3593 lines
139 KiB
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<title>Case Study for Single Institutional Review Board (sIRB) Policy | Grants & Funding</title>
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<div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><!--
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[AVK] -- TO DO
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Emrul, I removed all the ID attributes as the name attributes are the only things needed to handle a form submission
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but feel free to adjust this snippet with whatever is needed to make it work.
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--><form action="//search.usa.gov/search" method="get" accept-charset="UTF-8" autocomplete="off" target="_blank"><p><input name="utf8" type="hidden" value="✓"> <input name="affiliate" type="hidden" value="grants.nih.gov"></p><div class="input-group pt-3"><input class="form-search form-control rounded-0 py-1" title="Enter the terms you wish to search for" placeholder="Search this Site" type="search" name="query" value="" maxlength="128" aria-label="Search button (required)" aria-required="true" autocomplete="off" required=""> <button class="input-group-text btn btn-primary px-3 py-1" type="submit" title="Search">
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<a href="/new-to-nih" title="As you begin your journey in search of NIH grant funding, the information in this section can help you understand the structure of NIH and why it’s important to successfully navigate the grants process." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex justify-content-lg-around" data-drupal-link-system-path="node/83">New to NIH</a>
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<a href="/funding" title="As the largest public funder of biomedical research in the world, NIH supports a variety of programs from grants and contracts to loan repayment. Learn about assistance programs, how to identify a potential funding organization, and past NIH funding." class="nav-link position-relative px-0 btn btn-primary rounded-0 text-lg-center text-uppercase fw-bold me-0 py-2 px-3 py-lg-3 d-flex collapsed justify-content-between d-lg-block" data-bs-toggle="collapse" data-bs-target="#Funding" aria-expanded="false" data-drupal-link-system-path="node/23"> Funding <i class="bi bi-caret-down-fill"></i>
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<strong class="h4 d-none d-lg-block text-secondary">Funding</strong>
|
||
<p class="d-none d-lg-block">As the largest public funder of biomedical research in the world, NIH supports a variety of programs from grants and contracts to loan repayment. Learn about assistance programs, how to identify a potential funding organization, and past NIH funding.</p>
|
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<a href="/funding" title="As the largest public funder of biomedical research in the world, NIH supports a variety of programs from grants and contracts to loan repayment. Learn about assistance programs, how to identify a potential funding organization, and past NIH funding." class="btn btn-block btn-primary ms-0 my-3 my-lg-0 px-4" data-drupal-link-system-path="node/23">Explore Funding</a>
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<a href="/funding/nih-guide-for-grants-and-contracts" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/45">NIH Guide for Grants and Contracts</a>
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<a href="/funding/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 class="nav-item d-flex flex-wrap flex-column position-static mb-2">
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<a href="/funding/find-a-fit-for-your-research-nih-institutes-centers-offices" class="1 nav-link position-relative px-0 py-2 py-lg-1 fw-bold" data-drupal-link-system-path="node/25">Find a Fit for Your Research: NIH Institutes, Centers, and Offices</a>
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<li class="nav-item d-flex flex-wrap flex-column position-static mb-2">
|
||
|
||
<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">
|
||
<a id="main-content" tabindex="-1"></a>
|
||
|
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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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|
||
<nav aria-label="breadcrumb">
|
||
<h2 id="system-breadcrumb" class="visually-hidden">Breadcrumb</h2>
|
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<ol class="breadcrumb">
|
||
<li class="breadcrumb-item">
|
||
<a href="/">Home</a>
|
||
</li>
|
||
<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance">Policy & Compliance</a>
|
||
</li>
|
||
<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance/policy-topics">Policy Topics</a>
|
||
</li>
|
||
<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance/policy-topics/human-subjects">Human Subjects Research</a>
|
||
</li>
|
||
<li class="breadcrumb-item">
|
||
<a href="/policy-and-compliance/policy-topics/human-subjects/single-irb-policy-multi-site-research">Single IRB for Multi-Site or Cooperative Research </a>
|
||
</li>
|
||
<li class="breadcrumb-item">
|
||
Case Study for Single Institutional Review Board (sIRB) Policy
|
||
</li>
|
||
</ol>
|
||
</nav>
|
||
|
||
</div>
|
||
|
||
</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">
|
||
|
||
<h5 class="visually-hidden" id="block-nihod5-subtheme-mainnavigation-menu">Main navigation (Sidebar Template)</h5>
|
||
|
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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">
|
||
|
||
|
||
<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">
|
||
|
||
<ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush">
|
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|
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|
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|
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<li class="level-1 py-0 px-0 border-0 dropdown list-inline">
|
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|
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|
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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>
|
||
</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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|
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|
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<li class="level-2 py-0 px-0 border-0 list-inline">
|
||
|
||
|
||
<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>
|
||
<div class="d-none">
|
||
|
||
|
||
</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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|
||
<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>
|
||
<div class="d-none">
|
||
|
||
|
||
</div>
|
||
</li>
|
||
|
||
|
||
|
||
|
||
|
||
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<a href="/policy-and-compliance/policy-topics/clinical-trials" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Clinical Trial Requirements for Grants and Contracts" data-drupal-link-system-path="node/434"> Clinical Trial Requirements for Grants and Contracts <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/ct-decision" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Decision Tool: Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?" data-drupal-link-system-path="node/711">Decision Tool: Does Your Human Subjects Study Meet the NIH Definition of a Clinical Trial?</a>
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<a href="https://www.era.nih.gov/help-tutorials/hss" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Human Subjects System">Human Subjects System</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Requirements for Registering & Reporting NIH-Funded Clinical Trials" data-drupal-link-system-path="node/298"> Requirements for Registering & Reporting NIH-Funded Clinical Trials <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting/nih-policy" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information" data-drupal-link-system-path="node/885">NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting/steps" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Steps to Compliance for NIH Awardees" data-drupal-link-system-path="node/896">Steps to Compliance for NIH Awardees</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/reporting/understanding" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Policy and Regulation on ClinicalTrials.gov Registration and Reporting" data-drupal-link-system-path="node/452">Policy and Regulation on ClinicalTrials.gov Registration and Reporting</a>
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<a href="/policy-and-compliance/policy-topics/clinical-trials/why-changes" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Information about NIH Clinical Trial Stewardship" data-drupal-link-system-path="node/579">Information about NIH Clinical Trial Stewardship</a>
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<a href="/policy-and-compliance/policy-topics/federal-funding" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Communicating, and Acknowledging Federal Funding" data-drupal-link-system-path="node/112">Communicating, and Acknowledging Federal Funding</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Early Stage Investigator Policies" data-drupal-link-system-path="node/758"> Early Stage Investigator Policies <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/policy" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Early Stage Investigators Policy" data-drupal-link-system-path="node/260">NIH Early Stage Investigators Policy</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/determining-status" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Determining Early Stage Investigator (ESI) Status" data-drupal-link-system-path="node/215">Determining Early Stage Investigator (ESI) Status</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/related-data" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Early Stage Investigator Related Data" data-drupal-link-system-path="node/690">Early Stage Investigator Related Data</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/history" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu History of NIH Support for Early Career Investigators" data-drupal-link-system-path="node/470">History of NIH Support for Early Career Investigators</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/notices-laws-statements" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Related Notices, Laws, Statements and Reports" data-drupal-link-system-path="node/285">Related Notices, Laws, Statements and Reports</a>
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<a href="/policy-and-compliance/policy-topics/early-stage-investigators/list-smaller-grants" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu List of smaller grants & awards that maintain ESI status" data-drupal-link-system-path="node/907">List of smaller grants & awards that maintain ESI status</a>
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<a href="/policy-and-compliance/policy-topics/nih-family-friendly-initiative" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Family-Friendly Initiatives" data-drupal-link-system-path="node/665">Family-Friendly Initiatives</a>
