3926 lines
161 KiB
Text
3926 lines
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<title>Basic Experimental Studies Involving Humans (BESH) | Grants & Funding</title>
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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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--><form action="//search.usa.gov/search" method="get" accept-charset="UTF-8" autocomplete="off" target="_blank"><p><input name="utf8" type="hidden" value="✓"> <input name="affiliate" type="hidden" value="grants.nih.gov"></p><div class="input-group pt-3"><input class="form-search form-control rounded-0 py-1" title="Enter the terms you wish to search for" placeholder="Search this Site" type="search" name="query" value="" maxlength="128" aria-label="Search button (required)" aria-required="true" autocomplete="off" required=""> <button class="input-group-text btn btn-primary px-3 py-1" type="submit" title="Search">
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<a href="/new-to-nih" title="As you begin your journey in search of NIH grant funding, the information in this section can help you understand the structure of NIH and why it’s important to successfully navigate the grants process." 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 justify-content-lg-around" data-drupal-link-system-path="node/83">New to NIH</a>
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<a href="/funding" title="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." 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="#Funding" aria-expanded="false" data-drupal-link-system-path="node/23"> Funding <i class="bi bi-caret-down-fill"></i>
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<strong class="h4 d-none d-lg-block text-secondary">Funding</strong>
|
||
<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" title="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." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/23">Explore Funding</a>
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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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<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
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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>
|
||
<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">
|
||
|
||
|
||
|
||
<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>
|
||
|
||
|
||
|
||
|
||
</nav>
|
||
|
||
</div>
|
||
|
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</div>
|
||
</div>
|
||
</header>
|
||
<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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|
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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">
|
||
<a href="/policy-and-compliance">Policy & Compliance</a>
|
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</li>
|
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<li class="breadcrumb-item">
|
||
<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/clinical-trials">Clinical Trial Requirements for Grants and Contracts</a>
|
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</li>
|
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<li class="breadcrumb-item">
|
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Basic Experimental Studies Involving Humans (BESH)
|
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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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|
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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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|
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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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|
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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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|
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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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<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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|
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</div>
|
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</li>
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|
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|
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<li class="level-2 py-0 px-0 border-0 list-inline">
|
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|
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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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<li class="level-2 py-0 px-0 border-0 list-inline">
|
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|
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|
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<a href="/policy-and-compliance/changes-coming-2025/updates-to-training-grants" title="Expand menu Updates to NIH Institutional Training Grant Applications" class="dropdown-item py-2 ps-2 text-wrap" role="button" data-drupal-link-system-path="node/727">Updates to NIH Institutional Training Grant Applications</a>
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<a href="/policy-and-compliance/policy-topics/air/alternatives" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu When Are Alternatives to Animals Used in Research" data-drupal-link-system-path="node/880">When Are Alternatives to Animals Used in Research</a>
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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-down me-24"></i>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/definition" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH's Definition of a Clinical Trial" data-drupal-link-system-path="node/728">NIH's Definition of a Clinical Trial</a>
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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="/policy-and-compliance/policy-topics/clinical-trials/specific-funding-opportunities" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Clinical Trial-Specific Funding Opportunities" data-drupal-link-system-path="node/525">Clinical Trial-Specific Funding Opportunities</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/review-criteria" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Clinical Trial-Specific Review Criteria" data-drupal-link-system-path="node/287">Clinical Trial-Specific Review Criteria</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/good-clinical-training" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Good Clinical Practice Training" data-drupal-link-system-path="node/386">Good Clinical Practice Training</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/new-human-subject-clinical-trial-info-form" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Human Subjects and Clinical Trials Information Form" data-drupal-link-system-path="node/94">Human Subjects and Clinical Trials Information