policy & Compliance</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/changes-coming-2025" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/188">Changes Coming for 2025</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/nihgps" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/216">Grants Policy Statement</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/notice-of-policy-changes" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="policy-and-compliance/notice-of-policy-changes">Notices of Policy Changes</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/compliance-and-oversight" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/259">Compliance & Oversight</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/policy-topics" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1075">Policy Topics</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/news-events" title="Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#NewsEvents" aria-expanded="false" data-drupal-link-system-path="news-events"> News & Events <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="NewsEvents" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">News & Events</strong>
|
||
<p class="d-none d-lg-block">Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more.</p>
|
||
<a href="/news-events" title="Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="news-events">Explore News & Events</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/calendar-of-events" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="news-events/calendar-of-events">Calendar of Events</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/on-demand-event-resources" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/335">On-Demand Event Resources</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/subscribe-follow" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1118">Subscribe and Follow</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="https://nexus.od.nih.gov/all/category/open-mike/" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold">"Open Mike" Blog</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="https://nexus.od.nih.gov/all/" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold">Extramural Nexus (News)</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/podcasts" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/712">Podcasts</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/aboutoer" title="Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#AboutUs" aria-expanded="false" data-drupal-link-system-path="node/597"> About Us <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="AboutUs" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">About Us</strong>
|
||
<p class="d-none d-lg-block">Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio.</p>
|
||
<a href="/aboutoer" title="Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/597">Explore About Us</a>
|
||
</div>
|
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<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
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|
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<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
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|
||
|
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|
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<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/aboutoer/oer-offices" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/514">OER Offices</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
|
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|
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|
||
</nav>
|
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|
||
</div>
|
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|
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</div>
|
||
</div>
|
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</header>
|
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<main role="main">
|
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<a id="main-content" tabindex="-1"></a>
|
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|
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|
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<div class="container my-0 p-4 px-lg-0">
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<div class="region region-breadcrumb">
|
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<div id="block-nihod5-subtheme-breadcrumbs" class="block block-system block-system-breadcrumb-block">
|
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|
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<nav aria-label="breadcrumb">
|
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<h2 id="system-breadcrumb" class="visually-hidden">Breadcrumb</h2>
|
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<ol class="breadcrumb">
|
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<li class="breadcrumb-item">
|
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<a href="/">Home</a>
|
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</li>
|
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<li class="breadcrumb-item">
|
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<a href="/policy-and-compliance">Policy & Compliance</a>
|
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</li>
|
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<li class="breadcrumb-item">
|
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<a href="/policy-and-compliance/policy-topics">Policy Topics</a>
|
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</li>
|
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<li class="breadcrumb-item">
|
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<a href="/policy-and-compliance/policy-topics/inclusion">Inclusion Policies for Human Subjects</a>
|
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</li>
|
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<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance/policy-topics/inclusion/women-and-minorities">Inclusion of Women and Minorities as Participants in Research Involving Human Subjects</a>
|
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</li>
|
||
<li class="breadcrumb-item">
|
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NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
|
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</li>
|
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</ol>
|
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</nav>
|
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|
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</div>
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|
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</div>
|
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<div class="row">
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<div class="order-2 order-lg-1 d-none d-lg-block col-lg-3">
|
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<div class="region region-sidebar-first p-0">
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<nav role="navigation" aria-labelledby="block-nihod5-subtheme-mainnavigation-menu" id="block-nihod5-subtheme-mainnavigation" class="block block-menu navigation menu--main">
|
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<h5 class="visually-hidden" id="block-nihod5-subtheme-mainnavigation-menu">Main navigation (Sidebar Template)</h5>
|
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|
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|
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|
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|
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<ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="navbar-nav">
|
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|
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|
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<li class="level-0 py-0 px-0 border-0 dropdown">
