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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/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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<a href="/funding/find-a-fit-for-your-research-nih-institutes-centers-offices" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/25">Find a Fit for Your Research: NIH Institutes, Centers, and Offices</a>
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|
||
<a href="/funding/explore-data-on-funded-projects" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/24">Explore Who and What NIH Funds</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/grants-process" title="Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#GrantsProcess" aria-expanded="false" data-drupal-link-system-path="node/49"> Grants Process <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="GrantsProcess" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">Grants Process</strong>
|
||
<p class="d-none d-lg-block">Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting.</p>
|
||
<a href="/grants-process" title="Take time to learn about each step in the grants process from planning to apply through developing and submitting your application to award and post-award reporting." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/49">Explore Grants Process</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/plan-to-apply" title="Plan ahead, assess funding opportunities, and take other early steps. Learn to work with your organization, assess resources and teammates, identify a funding opportunity, check application policies, and lay out your timeline." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1073">Plan to Apply</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/write-application" title="Find the official grant application instructions, preview application forms, get advice on grant writing, check out sample grant applications, and read our tips on specific application attachments and sections." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/670">Write Application</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/submit" title="Learn about the steps you must take after filling out your application forms to complete the submission process, how NIH checks your application for completeness prior to review, and NIH submission policies." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/43">Submit</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/review" title="What happens between the time you submit the application and NIH lets you know you will be funded? Learn more about receipt and referral and NIH’s peer review process." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1082">Review</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/award" title="When NIH awards a grant, we are formalizing our partnership with the recipient to ensure compliance with federal laws, regulations and policies." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1083">Award</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/grants-process/post-award-monitoring-and-reporting" title="If your organization is the recipient of a grant from the NIH, you will need to pay close attention to the terms of award to be successful stewards of federal funds. Learn about reporting and monitoring requirements." class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/349">Post-Award Monitoring and Reporting</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/policy-and-compliance" title="By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block bg-gradient shadow" data-bs-toggle="collapse" data-bs-target="#PolicyCompliance" aria-expanded="false" data-drupal-link-system-path="node/3"> Policy & Compliance <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="PolicyCompliance" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">Policy & Compliance</strong>
|
||
<p class="d-none d-lg-block">By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise.</p>
|
||
<a href="/policy-and-compliance" title="By accepting a grant award, recipients agree to comply with the requirements in the NIH Grants Policy Statement unless the notice of award states otherwise." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/3">Explore Policy & Compliance</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/changes-coming-2025" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/188">Changes Coming for 2025</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/nihgps" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/216">Grants Policy Statement</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/notice-of-policy-changes" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="policy-and-compliance/notice-of-policy-changes">Notices of Policy Changes</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/compliance-and-oversight" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/259">Compliance & Oversight</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/policy-and-compliance/policy-topics" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1075">Policy Topics</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/news-events" title="Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#NewsEvents" aria-expanded="false" data-drupal-link-system-path="news-events"> News & Events <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="NewsEvents" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">News & Events</strong>
|
||
<p class="d-none d-lg-block">Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more.</p>
|
||
<a href="/news-events" title="Get the "scoop" on the latest news related to the NIH grant application and award processes, grants policy, research funding and biomedical workforce analyses, and more." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="news-events">Explore News & Events</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
||
|
||
<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/calendar-of-events" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="news-events/calendar-of-events">Calendar of Events</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/on-demand-event-resources" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/335">On-Demand Event Resources</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/subscribe-follow" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/1118">Subscribe and Follow</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="https://nexus.od.nih.gov/all/category/open-mike/" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold">"Open Mike" Blog</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="https://nexus.od.nih.gov/all/" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold">Extramural Nexus (News)</a>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/news-events/podcasts" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/712">Podcasts</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static d-lg-block flex-grow-1">
|
||
|
||
|
||
|
||
<a href="/aboutoer" title="Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#AboutUs" aria-expanded="false" data-drupal-link-system-path="node/597"> About Us <i class="bi bi-caret-down-fill"></i>
|
||
</a>
|
||
<div>
|
||
<div class="container-fluid rounded-0 w-100 start-0 bg-white text-black shadow position-absolute collapse z-3" id="AboutUs" data-bs-parent="#block-nihod5-subtheme-main-navigation">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-12 col-lg-6 px-4 p-lg-5">