Form</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/informedconsent" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Posting Clinical Trial Informed Consent Forms" data-drupal-link-system-path="node/346">Posting Clinical Trial Informed Consent Forms</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/protocol-template" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Protocol Templates for Clinical Trials" data-drupal-link-system-path="node/427">Protocol Templates for Clinical Trials</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/clinical-trials/training-resources" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Training & Resources for NIH Clinical Trial Policies" data-drupal-link-system-path="node/873">Training & Resources for NIH Clinical Trial Policies</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/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/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/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-right 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" 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">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/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/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/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/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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|
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<a href="https://grants.nih.gov/grants-process/submit/submission-policies" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Submission Policies">Submission Policies</a>
|
||
<div class="d-none">
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</a>
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||
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<a href="/policy-and-compliance/policy-topics/harassment/actions-oversight" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu NIH Actions and Oversight" data-drupal-link-system-path="node/405"> NIH Actions and Oversight <i class="bi bi-caret-right me-24"></i>
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</a>
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<div class="d-none">
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<a href="/policy-and-compliance/policy-topics/harassment/find-help" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Find Help" data-drupal-link-system-path="node/569"> Find Help <i class="bi bi-caret-right me-24"></i>
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</a>
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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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<div class="order-1 order-lg-2 syndicate col-12 col-lg-9 ps-0 ps-lg-5">
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<div class="region region-content">
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<div data-drupal-messages-fallback class="hidden"></div>
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<div id="block-nihod5-subtheme-page-title" class="block block-core block-page-title-block">
|
||
|
||
|
||
|
||
<h1><strong><span class="field field--name-title field--type-string field--label-hidden">Basic Experimental Studies Involving Humans (BESH)</span>
|
||
</strong></h1>
|
||
|
||
|
||
</div>
|
||
|
||
<div id="block-nihod5-subtheme-content" class="block block-system block-system-main-block">
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<article class="node node--type-page node--view-mode-full">
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<div class="node__content">
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<div class="layout layout--onecol">
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<div class="layout__region layout__region--content">
|
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|
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<div class="block block-layout-builder block-field-block-node-page-field-scope-note">
|
||
|
||
|
||
|
||
<div class="clearfix text-formatted field field--name-field-scope-note field--type-text-long field--label-visually_hidden">
|
||
<div class="field__label visually-hidden">Scope Note</div>
|
||
<div class="field__item"><p>Basic experimental studies involving humans (<a href="/grants/glossary.htm#BasicExperimentalStudieswithHumans">BESH</a>) are studies that meet both the definition of <a href="/grants/glossary.htm#BasicResearch">basic research</a> and the NIH definition of a <a href="/grants/glossary.htm#ClinicalTrial">clinical trial</a>. BESH therefore are subject to NIH clinical trials policies such as registration and results reporting.</p><p>All BESH meet the NIH definition of a clinical trial, but not all clinical trials are BESH.</p></div>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
<div class="block block-layout-builder block-field-block-node-page-body">
|
||
|
||
|
||
|
||
<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><h2>Key Characteristics of BESH</h2><p>Basic Experimental Studies involving Humans (BESH) are studies that fall within the NIH definition of a <a href="/grants/glossary.htm#ClinicalTrial">clinical trial</a> and also meet the definition of <a href="/grants/glossary.htm#BasicResearch">basic research</a>. Here are some key characteristics to help identify if your study fits within a BESH funding opportunity:</p><h3>The study has the purpose of understanding fundamental aspects of phenomena <em>without</em> specific application towards processes or products in mind</h3><p>We define “process or products” as the application of biomedical or behavioral products, procedures, or services intended to affect a health-related outcome either by better understanding the mechanism of action of an intervention or a measurable improvement in health. If the study does have specific applications toward processes or products in mind (e.g., Phase I drug or device study), then the application should be submitted under a clinical trial funding opportunity, not a BESH funding opportunity.</p></div>
|
||
|
||
</div>
|
||
|
||
<div class="block block-layout-builder block-field-block-node-page-field-body-3">
|
||
|
||
|
||
|
||
<div class="clearfix text-formatted field field--name-field-body-3 field--type-text-long field--label-hidden field__item"><table data-ds-id="rf1swbxy" class="table border-dark">
|
||
<tr>
|
||
<td width="300">
|
||
<h5 class="card-title">Basic Research</h5>
|
||
<p>
|
||
A systematic study directed toward greater knowledge or understanding of the fundamental aspects of
|
||
phenomena and of
|
||
observable facts without specific applications towards processes or products in mind. (32 CFR 272.3)
|
||
</p>
|
||
</td>
|
||
<td>
|
||
<img src="/sites/default/files/BESH-venn.JPG" width="300" alt="Venn diagram with Basic Research in the left circle, Clinical Trial in the right circle, and BESH in the center overlapping area." />
|
||
</td>
|
||
<td>
|
||
<h5 class="card-title">Clinical Trial</h5>
|
||
<p>
|
||
A research study in which one or more human subjects are prospectively assigned to one or more
|
||
interventions (which may
|
||
include placebo or other control) to evaluate the effects of those interventions on health-related
|
||
biomedical or
|
||
behavioral outcomes.
