806 lines
74 KiB
Text
806 lines
74 KiB
Text
<!DOCTYPE html>
|
||
<html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#" data-nid="1444">
|
||
<head>
|
||
<meta charset="utf-8" />
|
||
<meta name="description" content="Points to Consider about Recruitment and Retention While Preparing a Clinical Research Study" />
|
||
<link rel="canonical" href="https://www.nimh.nih.gov/funding/grant-writing-and-application-process/points-to-consider-about-recruitment-and-retention-while-preparing-a-clinical-research-study" />
|
||
<meta property="og:site_name" content="National Institute of Mental Health (NIMH)" />
|
||
<meta property="og:title" content="Points to Consider About Recruitment and Retention While Preparing a Clinical Research Study" />
|
||
<meta property="og:description" content="Points to Consider about Recruitment and Retention While Preparing a Clinical Research Study" />
|
||
<meta name="twitter:description" content="Points to Consider about Recruitment and Retention While Preparing a Clinical Research Study" />
|
||
<meta name="twitter:title" content="Points to Consider About Recruitment and Retention While Preparing a Clinical Research Study" />
|
||
<meta name="twitter:site" content="@nimhgov" />
|
||
<meta name="google-site-verification" content="lKfmfhtNgohd8-snRwpaLWOcbbkS_saLoN9IUJKBvUM" />
|
||
<meta name="Generator" content="Drupal 10 (https://www.drupal.org)" />
|
||
<meta name="MobileOptimized" content="width" />
|
||
<meta name="HandheldFriendly" content="true" />
|
||
<meta name="viewport" content="width=device-width, initial-scale=1.0" />
|
||
<script>
|
||
var mainDomain = document.location.hostname.match(/(([^.\/]+\.[^.\/]{2,3}\.[^.\/]{2})|(([^.\/]+\.)[^.\/]{2,4}([^.\/]+\.)[^.\/]{2,4}))(\/.*)?$/)[1];
|
||
try{dataLayer.push({'baseDomain': mainDomain.toLowerCase()});}
|
||
catch(err){ dataLayer = [{'baseDomain': mainDomain.toLowerCase()}];} (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':
|
||
new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],
|
||
j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src=
|
||
'https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);
|
||
})(window,document,'script','dataLayer','GTM-T58NF4');
|
||
</script>
|
||
<script>
|
||
window._monsido = window._monsido || {
|
||
token: "VsAIOc905Tjeazm18evt9w",
|
||
statistics: {
|
||
enabled: true,
|
||
cookieLessTracking: true,
|
||
documentTracking: {
|
||
enabled: true,
|
||
documentCls: "",
|
||
documentIgnoreCls: "",
|
||
documentExt: ["doc","docx","pdf","ppt","pptx","rtf","txt","xls","xlsx"],
|
||
},
|
||
},
|
||
heatmap: {
|
||
enabled: true,
|
||
},
|
||
};
|
||
</script>
|
||
<script type="text/javascript" src="https://app-script.monsido.com/v2/monsido-script.js" async></script>
|
||
<link rel="icon" href="/themes/nimhtheme/favicon.ico" type="image/vnd.microsoft.icon" />
|
||
|
||
<title>Points to Consider About Recruitment and Retention While Preparing a Clinical Research Study - National Institute of Mental Health (NIMH)</title>
|
||
<link rel="stylesheet" media="all" href="/sites/default/files/css/css_hWncu7OJItJxjVfV8d-pQlCh3OkWfqGUIp5yRJgumac.css?delta=0&language=en&theme=nimhtheme&include=eJxFybkNACAMBLCFQMwE0hGQ8hSXJttT4tZ-7eSBYYjGmtqZpdel-Y8IUfQdnmwsJmysSTy5aRcg" />
|
||
<link rel="stylesheet" media="all" href="/sites/default/files/css/css_hCFOd9odoQi9Sb_-X1tdJUsdnGzf9PI7mC1Uc81hfRY.css?delta=1&language=en&theme=nimhtheme&include=eJxFybkNACAMBLCFQMwE0hGQ8hSXJttT4tZ-7eSBYYjGmtqZpdel-Y8IUfQdnmwsJmysSTy5aRcg" />
|
||
<link rel="stylesheet" media="all" href="//fonts.googleapis.com/css?family=Open+Sans:400,700|Roboto:400,500|Petit+Formal+Script" />
|
||
|
||
|
||
</head>
|
||
<body>
|
||
<a href="#main-content" class="visually-hidden focusable">
|
||
Skip to main content
|
||
</a>
|
||
<noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-T58NF4" height="0" width="0" style="display:none;visibility:hidden"></iframe>