|
||
<strong class="h4 d-none d-lg-block text-secondary">About Us</strong>
|
||
<p class="d-none d-lg-block">Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio.</p>
|
||
<a href="/aboutoer" title="Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/597">Explore About Us</a>
|
||
</div>
|
||
<div class="col-12 col-lg-6 px-4 pb-3 p-lg-5 ps-lg-0">
|
||
<div class="border-start ps-4">
|
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|
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<ul class="bg-white p-0 start-0 ps-lg-5 border-lg-start border-light h-100 menu-level-1">
|
||
|
||
|
||
|
||
<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<a href="/aboutoer/oer-offices" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/514">OER Offices</a>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
|
||
</ul>
|
||
|
||
|
||
|
||
|
||
</nav>
|
||
|
||
</div>
|
||
|
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</div>
|
||
</div>
|
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</header>
|
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<main role="main">
|
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<a id="main-content" tabindex="-1"></a>
|
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|
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|
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<div class="container my-0 p-4 px-lg-0">
|
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<div class="region region-breadcrumb">
|
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<div id="block-nihod5-subtheme-breadcrumbs" class="block block-system block-system-breadcrumb-block">
|
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|
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<nav aria-label="breadcrumb">
|
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<h2 id="system-breadcrumb" class="visually-hidden">Breadcrumb</h2>
|
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<ol class="breadcrumb">
|
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<li class="breadcrumb-item">
|
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<a href="/">Home</a>
|
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</li>
|
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<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance">Policy & Compliance</a>
|
||
</li>
|
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<li class="breadcrumb-item">
|
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NIH Welcome Wagon Letter – Information for New Recipient Organizations
|
||
</li>
|
||
</ol>
|
||
</nav>
|
||
|
||
</div>
|
||
|
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</div>
|
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|
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<div class="row">
|
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<div class="order-1 order-lg-2 syndicate col-12">
|
||
<div class="region region-content">
|
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<div data-drupal-messages-fallback class="hidden"></div>
|
||
|
||
<div id="block-nihod5-subtheme-page-title" class="block block-core block-page-title-block">
|
||
|
||
|
||
|
||
<h1><strong><span class="field field--name-title field--type-string field--label-hidden">NIH Welcome Wagon Letter – Information for New Recipient Organizations</span>
|
||
</strong></h1>
|
||
|
||
|
||
</div>
|
||
|
||
<div id="block-nihod5-subtheme-content" class="block block-system block-system-main-block">
|
||
|
||
|
||
|
||
<article class="node node--type-page node--view-mode-full">
|
||
|
||
|
||
|
||
|
||
|
||
<div class="node__content">
|
||
<div class="layout layout--onecol">
|
||
<div class="layout__region layout__region--content">
|
||
|
||
<div class="block block-layout-builder block-field-block-node-page-body">
|
||
|
||
|
||
|
||
<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><!--- Start Common Content ---><!--- NOTE: Content from here down is identical to "http://odoerdb2-1.od.nih.gov/gmac/sources/pol_welcome2.html"
|
||
with the following exceptions on the Public site:
|
||
1. Add Exit Disclaimer (2 links - search for .edu) - <cfinclude template="/CommonGrants/exit_disclaimer.cfm">
|
||
2. Replace "subtitle" style with "headline3_black" - 21 replacements
|
||
ANY CHANGES TO THIS FILE ALSO NEED TO BE MADE TO THE COMPANION VERSION ABOVE AND TO THE MS WORD FILE:
|
||
"http://odoerdb2-1.od.nih.gov/gmac/download/welcome2.doc"
|
||
---><!--
|
||
<table cellpadding="0" cellspacing="0" style="width:100%">
|
||
|
||
|
||
<tbody>
|
||
|
||
|
||
<tr>
|
||
|
||
|
||
<td align="center">
|
||
<a href="/grants/funding/welcomewagon.htm?ShowTOC=No">Hide Table of Contents</a> <a href="/grants/funding/welcomewagon.htm?ShowTOC=Yes">Show Table of Contents</a><br />
|
||
<br />
|
||
|
||
|
||
|
||
</td>
|
||
|
||
|
||
</tr>
|
||
|
||
|
||
</tbody>
|
||
</table>
|
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--><table style="width:90%;" align="center" bgcolor="#e7e7e7" border="1" cellpadding="10" cellspacing="0"><tbody><tr><td style="text-align:center;" colspan="2"><strong>Table of Contents</strong></td></tr><tr><td style="vertical-align:top;" align="left" height="330" width="48%"><table style="height:306px;width:100%;" border="0" cellpadding="0" cellspacing="0"><tbody><tr><td style="vertical-align:top;" width="96%"><ul style="list-style-type:none;"><li><a href="#req"><strong>I. Requirements and Provisions</strong></a><ul style="list-style-type:none;"><li><a href="#term"><strong>A. </strong>Terms of Award </a><ul style="list-style-type:none;"><li><a href="#gps"><strong>A.1. </strong>The National Institutes of Health Grants Policy Statement </a><br><a href="#cost"><strong>A.2. </strong>Administrative Regulations (including Cost Principles)</a></li></ul></li><li><a href="#rprtreq"><strong>B. </strong>Reporting Requirements</a><ul style="list-style-type:none;"><li><a href="#transparency"><strong>B.1. </strong>Transparency Act Subaward and Executive Compensation Reporting</a></li><li><a href="#progressreport"><strong>B.2. </strong>Progress Reporting (Annual, Interim and Final)</a></li><li><a href="#ffr"><strong>B.3.</strong> Financial Reporting on the Federal Financial Report (FFR or SF 425)</a></li><li><a href="#inventionsrprt"><strong>B.4.</strong> Inventions Report</a></li><li><a href="#sbirsttr"><strong>B.5.</strong> SBIR/STTR Reporting Requirements</a></li><li><a href="#auditrprt"><strong>B.6. </strong>Audit Reporting Requirements</a></li></ul></li></ul></li></ul></td></tr></tbody></table></td><td style="vertical-align:top;" align="left" width="52%"><table style="height:234px;width:100%;" border="0" cellpadding="0" cellspacing="0"><tbody><tr><td style="vertical-align:top;" width="96%"><ul style="list-style-type:none;"><li> <ul style="list-style-type:none;"><li><a href="#publicpolicyreq"><strong>C.</strong> Public Policy Requirements</a><ul style="list-style-type:none;"><li><a href="#humansubjects"><strong>C1.</strong> Protection of Human Subjects in Research</a></li><li><a href="#clinicaltrials"><strong>C2.</strong> Registering Clinical Trials</a></li><li><a href="#lar"><strong>C3.</strong> Care and Use of Laboratory Animals in Research</a></li><li><a href="#dna"><strong>C4.</strong> Recombinant DNA</a></li><li><a href="#misconduct"><strong>C5.</strong> Research Integrity and Research Misconduct</a></li><li><a href="#fcoi"><strong>C6.</strong> Objectivity in Research (Financial Conflict of Interest)</a></li></ul></li></ul></li><li><a href="#otherinfo"><strong>II. Other Information </strong></a><ul style="list-style-type:none;"><li><a href="#payment"><strong>A.