3343 lines
135 KiB
Text
3343 lines
135 KiB
Text
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<title>Resources for Preparing Your Application | Grants & Funding</title>
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>
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A <strong>.gov</strong> website belongs to an official government<br />
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A <strong>lock</strong> (🔒) or <strong>https://</strong> means you've safely connected to the .gov website.<br class="d-none d-lg-block">Share sensitive information only on official, secure websites.
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<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><div id="redirect-banner" class="alert rounded-0 d-flex bg-info bg-opacity-50 alert-dismissible px-3 px-lg-5 mb-0 d-none" role="alert">
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<h5><strong>Redirect Notice</strong></h5>
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It looks like you have reached this page through a <em>permanent</em> redirect. Please update your links/bookmarks to the new URL.
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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="https://www.era.nih.gov/" class="nav-link px-3 py-0 border-end">eRA</a>
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<a href="/grants/glossary.htm" class="nav-link px-3 py-0 border-end" data-drupal-link-system-path="node/33">Glossary</a>
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<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
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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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<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
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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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</a>
|
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<div>
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<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="Funding" data-bs-parent="#block-nihod5-subtheme-main-navigation">
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<div class="container">
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<div class="row">
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<div class="col-12 col-lg-6 px-4 p-lg-5">
|
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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>
|
||
<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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</div>
|
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<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
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<div class="border-start ps-4">
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<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
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<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
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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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</li>
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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/funding-categories" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/21">Funding Categories</a>
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</li>
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<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
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|
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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>
|
||
</li>
|
||
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<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
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|
||
<a href="/funding/explore-data-on-funded-projects" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/24">Explore Who and What NIH Funds</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/grants-process" title="Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#GrantsProcess" aria-expanded="false" data-drupal-link-system-path="node/49"> Grants Process <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="GrantsProcess" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">Grants Process</strong>
|
||
<p class="d-none d-lg-block">Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting.</p>
|
||
<a href="/grants-process" title="Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/49">Explore Grants Process</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/plan-to-apply" title="Plan ahead, assess funding opportunities, and take other early steps. Learn to work with your organization, assess resources and teammates, identify a funding opportunity, check application policies, and lay out your timeline." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1073">Plan to Apply</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/write-application" title="Find the official grant application instructions, preview application forms, get advice on grant writing, check out sample grant applications, and read our tips on specific application attachments and sections." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/670">Write Application</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/submit" title="Learn about the steps you must take after filling out your application forms to complete the submission process, how NIH checks your application for completeness prior to review, and NIH submission policies." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/43">Submit</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/review" title="What happens between the time you submit the application and NIH lets you know you will be funded? Learn more about receipt and referral and NIH’s peer review process." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1082">Review</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/award" title="When NIH awards a grant, we are formalizing our partnership with the recipient to ensure compliance with federal laws, regulations and policies." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1083">Award</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/post-award-monitoring-and-reporting" title="If your organization is the recipient of a grant from the NIH, you will need to pay close attention to the terms of award to be successful stewards of federal funds. Learn about reporting and monitoring requirements." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/349">Post-Award Monitoring and Reporting</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/policy-and-compliance" title="By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block bg-gradient shadow" data-bs-toggle="collapse" data-bs-target="#PolicyCompliance" aria-expanded="false" data-drupal-link-system-path="node/3"> Policy & Compliance <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="PolicyCompliance" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">Policy & Compliance</strong>