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<a href="/policy-and-compliance/policy-topics/fcoi" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Financial Conflict of Interest" data-drupal-link-system-path="node/831"> Financial Conflict of Interest <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/fcoi/fcoi-training" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu FCOI Training" data-drupal-link-system-path="node/390">FCOI Training</a>
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<a href="/policy-and-compliance/policy-topics/fcoi/important-highlights" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Important Highlights of FCOI Regulatory Requirements for Foreign Institutions" data-drupal-link-system-path="node/312">Important Highlights of FCOI Regulatory Requirements for Foreign Institutions</a>
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<a href="/policy-and-compliance/policy-topics/fcoi/guide-notices" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Guide Notices Related to Financial Conflict of Interest" data-drupal-link-system-path="node/786">NIH Guide Notices Related to Financial Conflict of Interest</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Foreign Interference" data-drupal-link-system-path="node/447"> Foreign Interference <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/about-foreign-interference" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu About Foreign Interference" data-drupal-link-system-path="node/326">About Foreign Interference</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/requirements-for-disclosure" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Requirements for Disclosure of Other Support, Foreign Components and Conflicts of Interest" data-drupal-link-system-path="node/496">Requirements for Disclosure of Other Support, Foreign Components and Conflicts of Interest</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/handling-allegations" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Process for Handling Allegations Related to Foreign Interference" data-drupal-link-system-path="node/668">Process for Handling Allegations Related to Foreign Interference</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/notices-statements-reports" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Notices, Statements, and Reports" data-drupal-link-system-path="node/564">Notices, Statements, and Reports</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/case-studies" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Case Studies" data-drupal-link-system-path="node/627">Case Studies</a>
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<a href="/policy-and-compliance/policy-topics/foreign-interference/fi-data" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Data" data-drupal-link-system-path="node/864">Data</a>
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<a href="/policy-and-compliance/policy-topics/human-subjects" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Human Subjects Research" data-drupal-link-system-path="node/332"> Human Subjects Research <i class="bi bi-caret-down 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/inclusion/lifespan" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Inclusion Across the Lifespan in Human Subjects Research" data-drupal-link-system-path="node/734">Inclusion Across the Lifespan in Human Subjects Research</a>
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<a href="/policy-and-compliance/policy-topics/intellectual-property" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Intellectual Property Policy" data-drupal-link-system-path="node/149"> Intellectual Property Policy <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/natural-disasters" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Natural Disasters" data-drupal-link-system-path="node/208"> Natural Disasters <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding" data-drupal-link-system-path="node/793"> Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus/history-update" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Applicant/Recipient COVID-19 Update History" data-drupal-link-system-path="node/858">Applicant/Recipient COVID-19 Update History</a>
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<a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus/nih-omb-memo" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Implementation of OMB Memorandum M-20-26 “Extension of Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations” dated June 18, 2020" data-drupal-link-system-path="node/747">NIH Implementation of OMB Memorandum M-20-26 “Extension of Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations” dated June 18, 2020</a>
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<a href="/policy-and-compliance/policy-topics/natural-disasters/corona-virus/impact-research-community" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu The Impact of COVID-19 on the Research Community" data-drupal-link-system-path="node/640">The Impact of COVID-19 on the Research Community</a>
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<a href="/policy-and-compliance/policy-topics/ngri" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Next Generation Researchers Initiative" data-drupal-link-system-path="node/884"> Next Generation Researchers Initiative <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/nih-fiscal-policies" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu NIH Fiscal Policies" data-drupal-link-system-path="node/510"> NIH Fiscal Policies <i class="bi bi-caret-right me-24"></i>