|
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|
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<a href="/policy-and-compliance" title="Expand menu Policy & Compliance" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center nav-link fs-5 mb-3 border-bottom border-3 border-primary fw-bold" role="button" data-drupal-link-system-path="node/3">Policy & Compliance</a>
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<div class="d-block">
|
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<ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush">
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<li class="level-1 py-0 px-0 border-0 dropdown list-inline">
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<a href="/policy-and-compliance/changes-coming-2025" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center fw-bold" role="button" title="Expand menu Changes Coming for 2025" data-drupal-link-system-path="node/188"> Changes Coming for 2025 <i class="bi bi-caret-right-fill me-24"></i>
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</a>
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<div class="d-none">
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<ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush ps-3">
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<li class="level-2 py-0 px-0 border-0 list-inline">
|
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|
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<a href="https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Simplified Review Framework for Most Research Project Grants (RPGs) ">Simplified Review Framework for Most Research Project Grants (RPGs) </a>
|
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<div class="d-none">
|
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|
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</div>
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</li>
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<li class="level-2 py-0 px-0 border-0 list-inline">
|
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|
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<a href="https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/revisions-nih-fellowship-application-review-process" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Revisions to the NIH Fellowship Application and Review Process ">Revisions to the NIH Fellowship Application and Review Process </a>
|
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<div class="d-none">
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|
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|
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</div>
|
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</li>
|
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|
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|
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|
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|
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|
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<a href="/policy-and-compliance/policy-topics/clinical-trials" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Clinical Trial Requirements for Grants and Contracts" data-drupal-link-system-path="node/434"> Clinical Trial Requirements for Grants and Contracts <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/ct-decision" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Decision Tool: Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?" data-drupal-link-system-path="node/711">Decision Tool: Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?</a>
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<a href="https://www.era.nih.gov/help-tutorials/hss" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Human Subjects System">Human Subjects System</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Requirements for Registering & Reporting NIH-Funded Clinical Trials" data-drupal-link-system-path="node/298"> Requirements for Registering & Reporting NIH-Funded Clinical Trials <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting/nih-policy" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information" data-drupal-link-system-path="node/885">NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting/steps" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Steps to Compliance for NIH Awardees" data-drupal-link-system-path="node/896">Steps to Compliance for NIH Awardees</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting/understanding" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Policy and Regulation on ClinicalTrials.gov Registration and Reporting" data-drupal-link-system-path="node/452">Policy and Regulation on ClinicalTrials.gov Registration and Reporting</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/why-changes" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Information about NIH Clinical Trial Stewardship" data-drupal-link-system-path="node/579">Information about NIH Clinical Trial Stewardship</a>
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<a href="/policy-and-compliance/policy-topics/federal-funding" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Communicating, and Acknowledging Federal Funding" data-drupal-link-system-path="node/112">Communicating, and Acknowledging Federal Funding</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Early Stage Investigator Policies" data-drupal-link-system-path="node/758"> Early Stage Investigator Policies <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/policy" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Early Stage Investigators Policy" data-drupal-link-system-path="node/260">NIH Early Stage Investigators Policy</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/determining-status" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Determining Early Stage Investigator (ESI) Status" data-drupal-link-system-path="node/215">Determining Early Stage Investigator (ESI) Status</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/related-data" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Early Stage Investigator Related Data" data-drupal-link-system-path="node/690">Early Stage Investigator Related Data</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/history" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu History of NIH Support for Early Career Investigators" data-drupal-link-system-path="node/470">History of NIH Support for Early Career Investigators</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/notices-laws-statements" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Related Notices, Laws, Statements and Reports" data-drupal-link-system-path="node/285">Related Notices, Laws, Statements and Reports</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/list-smaller-grants" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu List of smaller grants & awards that maintain ESI status" data-drupal-link-system-path="node/907">List of smaller grants & awards that maintain ESI status</a>
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<a href="/policy-and-compliance/policy-topics/nih-family-friendly-initiative" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Family-Friendly Initiatives" data-drupal-link-system-path="node/665">Family-Friendly Initiatives</a>
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<a href="/policy-and-compliance/policy-topics/fcoi" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Financial Conflict of Interest" data-drupal-link-system-path="node/831"> Financial Conflict of Interest <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/fcoi/fcoi-training" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu FCOI Training" data-drupal-link-system-path="node/390">FCOI Training</a>
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<a href="/policy-and-compliance/policy-topics/fcoi/important-highlights" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Important Highlights of FCOI Regulatory Requirements for Foreign Institutions" data-drupal-link-system-path="node/312">Important Highlights of FCOI Regulatory Requirements for Foreign Institutions</a>