|
||
</noscript>
|
||
|
||
<div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas>
|
||
<div class="layout-container">
|
||
<div>
|
||
<div id="block-nimhtheme-governmentdomainbanner" class="block block-block-content block-block-content976fab65-59c7-46e1-bf9f-cf5178b680b4">
|
||
|
||
|
||
<div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><section class="usa-banner" aria-label="Official website of the United States government"><div class="usa-accordion"><header class="usa-banner__header"><div class="usa-banner__inner"><div class="grid-col-auto"><img class="usa-banner__header-flag" aria-hidden="true" src="/themes/nimhtheme/uswds/images/us_flag_small.png" alt></div><div class="grid-col-fill tablet:grid-col-auto" aria-hidden="true"><p class="usa-banner__header-text">An official website of the United States government</p><p class="usa-banner__header-action">Here’s how you know</p></div><p class="m-0 p-0"><button class="usa-accordion__button usa-banner__button" type="button" aria-expanded="false" aria-controls="gov-banner-default"><span class="usa-banner__button-text">Here’s how you know</span></button></p></div></header><div class="usa-banner__content usa-accordion__content" id="gov-banner-default" hidden><div class="grid-row grid-gap-lg"><div class="usa-banner__guidance tablet:grid-col-6"><p><img class="usa-banner__icon usa-media-block__img" src="/themes/nimhtheme/uswds/images/icon-dot-gov.svg" role="img" alt aria-hidden="true"></p><div class="usa-media-block__body"><p><strong>Official websites use .gov</strong><br>A <strong>.gov</strong> website belongs to an official government organization in the United States.</p></div></div><div class="usa-banner__guidance tablet:grid-col-6"><p><img class="usa-banner__icon usa-media-block__img" src="/themes/nimhtheme/uswds/images/icon-https.svg" role="img" alt aria-hidden="true"></p><div class="usa-media-block__body"><p><strong>Secure .gov websites use HTTPS</strong><br>A <strong>lock</strong> ( <span class="icon-lock"><svg class="usa-banner__lock-image" width="52" height="64" viewBox="0 0 52 64" role="img" aria-labelledby="banner-lock-description-default" focusable="false"><title id="banner-lock-title-default">Lock</title> <desc id="banner-lock-description-default">Locked padlock icon</desc> <path fill="#000000" fill-rule="evenodd" d="M26 0c10.493 0 19 8.507 19 19v9h3a4 4 0 0 1 4 4v28a4 4 0 0 1-4 4H4a4 4 0 0 1-4-4V32a4 4 0 0 1 4-4h3v-9C7 8.507 15.507 0 26 0zm0 8c-5.979 0-10.843 4.77-10.996 10.712L15 19v9h22v-9c0-6.075-4.925-11-11-11z" /></svg></span>) or <strong>https://</strong> means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.</p></div></div></div></div></div></section></div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
<div class="header-wrapper">
|
||
<div class="header-container">
|
||
<header role="banner">
|
||
<div id="main-header-layout" >
|
||
<div id="block-sitebranding-2" class="block block-system block-system-branding-block">
|
||
|
||
|
||
<a href="/" title="NIMH Home" rel="home">
|
||
<img src="/themes/nimhtheme/nimh-logo.svg" alt="NIMH Logo" />
|
||
</a>
|
||
|
||
</div>
|
||
<div id="block-nimhtheme-incrisisstickybox" class="block block-block-content block-block-content34cda229-f96b-4500-8796-12d7fc307d77">
|
||
|
||
|
||
<div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><div id="nimh-in-crisis-callout"><a href="https://988lifeline.org/"><i class="fa-light fa-circle-exclamation" aria-hidden="true"></i> In Crisis? Call or Text 988 <i class="fa-regular fa-angles-right"></i></a></div></div>
|
||
|
||
</div>
|
||
<div id="block-tagline" class="block block-block-content block-block-contentf3b653dc-7e5d-4582-8234-a93001424fde">
|
||
|
||
|
||
<div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><p id="tagline">Transforming the understanding
|
||
<br>
|
||
and treatment of mental illnesses.