|
||
</p>
|
||
</td>
|
||
</tr>
|
||
</table>
|
||
<h3>
|
||
The study uses an experimental manipulation/intervention to understand a basic phenomenon
|
||
</h3>
|
||
<p>
|
||
Basic research uses a range of probes or experimental manipulations to perturb a physiological process (including
|
||
cognitive and perceptual processes). Under the NIH definition of a clinical trial, most experimental manipulations
|
||
involving humans are considered to be interventions.
|
||
</p>
|
||
<h3>
|
||
The intervention/experimental manipulation is not intended to change the health status of the participants
|
||
</h3>
|
||
<br>
|
||
<div data-ds-id="aas23v54" class="d-flex mb-4">
|
||
<div class="d-flex flex-column">
|
||
<small class="bg-secondary bi bi-book-fill d-flex p-1 rounded-circle text-white"></small>
|
||
<div class="d-flex h-100 justify-content-around mt-1 mx-2">
|
||
<div class="bg-secondary h-100" style="width: 3px;"></div>
|
||
</div>
|
||
</div>
|
||
<div class="ps-3">
|
||
<strong>Definition</strong>
|
||
<div>Basic experimental studies involving humans (<a
|
||
href="/grants/glossary.htm#BasicExperimentalStudieswithHumans">BESH</a>) are studies
|
||
that meet both the definition of <a href="/grants/glossary.htm#BasicResearch">basic research</a> and the
|
||
NIH definition of a <a href="/grants/glossary.htm#ClinicalTrial">clinical trial</a>. BESH therefore are
|
||
subject to all NIH clinical trials policies, including but not limited to <a
|
||
href="/policy-and-compliance/policy-topics/clinical-trials/reporting">Clinical Trials Registration and
|
||
Reporting</a> requirements, <a
|
||
href="/policy-and-compliance/policy-topics/human-subjects/policies-and-regulations/data-safety">Data and
|
||
Safety Monitoring</a>, and <a
|
||
href="/policy-and-compliance/policy-topics/clinical-trials/good-clinical-training">Good Clinical
|
||
Practice Training</a>.</div>
|
||
</div>
|
||
</div>
|
||
<p>
|
||
This definition is not limited to manipulations that improve health-related endpoints in a long-term fashion. Many
|
||
experimental manipulations are considered to be interventions even if the manipulation is being used to study the
|
||
normal
|
||
function of a physiological system and the effects are short-lived, reversible, and/or benign.
|
||
</p>
|
||
<h2>
|
||
Answering the 4 Clinical Trial Questions for BESH
|
||
</h2>
|
||
<p>
|
||
There are 4 key questions that determine if a study meets the NIH definition of a clinical trial. Here are some
|
||
specific
|
||
things to consider when answering these questions in the context of basic research studies.
