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283 KiB
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6006 lines
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<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><!--
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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>
|
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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">
|
||
|
||
|
||
|
||
<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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|
||
</nav>
|
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|
||
</div>
|
||
|
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</div>
|
||
</div>
|
||
</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">
|
||
<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/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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NIH Definition of Clinical Trial Case Studies
|
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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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<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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<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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<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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<li class="level-2 py-0 px-0 border-0 list-inline">
|
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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" 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-right 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-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/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/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/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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<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 href="https://www.nih.gov/anti-sexual-harassment/nih-staff" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Anti-Sexual Harassment Policies and Resources for NIH Staff">Anti-Sexual Harassment Policies and Resources for NIH Staff</a>
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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">
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<h1><strong><span class="field field--name-title field--type-string field--label-hidden">NIH Definition of Clinical Trial Case Studies</span>
|
||
</strong></h1>
|
||
|
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<div id="block-nihod5-subtheme-content" class="block block-system block-system-main-block">
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<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>The case studies provided below are designed to help you identify whether your study would be considered by NIH to be a clinical trial. Expect the case studies and related guidance to evolve over the upcoming year. For continuity and ease of reference, case studies will retain their original numbering and will not be renumbered if cases are revised or removed.</p></div>
|
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|
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|
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margin-bottom: 3cm !important;
|
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border: 1px solid !important;
|
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}
|
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}
|
||
</style>
|
||
|
||
<p>The simplified case studies apply the following four questions to determine whether NIH would consider the research
|
||
study to be a clinical trial:</p>
|
||
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong></li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong></li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the participants?</strong></li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral outcome?</strong></li>
|
||
</ul>
|
||
|
||
<p>If the answer to all four questions is “yes,” then the clinical study would be considered a clinical trial according
|
||
to the NIH definition.</p>
|
||
<br />
|
||
|
||
<div style="text-align: right">
|
||
<a href="#" onclick="return toggleAll()" id="toggleAll">Show All</a>
|
||
</div>
|
||
<div class="fancySection" style="margin: 10px 0">
|
||
<h3>General Case Studies</h3>
|
||
<small>Updated: 4/28/2021</small>
|
||
</div>
|
||
<div class="flexedBetween">
|
||
<div>
|
||
<select id="accordionFilterTerms" class="form-control" style="width: initial; display: inline-block">
|
||
<option value="" disabled="" selected="selected">Select a Filter</option>
|
||
<option value="besh">Basic Experimental Studies Involving Humans (BESH)</option>
|
||
<option value="behavioral">Behavioral</option>
|
||
<option value="biospecimens">Biospecimens</option>
|
||
<option value="clinicalcare">Clinical Care</option>
|
||
<option value="device">Device</option>
|
||
<option value="drug">Drug</option>
|
||
<option value="mechanistic">Mechanistic</option>
|
||
<option value="observational">Observational</option>
|
||
</select>
|
||
<button type="button" class="btn btn-primary" onclick="filterAccordion()">Apply</button>
|
||
<button type="button" class="btn btn-default" onclick="filterAccordion(true)">Clear</button>
|
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</div>
|
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<a href="#" onclick="window.print()"> Print as PDF </a>
|
||
</div>
|
||
|
||
<br />
|
||
<div class="panel-group" id="accordion" role="tablist" aria-multiselectable="true" data-status="closed">
|
||
<div class="card" data-filter="drug mechanistic">
|
||
<div class="card-header" role="tab" id="case1">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse1" aria-expanded="false" aria-controls="collapse1"
|
||
class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #1</strong>
|
||
<p>The study involves the recruitment of research participants who are randomized to receive one of
|
||
two approved drugs. It is designed to compare the effects of the drugs on the blood level of a
|
||
protein.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse1" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case1"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to receive an intervention, one of two drugs.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of the drugs on the
|
||
level of the protein in the participants’ blood.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, the level of a protein, is a
|
||
health-related biomedical outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug, Mechanistic</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="drug mechanistic">
|
||
<div class="card-header" role="tab" id="case2">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse2" aria-expanded="false" aria-controls="collapse2"
|
||
class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #2</strong>
|
||
<p>The study involves the recruitment of research participants with condition Y to receive a drug
|
||
that has been approved for another indication. It is designed to measure the drug’s effects on
|
||
the level of a biomarker associated with the severity of condition Y.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse2" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case2"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to receive an intervention, the approved drug.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the drug’s effect on the level
|
||
of the biomarker.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, the level of a biomarker, is a
|
||
health-related biomedical outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug, Mechanistic</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="drug mechanistic">
|
||
<div class="card-header" role="tab" id="case3">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse3" aria-expanded="false" aria-controls="collapse3"
|
||
class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #3</strong>
|
||
<p>The study involves the recruitment of research participants with condition X to receive
|
||
investigational compound A. It is designed to assess the pharmacokinetic properties of compound
|
||
A.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse3" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case3"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to receive an intervention, compound A.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate how the body interacts with
|
||
compound A</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, pharmacokinetic properties, is a
|
||
health-related biomedical outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug, Mechanistic</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="drug">
|
||
<div class="card-header" role="tab" id="case4a">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse4a" aria-expanded="false"
|
||
aria-controls="collapse4a" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #4a</strong>
|
||
<p>The study involves the recruitment of research participants with disease X to receive an
|
||
investigational drug. It is designed to assess safety and determine the maximum tolerated dose
|
||
of the drug.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse4a" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case4a"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to receive an intervention, the investigational drug.
|
||
</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to assess safety and determine the maximum
|
||
tolerated dose of the investigational drug.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, safety and maximum tolerated dose, is a
|
||
health-related biomedical outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="clinicalcare">
|
||
<div class="card-header" role="tab" id="case4b">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse4b" aria-expanded="false"
|
||
aria-controls="collapse4b" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #4b</strong>
|
||
<p>The study involves the recruitment of research participants with disease X to receive a chronic
|
||
disease management program. It is designed to assess usability and to determine the maximum
|
||
tolerated dose of the chronic disease program (e.g., how many in-person and telemedicine visits
|
||
with adequate adherence).</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse4b" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case4b"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to receive an intervention, the chronic disease
|
||
management program.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to determine the maximum tolerated dose of
|
||
the program to obtain adequate adherence.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, tolerable intensity and adequate
|
||
adherence of the intervention, is a health-related outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Clinical Care</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="drug">
|
||
<div class="card-header" role="tab" id="case5">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse5" aria-expanded="false" aria-controls="collapse5"
|
||
class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #5</strong>
|
||
<p>The study involves the recruitment of research participants with disease X to receive either an
|
||
investigational drug or a placebo. It is designed to evaluate the efficacy of the
|
||
investigational drug to relieve disease symptoms.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse5" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case5"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to receive an intervention, the investigational drug or
|
||
placebo.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of the
|
||
investigational drug on the participants’ symptoms.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, relief of symptoms, is a health-related
|
||
outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="drug">
|
||
<div class="card-header" role="tab" id="case6">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse6" aria-expanded="false" aria-controls="collapse6"
|
||
class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #6</strong>
|
||
<p>The study involves the recruitment of research participants with disease X to receive an
|
||
investigational drug. It is designed to assess whether there is a change in disease progression
|
||
compared to baseline. There is no concurrent control used in this study.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse6" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case6"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to receive an intervention, the investigational drug.