|
||
</p></div>
|
||
|
||
</div>
|
||
<div id="block-nimhtheme-searchsite" class="block block-block-content block-block-content0946d2cf-ffcf-44fb-b65d-3057740945c0">
|
||
|
||
|
||
<div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><p class="m-0 text-small text-right d-none d-lg-block"><a href="/">Home</a> | <a href="/site-info/contact-nimh" data-entity-type="node" data-entity-uuid="3b82dd34-6040-4763-a9ff-db0c3d5b6a38" data-entity-substitution="canonical">Contact Us</a> | <a href="/health/find-help" data-entity-type="node" data-entity-uuid="95a25c22-6bc4-4ac3-ad7b-d3aca76eaed0" data-entity-substitution="canonical">Help for Mental Illnesses</a></p><div class="mobile-helper-icons"><span class="hidden-md hidden-lg"><i class="fas fa-search search_icon"></i></span> <span class="menu_icon sb-toggle-right hidden-md hidden-lg"><i class="fas fa-bars"></i></span></div><form class="search-in-banner" accept-charset="UTF-8" action="/search-nimh" id="search_form" method="get" name="Search" role="search"><p class="mt-2 mb-1"><label for="query"><span class="hidden">Search the NIMH Website: </span></label><input class="searchbox usagov-search-autocomplete ui-autocomplete-input" aria-label="Search the NIMH website" autocomplete="off" id="query" name="query" placeholder="Search the NIMH website" type="text"> <input type="submit" value="Search"></p></form><div class="hidden-xs hidden-sm"><p class="small text-right m-0"><a href="/health/topics/espanol" data-entity-type="node" data-entity-uuid="d6df42f3-6876-496e-918c-cc34cc7681f7" data-entity-substitution="canonical" lang="es">Información en español</a></p></div></div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</header>
|
||
</div>
|
||
</div> <div id="menu_horizontal" class="primary-menu-container">
|
||
<div>
|
||
<nav id="block-nimhtheme-main-menu" role="navigation" aria-label="Main navigation" id="block-nimhtheme-main-menu">
|
||
|
||
|
||
|
||
|
||
<ul class="main-menu-content">
|
||
<li class="navmenu_link">
|
||
<a href="/health" class="main-menu__health" data-drupal-link-system-path="node/1925">Mental Health Information</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/get-involved" class="main-menu__getinvolved" data-drupal-link-system-path="node/2019">Get Involved</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/research" class="main-menu__research" data-drupal-link-system-path="node/7518">Research</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/funding" class="main-menu__funding" data-drupal-link-system-path="node/1128">Funding</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/news" class="main-menu__news" data-drupal-link-system-path="node/2128">News & Events</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/about" class="main-menu__about" data-drupal-link-system-path="node/7558">About Us</a>
|
||
</li>
|
||
</ul>
|
||
<div class="megamenu_container">
|
||
<div id="health-megamenu" class="megamenu">
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/health/topics">
|
||
<h2>Health Topics</h2>
|
||
<p>NIMH offers expert-reviewed information on mental disorders and a range of topics.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/health/statistics">
|
||
<h2>Statistics</h2>
|
||
<p>NIMH statistics pages include statistics on the prevalence, treatment, and costs of mental illness for the population of the United States.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/health/publications">
|
||
<h2>Brochures and Fact Sheets</h2>
|
||
<p>Download, read, and order free NIMH brochures and fact sheets about mental disorders and related topics.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/health/find-help">
|
||
<h2>Help for Mental Illnesses</h2>
|
||
<p>If you or someone you know has a mental illness, there are ways to get help. Use these resources to find help for yourself, a friend, or a family member.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/health/trials">
|
||
<h2>Clinical Trials</h2>
|
||
<p>If you or a friend or family member are thinking about taking part in clinical research, this page contains basic information about clinical trials.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<div id="getinvolved-megamenu" class="megamenu">
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/get-involved/public-involvement">
|
||
<h2>Stakeholder Engagement</h2>
|
||
<p>Find out how NIMH engages a range of stakeholder organizations as part of its efforts to ensure the greatest public health impact of the research we support.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/get-involved/connect-with-nimh">
|
||
<h2>Connect with NIMH</h2>
|
||
<p>Learn more about NIMH newsletters, public participation in grant reviews, research funding, clinical trials, the NIMH Gift Fund, and connecting with NIMH on social media. </p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/get-involved/digital-shareables">
|
||
<h2>Digital Shareables</h2>
|
||
<p>Use these free education and outreach materials in your community and on social media to spread the word about mental health and related topics.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/get-involved/science-education">