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<a href="/policy-and-compliance/policy-topics/fcoi/guide-notices" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Guide Notices Related to Financial Conflict of Interest" data-drupal-link-system-path="node/786">NIH Guide Notices Related to Financial Conflict of Interest</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Foreign Interference" data-drupal-link-system-path="node/447"> Foreign Interference <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/about-foreign-interference" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu About Foreign Interference" data-drupal-link-system-path="node/326">About Foreign Interference</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/requirements-for-disclosure" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Requirements for Disclosure of Other Support, Foreign Components and Conflicts of Interest" data-drupal-link-system-path="node/496">Requirements for Disclosure of Other Support, Foreign Components and Conflicts of Interest</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/handling-allegations" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Process for Handling Allegations Related to Foreign Interference" data-drupal-link-system-path="node/668">Process for Handling Allegations Related to Foreign Interference</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/notices-statements-reports" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Notices, Statements, and Reports" data-drupal-link-system-path="node/564">Notices, Statements, and Reports</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/case-studies" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Case Studies" data-drupal-link-system-path="node/627">Case Studies</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/fi-data" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Data" data-drupal-link-system-path="node/864">Data</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Human Subjects Research" data-drupal-link-system-path="node/332"> Human Subjects Research <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/human-subjects/research" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Definition of Human Subjects Research" data-drupal-link-system-path="node/696"> Definition of Human Subjects Research <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/human-subjects/hs-decision" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Decision Tool: Am I Doing Human Subjects Research?" data-drupal-link-system-path="node/777">Decision Tool: Am I Doing Human Subjects Research?</a>
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<a href="/sites/default/files/human-subjects-research-infographic.pdf" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Human Subjects Research Infographic">Human Subjects Research Infographic</a>
|
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<a href="/sites/default/files/exemption_infographic_v8_508c_1-15-2020.pdf" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Exempt Human Subjects Research Infographic">Exempt Human Subjects Research Infographic</a>
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<a href="/grants/policy/hs/private-information-biospecimens-flowchart.pdf" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Research Involving Private Information or Biospecimens Flowchart"> Research Involving Private Information or Biospecimens Flowchart</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects/research/public-health" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Public Health Surveillance Exclusions" data-drupal-link-system-path="node/703">Public Health Surveillance Exclusions</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects/pre-and-post-award-processes" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Pre-Award and Post-Award Processes for Projects Involving Human Subjects Research" data-drupal-link-system-path="node/547"> Pre-Award and Post-Award Processes for Projects Involving Human Subjects Research <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/human-subjects/pre-and-post-award-processes/considerations" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Grant Application and Proposal Considerations for Human Subjects Research" data-drupal-link-system-path="node/801">NIH Grant Application and Proposal Considerations for Human Subjects Research</a>
|
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<a href="/policy-and-compliance/policy-topics/human-subjects/pre-and-post-award-processes/peer-review" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Human Subjects in Peer Review" data-drupal-link-system-path="node/252">Human Subjects in Peer Review</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects/pre-and-post-award-processes/jit" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Just In Time (JIT) Information for Grants Involving Human Subjects" data-drupal-link-system-path="node/763">Just In Time (JIT) Information for Grants Involving Human Subjects</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects/pre-and-post-award-processes/study-monitoring" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Human Subjects Study Monitoring and Progress Reporting" data-drupal-link-system-path="node/502">Human Subjects Study Monitoring and Progress Reporting</a>
|
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Certificates of Confidentiality" data-drupal-link-system-path="node/109"> Certificates of Confidentiality <i class="bi bi-caret-right me-24"></i>
|
||
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc/information-protected-coc" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Information Protected by a CoC" data-drupal-link-system-path="node/420">Information Protected by a CoC</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc/information-institutional-responsibilities" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Investigator and Institutional CoC Responsibilities" data-drupal-link-system-path="node/632">Investigator and Institutional CoC Responsibilities</a>
|
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc/nih-funded-research" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu CoCs for NIH-Funded Research" data-drupal-link-system-path="node/264">CoCs for NIH-Funded Research</a>
|
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc/for-research-not-funded-by-nih" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu CoCs for Research Not Funded by NIH" data-drupal-link-system-path="node/399">CoCs for Research Not Funded by NIH</a>
|
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<a href="/policy-and-compliance/policy-topics/human-subjects/coc/background-information" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH CoC Policy Background Information" data-drupal-link-system-path="node/725">NIH CoC Policy Background Information</a>
|
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<a href="/policy-and-compliance/policy-topics/inclusion" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Inclusion Policies for Human Subjects Research" data-drupal-link-system-path="node/845"> Inclusion Policies for Human Subjects Research <i class="bi bi-caret-down me-24"></i>
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<a href="/policy-and-compliance/policy-topics/inclusion/women-and-minorities" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Inclusion of Women and Minorities as Participants in Research Involving Human Subjects" data-drupal-link-system-path="node/430"> Inclusion of Women and Minorities as Participants in Research Involving Human Subjects <i class="bi bi-caret-down me-24"></i>
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<a href="/policy-and-compliance/policy-topics/inclusion/women-and-minorities/analyses" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Analyses by Sex or Gender, Race and Ethnicity for NIH-defined Phase III Clinical Trials (Valid Analysis)" data-drupal-link-system-path="node/866">Analyses by Sex or Gender, Race and Ethnicity for NIH-defined Phase III Clinical Trials (Valid Analysis)</a>