|
||
</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of the
|
||
investigational drug on the subject’s disease progression.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, disease progression, is a health-related
|
||
outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="device">
|
||
<div class="card-header" role="tab" id="case7a">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse7a" aria-expanded="false"
|
||
aria-controls="collapse7a" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #7a</strong>
|
||
<p>The study involves the recruitment of research participants with disease X to test an
|
||
investigational in vitro diagnostic device (IVD). It is designed to evaluate the ability of the
|
||
device to measure the level of an antibody in blood.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse7a" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case7a"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, in this
|
||
context the IVD would not be considered an intervention. The IVD is being used to test its
|
||
ability to measure antibody levels, but not to test its effects on any health-related biomedical
|
||
or behavioral outcomes. </li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Device</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="device clinicalcare">
|
||
<div class="card-header" role="tab" id="case7b">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse7b" aria-expanded="false"
|
||
aria-controls="collapse7b" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #7b</strong>
|
||
<p>The study involves the recruitment of research participants with disease X to be evaluated with
|
||
an investigational in vitro diagnostic device (IVD). The study is designed to evaluate how
|
||
knowledge of certain antibody levels impacts clinical management of disease.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse7b" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case7b"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to an intervention, measurement of an antibody level,
|
||
with the idea that knowledge of that antibody level might affect clinical management.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate how knowledge of the level of
|
||
an antibody might inform treatment.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being measured, how blood antibody levels inform
|
||
treatment, is a health-related outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Device, Clinical Care</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div data-ds-id="j2tmke3n" class="alert alert-warning border-0 border-start border-7 border-warning d-flex"
|
||
role="alert">
|
||
<i class="bi bi-exclamation-triangle-fill me-3 h4"></i>
|
||
<div>
|
||
<strong>Case #8 Update</strong><br />
|
||
As of April 28, 2021 <strong>case #8</strong> has been removed. Please refer to cases #7, #46 for related examples.
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral mechanistic besh">
|
||
<div class="card-header" role="tab" id="case9">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse9" aria-expanded="false" aria-controls="collapse9"
|
||
class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #9</strong>
|
||
<p>The study involves the recruitment of healthy volunteers who will be randomized to different
|
||
durations of sleep deprivation (including no sleep deprivation as a control) and who will have
|
||
stress hormone levels measured. It is designed to determine whether the levels of stress
|
||
hormones in blood rise in response to different durations of sleep deprivation.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse9" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case9"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the healthy volunteers are
|
||
human participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to an intervention, different durations of sleep
|
||
deprivation followed by a blood draw.</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 different
|
||
durations of sleep deprivation on stress hormone levels.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, stress hormone levels, is a
|
||
health-related biomedical outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This is a basic experimental study involving humans.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral, Mechanistic, Basic Experimental Study Involving Humans (BESH)</small>
|
||
</div>
|
||
<br /><br />
|
||
<i>* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental
|
||
aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical
|
||
Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For
|
||
more information, see our
|
||
<a href="/policy-and-compliance/policy-topics/clinical-trials/besh">BESH webpage</a>.</i>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="drug biospecimens observational">
|
||
<div class="card-header" role="tab" id="case10a">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse10a" aria-expanded="false"
|
||
aria-controls="collapse10a" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #10a</strong>
|
||
<p>The study involves the analysis of de-identified, stored blood samples and de-identified medical
|
||
records of patients with disease X who were treated with an approved drug. The study is designed
|
||
to evaluate the level of a protein in the blood of patients that is associated with therapeutic
|
||
effects of the drug.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse10a" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case10a"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> No, the study does not involve human
|
||
participants because only de-identified samples and information are used.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug, Biospecimans, Observational</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="drug biospecimens observational">
|
||
<div class="card-header" role="tab" id="case10b">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse10b" aria-expanded="false"
|
||
aria-controls="collapse10b" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #10b</strong>
|
||
<p>The study involves the analysis of identifiable, stored blood samples and identified medical
|
||
records of patients with disease X who were treated with an approved drug. The study is designed
|
||
to evaluate the level of a protein in the blood of patients that is associated with therapeutic
|
||
effects of the drug.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse10b" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case10b"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, patients are human participants
|
||
because the blood and information are identifiable.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, secondary
|
||
research with biospecimens or health information is not a clinical trial.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug, Biospecimans, Observational</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="observational">
|
||
<div class="card-header" role="tab" id="case11">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse11" aria-expanded="false"
|
||
aria-controls="collapse11" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #11</strong>
|
||
<p>The study involves the recruitment of a healthy volunteers whose blood is drawn for genomic
|
||
analysis. It is designed to identify the prevalence of a genetic mutation in the cohort and
|
||
evaluate potential association between the presence of the mutation and the risk of developing a
|
||
genetic disorder.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse11" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case11"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the healthy volunteers are
|
||
human participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, sample
|
||
collection (blood draw) is not an intervention in this context.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Observational</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="observational">
|
||
<div class="card-header" role="tab" id="case12">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse12" aria-expanded="false"
|
||
aria-controls="collapse12" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #12</strong>
|
||
<p>
|
||
Physicians report that some patients being treated with drug A for disease X are also
|
||
experiencing some improvement in a second condition, condition Y. The study involves the
|
||
recruitment of research participants who have disease X and condition Y and are being treated
|
||
with drug A. The participants are surveyed to ascertain whether they are experiencing an
|
||
improvement in condition
|
||
Y.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse12" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case12"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No,
|
||
participants are not prospectively assigned to receive an intervention as they are receiving
|
||
drugs as part of their clinical care. The surveys are being used for measurement, not to modify
|
||
a biomedical or behavioral outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug, Observational</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="clinicalcare observational">
|
||
<div class="card-header" role="tab" id="case13a">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse13a" aria-expanded="false"
|
||
aria-controls="collapse13a" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #13a</strong>
|
||
<p>The study involves the recruitment of patients with disease X who are receiving one of three
|
||
standard therapies as part of their clinical care. It is designed to assess the relative
|
||
effectiveness of the three therapies by monitoring survival rates using medical records over a
|
||
few years.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse13a" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case13a"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, there is no
|
||
intervention. The therapies are prescribed as part of clinical care; they are not prospectively
|
||
assigned for the purpose of the study. The study is observational.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Clinical Care, Observational</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="mechanistic observational">
|
||
<div class="card-header" role="tab" id="case13b">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse13b" aria-expanded="false"
|
||
aria-controls="collapse13b" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #13b</strong>
|
||
<p>The study involves the recruitment of research participants with disease X vs. healthy controls
|
||
and comparing these participants on a range of health processes and outcomes including genomics,
|
||
biospecimens, self-report measures, etc. to explore differences that may be relevant to the
|
||
development of disease X.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse13b" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case13b"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, the
|
||
measures needed to assess the outcomes are not interventions in this context, as the study is
|
||
not intended to determine whether the measures modify a health-related biomedical or behavioral
|
||
outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Mechanistic, Observational</small>
|
||
</div>
|
||
<br />
|
||
<i>The details of Case #13B have been revised and updated as of April 28, 2021.</i>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="mechanistic besh">
|
||
<div class="card-header" role="tab" id="case14">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse14" aria-expanded="false"
|
||
aria-controls="collapse14" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #14</strong>
|
||
<p>The study involves the recruitment of healthy volunteers for a respiratory challenge study;
|
||
participants are randomized to receive different combinations of allergens. The study evaluates