|
||
<h2>Science Education</h2>
|
||
<p>Use these free digital, outreach materials in your community and on social media to spread the word about mental health.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/get-involved/events">
|
||
<h2>Upcoming Observances and Related Events</h2>
|
||
<p>Get Involved observances calendar</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<div id="research-megamenu" class="megamenu">
|
||
<div class="menu_flexbox_span6">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/research/research-funded-by-nimh">
|
||
<h2>Research Funded by NIMH</h2>
|
||
<p>NIMH supports research at universities, medical centers, and other institutions via grants, contracts, and cooperative agreements. Learn more about NIMH research areas, policies, resources, and initiatives.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span6">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/research/research-conducted-at-nimh">
|
||
<h2>Research Conducted at NIMH (Intramural Research Program)</h2>
|
||
<p>The Division of Intramural Research Programs (IRP) is the internal research division of the NIMH. Over 40 research groups conduct basic neuroscience research and clinical investigations of mental illnesses, brain function, and behavior at the NIH campus in Bethesda, Maryland. Learn more about research conducted at NIMH.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span6">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/research/priority-research-areas">
|
||
<h2>Priority Research Areas</h2>
|
||
<p>Learn about NIMH priority areas for research and funding that have the potential to improve mental health care over the short, medium, and long term.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span6">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/research/research-funded-by-nimh/research-resources">
|
||
<h2>Resources for Researchers</h2>
|
||
<p>Information about resources such as data, tissue, model organisms and imaging resources to support the NIMH research community.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<div id="funding-megamenu" class="megamenu">
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/funding/opportunities-announcements">
|
||
<h2>Opportunities & Announcements</h2>
|
||
<p>Find all NIMH and cross-NIH funding opportunities.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/funding/funding-strategy-for-research-grants">
|
||
<h2>Funding Strategy for Grants</h2>
|
||
<p>Read more about the NIMH Strategic Plan for Research, Strategic Research Priorities, the anatomy of NIMH funding, and our yearly funding strategy for research grants.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/funding/grant-writing-and-application-process">
|
||
<h2>Application Process</h2>
|
||
<p>Explore the NIMH grant application process, including how to write your grant, how to submit your grant, and how the review process works.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/funding/managing-your-grant">
|
||
<h2>Managing Grants</h2>
|
||
<p>Learn about how NIMH manages research grants, including policies and reporting requirements.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/funding/clinical-research">
|
||
<h2>Clinical Research</h2>
|
||
<p>Find the latest NIH and NIMH policies, guidance, and resources for clinical research.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/funding/training">
|
||
<h2>Training</h2>
|
||
<p>Explore NIMH research training and career development opportunities.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/funding/sbir">
|
||
<h2>Small Business Research</h2>
|
||
<p>Learn about funding opportunities for small businesses.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner_extra">
|
||
<div class="menu_inner_pad">
|
||
<section class="box">
|
||
<h3>Quick Links</h3>
|
||
<p><a href="/funding/opportunities-announcements/funding-grant-news">Funding & Grant News</a></p>
|
||
<p><a href="/funding/opportunities-announcements/clinical-trials-foas">Support for Clinical Trials at NIMH</a></p>
|
||
</section>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<div id="news-megamenu" class="megamenu">
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/news/science-updates">
|
||
<h2>Science Updates</h2>
|
||
<p>List of NIMH science updates including press releases, research highlights, and institute announcements.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/news/events">
|
||
<h2>Meetings and Events</h2>
|
||
<p>Details about upcoming events—including meetings, conferences, workshops, lectures, webinars, and chats—sponsored by NIMH.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/news/media">
|
||
<h2>Multimedia</h2>
|
||
<p>NIMH videos and podcasts featuring science news, lecture series, meetings, seminars, and special events.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/news/social-media">
|
||
<h2>Social Media</h2>
|
||
<p>The latest information and resources on mental disorders shared on X, Facebook, YouTube, LinkedIn, and Instagram.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/news/press-resources">