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<a href="/policy-and-compliance/policy-topics/inclusion/women-and-minorities/guideline" class="dropdown-item py-2 ps-2 text-wrap is-active" role="button" title="Expand menu NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research" data-drupal-link-system-path="node/115" aria-current="page">NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research</a>
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<a href="/policy-and-compliance/policy-topics/inclusion/lifespan" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Inclusion Across the Lifespan in Human Subjects Research" data-drupal-link-system-path="node/734">Inclusion Across the Lifespan in Human Subjects Research</a>
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<a href="/policy-and-compliance/policy-topics/intellectual-property" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Intellectual Property Policy" data-drupal-link-system-path="node/149"> Intellectual Property Policy <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/natural-disasters" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Natural Disasters" data-drupal-link-system-path="node/208"> Natural Disasters <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Coronavirus Disease 2019 (COVID-19): 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>
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<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>
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<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>
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<a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus/impact-research-community" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu The Impact of COVID-19 on the Research Community" data-drupal-link-system-path="node/640">The Impact of COVID-19 on the Research Community</a>
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<a href="/policy-and-compliance/policy-topics/ngri" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Next Generation Researchers Initiative" data-drupal-link-system-path="node/884"> Next Generation Researchers Initiative <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/nih-fiscal-policies" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu NIH Fiscal Policies" data-drupal-link-system-path="node/510"> NIH Fiscal Policies <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/nih-fiscal-policies/salary-cap-summary" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Salary Cap Summary (FY 1990 - Present)" data-drupal-link-system-path="node/729">Salary Cap Summary (FY 1990 - Present)</a>
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<a href="/policy-and-compliance/policy-topics/nih-fiscal-policies/stipends-summary" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Stipends Summary – NRSA (FY 2018-Present)" data-drupal-link-system-path="node/1171">Stipends Summary – NRSA (FY 2018-Present)</a>
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<a href="/policy-and-compliance/policy-topics/peer-review" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" 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>
|
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<h1><strong><span class="field field--name-title field--type-string field--label-hidden">NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research</span>
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<div class="field__item"><div class="alert alert-info border-0 border-start border-7 border-info d-flex" data-ds-id="j2tmke3n" role="alert"><p><i class="bi bi-info-circle-fill me-3 h4"></i></p><div><strong>Information Alert</strong><br>The policy below is displayed as announced on October 9, 2001 in <a href="/grants/guide/notice-files/NOT-OD-02-001.html">NOT-OD-02-001</a>, and does not reflect the amendment <a href="/grants/guide/notice-files/NOT-OD-18-014.html">NOT-OD-18-014</a>, issued November 28, 2017. Additional information concerning the NIH Policy on Inclusion of Women and Minorities as Subjects in Clinical Research is available at <a href="/policy-and-compliance/policy-topics/inclusion/women-and-minorities">/policy-and-compliance/policy-topics/inclusion/women-and-minorities</a>.</div></div></div>
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<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><h2>Summary</h2><p>This notice updates the NIH policy on the inclusion of women and minorities as subjects in clinical research. It supercedes the 1994 Federal Register notice (<a href="/grants/guide/notice-files/not94-100.html">/grants/guide/notice-files/not94-100.html</a>) and the August 2000 notice in the NIH Guide to Grants and Contracts (<a href="/grants/guide/notice-files/NOT-OD-00-048.html">/grants/guide/notice-files/NOT-OD-00-048.html</a>). It incorporates the definition of clinical research as reported in the 1997 Report of the NIH Director's Panel on Clinical research. Also, this notice provides additional guidance on reporting analyses of sex/gender and racial/ethnic differences in intervention effects for NIH-defined Phase III clinical trials. The guidelines ensure that all NIH-funded clinical research will be carried out in a manner sufficient to elicit information about individuals of both sexes/genders and diverse racial and ethnic groups and, particularly in NIH-defined Phase III clinical trials, to examine differential effects on such groups. Since a primary aim of research is to provide scientific evidence leading to a change in health policy or standard of care, it is imperative to determine whether the intervention or therapy being studied affects women or men or members of minority groups and their subpopulations differently.</p><p>In June 2001, NIH adopted the definition of clinical research as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) Epidemiologic and behavioral studies; and (3) Outcomes research and health services research http://www.nih.gov/news/crp/97report/execsum.htm.</p><div class="alert alert-info border-0 border-start border-7 border-info d-flex" data-ds-id="j2tmke3n" role="alert"><p><i class="bi bi-info-circle-fill me-3 h4"></i></p><div><strong>Effective Date</strong><br>This amended policy is effective immediately and applies to all grants and cooperative agreements currently active and to be awarded. Contract solicitations issued as of October 2001 must adhere to the amended policy..</div></div><h2>I. Legislative Background</h2><p>The NIH Revitalization Act of 1993, PL 103-43, signed into law on June 10, 1993, directed the NIH to establish guidelines for inclusion of women and minorities in clinical research.<br>The statute states that:</p><div class="card mb-4" data-ds-id="pb43iac5"><div class="card-body"><p class="card-text">In conducting or supporting clinical research for the purposes of this title, the Director of NIH shall ... ensure that (a) women are included as subjects in each project of such research; and (b) members of minority groups are included in such research. 492B(a)(1)<br>The statute further directed the NIH to establish guidelines to specify:<br>(a) the circumstances under which the inclusion of women and minorities as subjects in projects of clinical research is inappropriate …;<br>(b) the manner in which clinical trials are required to be designed and carried out; and<br>(c) the operation of outreach programs, 492B(d)(1)</p></div></div><p>The statute defines "clinical research" to include "clinical trials" and states that:</p><div class="card mb-4" data-ds-id="pb43iac5"><div class="card-body"><p class="card-text">In the case of any clinical trial in which women or members of minority groups will be included as subjects, the Director of NIH shall ensure that the trial is designed and carried out in a manner sufficient to provide for valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial. 492B(c)</p></div></div><p>Specifically addressing the issue of minority groups, the statute states that:</p><div class="card mb-4" data-ds-id="pb43iac5"><div class="card-body"><p class="card-text">The term "minority group" includes subpopulations of minority groups. The Director of NIH shall, through the guidelines established...define the terms "minority group" and "subpopulation" for the purposes of the preceding sentence. 