</strong> Payment </a><br><a href="#rateneg"><strong>B.</strong> Rate Negotiations</a><br><a href="#eRA"><strong>C.</strong> eRA Commons</a><br><a href="#oer"><strong>D.</strong> OER Resources</a></li></ul></li></ul></td></tr></tbody></table></td></tr></tbody></table><p><br><!--- Page Content ---></p><p>Dear Institutional Official:</p><p class="rtejustify">This letter provides important information that is critical to the successful administration and fiscal management of your grant award or cooperative agreement (hereinafter referred to as a “grant” or “award”) from the <a href="http://www.nih.gov/">National Institutes of Health</a> (NIH). Key requirements, referrals to important sources of information, and identification of NIH and other <a href="https://www.hhs.gov/">Department of Health and Human Services</a> (HHS) offices with responsibility for certain administrative functions are included.<br><br>While this letter highlights or summarizes important issues, it does not serve as a substitute for the <a href="/policy-and-compliance/nihgps">NIH Grants Policy Statement</a> (NIHGPS) or any other federal requirements, provisions or terms of award.</p><h2 id="req">I. Requirements and Provisions</h2><h3 id="term">A. Terms of Award</h3><p class="rtejustify">Acceptance of an award from NIH obligates the recipient to be aware of and comply with the terms and conditions of award. Each <a href="/grants/policy/nihgps/HTML5/section_5/5_the_notice_of_award.htm">Notice of Award</a> (NoA) states:<br><br>"...This award is based on the application submitted to, and as approved by, NIH . . . and is subject to the terms and conditions incorporated either directly or by reference in the following:</p><ul><li class="rtejustify">The grant program legislation and program regulation cited in this Notice of Award.</li><li class="rtejustify">Conditions on activities and expenditure of funds in other statutory requirements, such as those included in <a href="/policy-and-compliance/policy-topics/nih-fiscal-policies">appropriation acts</a>.</li><li class="rtejustify">45 CFR Part 75.</li><li class="rtejustify">The National Policy Requirements and all other requirements described in the National Institutes of Health Grants Policy Statement including addenda in effect at the beginning date of the budget period.</li><li class="rtejustify">Federal Award Performance Goals: As required by the periodic report in the Research Performance Progress Report (RPPR) or in the Final RPPR when applicable.</li><li class="rtejustify">This award notice, INCLUDING THE TERMS AND CONDITIONS CITED BELOW.</li></ul><p class="rtejustify">See the <a href="/grants-process/award/awards-conditions-and-information-for-nih-grants">Award Conditions and Information for NIH Grants</a> page on the <a href="/">NIH Grants & Funding</a> website for references cited above.</p><p id="gps"><strong>A.1. The National Institutes of Health Grants Policy Statement</strong></p><p class="rtejustify">The <a href="/policy-and-compliance/nihgps">NIHGPS</a> is a term and condition for all NIH awards; <a href="/grants/policy/nihgps/HTML5/part_ii_subpart_b.htm">Part II, Terms and Conditions of NIH Grant Awards</a> contains the legally binding requirements for all grant recipients. By drawing funds from the designated payment system, the recipient agrees to the terms and conditions of an award.<br><br>The NIHGPS covers policy topics including, but not limited to, modular applications, SNAP (streamlined non-competing award process), prior approval requirements, and awards to foreign entities. A search mechanism is provided to facilitate easy access to the information that is contained within the NIHGPS.<br><br>See <a href="/policy-and-compliance/nihgps">NIH Grants Policy Statement</a> page for PDF and HTML versions of the NIHGPS.</p><p id="cost"><strong>A. 2. Administrative Regulations (including Cost Principles)</strong></p><p class="rtejustify">The HHS rules and requirements that govern the administration of grants are found at Title 2 Code of Federal Regulations (CFR) Part 200 (codified by HHS at <a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=f76b1a39eff9c6202de471fe1141835d&mc=true&node=pt45.1.75&rgn=div5">45 CFR Part 75</a>). Part 75 applies to all recipients of NIH awards. These regulations (in addition to the NIHGPS) are a term and condition of award. Grant recipients must be aware of and comply with these regulations.<br><br>The Uniform regulations include reference to the applicable cost principles. The costs of a grant-supported activity are comprised of allowable direct costs, plus the allocable portion of the organization's associated facilities and administrative (F&A) costs. Direct costs are costs that can be specifically identified with a particular project or program, while F&A costs are incurred for common or joint objectives and which therefore cannot be identified specifically with a particular project or program. The allowability, reasonableness, and necessity of direct and F&A costs that may be charged to NIH grants are currently outlined in the following three areas where recipients can locate the applicable set of cost principles:</p><table border="1" cellpadding="2" cellspacing="2"><tbody><tr><td style="vertical-align:top;"><a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=f76b1a39eff9c6202de471fe1141835d&mc=true&node=pt45.1.75&rgn=div5#sp45.1.75.e">45 CFR Part 75, Subpart E</a></td><td style="vertical-align:top;">Institutions of Higher Education, State and Local Governments and Indian Tribes and Nonprofit Organizations</td></tr><tr><td style="vertical-align:top;"><a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=f76b1a39eff9c6202de471fe1141835d&mc=true&node=pt45.1.75&rgn=div5#ap45.1.75_1521.ix">45 CFR Part 75</a> , Appendix IX</td><td style="vertical-align:top;">Hospitals</td></tr><tr><td style="vertical-align:top;">48 CFR Subpart 31.2 (<a href="https://www.acquisition.gov/far/subpart-31.2">Federal Acquisition Regulations, or FAR</a>)</td><td style="vertical-align:top;">For-profit Organizations</td></tr></tbody></table><p> </p><h3 id="rprtreq">B. Reporting Requirements</h3><p class="rtejustify">There are reporting requirements associated with every NIH grant. This section includes information on reports required by the Transparency Act, financial reports, progress reports, invention reports, and audit reports. Recipients are reminded that these reports are due at specific times during the life cycle of a grant. It is important that all reports are accurate, complete, and submitted on time. See also the following section on Public Policy Requirements for highlighted requirements that include ongoing reporting.</p><p id="transparency"><strong>B. 1. Transparency Act Subaward and Executive Compensation Reporting</strong></p><p class="rtejustify">The Federal Funding Accountability and Transparency Act of 2006, as amended ("Transparency Act"), required the establishment of a single searchable database, accessible to the public, with information on financial assistance awards made by Federal agencies. Recipients of Federal grants are also required to report subaward and executive compensation (e.g., names and total compensation of the five most highly compensated officers) information in regards to first-tier subawards greater than or equal to $25,000 into the <a href="https://www.fsrs.gov/">Federal Subaward Reporting System (FSRS)</a> no later than the end of the month following the month in which the obligation was made. </p><p class="rtejustify">In addition to those requirements, once fully implemented The Digital Accountability and Transparency Act of 2014, (DATA Act) will amend the Transparency Act, to require full disclosure of all Federal agency expenditures. Full implementation of the DATA Act will require the development of Government-wide data standards which will simplify financial reporting and improve the quality of spending data made available on <a href="https://www.usaspending.gov/">USAspending.gov</a>.