|
||
<p class="d-none d-lg-block">By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise.</p>
|
||
<a href="/policy-and-compliance" title="By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/3">Explore Policy & Compliance</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/changes-coming-2025" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/188">Changes Coming for 2025</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/nihgps" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/216">Grants Policy Statement</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/notice-of-policy-changes" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="policy-and-compliance/notice-of-policy-changes">Notices of Policy Changes</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/compliance-and-oversight" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/259">Compliance & Oversight</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/policy-topics" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1075">Policy Topics</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/news-events" title="Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#NewsEvents" aria-expanded="false" data-drupal-link-system-path="news-events"> News & Events <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="NewsEvents" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">News & Events</strong>
|
||
<p class="d-none d-lg-block">Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more.</p>
|
||
<a href="/news-events" title="Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="news-events">Explore News & Events</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/calendar-of-events" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="news-events/calendar-of-events">Calendar of Events</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/on-demand-event-resources" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/335">On-Demand Event Resources</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/subscribe-follow" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1118">Subscribe and Follow</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="https://nexus.od.nih.gov/all/category/open-mike/" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold">"Open Mike" Blog</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="https://nexus.od.nih.gov/all/" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold">Extramural Nexus (News)</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/podcasts" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/712">Podcasts</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/aboutoer" title="Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#AboutUs" aria-expanded="false" data-drupal-link-system-path="node/597"> About Us <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="AboutUs" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">About Us</strong>
|
||
<p class="d-none d-lg-block">Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio.</p>
|
||
<a href="/aboutoer" title="Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/597">Explore About Us</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/aboutoer/oer-offices" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/514">OER Offices</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
|
||
|
||
|
||
</nav>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
</header>
|
||
<main role="main">
|
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<a id="main-content" tabindex="-1"></a>
|
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|
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|
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|
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<div class="container my-0 p-4 px-lg-0">
|
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<div class="region region-breadcrumb">
|
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|
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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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|
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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>
|
||
<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance">Policy & Compliance</a>
|
||
</li>
|
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<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance/policy-topics">Policy Topics</a>
|
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</li>
|
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<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance/policy-topics/reproducibility">Enhancing Reproducibility through Rigor and Transparency</a>
|
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</li>
|
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<li class="breadcrumb-item">
|
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Resources for Preparing Your Application
|
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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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|
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<div class="row">
|
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<div class="order-2 order-lg-1 d-none d-lg-block col-lg-3">
|
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<div class="region region-sidebar-first p-0">
|
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<nav role="navigation" aria-labelledby="block-nihod5-subtheme-mainnavigation-menu" id="block-nihod5-subtheme-mainnavigation" class="block block-menu navigation menu--main">
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|
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<h5 class="visually-hidden" id="block-nihod5-subtheme-mainnavigation-menu">Main navigation (Sidebar Template)</h5>
|
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|
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|
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|
||
|
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|
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<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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|
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|
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|
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|
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<li class="level-0 py-0 px-0 border-0 dropdown">
|
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|
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|
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<a href="/policy-and-compliance" title="Expand menu Policy & Compliance" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center nav-link fs-5 mb-3 border-bottom border-3 border-primary fw-bold" role="button" data-drupal-link-system-path="node/3">Policy & Compliance</a>