492B(g)(2)</p></div></div><p>The statute speaks specifically to outreach and states that:</p><div class="card mb-4" data-ds-id="pb43iac5"><div class="card-body"><p class="card-text">The Director of NIH, in consultation with the Director of the Office of Research on Women's Health and the Director of the Office of Research on Minority Health, shall conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in the projects of clinical research. 492B(a)(2)</p></div></div><p>The statute includes a specific provision pertaining to the cost of clinical research and, in particular clinical trials.</p><div class="card mb-4" data-ds-id="pb43iac5"><div class="card-body"><p class="card-text">(A)(i) In the case of a clinical trial, the guidelines shall provide that the costs of such inclusion in the trial is (sic) not a permissible consideration in determining whether such inclusion is inappropriate. 492B(d)(2)</p><p>(ii) In the case of other projects of clinical research, the guidelines shall provide that the costs of such inclusion in the project is (sic) not a permissible consideration in determining whether such inclusion is inappropriate unless the data regarding women or members of minority groups, respectively, that would be obtained in such project (in the event that such inclusion were required) have been or are being obtained through other means that provide data of comparable quality. 492B(d)(2)</p></div></div><p>Exceptions to the requirement for inclusion of women and minorities are stated in the statute, as follows:</p><div class="card mb-4" data-ds-id="pb43iac5"><div class="card-body"><p class="card-text">The requirements established regarding women and members of minority groups shall not apply to the project of clinical research if the inclusion, as subjects in the project, of women and members of minority groups, respectively-</p><p>(1) is inappropriate with respect to the health of the subjects;<br>(2) is inappropriate with respect to the purpose of the research; or<br>(3) is inappropriate under such other circumstances as the Director of NIH may designate. 492B(b)</p><p>(B) In the case of a clinical trial, the guidelines may provide that such inclusion in the trial is not required if there is substantial scientific data demonstrating that there is no significant difference between-</p><p>(i) the effects that the variables to be studied in the trial have on women or members of minority groups, respectively; and</p><p>(ii) the effects that the variables have on the individuals who would serve as subjects in the trial in the event that such inclusion were not required. 492B(d)(2)</p></div></div><h2>II. Policy</h2><h3>A. Inclusion of Women and Minorities as Subjects in Clinical Research</h3><p>It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH-funded clinical research, unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made by the Director, NIH, upon the recommendation of an Institute/Center Director based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. This policy applies to research subjects of all ages in all NIH-supported clinical research studies.</p><p>The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design or contract proposal appropriate to the scientific objectives of the study/contract. The research plan/proposal should describe the composition of the proposed study population in terms of sex/gender and racial/ethnic group, and provide a rationale for selection of such subjects. Such a plan/proposal should contain a description of the proposed outreach programs for recruiting women and minorities as participants.</p><h3>B. NIH-defined Phase III Clinical Trials: Planning, Conducting, and Reporting of Analyses for Sex/Gender and Race/Ethnicity Differences.</h3><p>When an NIH-defined Phase III clinical trial is proposed, evidence must be reviewed to show whether or not clinically important sex/gender and race/ethnicity differences in the intervention effect are to be expected. This evidence may include, but is not limited to, data derived from prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology and other relevant studies.</p><p>Investigators must consider the following when planning, conducting, analyzing, and reporting an NIH-Defined Phase III clinical trial. Based on prior studies, one of the three situations below will apply:<br><br><strong>1. Prior Studies Support the Existence of Significant Differences</strong><br><br>If the data from prior studies strongly support the existence of significant differences of clinical or public health importance in intervention effect based on sex/gender, racial/ethnic, and relevant subpopulation comparisons, the primary question(s) to be addressed by the proposed NIH-defined Phase III clinical trial and the design of that trial must specifically accommodate this. For example, if men and women are thought to respond differently to an intervention, then the Phase III clinical trial must be designed to answer two separate primary questions, one for men and the other for women, with adequate sample size for each.<br><br>The Research Plan (for grant applications) or Proposal (for contract solicitations) must include a description of plans to conduct analyses to detect significant differences in intervention effect (<a href="/grants/glossary.htm#SignificantDifferences">see DEFINITIONS - Significant Difference</a>) by sex/gender, racial/ethnic groups, and relevant subpopulations, if applicable. The final protocol(s) approved by the Institutional Review Board (IRB) must include these plans for analysis. The award will require that for each funded protocol, investigators must report in their annual Progress Report cumulative subject accrual and progress in conducting analyses for sex/gender and race/ethnicity differences. If final analyses of sex/gender and race/ethnicity are not available at the time of the Final Progress Report or Competing Continuation for the grant, a justification and plan ensuring completion and reporting of the analyses are required. If final analyses are required as part of the contract, these analyses must be included as part of the deliverables. These requirements will be cited in the terms and conditions of all awards for grants, cooperative agreements and contracts supporting NIH-defined Phase III clinical trials.<br><br>Inclusion of the results of sex/gender, race/ethnicity and relevant subpopulations analyses is strongly encouraged in all publication submissions. If these analyses reveal no differences, a brief statement to that effect, indicating the groups and/or subgroups analyzed, will suffice.<br><br><strong>2. Prior Studies Support No Significant Differences</strong><br>If the data from prior studies strongly support no significant differences of clinical or public health importance in intervention effect based on sex/gender, racial/ethnic and/or relevant subpopulation comparisons, then sex/gender and race/ethnicity will not be required as subject selection criteria. However, the inclusion and analysis of sex/gender and/or racial/ethnic subgroups is still strongly encouraged.<br><br><strong>3. Prior Studies Neither Support nor Negate Significant Differences</strong><br>If the data from prior studies neither strongly support nor strongly negate the existence of significant differences of clinical or public health importance in intervention effect based on sex/gender, racial/ethnic, and relevant subpopulation comparisons, then the NIH-defined Phase III clinical trial will be required to include sufficient and appropriate entry of sex/gender and racial/ethnic participants, so that valid analysis of the intervention effects can be performed. However, the trial will not be required to provide high statistical power for these comparisons.