|
||
the severity and mechanism of the immune response to different combinations of allergens
|
||
introduced via inhalation.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse14" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case14"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, healthy volunteers are human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, healthy
|
||
volunteers are prospectively assigned to randomly selected combinations of allergens.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is evaluating the effects of different combinations of
|
||
allergens on the immune response in healthy individuals.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the study evaluates the severity and mechanism of the immune reaction
|
||
to allergens, which are health-related biomedical outcomes.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This is a basic experimental study involving humans</span>
|
||
</div>
|
||
<small>Keyword(s): Mechanistic; Basic Experimental Study Involving Humans (BESH)</small>
|
||
</div>
|
||
<br /><br />
|
||
<i>* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental
|
||
aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical
|
||
Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For
|
||
more information, see our
|
||
<a href="/policy-and-compliance/policy-topics/clinical-trials/besh">BESH webpage</a>.</i>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="drug behavioral">
|
||
<div class="card-header" role="tab" id="case15">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse15" aria-expanded="false"
|
||
aria-controls="collapse15" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #15</strong>
|
||
<p>The study involves the recruitment of research participants with Alzheimer’s disease (AD) to
|
||
evaluate the effects of an investigational drug on memory, and retention and recall of
|
||
information.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse15" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case15"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes,
|
||
participants are prospectively assigned to receive the investigational drug.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is evaluating the effects of the drug on participants’
|
||
memory.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the study evaluates memory, and retention and recall of information
|
||
in the context of AD.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug, Behavioral</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="drug behavioral">
|
||
<div class="card-header" role="tab" id="case16">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse16" aria-expanded="false"
|
||
aria-controls="collapse16" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #16</strong>
|
||
<p>The study involves the recruitment of individuals to receive a new behavioral intervention for
|
||
sedentary behavior. It is designed to measure the effect of the intervention on hypothesized
|
||
differential mediators of behavior change.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse16" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case16"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes,
|
||
participants are prospectively assigned to receive a behavioral intervention.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is evaluating the effects of the intervetion on
|
||
mediators of behavior change.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, mediators of behavior change, are
|
||
behavioral outcomes relevant to health.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug, Behavioral</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral">
|
||
<div class="card-header" role="tab" id="case17">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse17" aria-expanded="true"
|
||
aria-controls="collapse17" class="">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #17</strong>
|
||
<p>The study involves the recruitment of patients with disease X to be evaluated with a new visual
|
||
acuity task. It is designed to evaluate the ability of the new task to measure visual acuity as
|
||
compared with the gold standard Snellen Test</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse17" class="panel-collapse collapse in" role="tabpanel" aria-labelledby="case17"
|
||
aria-expanded="true" style="">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to an intervention, the new visual acuity test.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> No, the study is designed to evaluate the ability of the new visual
|
||
acuity test to measure visual acuity as compared to the gold standard Snellen Test, but not to
|
||
modify visual acuity.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral</small>
|
||
</div>
|
||
<br />
|
||
<i>The details of Case #17 have been revised and updated as of April 28, 2021.</i>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="observational behavioral mechanistic">
|
||
<div class="card-header" role="tab" id="case18">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #18</strong>
|
||
<i>Note: As of April 28, 2021 case #18 has been removed. Please refer to cases #40, #43, #44, #45 for related
|
||
examples.</i>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="observational clinicalcare">
|
||
<div class="card-header" role="tab" id="case19">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse19" aria-expanded="false"
|
||
aria-controls="collapse19" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #19</strong>
|
||
<p>The study involves the recruitment of research participants with CHF who were hospitalized before
|
||
or after implementation of the Medicare incentives to reduce re-hospitalizations. Morbidity,
|
||
mortality, and quality of life of these participants are evaluated to compare the effects of
|
||
these Medicare incentives on these outcomes.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse19" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case19"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, the
|
||
intervention (incentives to reduce re-hospitalization) were assigned by Medicare, not by the
|
||
research study.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Observational, Clinical Care</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="clinicalcare">
|
||
<div class="card-header" role="tab" id="case20">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse20" aria-expanded="false"
|
||
aria-controls="collapse20" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #20</strong>
|
||
<p>The study involves the recruitment of healthcare providers to assess the extent to which being
|
||
provided with genomic sequence information about their patients informs their treatment of those
|
||
patients towards improved outcomes.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse20" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case20"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, both the physicians and the
|
||
patients are human participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, physicians
|
||
are prospectively assigned to receive genomic sequence information, which is the intervention.
|
||
</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of intervening with
|
||
physicians, on the treatment they provide to their patients.</li>
|
||
<li><strong>Is the effect being evaluated a health-related, biomedical, or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, the extent to which providing specific
|
||
information to physicians informs the treatment of patients, is a health-related outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Clinical Care</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral">
|
||
<div class="card-header" role="tab" id="case21">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse21" aria-expanded="false"
|
||
aria-controls="collapse21" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #21</strong>
|
||
<p>
|
||
The study involves the recruitment of research participants with a behavioral condition to
|
||
receive either an investigational behavioral intervention or a behavioral intervention in
|
||
clinical use. It is designed to evaluate the effectiveness of the investigational intervention
|
||
compared to the intervention in clinical use in reducing the severity of the obsessive
|
||
compulsive
|
||
disorder.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse21" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case21"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to an intervention, either the investigational
|
||
intervention or an intervention in clinical use.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate whether the investigational
|
||
intervention is as effective as the standard intervention, at changing behavior.</li>
|
||
<li><strong>Is the effect being evaluated a health-related, biomedical, or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, the interventions’ effectiveness in
|
||
reducing the severity of the condition, is a health-related behavioral outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="clinicalcare">
|
||
<div class="card-header" role="tab" id="case23">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse23" aria-expanded="false"
|
||
aria-controls="collapse23" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #23</strong>
|
||
<p>
|
||
The study involves the recruitment of physicians who will be randomly assigned to use a new app
|
||
or an existing app, which cues directed interviewing techniques. The study is designed to
|
||
determine whether the new app is better than the existing app at assisting physicians in
|
||
identifying families in need of social service support. The number of community service
|
||
referrals will be
|
||
measured.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse23" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case23"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, both the physicians and the
|
||
families are human participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, physicians
|
||
are prospectively assigned to use one of two apps, which are the interventions.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of intervening with
|
||
physicians, on social service support referral for families.</li>
|
||
<li><strong>Is the effect being evaluated a health-related, biomedical, or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, the number of referrals, is a
|
||
health-related outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Clinical Care</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral">
|
||
<div class="card-header" role="tab" id="case27">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse27" aria-expanded="false"
|
||
aria-controls="collapse27" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #27</strong>
|
||
<p>The study involves the recruitment of parents to participate in focus groups to discuss topics
|
||
related to parental self-efficacy and positive parenting behaviors. It is designed to gather
|
||
information needed to develop an intervention to promote parental self-efficacy and positive
|
||
parenting behaviors.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse27" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case27"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the parents are human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, a focus
|
||
group is not an intervention.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral">
|
||
<div class="card-header" role="tab" id="case28">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse28" aria-expanded="false"
|
||
aria-controls="collapse28" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #28</strong>
|
||
<p>The study involves the recruitment of healthy volunteers to test a new behavioral intervention.