|
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<div class="d-block">
|
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|
||
<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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|
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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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|
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<li class="level-2 py-0 px-0 border-0 list-inline">
|
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|
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|
||
<a href="https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Simplified Review Framework for Most Research Project Grants (RPGs) ">Simplified Review Framework for Most Research Project Grants (RPGs) </a>
|
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<div class="d-none">
|
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|
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|
||
</div>
|
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</li>
|
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|
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|
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|
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|
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<li class="level-2 py-0 px-0 border-0 list-inline">
|
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|
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|
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<a href="https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/revisions-nih-fellowship-application-review-process" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Revisions to the NIH Fellowship Application and Review Process ">Revisions to the NIH Fellowship Application and Review Process </a>
|
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<div class="d-none">
|
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|
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|
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</div>
|
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</li>
|
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|
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|
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|
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|
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|
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|
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<li class="level-2 py-0 px-0 border-0 list-inline">
|
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|
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|
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<a href="/policy-and-compliance/changes-coming-2025/updates-to-training-grants" title="Expand menu Updates to NIH Institutional Training Grant Applications" class="dropdown-item py-2 ps-2 text-wrap" role="button" data-drupal-link-system-path="node/727">Updates to NIH Institutional Training Grant Applications</a>
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<a href="/policy-and-compliance/policy-topics/air/alternatives" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu When Are Alternatives to Animals Used in Research" data-drupal-link-system-path="node/880">When Are Alternatives to Animals Used in Research</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Clinical Trial Requirements for Grants and Contracts" data-drupal-link-system-path="node/434"> Clinical Trial Requirements for Grants and Contracts <i class="bi bi-caret-right 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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<h1><strong><span class="field field--name-title field--type-string field--label-hidden">Resources for Preparing Your Application</span>
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<div class="field__label visually-hidden">Scope Note</div>
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<div class="field__item"><p>Wondering how to translate the application instructions to successfully demonstrate rigor in your application? Learn more about how to prepare a rigorous application with examples of rigor, and resources like the experimental design assistant (EDA), guidance on sample size calculation, authentication plan examples, and more. </p></div>
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<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><h2>Scientific Rigor Examples</h2><p> These brief excerpts of rigor are taken from awarded applications reviewed under a pilot funding opportunity for rigorous experimental design. Note that these examples were selected based on high overall impact scores and positive reviewer comments specific to rigor. These examples are provided to show how elements of rigor and transparency have been succinctly provided in applications; they may not represent all of the aspects and may still have room for improvement. These examples may be updated as applications are reviewed and awarded under the revised rigor and transparency review language.<br> </p><h3>Example #1</h3><p><strong>Aim 3:</strong> Male and female mice will be randomly allocated to experimental groups at age 3 months. At this age the accumulation of CUG repeat RNA, sequestration of MBNL1, splicing defects, and myotonia are fully developed. The compound will be administered at 3 doses (25%, 50%, and 100% of the MTD) for 4 weeks, compared to vehicle-treated controls. IP administration will be used unless biodistribution studies indicate a clear preference for the IV route. A group size of n = 10 (5 males, 5 females) will provide 90% power to detect a 22% reduction of the CUG repeat RNA in quadriceps muscle by qRT-PCR (ANOVA, α set at 0.05). The treatment assignment will be blinded to investigators who participate in drug administration and endpoint analyses. This laboratory has previous experience with randomized allocation and blinded analysis using this mouse model [refs]. Their results showed good reproducibility when replicated by investigators in the pharmaceutical industry [ref].<br> </p><h3>Example #2</h3><p><strong>Aim 1:</strong> Primary screen: In this high throughput screening assay, we combined the SMN promoter with exons 1-6 and an exon 7 splicing cassette in a single construct that should respond to compounds that increase SMN transcription, exon 7 inclusion, or potentially stabilize the SMN RNA or protein [refs]. The details of the assay and the SMN2-luciferase reporter HEK393 cell line have been extensively validated [refs]. Each point is run in triplicate, the compounds are tested on three separate occasions, and the results are averaged to give an EC50 with standard deviation. Secondary screen: …We analyze SMN protein levels by dose response in quantitative immunoblots with statistical analysis by one-way ANOVA with post-hoc analysis using Dunnett or Bonferroni, as appropriate.