|
||
</p>
|
||
<table data-ds-id="jyy8ojkr" class="h-100">
|
||
<tr>
|
||
<td>
|
||
<i class="bi bi-1-circle h2"></i>
|
||
</td>
|
||
<td class="ps-4">
|
||
<strong class="h4">Does the study involve human participants?</strong>
|
||
</td>
|
||
</tr>
|
||
<tr class="h-100">
|
||
<td class="h-100 py-1">
|
||
<div class="bg-opacity-25 bg-primary h-100 mx-auto w-25"></div>
|
||
</td>
|
||
<td class="ps-4">
|
||
<p>By definition, BESH involve human participants. According to <a
|
||
href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html"
|
||
target="_blank">45 CFR 46</a>, a human subject is a living individual about whom an investigator
|
||
(whether professional or student) conducting
|
||
research:
|
||
<ul>
|
||
<li>
|
||
Obtains information or biospecimens through intervention or interaction with the individual, and
|
||
uses, studies, or
|
||
analyzes the information or biospecimens; or
|
||
</li>
|
||
<li>
|
||
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable
|
||
biospecimens.
|
||
</li>
|
||
</ul>
|
||
</p>
|
||
<p>
|
||
For further information about whether your study qualifies as human subjects research, see <a
|
||
href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html"
|
||
target="_blank">45 CFR 46</a>.
|
||
</p>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td>
|
||
<i class="bi bi-2-circle h2"></i>
|
||
</td>
|
||
<td class="ps-4">
|
||
<strong class="h4">Are the participants prospectively assigned to an intervention?</strong>
|
||
</td>
|
||
</tr>
|
||
<tr class="h-100">
|
||
<td class="h-100 py-1">
|
||
<div class="bg-opacity-25 bg-primary h-100 mx-auto w-25"> </div>
|
||
</td>
|
||
<td class="ps-4">
|
||
<p>Prospective assignment is not limited to random assignment to a manipulation or condition. “Prospectively
|
||
assigned”
|
||
means the experimental manipulation (intervention) is assigned per a predefined protocol. The method of
|
||
prospective
|
||
assignment also does not matter. Neither does the number of conditions.</p>
|
||
<p>
|
||
For more about interventions, see question #3 below.
|
||
</p>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td>
|
||
<i class="bi bi-3-circle h2"></i>
|
||
</td>
|
||
<td class="ps-4">
|
||
<strong class="h4">Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong>
|
||
</td>
|
||
</tr>
|
||
<tr class="h-100">
|
||
<td>
|
||
<div class="bg-opacity-25 bg-primary h-100 mx-auto w-25"></div>
|
||
</td>
|
||
<td class="ps-4">
|
||
<p>For BESH, the “intervention” is often an experimental manipulation being used as a probe to understand a
|
||
basic
|
||
phenomenon, process, or the mechanism of action of the manipulation. Interventions are manipulations of
|
||
the subject or
|
||
the subject’s environment that are performed for research purposes. For BESH, interventions include a
|
||
wide range of
|
||
probes, tasks, or other procedures to control, isolate, and/or manipulate a study variable (typically
|
||
the independent
|
||
variable).</p>
|
||
<p>
|
||
For example, evaluating the effect of the intervention on the participants in BESH often takes the form
|
||
of observing the
|
||
effect of the manipulation on a physiological, psychological, or social process (including cognitive and
|
||
perceptual
|
||
processes).
|
||
</p>
|
||
<p>
|
||
<strong>It is useful for BESH investigators to think of an experimental intervention as an independent
|
||
variable, which the
|
||
investigator changes or controls. The intervention (ie, independent variable) will have a direct
|
||
effect on a participant
|
||
which can be measured (i.e., directly effects a dependent variable which is tested and measured in
|
||
an experiment).</strong> In contrast to BESH, researchers conducting observational studies do not
|
||
control an independent variable. They observe
|
||
and measure variables of interest (in some cases, over time) and look for relationships between them.
|
||
The variables are
|
||
measured, but not manipulated.
|
||
</p>
|
||
<p>
|
||
For help distinguishing an intervention versus a measurement, see below.