|
||
<h2>Press Resources</h2>
|
||
<p>Information about NIMH, research results, summaries of scientific meetings, and mental health resources.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/news/email-updates">
|
||
<h2>Email Updates</h2>
|
||
<p>Updates about mental health topics, including NIMH news, upcoming events, mental disorders, funding opportunities, and research.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/news/innovation-speaker-series">
|
||
<h2>Innovation Speaker Series</h2>
|
||
<p>An annual lecture series dedicated to innovation, invention, and scientific discovery.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span4">
|
||
<div class="menu_inner_extra">
|
||
<div class="menu_inner_pad">
|
||
<h3>Contact the Press Office</h3>
|
||
<p>301-443-4536</p>
|
||
<p><a class="single-link" href="mailto:NIMHpress@nih.gov">NIMHpress@nih.gov</a></p>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<div id="about-megamenu" class="megamenu">
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/about/director">
|
||
<h2>About the Acting NIMH Director</h2>
|
||
<p>Learn more about the Acting Director of the NIMH, Shelli Avenevoli, Ph.D.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/about/advisory-boards-and-groups">
|
||
<h2>Advisory Boards and Groups</h2>
|
||
<p>Read about the boards and groups that advise and provide guidance to the Institute.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/about/strategic-planning-reports">
|
||
<h2>Strategic Plan</h2>
|
||
<p>Learn more about NIMH's roadmap for the Institute’s research priorities over the next five years.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/about/organization">
|
||
<h2>Offices and Divisions</h2>
|
||
<p>Learn more about the functions of each NIMH office and division.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/about/budget">
|
||
<h2>Budget</h2>
|
||
<p>Read the annual NIMH Congressional Justifications.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/about/careers">
|
||
<h2>Careers at NIMH</h2>
|
||
<p>Search for jobs, including scientific, administrative and executive careers at NIMH.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/about/staff-directories">
|
||
<h2>Staff Directories</h2>
|
||
<p>Find the names, telephone numbers, email addresses, and office locations of NIMH staff.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/about/nimh-history">
|
||
<h2>History</h2>
|
||
<p>Explore key milestones, discoveries, and the impact of NIMH-funded studies on mental health.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner">
|
||
<a class="megamenu_nav_i" href="/about/connect-with-nimh">
|
||
<h2>Getting to NIMH</h2>
|
||
<p>Find directions, maps, parking information, and other visitor information for NIMH.</p>
|
||
</a>
|
||
</div>
|
||
</div>
|
||
<div class="menu_flexbox_span3">
|
||
<div class="menu_inner_extra">
|
||
<div class="menu_inner_pad">
|
||
<h3>Quick Links</h3>
|
||
<p><strong><a href="/about/connect-with-nimh/donate-to-mental-health-research" title="Donate to Mental Health Research">Contribute to Mental Health Research</a></strong></p>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
|
||
|
||
</nav>
|
||
<nav id="block-mobilenavigation" role="navigation" aria-label="Mobile navigation" id="block-mobilenavigation">
|
||
|
||
|
||
|
||
<p class="mobile-menu-close"><i class="fas fa-times fa-2x"></i></p>
|
||
<ul class="main-menu-content">
|
||
<li class="navmenu_link">
|
||
<a href="/health" class="mobile-menu-top-level health-menu" data-drupal-link-system-path="node/1925">Mental Health Information</a>
|
||
<ul>
|
||
<li class="navmenu_link">
|
||
<a href="/health" data-drupal-link-system-path="node/1925">Mental Health Information Home</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/health/topics" data-drupal-link-system-path="node/1926">Health Topics</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/health/statistics" data-drupal-link-system-path="node/1243">Statistics</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/health/publications" data-drupal-link-system-path="node/1927">Brochures and Fact Sheets</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/health/find-help" data-drupal-link-system-path="node/1944">Help for Mental Illnesses</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/health/trials" data-drupal-link-system-path="node/2009">Clinical Trials</a>
|
||
</li>
|
||
</ul>
|
||
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/get-involved" class="mobile-menu-top-level getinvolved-menu" data-drupal-link-system-path="node/2019">Get Involved</a>
|
||
<ul>
|
||
<li class="navmenu_link">
|
||
<a href="/get-involved" data-drupal-link-system-path="node/2019">Get Involved Home</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/get-involved/public-involvement" data-drupal-link-system-path="node/2127">Stakeholder Engagement</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/get-involved/connect-with-nimh" data-drupal-link-system-path="node/8488">Connect with NIMH</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/get-involved/digital-shareables" data-drupal-link-system-path="node/7521">Digital Shareables</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/get-involved/science-education" data-drupal-link-system-path="node/10164">Science Education</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/get-involved/events" data-drupal-link-system-path="node/8489">Upcoming Observances and Related Events</a>