|
||
It is designed to evaluate the effect of a meditation intervention on adherence to exercise
|
||
regimens and quality of life to inform the design of a subsequent, fully-powered trial.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse28" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case28"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, study participants are human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to a behavioral intervention.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of the intervention
|
||
on adherence, and quality of life.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, adherence and quality of life are health-related outcomes.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral">
|
||
<div class="card-header" role="tab" id="case29">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse29" aria-expanded="false"
|
||
aria-controls="collapse29" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #29</strong>
|
||
<p>
|
||
A study will test the feasibility a mobile phone app designed to increase physical activity. A
|
||
group of sedentary individuals will use the app for a week while their interactions with the app
|
||
are monitored. The number of interactions with the app will be measured, as well as any software
|
||
issues. Participants will also complete a survey indicating their satisfaction with and
|
||
willingness to use the app, as well as any feedback for improvement. The app’s effect on
|
||
physical activity, weight, or cardiovascular fitness will not be evaluated.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse29" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case29"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, sedentary individuals will be
|
||
enrolled.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> The
|
||
participants will interact with the app for a week.</li>
|
||
<li>
|
||
<strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> No. While the participants’ interactions are monitored (steps or
|
||
heart rate may be recorded in this process), the study is NOT measuring the effect of using the
|
||
app ON the participant. The study is only measuring the usability and acceptability of the app,
|
||
and testing for bugs
|
||
in the software. The effect on physical activity is NOT being measured.
|
||
</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> N/A</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral</small>
|
||
</div>
|
||
<br />
|
||
<i>The details of Case #29 have been revised and updated as of April 28, 2021.</i>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral">
|
||
<div class="card-header" role="tab" id="case30a">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse30a" aria-expanded="false"
|
||
aria-controls="collapse30a" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #30a</strong>
|
||
<p>The study involves the recruitment of healthy family members of patients hospitalized for disease
|
||
X to test two CPR training strategies. Participants will receive one of two training strategies.
|
||
The outcome is improved CPR skills retention.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse30a" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case30a"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, family members of patients are
|
||
human participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to one of two CPR educational strategies.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of educational
|
||
strategies on CPR skills.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, retention of CPR skills is a health-related behavioral outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral">
|
||
<div class="card-header" role="tab" id="case30b">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse30b" aria-expanded="false"
|
||
aria-controls="collapse30b" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #30b</strong>
|
||
<p>The study involves the recruitment of research participants in three different communities
|
||
(clusters) to test three CPR training strategies. The rate of out-of- hospital cardiac arrest
|
||
survival will be compared.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse30b" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case30b"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to receive one of three types of CPR training, which is
|
||
the intervention.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of different CPR
|
||
training strategies on patient survival rates post cardiac arrest.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, out-of-hospital cardiac arrest survival is a health-related outcome.
|
||
</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral">
|
||
<div class="card-header" role="tab" id="case31a">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse31a" aria-expanded="false"
|
||
aria-controls="collapse31a" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #31a</strong>
|
||
<p>A study involves the recruitment of school children to evaluate two different tools for
|
||
monitoring food intake. Food consumption behavior will be measured by asking children to
|
||
activate a pocket camera during meals and to use a diary to record consumed food. The accuracy
|
||
of the two food monitoring methods in measuring energy intake will be assessed.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse31a" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case31a"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, children are human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, in this
|
||
context the monitoring methods would not be considered an intervention. The study is designed to
|
||
test the accuracy of two monitoring methods, but not to test the effect on any health-related
|
||
biomedical or behavioral outcomes. </li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral">
|
||
<div class="card-header" role="tab" id="case31b">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse31b" aria-expanded="false"
|
||
aria-controls="collapse31b" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #31b</strong>
|
||
<p>A study involves the recruitment of school children to evaluate two different tools for
|
||
monitoring food intake. Food consumption behavior will be measured by asking children to
|
||
activate a pocket camera during meals and to use a diary to record consumed food. Changes to
|
||
eating behavior will be assessed.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse31b" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case31b"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, children are human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to two food monitoring methods.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to determine whether using the monitoring
|
||
methods changes eating behavior.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, eating behavior is a health-related outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral observational">
|
||
<div class="card-header" role="tab" id="case32">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse32" aria-expanded="false"
|
||
aria-controls="collapse32" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #32</strong>
|
||
<p>A study involves the recruitment of children at two schools to monitor eating behavior.
|
||
Children’s food choices will be monitored using a remote food photography method. Food
|
||
consumption and the accuracy of food monitoring methods will be assessed.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse32" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case32"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the children participating in
|
||
this study are human participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, not in this
|
||
context. The study involves observing and measuring eating behavior, but not modifying it. This
|
||
is an observational study.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral, Observational</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral observational">
|
||
<div class="card-header" role="tab" id="case33">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse33" aria-expanded="false"
|
||
aria-controls="collapse33" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #33</strong>
|
||
<p>A study involves the recruitment of children at two schools to evaluate their preferences for
|
||
graphics and colors used in healthy food advertisements. Children will be presented with
|
||
multiple health advertisements and their preferences for graphics and colors will be assessed.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse33" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case33"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, children are human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to see different advertisements.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the advertisements.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> No, preferences are not health-related biomedical or behavioral outcomes.