|
||
</p>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td>
|
||
<i class="bi bi-4-circle h2"></i>
|
||
</td>
|
||
<td class="ps-4">
|
||
<strong class="h4">Is the effect being evaluated a health-related biomedical or behavioral outcome?</strong>
|
||
</td>
|
||
</tr>
|
||
<tr class="h-100">
|
||
<td></td>
|
||
<td class="ps-4">
|
||
<p>
|
||
Studies applying for NIH funding should have biomedical or behavioral outcomes in mind. In BESH, the
|
||
outcomes are often
|
||
biomedical or behavioral phenomenon or processes, or the mechanism of action of a biomedical or
|
||
behavioral manipulation.
|
||
These outcomes, even if transitory and benign, are considered health-related biomedical or behavioral
|
||
outcomes.
|
||
</p>
|
||
</td>
|
||
</tr>
|
||
</table>
|
||
<h2>
|
||
Intervention vs. Measurement
|
||
</h2>
|
||
<p>
|
||
It is possible that the same specific task or test could represent either an “intervention” or a “measurement”
|
||
depending
|
||
on how it is used, what is being measured, and why. Because of this, there cannot be a list of tests that are always
|
||
measurements, or always interventions.
|
||
</p>
|
||
<p>
|
||
<strong>If the task or test is being used to purposefully change or manipulate something about the participant and
|
||
is being used
|
||
to explore a concept – the task or test is probably an intervention. Think of the intervention as the
|
||
independent
|
||
variable in a study.</strong>
|
||
</p>
|
||
<p>
|
||
The two example cases below use the Stroop Effect, an established measure of executive function in which a person’s response
|
||
time to name the color of words presented is measured. In the standard version of the task, the colors of words
|
||
presented can be the same or different from the meaning of the word itself. The Stroop Effect is the slowing in
|
||
color
|
||
naming time for incongruent word presentations. Sometimes investigators modify the design, for example, to study the
|
||
effect of emotional content of the words (i.e. the independent variable) on the Stroop Effect. As such, depending on
|
||
how
|
||
the Stroop task is employed, it may or may not be considered an intervention.
|
||
</p>
|
||
|
||
<div data-ds-id="pb43iac5" class="card">
|
||
<div class="card-body">
|
||
<h5 class="card-title">Example A</h5>
|
||
<p class="card-text"><strong>A group of adolescents will participate in a longitudinal study examining changes in executive
|
||
function over the course
|
||
of a normal school year. Color naming performance on the standard version of the Stroop test will be
|
||
obtained. All
|
||
measures will be compared at multiple time points during the school year to examine changes in
|
||
executive function. The
|
||
purpose is to observe changes in executive function and to observe if differences exist in the
|
||
Stroop effect over the
|
||
course of the school year for these adolescents.</strong>
|
||
<ol>
|
||
<li>
|
||
<strong>Does the study involve human participants?</strong> Yes, adolescents will be enrolled in
|
||
this study.
|
||
</li>
|
||
<li>
|
||
<strong>Are the participants prospectively assigned to an intervention?</strong> No, there is no
|
||
intervention in this study and no independent variable manipulated. The adolescents are not
|
||
prospectively assigned to an intervention, but instead the investigator will examine variables
|
||
of interest (including
|
||
the Stroop test) over time. The Stroop effect is used as a measurement of point-in-time data.
|
||
</li>
|
||
<li>
|
||
<strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> N/A, there is no intervention. Performance on the Stroop test is a
|
||
well-established measure of executive function and
|
||
the test is not providing an independent variable of interest here. It is not being used to
|
||
manipulate the participants
|
||
or their environment. The purpose is simply to obtain a measure of executive function in
|
||
adolescents over the course of
|
||
the school year.
|
||
</li>
|
||
<li>
|
||
<strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> N/A. No effect of an intervention is being evaluated.