|
||
</li>
|
||
</ul>
|
||
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/research" class="mobile-menu-top-level research-menu" data-drupal-link-system-path="node/7518">Research</a>
|
||
<ul>
|
||
<li class="navmenu_link">
|
||
<a href="/research" data-drupal-link-system-path="node/7518">Research Home</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/research/research-funded-by-nimh" data-drupal-link-system-path="node/1992">Research Funded by NIMH</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/research/research-conducted-at-nimh" data-drupal-link-system-path="node/1123">Research Conducted at NIMH (Intramural Research Program)</a>
|
||
</li>
|
||
</ul>
|
||
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/funding" class="mobile-menu-top-level funding-menu" data-drupal-link-system-path="node/1128">Funding</a>
|
||
<ul>
|
||
<li class="navmenu_link">
|
||
<a href="/funding" data-drupal-link-system-path="node/1128">Funding Home</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/funding/opportunities-announcements" data-drupal-link-system-path="node/1029">Opportunities & Announcements</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/funding/funding-strategy-for-research-grants/strategy-for-research-grants" data-drupal-link-system-path="node/1137">Strategy for Research Grants</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/funding/grant-writing-and-application-process" data-drupal-link-system-path="node/1995">Grant Writing & Approval Process</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/funding/managing-your-grant" data-drupal-link-system-path="node/1140">Managing Grants</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/funding/clinical-research" data-drupal-link-system-path="node/1190">Clinical Research</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/funding/training" data-drupal-link-system-path="node/2007">Research Training and Career Development Opportunities</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/funding/sbir" data-drupal-link-system-path="node/1674">Small Business Research</a>
|
||
</li>
|
||
</ul>
|
||
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/news" class="mobile-menu-top-level news-menu" data-drupal-link-system-path="node/2128">News & Events</a>
|
||
<ul>
|
||
<li class="navmenu_link">
|
||
<a href="/news" data-drupal-link-system-path="node/2128">News & Events Home</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/news/science-updates" data-drupal-link-system-path="node/4730">Science Updates</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/news/events" data-drupal-link-system-path="node/1986">Meetings and Events</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/news/media" data-drupal-link-system-path="node/5039">Multimedia</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/news/social-media" data-drupal-link-system-path="node/1659">Social Media</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/news/press-resources" data-drupal-link-system-path="node/1653">Press Resources</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/news/email-updates" data-drupal-link-system-path="node/2023">Email Updates</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/news/innovation-speaker-series" data-drupal-link-system-path="node/7539">Innovation Speaker Series</a>
|
||
</li>
|
||
</ul>
|
||
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/about" class="mobile-menu-top-level about-menu" data-drupal-link-system-path="node/7558">About Us</a>
|
||
<ul>
|
||
<li class="navmenu_link">
|
||
<a href="/about" data-drupal-link-system-path="node/7558">About Us Home</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/about/director" data-drupal-link-system-path="node/7459">About the Acting NIMH Director</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/about/advisory-boards-and-groups" data-drupal-link-system-path="node/1964">Advisory Boards and Groups</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/about/strategic-planning-reports" data-drupal-link-system-path="node/1959">Strategic Plan</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/about/organization" data-drupal-link-system-path="node/1963">Offices and Divisions</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/about/budget" data-drupal-link-system-path="node/1967">Budget</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/about/careers" data-drupal-link-system-path="node/1960">Careers at NIMH</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/about/staff-directories" data-drupal-link-system-path="node/2030">Staff Directories</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/about/nimh-history" data-drupal-link-system-path="node/11838">History</a>
|
||
</li>
|
||