</p><p>Additional information on these reporting requirements can be found on the <a href="/grants-process/post-award-monitoring-and-reporting/reporting-requirements/federal-funding-accountability-and-transparency-act">NIH FFATA</a> website.</p><p id="progressreport"><strong>B. 2. Progress Reporting</strong> <strong>(Annual, Interim and Final)</strong></p><p class="rtejustify">Progress reports are required annually to document NIH recipient accomplishments and compliance with the terms and conditions of award. They describe scientific progress, identify significant changes, report on personnel, and describe plans for the subsequent budget period or year. NIH requires all recipients of NIH awards to submit annual progress reports using the Research Performance Progress Report (RPPR) module within eRA Commons. Reports submitted in any other format will not be processed and will require resubmission in the RPPR format.</p><p class="rtejustify">A Final RPPR is due no later than 120 days from the period of performance end date.</p><p class="rtejustify">However, if the recipient organization has submitted a renewal application on or before the date that the Final RPPR would be required for the most recent competitive segment, then the recipient must submit an "Interim RPPR" to document the progress of that competitive segment. </p><p class="rtejustify">The Final and Interim RPPR follow the same general format as the current annual RPPR with one exception. Recipients are required to report on Project Outcomes, which should be in plain language because they will be made publicly available.</p><p id="ffr"><strong>B. 3. Financial Reporting on the Federal Financial Report (FFR or SF 425)</strong></p><p class="rtejustify">Reports of expenditures are required as documentation of the financial status of grants according to the official accounting records of the recipient organization. Expenditure reporting is accomplished using the Standard Form 425 (SF425).<br><br>Except for awards under the Streamlined Non-Competing Award Process (SNAP) and awards that require more frequent reporting, the FFR expenditure data is required annually and must be submitted within 90 days following the calendar quarter in which the budget period ended. A final expenditure report for all grants, including those subject to SNAP, is due 120 days after the close of the competitive segment.<br><br>Institutions must submit expenditure reports electronically in the HHS Payment Management System.</p><p id="inventionsrprt"><strong>B. 4. Inventions Report</strong></p><p class="rtejustify">The Bayh-Dole Act (P.L. 96-517) grants recipients the right to elect title and retain ownership to inventions they develop with funding under an NIH funding award ("subject inventions"). In accepting an award, the recipient agrees to comply with applicable NIH policies, the Bayh-Dole Act, and its Government-wide implementing regulations found at Title 37, Code of Federal Regulations (CFR) Part 401.<br><br>A significant part of the regulations require that the recipient report all subject inventions to the awarding agency (see <a href="/grants/policy/nihgps/HTML5/section_8/8.4.1_reporting.htm#Inventio">NIH Grants Policy Statement, Section 8.4.1.6 Invention Reporting</a>), as well as include an acknowledgement of federal support in any U.S. patent applications and issued patents thereon (see 37 CFR 401.14(a)(f)(4) for specific language). NIH participates in the trans-government electronic <a href="https://www.nist.gov/iedison">Interagency Edison</a> system and requires recipients to use this system to comply with Bayh-Dole and related intellectual property reporting requirements. In addition, the invention must be reported in renewal and non-competing continuation applications. Invention reporting policy questions should be directed as follows:</p><p class="rtejustify">Division of Extramural Inventions and Technology Resources (DEITR),<br>Office of Policy for Extramural Research Administration (OPERA), OER, NIH<br>6705 Rockledge Drive, MSC 7980<br>Bethesda, MD 20892-7980<br>(301) 435-1986<br><a href="/cdn-cgi/l/email-protection#10557479637f7e507e79783e777f66"><span class="__cf_email__" data-cfemail="581d3c312b373618363130763f372e">[email protected]</span></a></p><p class="rtejustify">Invention reporting documents or questions pertaining to renewal and non-competing continuation applications should be directed to the NIH awarding Institute or Center, as specified on the NoA.</p><p class="rtejustify">All subject inventions also must be included on the Final Invention Statement and Certification (HHS 568), which is required within 120 days following the expiration or termination of the project (see <a href="/grants/policy/nihgps/HTML5/section_8/8.6.3_final_invention_statement_and_certification.htm">NIH Grants Policy Statement, Section 8.6.3 Final Invention Statement and Certification</a>). The Final Invention Statement and Certification should be submitted through the eRA Commons using the Closeout feature. </p><p id="sbirsttr"><strong>B. 5. SBIR/STTR Reporting Requirements</strong></p><p class="rtejustify">The Small Business Act requires agencies to collect meaningful information from Small Business Concerns (SBC) and ensure that reporting requirements are streamlined to minimize the burden on small businesses. For information regarding reporting requirements, see the <a href="https://www.sbir.gov/about#policy-directive">SBIR/STTR Policy Directive</a>.</p><p id="auditrprt"><strong>B. 6. Audit Reporting Requirements</strong></p><p class="rtejustify">NIH recipients or subrecipients (other than Federal institutions) that expend $750,000 or more in Federal awards (grants, cooperative agreements, and/or procurement contracts) during their fiscal year are subject to an audit requirement. Organizations expending less than $750,000 during their fiscal year are not required to have an annual audit for that year but must make their grant related records available to NIH or other designated officials for review or audit.</p><p class="rtejustify">Audit requirements for State and local governments, and non-profit organizations (including institutions of higher education) receiving Federal awards or subawards, are defined in <a href="http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75#sp45.1.75.f"><strong>45 CFR Part 75, Subpart F, Audit Requirements</strong></a>. A completed data collection form and the Single Audit reporting package (see <a href="https://facides.census.gov/InstructionsDocuments.aspx">Single Audit Checklist, Instructions, and Form</a>) must be submitted on line using the <a href="https://facides.census.gov/Account/Login.aspx">Federal Audit Clearinghouse's Internet Data Entry System (IDES)</a>.