|
||
</li>
|
||
</ol>
|
||
This study is not a BESH or a clinical trial.</p>
|
||
</div>
|
||
</div>
|
||
|
||
<div data-ds-id="pb43iac5" class="card">
|
||
<div class="card-body">
|
||
<h5 class="card-title">Example B</h5>
|
||
<p class="card-text"><strong>A group of participants with social anxiety will perform an experimentally manipulated Stroop
|
||
test. In this variant of
|
||
the Stroop test, the stimuli presented are varied to include emotional and neutral facial
|
||
expressions presented in
|
||
different colors. Participants are instructed to name the colors of the faces presented, with the
|
||
expectation that they
|
||
will be slower to name the color of the emotional face than the neutral face. The purpose of the
|
||
study is to examine the
|
||
degree to which participants with social anxiety will be slower to process emotional faces than
|
||
neutral faces.</strong>
|
||
<ol>
|
||
<li>
|
||
<strong>Does the study involve human participants?</strong> Yes, participants with social
|
||
anxiety will be enrolled in this study.
|
||
</li>
|
||
<li>
|
||
<strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants will be prospectively assigned to perform a modified Stroop test using different
|
||
colored
|
||
emotional/neutral faces to explore emotional processing in people with social anxiety. Note that
|
||
the independent
|
||
variable is the presentation of emotional vs neutral faces.
|
||
</li>
|
||
<li>
|
||
<strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to measure the effect of emotional valence
|
||
(i.e. emotional faces) on participant response
|
||
time to name the color. The purpose is to determine whether the response time to emotional faces
|
||
is exaggerated for
|
||
people with social anxiety as compared to neutral faces. Note that the response time to name the
|
||
colors is the dependent
|
||
variable in this study.
|
||
</li>
|
||
<li>
|
||
<strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the processing of emotional information is a health-related
|
||
biomedical outcome.
|
||
</li>
|
||
</ol>
|
||
This study is a basic experimental study involving humans (BESH).</p>
|
||
</div>
|
||
</div>
|
||
|
||
<p><br/>
|
||
As these examples show, the context of how a task is used is important in determining whether it is being used as an
|
||
intervention or a measurement.
|
||
</p>
|
||
<br>
|
||
<div data-ds-id="gt0zmcty" class="card mb-3">
|
||
<div class="row g-0">
|
||
<div class="col-4"
|
||
style="background: url(/sites/default/files/styles/large/public/foa-types-besh.png?itok=7yLHpP-X); background-size: cover">
|
||
</div>
|
||
<div class="col-8">
|
||
<div class="card-body">
|
||
<h5 class="card-title">About BESH Funding Opportunities</h5>
|
||
<p class="card-text">
|
||
NIH has issued a series of parent funding opportunities specifically designated as "Basic
|
||
Experimental
|
||
Studies with
|
||
Humans Required" in the funding opportunity's title. Refer to our chart of <a
|
||
href="/grants/Comparison-of-FOA-Types-Clinical-Trials.pdf" width="200">funding opportunity types
|
||
by clinical
|
||
trial
|
||
allowability</a> to determine what funding opportunity may fit you best.
|
||
<br><br>
|
||
Participation in BESH funding opportunities will vary by NIH Institute and Center (IC). Be sure to
|
||
check the
|
||
participating organizations section of the funding opportunity and talk with a Program Officer to
|
||
determine
|
||
the most
|
||
appropriate funding opportunity for your application.