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<a href="/policy-and-compliance/policy-topics/nih-fiscal-policies/salary-cap-summary" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Salary Cap Summary (FY 1990 - Present)" data-drupal-link-system-path="node/729">Salary Cap Summary (FY 1990 - Present)</a>
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<a href="/policy-and-compliance/policy-topics/nih-fiscal-policies/stipends-summary" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Stipends Summary – NRSA (FY 2018-Present)" data-drupal-link-system-path="node/1171">Stipends Summary – NRSA (FY 2018-Present)</a>
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<a href="/policy-and-compliance/policy-topics/peer-review" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Peer Review Policies and Practices" data-drupal-link-system-path="node/744"> Peer Review Policies and Practices <i class="bi bi-caret-right me-24"></i>
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|
||
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|
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|
||
|
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|
||
<a href="/policy-and-compliance/policy-topics/subawards" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Subawards" data-drupal-link-system-path="node/350">Subawards</a>
|
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<div class="d-none">
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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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|
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|
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<li class="level-2 py-0 px-0 border-0 list-inline">
|
||
|
||
|
||
<a href="https://grants.nih.gov/grants-process/submit/submission-policies" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Submission Policies">Submission Policies</a>
|
||
<div class="d-none">
|
||
|
||
|
||
</div>
|
||
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|
||
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|
||
|
||
|
||
<a href="/policy-and-compliance/policy-topics/harassment" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Supporting a Safe and Respectful Workplace" data-drupal-link-system-path="node/245"> Supporting a Safe and Respectful Workplace <i class="bi bi-caret-right me-24"></i>
|
||
</a>
|
||
<div class="d-none">
|
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<ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush ps-3">
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<li class="level-3 py-0 px-0 border-0 list-inline">
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||
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|
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|
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<li class="level-3 py-0 px-0 border-0 dropdown list-inline">
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||
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|
||
<a href="/policy-and-compliance/policy-topics/harassment/actions-oversight" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu NIH Actions and Oversight" data-drupal-link-system-path="node/405"> NIH Actions and Oversight <i class="bi bi-caret-right me-24"></i>
|
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</a>
|
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<div class="d-none">
|
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<ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush ps-3">
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<li class="level-4 py-0 px-0 border-0 list-inline">
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<a href="/policy-and-compliance/policy-topics/harassment/allegation-process" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu NIH Process for Handling Allegations of Harassment on an NIH-Funded Project at a Recipient Institution" data-drupal-link-system-path="node/114">NIH Process for Handling Allegations of Harassment on an NIH-Funded Project at a Recipient Institution</a>
|
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<div class="d-none">
|
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</div>
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|
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<li class="level-3 py-0 px-0 border-0 dropdown list-inline">
|
||
|
||
|
||
<a href="/policy-and-compliance/policy-topics/harassment/find-help" class="dropdown-item py-2 ps-2 text-wrap d-flex justify-content-between align-items-center" role="button" title="Expand menu Find Help" data-drupal-link-system-path="node/569"> Find Help <i class="bi bi-caret-right me-24"></i>
|
||
</a>
|
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<div class="d-none">
|
||
|
||
<ul data-block="sidebar_first" block="block-nihod5-subtheme-mainnavigation" class="list-group list-group-flush ps-3">
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<li class="level-4 py-0 px-0 border-0 list-inline">
|
||
|
||
|
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<a href="/policy-and-compliance/policy-topics/harassment/notify" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu What to Expect When Notifying NIH" data-drupal-link-system-path="node/661">What to Expect When Notifying NIH</a>
|
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<div class="d-none">
|
||
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||
|
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</div>
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</li>
|
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<li class="level-3 py-0 px-0 border-0 list-inline">
|