</p><p class="rtejustify">Audit requirements for for-profit (commercial) organizations, including for-profit hospitals, are defined in <strong>45 CFR Part 75.501 (h)-(k). </strong>A for-profit organization is required to have a non-Federal audit if, during its fiscal year, it expended a total of $750,000 or more under one or more HHS awards (as a direct recipient or consortium participant). Foreign organizations must follow the same requirements as for-profit organizations as stated in the NIH GPS. For-profit and foreign organizations are provided with two options to satisfy the audit requirements: either (1) a financial-related audit of all HHS awards as defined in, and in accordance with, the Government Auditing Standards (commonly known as the <a href="https://www.gao.gov/yellowbook">Yellow Book</a>); or (2) an audit that meets the requirements of <strong>45 CFR Part 75, Subpart F- Audit Requirements</strong>. The SF-SAC data collection form is not required to accompany the audit report. Audit reports of for-profit and foreign organizations should be electronically submitted by email to:</p><p class="rtejustify">Department of Health and Human Services<br>Audit Resolution Division<br>(833) 524-0169<br><a href="/cdn-cgi/l/email-protection#b6f7c3d2dfc2e4d3c5d9dac3c2dfd9d8f6dedec598d1d9c0"><span class="__cf_email__" data-cfemail="1150647578654374627e7d6465787e7f517979623f767e67">[email protected]</span></a></p><p class="rtejustify">Additional information relating to audit requirements for for-profit organizations is available on the <a href="https://oamp.od.nih.gov/division-of-financial-advisory-services/dfas-frequently-asked-questions/for-profit-audits">Division of Financial Advisory Services Frequently Asked Questions</a> website. It is imperative that recipients submit required audit within the specified time limits.</p><h3 id="publicpolicyreq">C. Public Policy Requirements</h3><p class="rtejustify">NIH grants are subject to requirements intended to ensure that recipient organizations handle their Federal awards responsibly. The term "public policy" indicates that the requirement is based on social, economic, or other objectives or considerations that may be attached to the expenditure of Federal funds by recipients, consortium participants, and contractors, in general, or may relate to the expenditure of Federal funds for research or other specified activities. Refer to Exhibit 4 in <a href="/grants/policy/nihgps/HTML5/section_4/4.1_public_policy_requirements_and_objectives.htm">NIH Grants Policy Statement, Section 4.1 Public Policy Requirements and Objectives</a>. </p><p class="rtejustify">Upon signing an application requesting Federal financial assistance, applicants certify compliance with public policy requirements, some of which are established or originate in legislative or regulatory provisions. These policies govern such areas as objectivity in research, civil rights, environmental impact, biosafety, drug-free workplace, debarment and suspension, Federal debt, and lobbying with Federal funds, and are intended to ensure fairness and equity, as well as physical and other protections in activities which receive PHS financial assistance. The public policy requirements and objectives governing NIH awards are fully presented in the NIHGPS; recipients must understand their compliance responsibilities with these public policy requirements.<br><br>Public policy requirements concerning civil rights, handicapped individuals, sex discrimination, and age discrimination require the one-time submission of <a href="https://www.hhs.gov/sites/default/files/forms/hhs-690.pdf">Assurance Form HHS 690</a> prior to award. In all subsequent applications, the recipient certifies that the form has been filed. To inquire as to whether your organization has previously filed the HHS 690, contact the <a href="https://www.hhs.gov/ocr/">HHS Office for Civil Rights</a> (<a href="https://www.hhs.gov/ocr/about-us/contact-us/index.html">OCR Contact Us</a>).<br><br>Selected Public Policy Requirements are described below; some of these requirements include ongoing reporting. See <a href="/grants/policy/nihgps/HTML5/section_4/4_public_policy_requirements__objectives_and_other_appropriation_mandates.htm">NIH Grants Policy Statement, Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates</a> for a full list of requirements applicable to NIH grants.</p><p id="humansubjects"><strong>C. 1. Protection of Human Subjects in Research</strong></p><p class="rtejustify">Every institution proposing to "engage" in human subjects research is required to obtain from the <a href="https://www.hhs.gov/ohrp/">HHS Office for Human Research Protections</a> (OHRP) a Federal-wide Assurance (FWA) that indicates that the institution will comply with the regulations pertaining to the protection of human subjects in research (<a href="https://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html">45 CFR Part 46</a>), unless the research is exempt under 45 CFR 46.101(b).<br><br>An institution becomes engaged in human subjects research when its employees or agents plan to (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes (45 CFR 46.102(d)(f)). An institution is automatically considered to be engaged in human subject’s research whenever it receives a direct HHS award to support such research.<br><br>NIH awards permitting research involving human subjects will be made only after OHRP has issued an FWA to the institution. In addition, the recipient must provide certification to NIH that the research has been reviewed and approved by an Institutional Review Board (IRB) within 12 months of the budget period start date, and that the research will be subject to continuing review by the IRB.<br><br>Instructions for obtaining <a href="http://ohrp.cit.nih.gov/efile/FwaStart.aspx">FWA</a>s and registering IRBs are found on the <a href="https://www.hhs.gov/ohrp/">OHRP website</a>. Obtaining FWAs and providing certification of IRB review and approval are "just-in-time" procedures (i.e., may be provided to NIH after peer review but prior to funding) as specified in <a href="/grants/policy/nihgps/HTML5/section_2/2.5.1_just-in-time_procedures.htm">NIH Grants Policy Statement, Section 2.5.1 Just-in-time Procedures</a>.<br><br>The recipient institution bears ultimate responsibility for protecting human subjects under the award, including human subjects at all collaborating sites, and for ensuring that collaborating sites have FWAs and certification of IRB review and approval before human subjects research is conducted.<br><br>Additional information is available on NIH websites regarding <a href="/policy-and-compliance/policy-topics/human-subjects">human subjects research</a>, <a href="/policy-and-compliance/policy-topics/human-subjects/pre-and-post-award-processes/study-monitoring">data safety and monitoring</a> for clinical trials, <a href="/faqs#/hs-human-subjects-education.htm">required education</a> for the protection of human research participants, <a href="/policy-and-compliance/policy-topics/inclusion/women-and-minorities">inclusion of women and minorities</a>, and <a href="/policy-and-compliance/policy-topics/inclusion/lifespan">inclusion across the lifespan</a>.</p><p id="clinicaltrials"><strong>C. 2. Registering Clinical Trials</strong></p><p class="rtejustify"><a href="http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf" title="http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf">Public Law 110-85</a>, also known as the Food and Drug Administration Amendments Act (FDAAA), which was enacted on September 27, 2007 amends the Public Health Service Act to expand the scope of clinical trials that must be registered in <a href="https://clinicaltrials.gov/">ClinicalTrials.gov</a>. It also increases the number of registration fields that must be submitted, requires certain results information to be included and sets penalties for noncompliance.