|
||
</p>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div></div>
|
||
|
||
</div>
|
||
|
||
<div class="block block-layout-builder block-field-block-node-page-field-body-4">
|
||
|
||
|
||
|
||
<div class="clearfix text-formatted field field--name-field-body-4 field--type-text-long field--label-hidden field__item"><h2>Policy Flexibilities for BESH Funding Opportunities</h2><p>BESH studies are subject to the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. However, NIH recognizes that registering and reporting results in <a href="https://clinicaltrials.gov/" target="_blank">ClinicalTrials.gov</a> may pose a challenge for some types of BESH. NIH has delayed the enforcement for ClinicalTrials.gov registration and results reporting through September 24, 2025.</p><p><strong>This delayed enforcement is only applicable to BESH studies submitted to funding opportunities designated as “basic experimental studies with humans” in the title. It does not apply to applications submitted under a clinical trials required or clinical trials optional funding opportunity.</strong></p><p>During this period of delayed enforcement, NIH continues to expect registration and results reporting for studies submitted to BESH funding opportunities, but with the additional flexibility to register and report results on alternative publicly available platforms.</p><p>Plans for meeting the NIH reporting expectations using an alternative platform should be described at the time of application in the Dissemination Plan attachment. Funded awardees for applications submitted to BESH-specific funding opportunities who are not using ClinicalTrials.gov to meet the policy expectation should provide in their annual progress reports the unique identifier assigned by the alternative platform, if available, and a link to the report (e.g., page or record) in the alternative platform.</p><p>NIH also continues to expect <a href="/policy-and-compliance/policy-topics/clinical-trials/good-clinical-training">Good Clinical Practice</a> (GCP) training for all personnel involved in the conduct, oversight, or management of Basic Experimental Studies involving Humans (BESH). Additionally, all such applications continue to require completion of the full <a href="/policy-and-compliance/policy-topics/clinical-trials/new-human-subject-clinical-trial-info-form">PHS Human Subjects and Clinical Trials Information form</a>, and will be evaluated using the <a href="/grants/guide/notice-files/NOT-OD-17-118.html">clinical trial review criteria</a>.</p><p>See <a href="/grants/guide/notice-files/NOT-OD-24-118.html">NOT-OD-24-118</a> for additional details.</p><h2>Tips for BESH Investigators</h2><p><strong>Talk to a Program Official:</strong> All applicants are strongly encouraged to talk with a Program Official before submitting an application. Program Officials can help determine the right funding opportunity for your specific research. If you are unsure who the right Program Official is, try out our <a href="https://reporter.nih.gov/matchmaker" target="_blank">Matchmaker Tool</a>!</p><p><strong>Review BESH Case Studies:</strong> Check out the BESH <a href="/policy-and-compliance/policy-topics/clinical-trials/case-studies?filter=besh#collapseS2_top">Case Studies</a> to help understand what type of studies meet the criteria for a BESH funding opportunity.</p><p><strong>Consider the Funding Opportunities:</strong> While BESH studies can be appropriately conducted under any “clinical trial required” or “clinical trial optional” funding opportunity, the policy flexibilities for BESH studies are only applicable to BESH studies conducted under specific BESH funding opportunities. Therefore, it is recommended that BESH studies apply to BESH funding opportunities when feasible.</p><p><strong>Get to know the Human Subjects & Clinical Trial Information Form:</strong> Take a <a href="https://www.youtube.com/watch?v=FNgOHqmk0rY&list=PLOEUwSnjvqBJeHcb4yai7_fDnFZFPEmQK&index=2&t=0s" target="_blank">video tour</a> of the application form to familiarize yourself with how this information is collected.</p></div>
|
||
|
||
</div>
|
||
|
||
<div class="block block-layout-builder block-extra-field-block-node-page-workbench-moderation-control">
|
||
|
||
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</article>
|
||
|
||
</div>
|
||
|
||
<div id="block-grants-learningcenterresources" class="block block-oer-resources-module block-learning-center-resources-block">
|
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|
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<div class="row">
|
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<h3 class="border-5 border-secondary border-top col-12 col-md-3 pt-3 text-secondary">FAQs</h3>
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<div class="border-5 border-top border-white col-12 col-md-9 pt-3">
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<div id="featured-faq-wrapper"></div>
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|
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|
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|
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</div>
|
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<div class="general-resources-block mb-4">
|
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<h4>
|
||
<strong>General</strong>
|
||
</h4>
|
||
<p>
|
||
<ul><li><a href="/news-events/podcasts?episode=966">All About Grants Podcast: Basic Experimental Studies Involving Humans</a></li></ul>
|
||
</p>
|
||
</div>
|
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<div class="videos-block mb-4">
|
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<h4>
|
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|
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