|
||
</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral, Observational</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="clinicalcare">
|
||
<div class="card-header" role="tab" id="case34">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse34" aria-expanded="false"
|
||
aria-controls="collapse34" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #34</strong>
|
||
<p>
|
||
The study involves ambulatory patients who have new-onset stable angina and who are recruited
|
||
from community practices. They are randomized to undergo CT angiography or an exercise stress
|
||
test of the doctor’s choice. To keep the trial pragmatic, the investigators do not prescribe a
|
||
protocol for how physicians should respond to test results. The study is designed to determine
|
||
whether the initial test (CT angiography or stress test) affects long-term rates of premature
|
||
death, stroke, or myocardial infarctions.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse34" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case34"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are randomized to undergo CT angiography or an exercise stress test.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to determine whether the initial test done
|
||
affects long-term rates of certain clinical events.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, premature death, stroke, and myocardial infarction are health-related
|
||
biomedical outcomes.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Clinical Care</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="clinicalcare observational">
|
||
<div class="card-header" role="tab" id="case35">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse35" aria-expanded="false"
|
||
aria-controls="collapse35" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #35</strong>
|
||
<p>
|
||
The study involves patients who present with stable angina to community practices. As part of
|
||
their routine care some of their physicians refer them for CT angiography, while others refer
|
||
them for exercise stress tests. The study is designed to see whether or not there's an
|
||
association between the type of test that is chosen and long-term risk of death, stroke, or
|
||
myocardial
|
||
infarction.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse35" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case35"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, the
|
||
intervention is not prospectively assigned by the investigators. Rather, the intervention, in
|
||
this case diagnostic study, occurs as part of routine clinical care.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Clinical Trial, Observational</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral clinicalcare observational">
|
||
<div class="card-header" role="tab" id="case36a">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse36a" aria-expanded="false"
|
||
aria-controls="collapse36a" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #36a</strong>
|
||
<p>The investigators conduct a longitudinal study of patients with schizophrenia. Their physicians,
|
||
as part of their standard clinical care, prescribe antipsychotic medication. The investigators
|
||
conduct an imaging session before starting treatment; they repeat imaging 4-6 weeks later.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse36a" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case36a"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention? </strong>No, not in this
|
||
context. Antipsychotic medications are given as part of clinical care, not as part of a
|
||
prospective, approved research protocol. </li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral, Clinical Care, Observational</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral clinicalcare">
|
||
<div class="card-header" role="tab" id="case36b">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse36b" aria-expanded="false"
|
||
aria-controls="collapse36b" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #36b</strong>
|
||
<p>
|
||
The investigators conduct a longitudinal study of patients with schizophrenia. Their physicians,
|
||
as part of their standard clinical care, prescribe antipsychotic medication. As part of the
|
||
research protocol, all participants will be prescribed the same dose of the antipsychotic
|
||
medication. The investigators conduct an imaging session before starting treatment; they repeat
|
||
imaging
|
||
4-6 weeks later.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse36b" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case36b"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention? </strong>Yes, although
|
||
participants are all receiving antipsychotic medication as part of their standard medical care,
|
||
the dose of the antipsychotic medication is determined by the research protocol, rather than
|
||
individual clinical need.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of a dose of
|
||
antipsychotic medication on brain function.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome</strong>? Yes, brain function measured by imaging is a health-related outcome.
|
||
</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral, Clinical Care</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="clinicalcare">
|
||
<div class="card-header" role="tab" id="case37">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse37" aria-expanded="false"
|
||
aria-controls="collapse37" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #37</strong>
|
||
<p>The study involves recruitment of healthy volunteers who will wear a thermal compression device
|
||
around their legs. This pilot study is designed to examine preliminary performance and safety of
|
||
a thermal compression device worn during surgery. Investigators will measure core temperature,
|
||
comfort, and presence of skin injury in 15-minute intervals.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse37" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case37"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention? </strong>Yes,
|
||
participants are assigned to wear a thermal compression device.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of the thermal
|
||
compression device on participant core temperature, comfort, and presence of skin injury.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome</strong>? Yes, participant core temperature, comfort, and presence of skin
|
||
injury are health-related biomedical outcomes.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Clinical Care</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="clinicalcare observational">
|
||
<div class="card-header" role="tab" id="case38">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse38" aria-expanded="false"
|
||
aria-controls="collapse38" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #38</strong>
|
||
<p>The study involves collection of data on hospitalizations for various acute illnesses among
|
||
people who live close to a border between two states that have recently implemented different
|
||
laws related to public health (e.g. smoking regulations, soda taxes). The investigators want to
|
||
take advantage of this “natural experiment” to assess the health impact of the laws.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse38" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case38"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, the
|
||
interventions were assigned by state laws and state of residence, not by the research study.
|
||
</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Clinical Care, Observational</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="observational behavioral mechanistic">
|
||
<div class="card-header" role="tab" id="case39">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #39</strong>
|
||
<i>Note: As of April 28, 2021 case #39 has been removed. </i>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="mechanistic besh">
|
||
<div class="card-header" role="tab" id="case40">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse40" aria-expanded="false"
|
||
aria-controls="collapse40" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #40</strong>
|
||
<p>The study involves recruitment of healthy volunteers to engage in working memory tasks while
|
||
undergoing transcranial magnetic stimulation (TMS) to induce competing local neuronal activity.
|
||
The study is measuring task performance to investigate the neural underpinnings of working
|
||
memory storage and processing.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse40" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case40"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the healthy volunteers are
|
||
human participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, healthy
|
||
volunteers are prospectively assigned to receive TMS stimulation protocols during a working
|
||
memory task.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is evaluating the effects of local TMS stimulation on
|
||
working memory performance and oscillatory brain activity in healthy individuals.</li>
|
||
<li><strong> Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the study evaluates working memory processes, which are
|
||
health-related biomedical outcomes.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This is a basic experimental study involving humans</span>
|
||
</div>
|
||
<small>Keyword(s): Mechanistic, Basic Experimental Study Involving Humans (BESH)</small>
|
||
</div>
|
||
<br /><br />
|
||
<i>* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental
|
||
aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical
|
||
Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For
|
||
more information, see our
|
||
<a href="/policy-and-compliance/policy-topics/clinical-trials/besh">BESH webpage</a>.</i>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="mechanistic drug besh">
|
||
<div class="card-header" role="tab" id="case41">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse41" aria-expanded="false"
|
||
aria-controls="collapse41" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #41</strong>
|
||
<p>The study involves recruitment of healthy volunteers to engage in a social valuation task while
|
||
dopamine tone in the brain is manipulated using tolcapone, an FDA-approved medication. The study
|
||
aims to understand the role of dopamine in social decision-making and to search for neural
|
||
correlates of this valuation using fMRI.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse41" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case41"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, healthy volunteers are human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention? </strong> Yes, healthy
|
||
volunteers are prospectively assigned to receive tolcapone during a social valuation task.</li>
|
||
<li>
|
||
<strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is evaluating the effects of modulating dopamine tone
|
||
on social decision-making. Although this study uses an FDA-approved drug to modulate dopamine
|
||
tone, the goal of this intervention is to understand the role of dopamine in a fundamental
|
||
phenomenon (social
|
||
valuation), and not to study the mechanism of action of the drug or its clinical effects.