<br><br>FDAAA includes the requirement that if an “applicable clinical trial” is funded in whole or in part by a grant from any agency of the Department of Health and Human Services, any grant or progress report forms required under such grant shall include a certification that the “responsible party” has made all required submissions for the applicable clinical trial to ClinicalTrials.gov.<br><br>For those awards that support an applicable clinical trial, applicants and recipients are required to certify compliance with FDAAA. See <a href="/policy-and-compliance/policy-topics/clinical-trials/reporting">Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov</a>.</p><p class="rtejustify">NIH issued a policy on the Dissemination of NIH-Funded Clinical Trial Information. The policy is complementary to the requirements of FDAAA and establishes the expectation that all investigators conducting clinical trials funded in whole or in part by NIH will ensure that these trials are registered at and results information is reported in ClinicalTrials.gov. The policy applies to all NIH-funded clinical trials regardless of the study phase, type of intervention, or whether they are subject to FDAAA. However, the policy does not apply to a clinical trial that uses NIH-supported infrastructure but does not receive NIH funds to support its content.</p><p id="lar"><strong>C. 3. Care and Use of Laboratory Animals in Research</strong></p><p class="rtejustify">The <a href="https://olaw.nih.gov/policies-laws/phs-policy.htm">Public Health Service Policy on Humane Care and Use of Laboratory Animals</a> (PHS Policy) governs the use of all live vertebrate animals in activities supported by NIH. This policy provides for institutional oversight of the humane use of animal research subjects and requires that domestic institutions follow the <a href="http://www.nap.edu/catalog.php?record_id=12910">Guide for the Care and Use of Laboratory Animals</a>. Foreign recipients are required to follow the <a href="https://olaw.nih.gov/sites/default/files/Guiding_Principles_2012.pdf">International Guiding Principles for Biomedical Research Involving Animals</a>. Awards involving the use of animals will not be made unless the NIH <a href="https://olaw.nih.gov/">Office of Laboratory Animal Welfare</a> (OLAW) has approved an Animal Welfare Assurance and the Institutional Animal Care and Use Committee (IACUC) has approved those components of the application related to the care and use of animals. Collaborating institutions and performance sites where animal work will be conducted under the award must also obtain the necessary Assurances. Except in exceptional circumstances, awards are not made until the institution provides verification of IACUC review and approval in accord with the NIHGPS. Obtaining Assurances and providing verification of IACUC approval are also just-in-time procedures as specified in <a href="/grants/policy/nihgps/HTML5/section_2/2.5.1_just-in-time_procedures.htm">NIH Grants Policy Statement, Section 2.5.1 Just-in-Time Procedures</a>.</p><p class="rtejustify">Additional resources are available on the <a href="https://olaw.nih.gov/">OLAW website</a>, including a <a href="https://olaw.nih.gov/resources/documents/assur.htm">sample Animal Welfare Assurance</a>, <a href="https://olaw.nih.gov/resources/documents/foreign.htm">sample Foreign Assurance</a>, <a href="https://olaw.nih.gov/resources/tutorial">PHS Policy Tutorial</a>, <a href="https://olaw.nih.gov/guidance/ARENA-OLAW-IACUC-guidebook.htm">IACUC Guidebook</a>, <a href="http://www.nap.edu/catalog.php?record_id=12910">Guide for the Care and Use of Laboratory Animals</a>, and <a href="https://olaw.nih.gov/faqs#/guidance/faqs">Frequently Asked Questions</a>. To obtain information regarding animal welfare assurance requirements contact:</p><p class="rtejustify">Office of Laboratory Animal Welfare (OLAW)<br>National Institutes of Health<br>6700B Rockledge Drive, Suite 2500, MSC 6910<br>Bethesda, MD 20892<br>Bethesda, MD 20817 (non-USPS mail)<br>(301) 496-7163<br><a href="/cdn-cgi/l/email-protection#8fe0e3eef8cfe2eee6e3a1e1e6e7a1e8e0f9"><span class="__cf_email__" data-cfemail="cba4a7aabc8ba4afe5a5a2a3e5aca4bd">[email protected]</span></a></p><p id="dna"><strong>C. 4. Recombinant DNA</strong></p><p class="rtejustify">Organizations planning to conduct research involving recombinant DNA, including human gene transfer, are required to comply with the <a href="https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2/">NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)</a> found on the <a href="https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy/">Biosafety and Biosecurity Policy</a> website. The <a href="https://osp.od.nih.gov/">NIH Office of Science Policy</a> oversees the implementation of the NIH Guidelines.</p><p class="rtejustify">Institutions subject to the NIH Guidelines must establish a standing Institutional Biosafety Committee. The requirements for the composition of this committee can be found in Section IV-B-2-a of the NIH Guidelines.</p><p class="rtejustify">Office of Science Policy<br>National Institutes of Health<br>6705 Rockledge Drive, Suite 750, MSC 7985<br>Bethesda, MD 20892-7985 (regular or US Postal Service Express mail)<br>Bethesda, MD 20817 (non-USPS mail)<br>(301) 496-9838<br><a href="/cdn-cgi/l/email-protection#185651505f6d717c7d7471767d6b58777c36767170367f776e"><span class="__cf_email__" data-cfemail="a9e7e0e1eedcc0cdccc5c0c7ccdae9c6cd87c7c0c187cec6df">[email protected]</span></a><br> </p><p id="misconduct"><strong>C. 5. Research Integrity and Research Misconduct</strong></p><p class="rtejustify">The HHS <a href="https://ori.hhs.gov/">Office of Research Integrity</a> (ORI) is responsible for implementing the assurance system related to procedures on scientific misconduct. An organization receiving NIH grant support for research is required to certify compliance with <a href="https://ori.hhs.gov/FR_Doc_05-9643">42 CFR Part 93</a>, Subpart A "PHS Policies on Research Misconduct". By signing the application, the Authorized Organizational Representative certifies that the organization has established administrative policies as required by the regulation. ORI requires an <a href="https://ori.hhs.gov/arprm/Login.php">annual report</a> (PHS Form 6349) detailing aggregate information on allegations, inquiries and investigations that were handled by a recipient organization. The annual report confirms that the organization has established internal policies and procedures and will comply with PHS regulations for reviewing, investigating and reporting allegations of misconduct in science conducted at, or sponsored by, the organization.</p><p class="rtejustify">To obtain the above referenced forms, or for additional information regarding scientific misconduct and research integrity, contact:</p><p class="rtejustify">Office of Research Integrity<br>Assurance Program<br>1101 Wootton Parkway, Suite 240<br>Rockville, MD 20852<br>(240) 453-8407<br><a href="/cdn-cgi/l/email-protection#3776445c78657e775f5f4419505841"><span class="__cf_email__" data-cfemail="1a5b69715548535a727269347d756c">[email protected]</span></a><br><a href="https://ori.hhs.gov/assurance-program">ORI Assurance Program</a></p><p id="fcoi"><strong>C. 6. Objectivity in Research (Financial Conflict of Interest [FCOI])</strong></p><p style="margin-bottom:10px;">NIH requires recipients and investigators (except Phase I SBIR/STTR applicants and recipients) to comply with the requirements of <a href="https://www.ecfr.gov/current/title-42/part-50/subpart-F">42 CFR Part 50, Subpart F</a>, "Promoting Objectivity in Research” (see <a href="/grants/policy/nihgps/HTML5/section_4/4.1.10_financial_conflict_of_interest.htm">NIH Grants Policy Statement, Section 4.1.10 Financial Conflict of Interest</a>) and the companion regulation at <a href="https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-94">45 CFR Part 94</a>, "Responsible Prospective Contractors."