<li class="navmenu_link">
|
||
<a href="/about/connect-with-nimh" data-drupal-link-system-path="node/7564">Getting to NIMH</a>
|
||
</li>
|
||
</ul>
|
||
|
||
</li>
|
||
</ul>
|
||
|
||
|
||
|
||
</nav>
|
||
|
||
</div>
|
||
|
||
</div> <div class="submenu">
|
||
<div class="container">
|
||
<div class="row">
|
||
<div class="col-md-12">
|
||
<ul class="group navbar">
|
||
<li class="span navbarli"><a href="/funding/opportunities-announcements" class="navbari topnav subroot">Opportunities & Announcements</a></li>
|
||
<li class="span navbarli"><a href="/funding/funding-strategy-for-research-grants" class="navbari topnav subroot">Funding Strategy for Grants</a></li>
|
||
<li class="span navbarli"><a href="/funding/grant-writing-and-application-process" class="navbari topnav subroot">Grant Writing & Approval Process</a></li>
|
||
<li class="span navbarli"><a href="/funding/managing-your-grant" class="navbari topnav subroot">Managing Grants</a></li>
|
||
<li class="span navbarli"><a href="/funding/clinical-research" class="navbari topnav subroot">Clinical Research</a></li>
|
||
<li class="span navbarli"><a href="/funding/training" class="navbari topnav subroot">Training</a></li>
|
||
<li class="span navbarli"><a href="/funding/sbir" class="navbari topnav subroot">Small Business Research</a></li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<div>
|
||
<div data-drupal-messages-fallback class="hidden"></div>
|
||
|
||
</div>
|
||
<div id="wrapper" class="pt-3 pt-sm-3 pt-md-3 pt-lg-0">
|
||
<div class="container pt-5 pt-sm-5 pt-md-5 pt-lg-0">
|
||
<div class="row"><div class="col-md-12 hidden-xs"><div class="breadcrumbs"><nav id="breadcrumbs" class="breadcrumbs__nav" aria-label="breadcrumb links" data-dirids="2290 2478"><a href="/" data-dirlevel="0">Home</a> > <a href="/funding" data-refid="1128" data-dirlevel="1" data-dirid="2290" >Funding</a> > <a href="/funding/grant-writing-and-application-process" data-refid="1995" data-dirlevel="2" data-dirid="2478" >Grant Writing & Approval Process</a> > <span data-refid="1444" data-dirlevel="3" data-dirid="2478" data-isleaf="1">Points to Consider About Recruitment and Retention While Preparing a Clinical Research Study</span></nav></div></div></div>
|
||
<div id="main_container">
|
||
<section class="share_links_wrap">
|
||
<div class="share_links_wrap_inner">
|
||
<h6 class="share_links_header">Share Page</h6>
|
||
<div class="share_links">
|
||
<a href="https://www.facebook.com/dialog/share?app_id=1086499805165807&display=popup&href=https://www.nimh.nih.gov%2Ffunding%2Fgrant-writing-and-application-process%2Fpoints-to-consider-about-recruitment-and-retention-while-preparing-a-clinical-research-study&redirect_uri=https://www.nimh.nih.gov%2Ffunding%2Fgrant-writing-and-application-process%2Fpoints-to-consider-about-recruitment-and-retention-while-preparing-a-clinical-research-study" rel="external noopener noreferrer" target="_blank" class="external-disclaimer" aria-label="Share this page on Facebook"><span class="facebook-share"><i class="fab fa-facebook-f"></i></span></a>
|
||
<a href="https://x.com/intent/post?url=https://www.nimh.nih.gov%2Ffunding%2Fgrant-writing-and-application-process%2Fpoints-to-consider-about-recruitment-and-retention-while-preparing-a-clinical-research-study&text=Points%20to%20Consider%20About%20Recruitment%20and%20Retention%20While%20Preparing%20a%20Clinical%20Research%20Study" rel="external noopener noreferrer" target="_blank" class="external-disclaimer" aria-label="Share this page on X"><span class="twitter-share"><i class="fab fa-x-twitter"></i></span></a>
|
||
<a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.nimh.nih.gov%2Ffunding%2Fgrant-writing-and-application-process%2Fpoints-to-consider-about-recruitment-and-retention-while-preparing-a-clinical-research-study&title=Points%20to%20Consider%20About%20Recruitment%20and%20Retention%20While%20Preparing%20a%20Clinical%20Research%20Study" rel="external noopener noreferrer" target="_blank" class="external-disclaimer" aria-label="Share this page on LinkedIn"><span class="linkedin-share"><i class="fa-brands fa-linkedin-in"></i></span></a>
|
||
<a href="mailto:?subject=I%20Saw%20This%20on%20www.nimh.nih.gov%20--%20Points%20to%20Consider%20About%20Recruitment%20and%20Retention%20While%20Preparing%20a%20Clinical%20Research%20Study&body=https://www.nimh.nih.gov%2Ffunding%2Fgrant-writing-and-application-process%2Fpoints-to-consider-about-recruitment-and-retention-while-preparing-a-clinical-research-study" aria-label="Share this page by email"><span class="email-share"><i class="fas fa-envelope"></i></span></a>
|
||
<button class="print_icon" aria-label="Open print helper modal"><i class="fas fa-print"></i></button>
|
||
</div>
|
||
</div>
|
||
</section>
|
||
<div class="row">
|
||
<div class="flex_main_container col-md-12">
|
||
|
||
<div id="main_content" class="areanav-false sidebar-false">
|
||
<main id="main-content">
|
||
<article id="main_content_inner">
|
||
<div>
|
||
<div id="block-nimhtheme-page-title" class="block block-core block-page-title-block">
|
||
|
||
|
||
|
||