<br><br>The Research Plan (for grant applications) or Proposal (for contract solicitations) must include a description of plans to conduct valid analysis (<a href="/grants/glossary.htm#ValidAnalysis">see DEFINITIONS - Valid Analysis</a>) by sex/gender, racial/ethnic groups, and relevant subpopulations, if applicable. The final protocol(s) approved by the Institutional Review Board (IRB) must include these plans for analysis. The award will require that for each funded protocol, investigators must report in their annual Progress Report cumulative subject accrual and progress in conducting analyses for sex/gender and race/ethnicity differences. If final analyses of sex/gender and race/ethnicity are not available at the time of the Final Progress Report or Competing Continuation for the grant, a justification and plan ensuring completion and reporting of the analyses are required. If final analyses are required as part of the contract, these analyses must be included as part of the deliverables. These requirements will be cited in the terms and conditions of all awards for grants, cooperative agreements and contracts supporting NIH-defined Phase III clinical trials.<br><br>Inclusion of the results of sex/gender, race/ethnicity and relevant subpopulations analyses is strongly encouraged in all publication submissions. If these analyses reveal no differences, a brief statement to that effect, indicating the groups and/or subgroups analyzed, will suffice.</p><p>For all three situations, cost is not an acceptable reason for exclusion of women and minorities from clinical trials.</p><h3>III. Roles and Responsibilities</h3><p>While this policy applies to all applicants/offerors for NIH-supported clinical research, certain individuals and groups have special roles and responsibilities with regard to its implementation.<br><br><strong>1. NIH Staff</strong><br>The NIH staff provide educational opportunities for the extramural and intramural communities concerning this policy; monitor its implementation during the development, review, award and conduct of research; and manage the NIH research portfolio to comply with the policy.<br><br><strong>2. Principal Investigators</strong><br>Principal investigators should assess the theoretical and/or scientific linkages between sex/gender, race/ethnicity, and their topic of study. Following this assessment, the principal investigator and the applicant/offeror institution will address the policy in each application and proposal, providing the required information on inclusion of women and minorities and their subpopulations in clinical research projects, and any required justifications for exceptions to the policy.<br><br>For foreign awards and domestic awards with a foreign component, the NIH policy on inclusion of women and minority groups in research is the same as that for research conducted in the U.S. If there is scientific rationale for examining subpopulation group differences within the foreign population, investigators should consider designing their studies to accommodate these differences.<br><br>Investigators and their staff(s) are urged to develop appropriate and culturally sensitive outreach programs and activities commensurate with the goals of the study or objectives of the contract. The objective should be to actively recruit and retain the most diverse study population consistent with the purposes of the research project. Indeed, the purpose should be to establish a relationship between the investigator(s) and staff(s) and populations and community(ies) of interest such that mutual benefit is derived for participants in the study. Investigator(s) should take precautionary measures to ensure that ethical issues are considered, such that there is minimal possibility of coercion or undue influence in the incentives or rewards offered in recruiting into or retaining participants in studies.<br><br>To assist investigators and potential study participants, NIH staff have prepared educational materials, including a notebook titled the, "NIH Outreach Notebook On the Inclusion of Women and Minorities in Biomedical and Behavioral Research." The notebook as well as the Frequently Asked Questions document, are located at the following URL: <a href="/grants/funding/women_min/women_min.htm">/grants/funding/women_min/women_min.htm</a><br><br><strong>3. Institutional Review Boards (IRBs)</strong><br>It is the responsibility of the IRBs to address the ethical issues as outlined in Section IV(2) for Principal Investigators. As the IRBs implement the regulation for the protection of human subjects as described in Title 45 CFR Part 46, "Protection of Human Subjects", <a href="https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html">http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html</a> they must also attend to the guidelines for the inclusion of women and minorities and their subpopulations in clinical research. They should take into account the Food and Drug Administration's "Guidelines for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs," Vol. 58 Federal Register 39406 http://www.fda.gov/cder/guidance/old036fn.pdf.<br><br><strong>4. Peer Review Groups</strong><br>In conducting peer review for scientific and technical merit, appropriately constituted initial review groups (including study sections), technical evaluation groups, and intramural review panels are instructed, as follows:</p><ul><li>to evaluate the proposed plan for the inclusion of minorities and both genders for appropriate representation or to evaluate the proposed justification when representation is limited or absent,</li><li>to evaluate the proposed exclusion of minorities and women on the basis that a requirement for inclusion is inappropriate with respect to the health of the subjects,</li><li>to evaluate the proposed exclusion of minorities and women on the basis that a requirement for inclusion is inappropriate with respect to the purpose of the research,</li><li>to determine whether the design of clinical trials is adequate to measure differences when warranted,</li><li>to evaluate the plans for valid analysis for NIH-defined Phase III clinical trials,</li><li>to evaluate the plans for recruitment/outreach for study participants, and</li><li>to include these criteria as part of the scientific assessment and evaluation.</li></ul><p>The review instructions for grants are available on line at the following URL: <a href="/grants/peer/hs_review_inst.pdf">/grants/peer/hs_review_inst.pdf</a><br><br>For contracts, the contracting officer will provide instructions for contract reviewers. Further information on instructions for contracts may be obtained at the following URL: http://oa.od.nih.gov/oamp/index.html.<br><br>Or contact:<br>National Institutes of Health<br>Division of Acquisition Policy and Evaluation<br>Office of Acquisition Management and Policy<br>6100 Executive Boulevard, Room 6C01<br>Phone: 301-496-6014<br>Fax: 301- 402-1199<br><br><strong>5. NIH Advisory Councils</strong><br>In addition to other responsibilities for review of projects where the peer review groups have raised questions about the appropriate inclusion of women and minorities, the Advisory Council/Board of each Institute/Center shall prepare biennial reports, for inclusion in the overall NIH Director's biennial report, describing the manner in which the Institute/Center has complied with the provisions of the statute.<br><br><strong>6. Institute/Center Directors</strong><br>Institute/Center Directors and their staff shall ensure compliance with the policy.<br><br><strong>7. NIH Director</strong></p><p>The NIH Director may approve, on a case-by-case basis, the exclusion of projects, as recommended by the Institute/Center Director, that may be inappropriate to include within the requirements of these guidelines on the basis of circumstances other than the health of the subjects, the purpose of the research, or costs.