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<a href="/policy-and-compliance/policy-topics/harassment/institutional-reporting" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Institutional Reporting" data-drupal-link-system-path="node/746">Institutional Reporting</a>
|
||
<div class="d-none">
|
||
|
||
|
||
</div>
|
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|
||
|
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|
||
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|
||
<li class="level-3 py-0 px-0 border-0 list-inline">
|
||
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||
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||
<a href="/policy-and-compliance/policy-topics/harassment/definitions" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Definitions" data-drupal-link-system-path="node/779">Definitions</a>
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<div class="d-none">
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||
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</div>
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|
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<li class="level-3 py-0 px-0 border-0 list-inline">
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||
|
||
|
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<a href="/policy-and-compliance/policy-topics/harassment/data" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Data - Sexual Harassment and Sex Discrimination" data-drupal-link-system-path="node/757">Data - Sexual Harassment and Sex Discrimination</a>
|
||
<div class="d-none">
|
||
|
||
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||
</div>
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<li class="level-3 py-0 px-0 border-0 list-inline">
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||
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|
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<div class="d-none">
|
||
|
||
|
||
</div>
|
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|
||
|
||
<li class="level-3 py-0 px-0 border-0 list-inline">
|
||
|
||
|
||
<a href="https://www.nih.gov/anti-sexual-harassment/nih-staff" class="dropdown-item py-2 ps-2 text-wrap" role="button" title="Expand menu Anti-Sexual Harassment Policies and Resources for NIH Staff">Anti-Sexual Harassment Policies and Resources for NIH Staff</a>
|
||
<div class="d-none">
|
||
|
||
|
||
</div>
|
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||
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</ul>
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||
|
||
|
||
|
||
</nav>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
<div class="order-1 order-lg-2 syndicate col-12 col-lg-9 ps-0 ps-lg-5">
|
||
<div class="region region-content">
|
||
<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">Case Study for Single Institutional Review Board (sIRB) Policy</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"><div data-ds-id="pb43iac5" class="card">
|
||
<div class="card-body">
|
||
<h5 class="card-title">Disclaimer</h5>
|
||
<p class="card-text">
|
||
This fictional case study is based on various real-life scenarios. The exercise includes
|
||
three sections covering single
|
||
institutional review board (sIRB) requirements, budgets and protocols, and exception requests—each with
|
||
associated
|
||
questions to consider. Review each section, answer the questions, and then check your answer by expanding
|
||
the question.
|
||
For background, refer to the <a href="/policy-and-compliance/policy-topics/human-subjects/single-irb-policy-multi-site-research">NIH
|
||
Single IRB (sIRB) Policy</a> page where you can find <a
|
||
href="/faqs#/hs-single-IRB-policy-for-multi-site-research.htm">sIRB Frequently Asked Questions</a>, <a
|
||
href="/sites/default/files/sIRB-Determination-workflow.pdf">sIRB Determination Workflow</a> <i
|
||
class="bi bi-file-earmark-pdf-fill"></i>, related NIH and Common Rule policy notices, and other
|
||
resources.
|
||
</p>
|
||
</div>
|
||
</div>
|
||
<br>
|
||
<h2>
|
||
Section 1. sIRB Requirements
|
||
</h2>
|
||
<p>
|
||
In this fictional case study, a principal investigator (PI) submitted a competing R01 application for a due date of
|
||
September 1, 2017. NIH awarded a grant to the PI's institution. The award supports one ongoing non-exempt human
|
||
subjects
|
||
research study that is being conducted at three U.S. sites. Each site relies on its own local IRB for review and
|
||
approval for the ongoing study. NIH plans to fund the PI's competing renewal award next month. NIH asks the PI for
|
||
Just-In-Time (JIT) information, including the name of the sIRB of record for the multi-site study.
|
||
</p>
|
||
<h3>
|
||
Sections 1 Questions
|
||
</h3>
|
||
<div data-ds-id="k4p5mvp5" class="accordion accordion-flush" id="section1">
|
||
<div class="accordion-item border border-light border-2 mb-2">
|
||
<h2 class="accordion-header" id="headingOne1">
|
||
<button class="accordion-button bg-light" type="button" data-bs-toggle="collapse"
|
||
data-bs-target="#collapseOne1" aria-expanded="true" aria-controls="collapseOne1"><strong
|
||
class="text-dark"> 1. Is the study required to have a sIRB? Why or why not?</strong></button>
|
||
</h2>
|
||
<div class="accordion-collapse collapse show" id="collapseOne1" aria-labelledby="headingOne1"
|
||
data-bs-parent="#section1">
|
||
<div class="accordion-body">
|
||
<strong>YES.</strong> The study is subject to the NIH sIRB policy because the study involves non-exempt
|
||
human subjects research at more than
|
||
one U.S. site and the competing renewal application was submitted for a due date after January 25, 2018.
|
||
This is true
|
||
even though the study is ongoing and has not previously used a sIRB. The sIRB should be in place before
|
||
the new award is
|
||
funded.