<br><br><strong>Aim 2:</strong> Each set of compounds will include a blinded negative control compound that has been determined to be inactive and that is solubilized in the same manner as test compounds. Mice will be randomly assigned within a litter, and data will be collected and submitted to the PI. For compounds that demonstrate extended survival, the PI will be sure to have these tested in {the collaborators’} labs, and data will be merged and evaluated. To calculate the number of the experimental mice, we will perform an SSD sample size power analysis to ensure that the appropriately minimal number of mice is used in each experimental context. Typically for each compound in life span studies, we will need ~20 SMA animals in the treated group; ~20 SMA animals in the vehicle treated group; ~20 SMA animals in the untreated group. If we can administer the compound in aqueous solution without expedient, the vehicle and untreated groups might be combined, as these should have identical survival. Therefore, no more than 80 SMA animals will be needed per compound.<br> </p><h3>Example #3</h3><p><strong>Aim 2:</strong> Intensity signal data will be transformed into log values and then modeled by longitudinal methods (reference cited). Specifically, the composite difference in mean intensity signals over time between the bi-specific T cells vs. control groups is assumed to be 2.8 logs with a composite standard deviation of 2.2 logs. Furthermore, we will assume at least five repeated measurements per mouse after T cell infusion and a within-mouse intra-correlation coefficient equal to 0.50. Thus, a sample size of 10 mice per group will provide at least 80% power to detect the above difference between treated versus control group with a 5% significance level. Log-rank test will be used to compare the survival distribution between groups.<br><br>VAS: Animal numbers are based on the requirement to perform each experiment (power and sample size calculations are described in the Research Strategy), which includes an independent experimental repeat.<br> </p><h3>Example #4</h3><p><strong>Aim 1:</strong> Statistical considerations: In our preliminary studies consisting of this same cohort of DFUs (n=100) and utilizing 16S rRNA sequencing, we were able to detect dimensions of DFU microbiome, including microbial diversity, that were significantly associated with DFU outcomes. We therefore anticipate that the sample size will provide sufficient power to detect significant differences using metagenomic sequencing, as this is a more sensitive and less-biased assay of microbial identification and diversity.<br><br><strong>Aim 3:</strong> Random Forests, a machine learning approach for classification, will be used to determine which metagenome features differentiate groups (e.g., antibiotics vs. no antibiotics; pre- vs. post-debridement). Random Forest uses a bootstrap method to assess test error, ideal in our situation of small sample size (n=18). For diversity and load measures, significance between groups will be assessed using non-parametric Wilcoxon rank-sum tests.<br> </p><p> </p><h2>Resources and Tools for Rigorous Experimental Design</h2><p><a href="https://www.nc3rs.org.uk/experimental-design-assistant-eda"><strong>The Experimental Design Assistant – EDA</strong></a><br>The Experimental Design Assistant (EDA) is a free online tool from the NC3Rs, designed to guide researchers through the design of their experiments, helping to ensure that they use the minimum number of animals consistent with their scientific objectives, methods to reduce subjective bias, and appropriate statistical analysis. <a href="https://eda.nc3rs.org.uk/experimental-design-group">See additional guidance on experimental design, including sample size estimation</a>.<br> <br><a href="http://www.equator-network.org/"><strong>EQUATOR Network Reporting Guidelines</strong></a><br>The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network is an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines. The Library contains a comprehensive searchable database of reporting guidelines and also links to other resources relevant to research reporting.<br> </p><h2>Authentication Plan Examples</h2><p> </p><h3>Example #1: Authentication of Key Biological and/or Chemical Resources</h3><p><strong>Chemicals </strong><br>All acquired compounds and reagents will be authenticated for both identity and purity using standard techniques and methods for the characterization of small molecules according to the guidelines of the American Chemical Society. Experimental techniques employed routinely in the lab for the authentication of chemicals include NMR, EPR, and UV-visible absorption spectroscopy, mass spectrometry, X-ray diffraction analysis, cyclic voltammetry, magnetometry, and combustion analysis. This information will be included in peer-reviewed publications on the project, along with details on commercial sources for precursors and any necessary purification, handling and storage of reagents and products (e.g., under an inert atmosphere).<br> <br><strong>Plasmid DNA </strong><br>Plasmid NNNN-NNN for the expression of NNNN in mammalian cells was obtained from Addgene (#NNNN) and validated through Sanger sequencing.<br> <br><strong>Antibodies </strong><br>Antibodies for proteins associated with NNNNN were obtained from commercial manufacturers providing hybridoma clone identification, lot number and appropriate references. The specificity of the antibodies employed in this study will be authenticated by immunoblot analysis (including knockdown samples when possible) and appropriate controls are included in every experiment. In addition, we will monitor the Antibody Registry database to be aware of any issues observed by other investigators with antibodies in use in our laboratory.<br> <br><strong>Cell lines </strong><br>The breast and colon adenocarcinoma cell lines (MCF7, MDA-MB-231, Caco-2) and the normal fibroblasts (MRC5 and CCD18-co) employed in this project so far were purchased from the American Tissue Culture Collection (ATCC). The pancreatic cancer cell lines to be used for testing of constructs targeting NNNN are available in the lab and have been authenticated by sequencing. Additional cell lines for the project will be obtained from ATCC or from the National Cancer Institute through the RAS Initiative. All our cell lines are authenticated periodically at the University of Arizona Genetics Core facility by Short Tandem Repeat (STR) profiling. Our cell cultures are continuously monitored for doubling times and morphology, and they are tested periodically for contamination from mycoplasma and bacteria using standard detection kits. Each culture is passaged less than 20 times. We typically assess the quality of commercially obtained reagents for cell-based assays (e.g., MTT, 2',7'-dichlorodihydrofluorescein) by NMR spectroscopy and/or liquid chromatography/mass spectrometry (LC-MS).<br> </p><p> </p></div>
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