</p><h2>IV. Definitions</h2><p>Throughout the section of the statute pertaining to the inclusion of women and minorities, terms are used which require definition for the purpose of implementing these guidelines. These terms, drawn directly from the statute, are defined below.<br><br><strong>A. Clinical Research</strong><br>Clinical research is defined as:<br><br>(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies, (2) Epidemiologic and behavioral studies, (3) Outcomes research and health services research.<br>http://www.nih.gov/news/crp/97report/execsum.htm<br><br><strong>B. NIH-defined Clinical Trial</strong> For the purpose of these guidelines, an NIH-defined "clinical trial" is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or control intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.<br><br><strong>C. Valid Analysis</strong> <br>The term "valid analysis" means an unbiased assessment. Such an assessment will, on average, yield the correct estimate of the difference in outcomes between two groups of subjects. Valid analysis can and should be conducted for both small and large studies. A valid analysis does not need to have a high statistical power for detecting a stated effect. The principal requirements for ensuring a valid analysis of the question of interest are:</p><ul><li>allocation of study participants of both sexes/genders (males and females) and different racial/ethnic groups to the intervention and control groups by an unbiased process such as randomization,</li><li>unbiased evaluation of the outcome(s) of study participants, and</li><li>use of unbiased statistical analyses and proper methods of inference to estimate and compare the intervention effects among the sex/gender and racial/ethnic groups.</li></ul><p><strong>D. Significant Difference</strong> <br>For purposes of this policy, a "significant difference" is a difference that is of clinical or public health importance, based on substantial scientific data. This definition differs from the commonly used "statistically significant difference," which refers to the event that, for a given set of data, the statistical test for a difference between the effects in two groups achieves statistical significance. Statistical significance depends upon the amount of information in the data set. With a very large amount of information, one could find a statistically significant, but clinically small difference that is of very little clinical importance.<br>Conversely, with less information one could find a large difference of potential importance that is not statistically significant.<br><br><strong>E. Racial and Ethnic Categories</strong> <br>1. Minority Groups<br><br>A minority group is a readily identifiable subset of the U.S. population that is distinguished by racial, ethnic, and/or cultural heritage.<br><br>The Office of Management and Budget (OMB) Directive No. 15 http://www.whitehouse.gov/omb/fedreg/ombdir15.html defines minimum standards for maintaining, collecting and presenting data on race and ethnicity for all Federal reporting. NIH is required to use these definitions to allow comparisons to other federal databases, especially the census and national health databases. The categories in this classification are social-political constructs and should not be interpreted as anthropological in nature.<br><br>When an investigator is planning data collection on race and ethnicity, these categories shall be used. The collection of greater detail is encouraged. However, more detailed items should be designed in a way that they can be aggregated into these required categories. Using respondent self-report or self-identification to collect an individual's data on ethnicity and race, investigators should use two separate questions with ethnicity information collected first followed by the option to select more than one racial designation. Respondents shall be offered the opportunity to select more than one racial designation. When data are collected separately, provision shall be made to report the number of respondents in each racial category who are Hispanic or Latino.</p><h4>The following definitions apply for ethnic categories.</h4><p><strong>Hispanic or Latino</strong> - a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term "Spanish origin" can also be used in addition to "Hispanic or Latino."<br><br><strong>Not Hispanic or Latino</strong><br>The following definitions apply for racial categories.<br><br><strong>American Indian or Alaska Native</strong> - a person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliations or community attachment.<br><br><strong>Asian</strong> - a person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.)<br><br><strong>Black or African American</strong> - a person having origins in any of the black racial groups of Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American."<br><br><strong>Native Hawaiian or Other Pacific Islander</strong> - a person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.<br><br>2. Majority Group<br><br><strong>White</strong> - a person having origins in any of the original peoples of Europe, the Middle East, or North Africa.<br><br>NIH recognizes the diversity of the U.S. population and that changing demographics are reflected in the changing racial and ethnic composition of the population. The terms "minority groups" and "minority subpopulations" are meant to be inclusive, rather than exclusive, of differing racial and ethnic categories.<br><br>3. Subpopulations<br>Each racial and ethnic group contains subpopulations that are delimited by geographic origins, national origins and/or cultural differences. It is recognized that there are different ways of defining and reporting racial and ethnic subpopulation data. The subpopulation to which an individual is assigned depends on self-reporting of specific origins and/or cultural heritage. Attention to subpopulations also applies to individuals who self identify with more than one race or ethnicity. Researchers should be cognizant of the possibility that these racial/ethnic combinations may have biomedical, behavioral, and/or social-cultural implications related to the scientific question under study.<br><br><strong>F. Outreach Strategies</strong> <br>These are outreach efforts by investigators and their staff(s) to appropriately recruit and retain populations of interest into research studies. Such efforts should represent a thoughtful and culturally sensitive plan of outreach and generally include involvement of other individuals and organizations relevant to the populations and communities of interest, e.g., family, religious organizations, community leaders and informal gatekeepers, and public and private institutions and organizations. The objective is to establish appropriate lines of communication and cooperation to build mutual trust and cooperation such that both the study and the participants benefit from such collaboration.