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<div class="accordion-item border border-light border-2 mb-2">
|
||
<h2 class="accordion-header" id="headingTwo">
|
||
<button class="accordion-button bg-light collapsed" type="button" data-bs-toggle="collapse"
|
||
data-bs-target="#collapseTwo1" aria-expanded="false" aria-controls="collapseTwo1"><strong
|
||
class="text-dark"> 2. If the initial IRB approval date for the study was December 1, 2019, does this
|
||
change your answer to question #1?</strong></button>
|
||
</h2>
|
||
<div class="accordion-collapse collapse" id="collapseTwo1" aria-labelledby="headingTwo"
|
||
data-bs-parent="#section1">
|
||
<div class="accordion-body">
|
||
<strong>NO.</strong> The initial IRB approval date is not a consideration for determining if the study
|
||
is subject to the NIH single IRB
|
||
Policy requirement.
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<h2>
|
||
Section 2. Justifications for an Exception to the NIH sIRB Policy
|
||
</h2>
|
||
<p>
|
||
The PI initially requested a budget for the renewal application without considering the cost associated with an
|
||
sIRB.
|
||
The PI now finds that sIRB costs will exceed the proposed budget and sends the Program Official (PO) an
|
||
exception
|
||
request to the sIRB requirement. In the request, the PI justifies the exception request by explaining that the
|
||
original
|
||
award budget would not cover the cost of an sIRB. Furthermore, because all the participating sites already have
|
||
their
|
||
own protocol documents, informed consent documents, and recruitment procedures, the PI believes that the sites
|
||
are
|
||
not
|
||
conducting the same research protocol and therefore are not subject to the NIH sIRB Policy requirement.
|
||
</p>
|
||
<h3>
|
||
Section 2 Questions
|
||
</h3>
|
||
<div class="accordion-item border border-light border-2 mb-2">
|
||
<h2 class="accordion-header" id="headingThree">
|
||
<button class="accordion-button bg-light" type="button" data-bs-toggle="collapse"
|
||
data-bs-target="#collapseThree1" aria-expanded="true" aria-controls="collapseThree1"><strong
|
||
class="text-dark"> 3. Is lack of money in the award budget sufficient rationale for an sIRB
|
||
exception request?</strong></button>
|
||
</h2>
|
||
<div class="accordion-collapse collapse" id="collapseThree1" aria-labelledby="headingThree"
|
||
data-bs-parent="#section1">
|
||
<div class="accordion-body">
|
||
<strong>NO.</strong> Applicants or offerors must include all <a
|
||
href="/faqs#/hs-single-IRB-policy-for-multi-site-research.htm?anchor=54923">necessary sIRB costs</a>
|
||
in the proposed budget of the NIH application or contract proposal. An Insufficient amount in the award
|
||
budget is not a
|
||
compelling justification for an sIRB exception to the NIH sIRB Policy. Check the <a
|
||
href="/policy-and-compliance/policy-topics/human-subjects/single-irb-policy-multi-site-research">NIH Single IRB for Multi-Site
|
||
or Cooperative Research website</a> for additional information.
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<div class="accordion-item border border-light border-2 mb-2">
|
||
<h2 class="accordion-header" id="headingFour">
|
||
<button class="accordion-button bg-light collapsed" type="button" data-bs-toggle="collapse"
|
||
data-bs-target="#collapseFour1" aria-expanded="false" aria-controls="collapseFour1"><strong
|
||
class="text-dark"> 4. The PI notes that each site has its own protocol which was approved by each
|
||
site's local IRB. The PI contends that
|
||
each site's unique recruitment procedures and forms mean that each site is conducting a different
|
||
protocol. Are the
|
||
three sites considered to be conducting different protocols under the NIH sIRB
|
||
Policy?</strong></button>
|
||
</h2>
|
||
<div class="accordion-collapse collapse" id="collapseFour1" aria-labelledby="headingFour"
|
||
data-bs-parent="#section1">
|
||
<div class="accordion-body">
|
||
<strong>NO.</strong> NIH considers protocols that address the same research questions, involve the same
|
||
research methodologies, and evaluate
|
||
the same outcomes to be the “same research protocol.” Sites that are accruing research participants for
|
||
studies that are
|
||
identical except for variations due to local context consideration, such as different recruitment
|
||
procedures and
|
||
different informed consent forms, are also conducting the “same research protocol.” See <a
|
||
href="/faqs#/hs-single-IRB-policy-for-multi-site-research.htm?anchor=56655">FAQ A2</a> on the <a
|
||
href="/faqs#/">NIH sIRB for Multi-Site or Cooperative Research FAQ page</a> for additional
|
||
information.