</p><p>The requirements under the FCOI regulation promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator FCOIs. An "Investigator" is defined by the regulation as the Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by NIH, or proposed for such funding, which may include, for example, collaborators or consultants.</p><p>Although institutions must comply with all provisions of the FCOI regulation, the following are some of the key requirements:</p><ul><li>The Institution must maintain an up-to-date written and enforced policy on financial conflict of interest that complies with the regulation (<a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F/section-50.604#p-50.604(a)">see 42 CFR 50.604(a)). </a> The Institution must (1) make its FCOI policy accessible on a public website, (2) post certain information concerning significant financial interests (SFIs) disclosed to the Institution that are identified as a financial conflict of interest and held by senior/key personnel, and (3) submit a PDF copy of the policy to NIH via the eRA Commons <a href="https://www.era.nih.gov/erahelp/Commons/#Commons/ipf/ipf.htm">Institution Profile Module</a> (see <a href="/grants/policy/nihgps/HTML5/section_4/4.1.10_financial_conflict_of_interest.htm">NIH Grants Policy Statement, Section 4.1.10 Financial Conflict of Interest</a> for more information).<br> </li><li>The Institution must require each Investigator to complete training regarding the<ul><li> Institution's FCOI policy</li><li> Investigator's disclosure responsibilities</li><li> The FCOI regulations<br> </li></ul></li><li style="list-style:none;">Investigator training must be completed before they engage in research related to any NIH-funded grant or cooperative agreement, at least every four years, and immediately under certain circumstances (see <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F/section-50.604">42 CFR Part 50.604(b)).</a><br> </li><li>If the Institution carries out NIH-funded research through subrecipients (e.g., consortium, subrecipients, contractors, or collaborators), the Institution must take reasonable steps to ensure that any subrecipient Investigator complies with the regulation. The Institution must incorporate as part of a written agreement with the subrecipient terms that establish whether the FCOI policy of the Institution or that of the subrecipient will apply to subrecipient Investigators and address disclosure and reporting requirements (see <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F/section-50.604">42 CFR Part 50.604(c)(1)</a>).<br> </li><li><a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50#p-50.603(Investigator)">Investigators</a> are required to disclose all domestic and foreign <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F#p-50.603(Significant%20financial%20interest)">Significant Financial Interests (SFIs</a>) (Including those of their spouse and dependent children) that are related to the Investigator’s institutional responsibilities (i.e., professional responsibilities the Investigator performs on behalf of the organization such as research, research consultation, teaching, clinical, etc.) that are received from or held in an entity outside the Institution. <br><br>It is important to note that disclosure of foreign financial interests differs from disclosure of domestic financial interests. Investigators, including subrecipient Investigators, must disclose all foreign financial interests (which includes income from seminars, lectures, or teaching engagements, income from service on advisory committees or review panels, and reimbursed for sponsored travel) received from any foreign entity, including Institutions of higher education or the government of another country (which includes local, provincial, or equivalent governments of another country) when such income meets the threshold for disclosure (e.g., income in excess of $5,000).<br> </li><li>Investigators must disclose their SFIs by the time an application is submitted to NIH for funding, within thirty days of discovering or acquiring a new SFI, and on an annual basis at intervals determined by the organization.<br> </li><li>Investigators must update all financial disclosures related to their institutional responsibilities during the period of award at least annually (in accordance with the specific period of time prescribed by the Institution) and within 30 days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI.<br> </li><li>Institutions are responsible for determining if an Investigator's SFI is related to their NIH-funded research, and, if so, whether the Investigator's SFI is an FCOI (i.e., a SFI that could directly and significantly affect the design, conduct, or reporting of NIH-funded research). Institutions must provide initial and annual (i.e., ongoing) FCOI reports to NIH through the <a href="https://www.era.nih.gov/recipients/submit-reports/fcoi.htm">eRA Commons FCOI Module</a>, and comply with all of the <a href="https://www.ecfr.gov/current/title-42/part-50/subpart-F#p-50.605(b)">reporting requirements</a>.<br> </li><li>Institutions must complete and document a <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F/section-50.605#p-50.605(a)(3)">retrospective review</a> in situations where noncompliance is identified at any time either during or after the period of performance of the grant. Specifically, when a FCOI is not identified or managed in a timely manner, including:<ul><li>Failure by the Investigator to disclose a SFI that is determined by the Institution to constitute a FCOI</li><li>Failure by the Institution to review or manage such a FCOI</li><li>Failure by the Investigator to comply with a FCOI management plan<br> </li></ul></li><li>If the retrospective review finds that there is bias in the design, conduct or reporting of NIH-funded research, the Institution must complete and submit a <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F/section-50.605#p-50.605(a)(3)(iii)">mitigation report</a> to NIH.</li></ul><p>Additional information is available on the <a href="/policy-and-compliance/policy-topics/fcoi">NIH Financial Conflict of Interest</a> website which includes many resources including, a tutorial on the requirements of the revised Final Rule, which fulfills that portion of the training requirement for Investigators related to the Federal regulation, and <a href="/faqs#/financial-conflict-of-interest.htm">Frequently Asked Questions</a>. General inquiries about the FCOI regulation for grants and cooperative agreements may be directed to: <a href="/cdn-cgi/l/email-protection#3573767a7c765a5845595c545b56507558545c591b5b5c5d1b525a43"><span class="__cf_email__" data-cfemail="4a0c0905030925273a26232b24292f0a272b232664242322642d253c">[email protected]</span></a>. General inquiries about the FCOI regulation for research contracts may be directed to: <a href="/cdn-cgi/l/email-protection#83e5e0eceae0ecedf7f1e2e0f7f0c3eee2eaefadedeaebade4ecf5"><span class="__cf_email__" data-cfemail="1a7c7975737975746e687b796e695a777b737634747372347d756c">[email protected]</span></a>.