</p><h2>V. NIH Contacts for More Information</h2><p>The following senior extramural staff from the NIH Institutes and Centers may be contacted for further information about the policy and relevant Institute/Center programs:<br><br>Dr. Paulette Gray<br>National Cancer Institute<br>6116 Executive Boulevard, Suite 8001<br>Bethesda, MD 20892-8327<br>Telephone: (301) 496-5147<br>Email: <a href="/cdn-cgi/l/email-protection#fc9b8e9d858cbc98999dd2929f95d2929594d29b938a"><span class="__cf_email__" data-cfemail="395e4b584049795d5c5817575a5017575051175e564f">[email protected]</span></a><br><br>Dr. Lore Anne McNicol<br>National Eye Institute<br>Executive Plaza South<br>6120 Executive Boulevard, Room 350<br>Rockville, MD 20892<br>Telephone: (301) 496-5301<br>Email: <a href="/cdn-cgi/l/email-protection#224e4d5047434c4c470c4f414c4b414d4e624c474b0c4c4b4a0c454d54"><span class="__cf_email__" data-cfemail="ff93908d9a9e91919ad1929c91969c9093bf919a96d1919697d1989089">[email protected]</span></a><br><br>Ms. Sharry Palagi<br>National Heart, Lung and Blood Institute<br>Building 31<br>31 Center Drive, Room 5A-07<br>Bethesda, MD 20892<br>Telephone: (301) 402-3424<br>Email: <a href="/cdn-cgi/l/email-protection#2252434e43454b51624c4b4a0c454d54"><span class="__cf_email__" data-cfemail="daaabbb6bbbdb3a99ab4b3b2f4bdb5ac">[email protected]</span></a><br><br>Dr. Miriam Kelty<br>National Institute on Aging<br>Gateway Building<br>7201 Wisconsin Avenue, Room 2C218<br>Bethesda, MD 20892<br>Telephone: (301) 496-9322<br>Email: <a href="/cdn-cgi/l/email-protection#177c727b636e5a57797e7639797e7f39707861"><span class="__cf_email__" data-cfemail="553e3039212c18153b3c347b3b3c3d7b323a23">[email protected]</span></a><br><br>Dr. Eleanor Hanna<br>National Institute on Alcohol Abuse and Alcoholism<br>Willco Building<br>6000 Executive Boulevard, Suite 514<br>Rockville, MD 20892<br>Telephone: (301) 594-6231<br>Email: <a href="/cdn-cgi/l/email-protection#4a2f222b24242b7b0a272b232664242322642d253c"><span class="__cf_email__" data-cfemail="0e6b666f60606f3f4e636f67622060676620696178">[email protected]</span></a><br><br>Dr. John McGowan<br>National Institute of Allergy and Infectious Diseases<br>6700 B Rockledge<br>6700 Rockledge Drive<br>Bethesda, MD 20817<br>Telephone: (301) 496-7291<br>Email: <a href="/cdn-cgi/l/email-protection#38525500085b78565150165f574e"><span class="__cf_email__" data-cfemail="b6dcdb8e86d5f6d8dfde98d1d9c0">[email protected]</span></a><br><br>Dr. Julia Freeman<br>National Institute of Arthritis and Musculoskeletal and Skin Diseases<br>Natcher Building<br>Building 45, Room 5AS19F<br>Bethesda, MD 20892<br>Telephone: (301) 594-4543<br>Email: <a href="/cdn-cgi/l/email-protection#b1d7c3d4d4dcd0dfdbf1d4c19fdfd8d0dcc29fdfd8d99fd6dec7"><span class="__cf_email__" data-cfemail="67011502020a06090d27021749090e060a1449090e0f49000811">[email protected]</span></a><br><br>Dr. Susan Streufert<br>National Institute of Child Health and Human Development<br>6100 Executive Boulevard<br>Building 61EB, Room 4A05<br>Bethesda, MD 20892<br>Telephone: (301) 435-6856<br>Email: <a href="/cdn-cgi/l/email-protection#790a0d0b1c0c1f1c0a391418101557171011571e160f"><span class="__cf_email__" data-cfemail="067572746373606375466b676f6a28686f6e28616970">[email protected]</span></a><br><br>Dr. Julie Gulya<br>National Institute on Deafness and Other Communication Disorders<br>Executive Plaza South<br>6120 Executive Boulevard, Room 400D-7<br>Rockville, MD 20892<br>Telephone: (301) 435-4085<br>Email: <a href="/cdn-cgi/l/email-protection#5a3d2f36233b301a37297434333e393e74343332743d352c"><span class="__cf_email__" data-cfemail="5730223b2e363d173a2479393e33343379393e3f79303821">[email protected]</span></a><br><br>Dr. Norman S. Braveman<br>National Institute on Dental and Craniofacial Research<br>Natcher Building<br>Building 45, Room 4AN24C<br>Bethesda, MD 20892<br>Telephone: (301) 594-2089<br>Email: <a href="/cdn-cgi/l/email-protection#94d6e6f5e2f1f9f5fadad4f0f1a0a1bafafdf0e6bafafdfcbaf3fbe2"><span class="__cf_email__" data-cfemail="3b79495a4d5e565a55757b5f5e0f0e1555525f4915555253155c544d">[email protected]</span></a><br><br>Dr. Robert Hammond<br>National Institute of Diabetes and Digestive and Kidney Diseases<br>2 Democracy Boulevard, Room 715<br>Bethesda, MD 20892<br>Telephone: (301) 594-8834<br>Email: <a href="/cdn-cgi/l/email-protection#ff979e929290919b8dbf9a878b8d9ed191969b9b94d1919697d1989089"><span class="__cf_email__" data-cfemail="f49c9599999b9a9086b4918c808695da9a9d90909fda9a9d9cda939b82">[email protected]</span></a><br><br>Dr. Teresa Levitin<br>National Institute on Drug Abuse<br>Neuroscience Building<br>6001 Executive Boulevard, Room 3158<br>Bethesda, MD 20852<br>Telephone: (301) 443-2755<br>Email: <a href="/cdn-cgi/l/email-protection#50243c35263924393e103e3934317e3e39387e373f26"><span class="__cf_email__" data-cfemail="01756d64776875686f416f6865602f6f68692f666e77">[email protected]</span></a><br><br>Dr. Anne P. Sassaman<br>National Institute of Environmental Health Sciences<br>P.O. Box 12233, MD EC-30<br>Research Triangle Park, NC 27709<br>Telephone: (919) 541-7723<br>Email: <a href="/cdn-cgi/l/email-protection#65160416160408040b250b0c000d164b0b0c0d4b020a13"><span class="__cf_email__" data-cfemail="75061406061418141b351b1c101d065b1b1c1d5b121a03">[email protected]</span></a><br><br>Mr. Gary Marlowe<br>National Institute of General Medical Sciences<br>Natcher Building<br>Building 45, Room 2AN12L<br>Bethesda, MD 20892<br>Telephone: (301) 594-5143<br>Email: <a href="/cdn-cgi/l/email-protection#442325363d6a292536282b3321042a2d2c6a232b32"><span class="__cf_email__" data-cfemail="e58284979ccb888497898a9280a58b8c8dcb828a93">[email protected]</span></a><br><br>Dr. Richard Nakamura<br>National Institute of Mental Health<br>Neuroscience Building<br>6001 Executive Boulevard, Room 8235<br>Bethesda, MD 20852<br>Telephone: (301) 443-3675<br>Email: <a href="/cdn-cgi/l/email-protection#a8dac6c9c3c9c5dddae8c5c9c1c486c6c1c086cfc7de"><span class="__cf_email__" data-cfemail="c2b0aca3a9a3afb7b082afa3abaeecacabaaeca5adb4">[email protected]</span></a><br><br>Ms. Lynn Morin<br>National Institute of Neurological Disorders and Stroke<br>Neuroscience Building<br>6001 Executive Boulevard, Room 2152<br>Bethesda, MD 20892<br>Telephone: (301) 496-3102<br>Email: <a href="/cdn-cgi/l/email-protection#2f42405d4641431e6f4146414b5c0141464701484059"><span class="__cf_email__" data-cfemail="b9d4d6cbd0d7d588f9d7d0d7ddca97d7d0d197ded6cf">[email protected]</span></a><br><br>Dr. Mark Guyer<br>National Human Genome Research Institute<br>Building 31<br>31 Center Drive, Room B2B07<br>Bethesda, MD 20892<br>Telephone: (301) 496-7531<br>Email: <a href="/cdn-cgi/l/email-protection#fd9a8884988f90bd98859e959c939a98d3939495d39a928b"><span class="__cf_email__" data-cfemail="3a5d4f435f48577a5f4259525b545d5f14545352145d554c">[email protected]</span></a><br><br>Dr. Carole Hudgings<br>National Institute of Nursing Research<br>Natcher Building<br>45 Center Drive, Room 3AN-12<br>Bethesda, MD 20892<br>Telephone: (301) 594-5976<br>Email: <a href="/cdn-cgi/l/email-protection#513230233e3d340e39243536383f3622113f38397f363e27"><span class="__cf_email__" data-cfemail="b5d6d4c7dad9d0eaddc0d1d2dcdbd2c6f5dbdcdd9bd2dac3">[email protected]</span></a><br><br>Dr. Christine Goertz<br>National Center for Complementary and Alternative Medicine<br>Building 31<br>31 Center Drive, Room 5B-58<br>Telephone: (301) 402-1030<br>Email: <a href="/cdn-cgi/l/email-protection#c88fa7adbabcb28b88a7ace6a6a1a0e6afa7be"><span class="__cf_email__" data-cfemail="f1b69e9483858bb2b19e95df9f9899df969e87">[email protected]</span></a><br><br>Dr. Geoffrey Cheung<br>National Center for Research Resources<br>Rockledge Centre I<br>6705 Rockledge Dr, Rm 6118<br>Bethesda, MD 20817<br>Telephone: (301) 435-0768<br>Email: <a href="/cdn-cgi/l/email-protection#395a515c4c575e5e79575a4b4b17575a4b4b17575051175e564f"><span class="__cf_email__" data-cfemail="52313a37273c3535123c3120207c3c3120207c3c3b3a7c353d24">[email protected]</span></a><br><br>Dr. Kenneth Bridbord<br>Fogarty International Center<br>Building 31<br>31 Center Drive, Room B2C39<br>Bethesda, MD 20892<br>Telephone: (301) 496-2516<br>Email: <a href="/cdn-cgi/l/email-protection#b0d2c2d9d4d2dfc2d4dbf0d6d9d3dfd49ed6d9d39eded9d89ed7dfc6"><span class="__cf_email__" data-cfemail="bedcccd7dadcd1ccdad5fed8d7ddd1da90d8d7dd90d0d7d690d9d1c8">[email protected]</span></a><br><br>Dr. Joan T. Harmon<br>National Institute of Biomedical Imaging and Bioengineering<br>Room 697<br>6707 Democracy Boulevard<br>Bethesda, MD 20892<br>Telephone: (301) 594-8813<br>Email: <a href="/cdn-cgi/l/email-protection#305a5f515e6f5851425d5f5e705e59581e575f46"><span class="__cf_email__" data-cfemail="a7cdc8c6c9f8cfc6d5cac8c9e7c9cecf89c0c8d1">[email protected]</span></a></p><p>Dr. Eric Bailey<br>National Center for Minority Health and Health Disparities<br>2 Democracy Boulevard, Suite 800<br>Bethesda, MD 20817<br>Telephone: (301) 402-1366<br>Email: <a href="/cdn-cgi/l/email-protection#b9dbd8d0d5dcc0dcf9d6dd97d7d0d197ded6cf"><span class="__cf_email__" data-cfemail="5436353d38312d31143b307a3a3d3c7a333b22">[email protected]</span></a></p></div>
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