|
||
</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the study evaluates working memory processes, which are
|
||
health-related biomedical outcomes.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This is a basic experimental study involving humans</span>
|
||
</div>
|
||
<small>Keyword(s): Mechanistic, Drug, Basic Experimental Study Involving Humans (BESH)</small>
|
||
</div>
|
||
<br /><br />
|
||
<i>* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental
|
||
aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical
|
||
Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For
|
||
more information, see our
|
||
<a href="/policy-and-compliance/policy-topics/clinical-trials/besh">BESH webpage</a>.</i>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="drug">
|
||
<div class="card-header" role="tab" id="case42a">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse42a" aria-expanded="false"
|
||
aria-controls="collapse42a" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #42a</strong>
|
||
<p>
|
||
The career development candidate proposes to independently lead a study to test a new drug A on
|
||
patients with disease X. Patients will be randomized to a test and control group, with the test
|
||
group receiving one dose of drug A per week for 12 months and controls receiving placebo. To
|
||
assess presence, number, and type of any polyps, a colonoscopy will be performed. To assess
|
||
biomarkers of precancerous lesions, colon mucosal biopsies will be collected. Complete blood
|
||
count will be measured, and plasma will be stored for potential biomarker evaluation.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse42a" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case42a"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention? </strong> Yes, the
|
||
participants are prospectively assigned to receive an intervention, drug A or placebo.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of drug A and
|
||
placebo on the presence and type of polyps.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, the presence and type of polyps, is a
|
||
health-related biomedical outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="mechanistic">
|
||
<div class="card-header" role="tab" id="case42b">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse42b" aria-expanded="false"
|
||
aria-controls="collapse42b" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #42b</strong>
|
||
<p>Ancillary Study to Case Study #42a: Some types of drug A being evaluated in Case Study #42a have
|
||
been reported to impact renal function. An internal medicine fellow performs an ancillary study
|
||
where stored plasma from Case Study #42a will be evaluated for multiple biomarkers of renal
|
||
function.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse42b" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case42b"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, patients are human participants
|
||
because the plasma and information are identifiable.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention? </strong> No, because
|
||
the assignment of participants to an intervention occurs as part of an existing, separately
|
||
funded clinical trial. This proposal would be considered an ancillary study that is not an
|
||
independent clinical trial.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Mechanistic</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="drug">
|
||
<div class="card-header" role="tab" id="case42c">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse42c" aria-expanded="false"
|
||
aria-controls="collapse42c" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #42c</strong>
|
||
<p>
|
||
Ancillary Study to Case Study #42a: An internal medicine fellow designs an independent ancillary
|
||
trial where a subset of patients from the parent trial in Case Study #42a will also receive drug
|
||
B, based on the assumption that a two-drug combination will work significantly better than a
|
||
single drug at both improving renal function and reducing polyps. The test subjects will be
|
||
evaluated for renal function via plasma clearance rates at 6 and 12 months after initiation of
|
||
drugs A and B.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse42c" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case42c"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention? </strong> Yes, the
|
||
participants are prospectively assigned to receive an intervention, drugs A and B.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of drugs A and B on
|
||
renal function.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the effect being evaluated, renal function, is a health-related
|
||
biomedical outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Drug</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="besh">
|
||
<div class="card-header" role="tab" id="case43">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse43" aria-expanded="false"
|
||
aria-controls="collapse43" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #43</strong>
|
||
<p>A group of healthy young adults will perform a Go/No-Go task while undergoing fMRI scans. The
|
||
purpose of the study is to characterize the pattern of neural activation in the frontal cortex
|
||
during response inhibition, and the ability of the participant to correctly withhold a response
|
||
on no-go</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse43" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case43"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, healthy young adults 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 Go/No-Go task, which involves different
|
||
levels of inhibitory control.</li>
|
||
<li>
|
||
<strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of the Go/No-Go
|
||
task on neural activation in the frontal cortex. The study will measure inhibitory control and
|
||
the neural systems being engaged. In this study, the Go/No-Go task is the independent variable,
|
||
and behavioral
|
||
performance and the associated fMRI activations are the dependent variables.
|
||
</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the neural correlates of inhibitory control and behavioral
|
||
performance are health-related biomedical outcomes.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This is a basic experimental study involving humans</span>
|
||
</div>
|
||
<small>Keyword(s): Basic Experimental Study Involving Humans (BESH)</small>
|
||
</div>
|
||
<br /><br />
|
||
<i>* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental
|
||
aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical
|
||
Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For
|
||
more information, see our
|
||
<a href="/policy-and-compliance/policy-topics/clinical-trials/besh">BESH webpage</a>.</i>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral observational">
|
||
<div class="card-header" role="tab" id="case44a">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse44a" aria-expanded="false"
|
||
aria-controls="collapse44a" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #44a</strong>
|
||
<p>
|
||
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 <span
|
||
onclick='window.open("/policy-and-compliance/policy-topics/clinical-trials/besh#stroop","_blank")'>standard version
|
||
of the Stroop test</span> 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.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse44a" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case44a"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<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> No, 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>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral, Observational</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral besh">
|
||
<div class="card-header" role="tab" id="case44b">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse44b" aria-expanded="false"
|
||
aria-controls="collapse44b" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #44b</strong>
|
||
<p>
|
||
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.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse44b" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case44b"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<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>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This is a basic experimental study involving humans.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral, Basic Experimental Study Involving Humans (BESH)</small>
|
||
</div>
|
||
<br /><br />
|
||
<i>* Basic Experimental Studies involving Humans (BESH) use an intervention to understand fundamental
|
||
aspects of phenomena. These studies are subject to NIH stewardship policies including Good Clinical
|
||
Practice Training and the NIH Policy on Dissemination of NIH-Funded Clinical Trial information. For
|
||
more information, see our
|
||
<a href="/policy-and-compliance/policy-topics/clinical-trials/besh">BESH webpage</a>.</i>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="behavioral">
|
||
<div class="card-header" role="tab" id="case45">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse45" aria-expanded="false"
|
||
aria-controls="collapse45" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #45</strong>
|
||
<p>The study involves healthy volunteers and compares temporal SNR obtained with a new fMRI pulse
|
||
sequence with that from another sequence.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse45" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case45"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the healthy volunteers are
|
||
human participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, in this
|
||
context the different pulse sequences would not be considered an intervention. The pulse
|
||
sequences are not being used to modify any biomedical or behavioral outcome; rather the
|
||
investigator is comparing performance characteristics of the two pulse sequences.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Behavioral</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card" data-filter="device">
|
||
<div class="card-header" role="tab" id="case46">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapse46" aria-expanded="false"
|
||
aria-controls="collapse46" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>Case #46</strong>
|
||
<p>
|
||
The study is designed to demonstrate that a new imaging technology (e.g. MRI, PET, ultrasound
|
||
technologies, or image processing algorithm) is equivalent to, or has better
|
||
sensitivity/specificity than a standard of care imaging technology. Aim one will use the new
|
||
imaging technology and the gold standard in ten healthy volunteers. Aim Two will use the new
|
||
imaging technology and
|
||
the gold standard before and after a standard care procedure in ten patients. In both aims the
|
||
performance of the new technology will be compared to the gold standard. No clinical care
|
||
decisions will be made based on the use of the device in this study.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapse46" class="panel-collapse collapse" role="tabpanel" aria-labelledby="case46"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> YES. Aim one will study ten healthy
|
||
volunteers, and aim two will study ten patient volunteers.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes,
|
||
participants will be prospectively assigned to be evaluated with a new imaging technology and
|
||
the gold standard technology.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the participants?