</p><h2 id="otherinfo">II. Other Information</h2><h3 id="payment">A. Payment</h3><p class="rtejustify">Payments for NIH recipients, except for grants or cooperative agreements to Federal Institutions (see <a href="/grants/policy/nihgps/HTML5/section_17/17.5_payment.htm">NIH Grants Policy Statement, Section 17.5 Payment</a>), are made through the <a href="https://pms.psc.gov/">Payment Management System</a> (PMS). PMS is administered by the HHS Program Support Center. Applicant organizations are assigned a 12-digit Entity Identification Number (EIN) for payment and accounting purposes; this number is provided on the NoA. The EIN number is an expansion of the 9-digit Employer or Tax Identification Number assigned to an organization by the Internal Revenue Service. Inquiries regarding payments and requests for downloadable forms should be directed to PMS (<a href="https://pms.psc.gov/support/help-desk.html">PMS Help Desk</a>). Inquiries regarding payments to Federal recipients should be sent to your Grants Management Specialist.</p><h3 id="rateneg">B. Rate Negotiations</h3><p class="rtejustify">Facilities and Administrative Rates: The payment of facilities & administrative (F&A) costs is generally based upon rates established through a formal agreement between the recipient organization and the cognizant agency for indirect costs. The negotiated rate is applied to the applicable direct cost base to determine the amount of F&A costs to be awarded. <a href="https://www.hhs.gov/about/agencies/asa/psc/index.html">HHS’s Cost Allocation Services Regional Offices</a> negotiate F&A rates for educational institutions, hospitals and non-profit organizations.</p><p class="rtejustify">The NIH <a href="http://oamp.od.nih.gov/dfas/">Division of Financial Advisory Services</a> will negotiate an F&A rate for commercial (for-profit) organizations. HHS/NIH recognizes F&A cost rates applicable to research activities negotiated by other Federal agencies adjusted for the HHS treatment of independent (self-sponsored) research and development (IR&D) costs.</p><p class="rtejustify">Exceptions to reimbursement of F&A costs on certain NIH grants are described in <a href="/grants/policy/nihgps/HTML5/section_7/7.4_reimbursement_of_facilities_and_administrative_costs.htm">NIH Grants Policy Statement, Section 7.4 Reimbursement of Facilities and Administrative Costs</a>.</p><p class="rtejustify">Patient Care Costs Rates: In instances where the proposed project represents a clinical research study, funds may be requested in a grant application for <a href="/grants/policy/nihgps/HTML5/section_19/19_research_patient_care_costs.htm">Patient Care Costs</a>. Due to the special nature of these costs, a detailed explanation is required in the application as to how the total amount requested was determined. In situations where the amount requested for patient care results in an award that exceeds $100,000 in that category for a single budget period, the recipient organization must either have in place or take steps to develop a negotiated patient care rate agreement with HHS.</p><p class="rtejustify">Hospitals and nonprofit organizations with questions concerning the negotiation of F&A cost rate agreements or patient care rate agreements should contact the appropriate office listed in <a href="/grants/policy/nihgps/HTML5/part_iii_points_of_contact.htm">NIH Grants Policy Statement, Part III Points of Contact</a>.</p><h3 id="eRA">C. eRA Commons</h3><p class="rtejustify">The <a href="https://public.era.nih.gov/commons/">eRA Commons</a> provides recipients with the ability to conduct extramural research business electronically with NIH. All recipient institutions, Program Directors/Principal Investigators (PD/PIs), and individuals in a postdoctoral role who participate in a project for at least one person month or more, must be registered in the eRA Commons. The Commons is the only place where PD/PIs can review assignment information, peer review outcomes, summary statements, and other related grant documents such as submitted applications and NoAs. Institutional officials can: 1) check the status of grant applications; 2) submit Just-In-Time information; 3) submit Progress Reports using the RPPR format; 4) review applications and NoAs; 5) access the face page for paper Progress Reports; and, 6) submit electronic FFRs, no-cost extension notifications, closeout documents and appointment forms and termination notices associated with NIH institutional training grants, institutional career development awards, individual fellowships, and research education grants.<br><br>eRA Commons login: <a href="http://public.era.nih.gov/commons/">https://public.era.nih.gov/commons/</a><br>General Information: <a href="https://www.era.nih.gov/help-tutorials">eRA Help & Tutorials</a><br>eRA Service Desk: <a href="https://www.era.nih.gov/need-help">https://www.era.nih.gov/need-help</a></p><h3 id="oer">D. OER Resources </h3><p class="rtejustify">The Office of Extramural Research (OER) is the hub for grants policy, grants administration, and the coordination of NIH's extramural programs and activities. The OER provides comprehensive information about NIH grants on the <a href="/">NIH Grants & Funding</a> website. You can receive updates on NIH policies and activities, and gain a better understanding of the operation of NIH extramural programs, by reading the <a href="https://nexus.od.nih.gov/all/">NIH Extramural Nexus</a>, an electronic monthly update. Subscriptions are available from the <a href="https://nexus.od.nih.gov/all/subscribe/">Subscription Center</a>.</p><p class="rtejustify">The <a href="/funding/searchguide/index.html#/">NIH Guide for Grants and Contracts</a> (NIH Guide), published daily and indexed weekly, provides information to the research community regarding new or changed NIH grants policy, NIH funding opportunities, Requests for (contract) Proposals (RFPs), and Requests for Information (RFI). funding opportunities can also be found at <a href="http://www.grants.gov/">Grants.gov</a>.</p><p class="rtejustify">A <a href="/funding/nih-guide-for-grants-and-contracts/subscribe">listserv subscription</a> to the weekly Table of Contents of the <a href="/funding/searchguide/index.html#/">NIH Guide</a> is highly recommended as the best means of keeping up-to-date with NIH announcements, policy changes and clarifications, and funding opportunities.</p><p class="rtejustify">Extramural award data is available from NIH's <a href="https://report.nih.gov/">Research Portfolio Online Reporting Tool</a> (RePORT). RePORT includes a variety of frequently requested reports including a link to the RePORT Expenditures and Results (<a href="https://reporter.nih.gov/">RePORTER</a>) tool where expanded information on funded scientific programs is available. If you have questions about statistics and award data, contact <a href="https://report.nih.gov/contactus">RePORT</a>. For comments on RePORT, or suggestions for additional content, please use the Contact Us button found at the bottom of each RePORT page.</p><p class="rtejustify">We wish you great success in our partnership to improve the health of the Nation.</p><p class="rtejustify">Sincerely,<br><br>Office of Policy for Extramural Research Administration<br>Office of Extramural Research<br>Office of the Director<br>National Institutes of Health</p></div>
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