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<div class="accordion-item border border-light border-2 mb-2">
|
||
<h2 class="accordion-header" id="headingFive">
|
||
<button class="accordion-button bg-light collapsed" type="button" data-bs-toggle="collapse"
|
||
data-bs-target="#collapseFive1" aria-expanded="false" aria-controls="collapseFive1"><strong
|
||
class="text-dark">
|
||
5. NIH informs the PI that the justification in the exception request is not compelling and will not
|
||
be considered for an
|
||
exception. The PI modifies the justification and points out that the new award will be made in one
|
||
month and it will
|
||
take at least six to eight months to stand up an sIRB for all three sites. The PI expresses concerns
|
||
that this delay
|
||
will halt the ongoing research study. Is this a sufficient justification for an sIRB exception to
|
||
the NIH sIRB Policy?</strong></button>
|
||
</h2>
|
||
<div class="accordion-collapse collapse" id="collapseFive1" aria-labelledby="headingFive"
|
||
data-bs-parent="#section1">
|
||
<div class="accordion-body">
|
||
<strong>NO.</strong> The NIH <a href="/grants/guide/notice-files/NOT-OD-16-094.html">sIRB Policy</a> is
|
||
clear that this study would need a single IRB at the time of the next competitive renewal. Recipients
|
||
are responsible
|
||
for initiating the steps with enough time to have the sIRB in place by the time of the competing renewal
|
||
award.
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<h2>
|
||
Section 3. Next Steps
|
||
</h2>
|
||
<p>
|
||
Ultimately, the PI's exception request is denied for the following reasons:
|
||
</p>
|
||
<ul>
|
||
<li>
|
||
NIH does not consider the cost associated with a sIRB as a compelling justification.
|
||
</li>
|
||
<li>
|
||
NIH considers the sites to be conducting the same research protocol, even when there are variations in site
|
||
procedures
|
||
due to local context considerations. Thus, the NIH sIRB policy requirements apply to all sites in this
|
||
study.
|
||
</li>
|
||
</ul>
|
||
<h3>
|
||
Section 3 Questions
|
||
</h3>
|
||
|
||
<div class="accordion-item border border-light border-2 mb-2">
|
||
<h2 class="accordion-header" id="headingSix">
|
||
<button class="accordion-button bg-light" type="button" data-bs-toggle="collapse"
|
||
data-bs-target="#collapseSix1" aria-expanded="true" aria-controls="collapseSix1"><strong
|
||
class="text-dark"> 6. Without an exemption, what should the PI do?</strong></button>
|
||
</h2>
|
||
<div class="accordion-collapse collapse" id="collapseSix1" aria-labelledby="headingSix"
|
||
data-bs-parent="#section1">
|
||
<div class="accordion-body">
|
||
The PI should contact their PO to discuss next steps. As soon as possible, the PI should begin steps to
|
||
establish a
|
||
single IRB for this study.
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<h2>
|
||
Summary
|
||
</h2>
|
||
<p>
|
||
The study described in this case is subject to the NIH single IRB Policy requirement.
|
||
</p>
|
||
<div data-ds-id="aas23v54" class="d-flex mb-4">
|
||
<div class="d-flex flex-column">
|
||
<small class="bg-secondary bi bi-lightbulb-fill d-flex p-1 rounded-circle text-white"></small>
|
||
<div class="d-flex h-100 justify-content-around mt-1 mx-2">
|
||
<div class="bg-secondary h-100" style="width: 3px;"></div>
|
||
</div>
|
||
</div>
|
||
<div class="ps-3">
|
||
<strong>Tip</strong>
|
||
<div>
|
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Learn more on the <a href="/policy-and-compliance/policy-topics/human-subjects/single-irb-policy-multi-site-research">NIH Single
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IRB
|
||
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