|
||
</strong> No, the study is not measuring the effect of the technologies ON the human subjects.
|
||
The study is determining if the new technology is equivalent or better than the gold standard
|
||
technology. No effect on the participant is being measured.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
<small>Keyword(s): Device</small>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="fancySection" id="iccs" style="margin: 30px 0 10px 0">
|
||
<h3>Institute or Center specific Case Studies</h3>
|
||
<small>New: 1/4/18</small>
|
||
</div>
|
||
|
||
<div data-ds-id="j2tmke3n" class="alert alert-warning border-0 border-start border-7 border-warning d-flex"
|
||
role="alert">
|
||
<i class="bi bi-exclamation-triangle-fill me-3 h4"></i>
|
||
<div>
|
||
<strong>Warning Alert</strong><br />
|
||
Note: Filters cannot be applied to Institute or Center
|
||
Specific Case Studies
|
||
</div>
|
||
</div>
|
||
|
||
<div class="panel-group" id="accordionS2" role="tablist" aria-multiselectable="true">
|
||
<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDCR_1">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_NIDCR_1" aria-expanded="false"
|
||
aria-controls="collapseS2_NIDCR_1" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDCR #1</strong>
|
||
<p>
|
||
An investigator proposes to add secondary outcomes to an already funded clinical trial of a
|
||
nutritional intervention. The trial is supported by other funding, but the investigator is
|
||
interested in obtaining NIH funding for studying oral health outcomes. Participants in the
|
||
existing trial would be assessed for oral health outcomes at baseline and at additional time
|
||
points during a
|
||
multi-week dietary intervention. The oral health outcomes would include measures of gingivitis
|
||
and responses to oral health related quality of life questionnaires. Oral fluids would be
|
||
collected for analysis of inflammatory markers and microbiome components.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_NIDCR_1" class="panel-collapse collapse" role="tabpanel" aria-labelledby="caseS2_NIDCR_1"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, because the
|
||
assignment of participants to an intervention (and the administration of the intervention) occur
|
||
as part of an existing, separately funded clinical trial. This proposal would be considered an
|
||
ancillary study that leverages an already existing clinical trial.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<!--<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDCR_2">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_NIDCR_2" aria-expanded="true"
|
||
aria-controls="collapseS2_NIDCR_2" class="">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDCR #2</strong>
|
||
<p>
|
||
The goal of the project is to use functional neuroimaging to distinguish patients with
|
||
temporomandibular disorders (TMD) who experience TMD pain through centralized pain processes
|
||
from those with TMD related to peripheral pain. Pain processing in a study cohort of TMD
|
||
patients and
|
||
healthy controls will be measured through functional magnetic resonance neuroimaging (fMRI)
|
||
following transient stimulation of pain pathways through multimodal automated quantitative
|
||
sensory testing (MAST QST). TMD patients will receive study questionnaires to better
|
||
correlate the
|
||
extent to which TMD pain centralization influences TMD prognosis and response to standard of
|
||
care peripherally targeted treatment (prescribed by physicians, independently of the study).
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_NIDCR_2" class="panel-collapse collapse in" role="tabpanel" aria-labelledby="caseS2_NIDCR_2"
|
||
aria-expanded="true">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, not in
|
||
this context. The transient stimulation of pain pathways and the fMRI are being performed to
|
||
measure and describe brain activity, but not to modify it.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px;">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>-->
|
||
|
||
<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDCR_3">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_NIDCR_3" aria-expanded="false"
|
||
aria-controls="collapseS2_NIDCR_3" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDCR #3</strong>
|
||
<p>
|
||
An investigator proposes to perform a study of induced gingivitis in healthy humans, to study
|
||
microbial colonization and inflammation under conditions of health and disease. During a 3-week
|
||
gingivitis induction period, each study participant will use a stent to cover the teeth in one
|
||
quadrant during teeth brushing. A contralateral uncovered quadrant will be exposed to the
|
||
individual's usual oral hygiene procedures, to serve as a control. Standard clinical assessments
|
||
for gingivitis will be made and biospecimens will be collected at the point of maximal induced
|
||
gingivitis, and again after normal oral hygiene is resumed. Biospecimens will be assessed for
|
||
microbial composition and levels of inflammation-associated chemokines.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_NIDCR_3" class="panel-collapse collapse" role="tabpanel" aria-labelledby="caseS2_NIDCR_3"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are prospectively assigned to an intervention, abstaining from normal oral hygiene
|
||
for a portion of the mouth, to induce gingivitis.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to evaluate the effect of the induced
|
||
gingivitis on microbial composition and levels of inflammatory chemokines in oral samples.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, the microbial composition and chemokine levels in oral samples are
|
||
health-related biomedical outcomes.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDCD_1">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_NIDCD_1" aria-expanded="false"
|
||
aria-controls="collapseS2_NIDCD_1" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDCD #1</strong>
|
||
<p>
|
||
The study will enroll older adults with hearing loss, comparing the effectiveness of enhanced
|
||
hearing health care (HHC) to usual HHC. In addition to routine hearing-aid consultation and
|
||
fitting, participants randomized to enhanced HCC will be provided patient-centered information
|
||
and education about a full range of hearing assistive technologies and services. Study outcomes
|
||
include the utilization of technology or services, quality of life, communication abilities, and
|
||
cognitive function.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_NIDCD_1" class="panel-collapse collapse" role="tabpanel" aria-labelledby="caseS2_NIDCD_1"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study enrolls older adults
|
||
with hearing loss.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes,
|
||
participants are randomized to receive enhanced HCC or usual HCC interventions.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study will evaluate enhanced HCC’s effectiveness in
|
||
modifying participant behavior and biomedical outcomes.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, rate of technology/service utilization is a behavioral outcome and
|
||
quality of life, communications, and cognition are biomedical outcomes that may be impacted by
|
||
the interventions.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDDK_1">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_NIDDK_1" aria-expanded="false"
|
||
aria-controls="collapseS2_NIDDK_1" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDDK #1</strong>
|
||
<p>The study involves the recruitment of obese individuals who will undergo a muscle biopsy before
|
||
and after either exercise training or diet-induced weight loss. Sarcolemmal 1,2-disaturated DAG
|
||
and C18:0 ceramide species and mitochondrial function will be measured. Levels will be
|
||
correlated with insulin sensitivity.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_NIDDK_1" class="panel-collapse collapse" role="tabpanel" aria-labelledby="caseS2_NIDDK_1"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are assigned to either exercise training or a diet.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to compare the effects of the
|
||
interventions on muscle metabolism.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, muscle metabolism/signaling is a health-related outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDDK_2">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_NIDDK_2" aria-expanded="false"
|
||
aria-controls="collapseS2_NIDDK_2" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDDK #2</strong>
|
||
<p>The study involves the recruitment of participants with type 2 diabetes who will undergo a muscle
|
||
biopsy before and after a fast to measure acetylation on lysine 23 of the mitochondrial solute
|
||
carrier adenine nucleotide translocase 1 (ANT1). Levels will be related to rates of fat
|
||
oxidation.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_NIDDK_2" class="panel-collapse collapse" role="tabpanel" aria-labelledby="caseS2_NIDDK_2"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are assigned to undergo a fast.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to compare the effects of the fast on
|
||
molecular parameters of metabolism.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, metabolism is a health-related outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDDK_3">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_NIDDK_3" aria-expanded="false"
|
||
aria-controls="collapseS2_NIDDK_3" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDDK #3</strong>
|
||
<p>
|
||
Insulin-resistant and insulin-sensitive nondiabetic adults who have a parent with type 2
|
||
diabetes will be followed over time to understand the role of mitochondrial dysfunction in the
|
||
development of diabetes. Oral glucose tolerance tests will be performed annually to measure
|
||
insulin sensitivity and glycemic status. Participants will also undergo a brief bout of
|
||
exercise, and
|
||
mitochondrial ATP synthesis rates will be measured by assessing the rate of recovery of
|
||
phosphocreatine in the leg muscle, using 31P magnetic resonance spectroscopy.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_NIDDK_3" class="panel-collapse collapse" role="tabpanel" aria-labelledby="caseS2_NIDDK_3"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, the
|
||
participants are not assigned to an intervention; the OGTT and 31P MRS are measures.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDDK_4">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_NIDDK_4" aria-expanded="false"
|
||
aria-controls="collapseS2_NIDDK_4" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDDK #4</strong>
|
||
<p>Participants with chronic kidney disease will be recruited to receive one of two drug agents.
|
||
After 6 weeks of therapy, subjects will undergo vascular function testing and have measures of
|
||
oxidative stress evaluated in their plasma and urine. Results of the function testing and the
|
||
oxidative stress biomarkers will be related to drug treatment.</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_NIDDK_4" class="panel-collapse collapse" role="tabpanel" aria-labelledby="caseS2_NIDDK_4"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are assigned to receive two different drugs.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to compare the effects of the drugs on
|
||
vascular function.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, vascular function is a health-related outcome.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDDK_5">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_NIDDK_5" aria-expanded="false"
|
||
aria-controls="collapseS2_NIDDK_5" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDDK #5</strong>
|
||
<p>
|
||
Participants with Autosomal Dominant Polycystic Kidney Disease will be recruited to receive an
|
||
oral curcumin therapy or placebo and the participants will undergo vascular function testing,
|
||
renal imaging to assess kidney size, and assessment of oxidative stress biomarkers in urine and
|
||
plasma after an ascorbic acid challenge. Changes in these outcomes will be related to oral
|
||
therapy.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_NIDDK_5" class="panel-collapse collapse" role="tabpanel" aria-labelledby="caseS2_NIDDK_5"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are assigned to receive medication or placebo.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> Yes, the study is designed to compare the effects of the drugs on
|
||
vascular function and kidney size.</li>
|
||
<li><strong>Is the effect being evaluated a health-related biomedical or behavioral
|
||
outcome?</strong> Yes, vascular function and kidney size are health-related outcomes.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-check-circle text-success" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-success">This study is a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDDK_6">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_NIDDK_6" aria-expanded="false"
|
||
aria-controls="collapseS2_NIDDK_6" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDDK #6</strong>
|
||
<p>Kidney transplant recipients will be recruited to undergo an experimental imaging procedure at
|
||
several timepoints up to 4 months post-transplantation. Output from the images will be related
|
||
to pathological assessments of the transplant as well as clinical measures of renal function.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_NIDDK_6" class="panel-collapse collapse" role="tabpanel" aria-labelledby="caseS2_NIDDK_6"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> No, the
|
||
participants are not assigned to receive an intervention. They undergo transplantation as part
|
||
of their routine clinical care. The imaging procedure is a measure and not an intervention.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDDK_7">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_NIDDK_7" aria-expanded="false"
|
||
aria-controls="collapseS2_NIDDK_7" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDDK #7</strong>
|
||
<p>
|
||
The study proposes the development of a novel probe to assess clearance of a nutritional
|
||
metabolite in a given disease state. The probe is a GMP grade, deuterated, intravenously
|
||
administered tracer and clearance is assessed by mass spectrometry analysis of serial blood
|
||
draws. Participants will either receive a micronutrient supplement or will receive no
|
||
supplementation. The
|
||
clearance rate of the probe will be compared in the two groups, to understand the performance of
|
||
the probe.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_NIDDK_7" class="panel-collapse collapse" role="tabpanel" aria-labelledby="caseS2_NIDDK_7"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are assigned to receive either a micronutrient supplement or nothing.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> No, the intervention is being used to assess the performance of the
|
||
probe and is not looking at an effect on the participant.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="card">
|
||
<div class="card-header" role="tab" id="caseS2_NIDDK_8">
|
||
<a role="button" data-bs-toggle="collapse" href="#collapseS2_top" aria-expanded="false"
|
||
aria-controls="collapseS2_top" class="collapsed">
|
||
<div class="fancyHeadings">
|
||
<strong>NIDDK #8</strong>
|
||
<p>
|
||
In order to assess the contribution of ingested glycolate to oxalate production, healthy
|
||
participants will be recruited to a study involving the consumption of a controlled diet for
|
||
three days, followed by an infusion of 13C2-glycolate. Blood and urine will be collected during
|
||
the subsequent 24 hours to assess the amount of labeled glycolate in plasma and urine oxalate.
|
||
</p>
|
||
</div>
|
||
</a>
|
||
</div>
|
||
<div id="collapseS2_top" class="panel-collapse collapse" role="tabpanel" aria-labelledby="caseS2_NIDDK_8"
|
||
aria-expanded="false" style="height: 0px">
|
||
<div class="card-body">
|
||
<ul>
|
||
<li><strong>Does the study involve human participants?</strong> Yes, the study involves human
|
||
participants.</li>
|
||
<li><strong>Are the participants prospectively assigned to an intervention?</strong> Yes, the
|
||
participants are assigned to receive a controlled diet for three days.</li>
|
||
<li><strong>Is the study designed to evaluate the effect of the intervention on the
|
||
participants?</strong> No, the intervention (controlled diet) is being used to minimize
|
||
exogenous dietary sources of oxalate in the participants prior to the labeled tracer infusion.
|
||
The study will not be evaluating the effect of the diet on the participants.</li>
|
||
</ul>
|
||
<div class="flexedBetween">
|
||
<div class="flexedBetween" style="margin-right: 20px">
|
||
<i class="fas fa-times-circle text-danger" style="font-size: 1.5em; margin-right: 10px"></i>
|
||
<span class="text-danger">This study is not a clinical trial.</span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
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|
||
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|
||
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|
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|
||
<ul>
|
||
<li>
|
||
<a href="/policy-and-compliance/policy-topics/clinical-trials/ct-decision">Decision Tool: Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?</a>
|
||
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|
||
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|
||
<a href="/policy-and-compliance/policy-topics/clinical-trials/definition">NIH Definition of a Clinical Trial</a>
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