<h1 class="splashBanner__title" >Points to Consider About Recruitment and Retention While Preparing a Clinical Research Study</h1>
|
||
|
||
|
||
</div>
|
||
<div id="block-nimhtheme-content" class="block block-system block-system-main-block">
|
||
|
||
|
||
<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd">
|
||
<html><body><div data-history-node-id="1444" class="node node--type-basic-page node--view-mode-full clearfix">
|
||
|
||
|
||
<div class="node__content clearfix">
|
||
<div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><p>The following “points to consider” are meant to serve as a resource as investigators plan a clinical research study and an NIMH grant application. These “points” outline common issues that can impact clinical recruitment and retention, and where applicable, strategies are suggested to address these issues. This document is not meant to serve as a “cookbook” of strategies that will assure successful recruitment and retention, but is meant to provoke thought and discussion. Naturally, each study will have to be tailored to suit the needs of the potential participants, investigators, research institutions, and communities. NIMH hopes that this document will help prepare researchers to address recruitment issues in advance so that the researchers will conduct a successful study while building positive and lasting relationships with the community.</p><table class="basicTable" summary="This table contains questions and answers about recruiting and retaining participants for clinical research studies."><thead><tr><th><h2>Points to Consider</h2></th><th><h2>Examples/Suggestions</h2></th></tr></thead><tbody><tr><td><p><strong>Community engagement</strong></p><ul><li>Have you identified the communities that you would like to engage?</li><li>What relationships have you established with communities in order to facilitate your study? What relationships will you need to establish?</li><li>How will you maintain these relationships?</li><li>What strategies will you use to engage different communities before and during your study?</li><li>What efforts has your University/Research Institution made in the past to engage these communities? Are there any ongoing collaborations/partnerships at your institution?</li><li>What will the participating communities receive in return for their involvement in the study?</li></ul></td><td><p><strong>Examples of communities:</strong> Potential participants and their family members, referring physicians, community-based organization directors, state mental health directors, civic organizations, advocacy organizations, faith-based organizations, churches, community centers, health clinics, and the media.</p><p><strong>Suggestions:</strong></p><ul><li>Establish relationships with people in the communities that you would like to engage for your study.</li><li>Establish a community-based research advisory board to facilitate the planning of your research project. Work with an established board, if it already exists.</li><li>Consider using qualitative focus groups to assess the needs and preferences of potential participants.</li><li>Develop plans to share the study results in formats most useful to the different communities involved, including participants, families of participants, consumers, and referring practitioners. Dissemination of information will be facilitated by having a representative community-based research advisory board.</li></ul></td></tr><tr><td><p><strong>Benefits to participation</strong></p><ul><li>What are the benefits to enrolling in this clinical research study, from the perspective of potential participants? How will you determine these benefits?</li><li>Does the study design include assessment/treatment strategies that are likely to foster enrollment and retention?</li></ul></td><td><p><strong>Suggestions:</strong></p><ul><li>Work with communities through focus groups, interviews, and surveys to develop a list of benefits (as well as barriers, see next item) to participating in the research study. The list of benefits can be communicated to potential participants, and specific benefits can be emphasized when speaking to different audiences.</li><li>When communicating with patients, you might emphasize that the study aims to improve our understanding of and treatments for a disorder. When speaking to family members, you could explain that the study will not require a patient to change his/her current treatment program.</li></ul></td></tr><tr><td><p><strong>Barriers to participation</strong></p><ul><li>What are the barriers to participation?</li><li>How will you prepare to address each of these barriers?</li><li>Will all study costs be covered for the participant? Is there a way to reduce any costs?</li><li>Have you considered the language requirements and literacy of proposed participants?</li><li>Are you familiar with how English is used by different racial and ethnic groups?</li></ul></td><td><p><strong>Examples:</strong></p><ul><li><strong>Participant barriers:</strong> time off work, transportation costs, childcare, care for an elderly relative, language differences, out-of-pocket expenses, not wanting to change current medical treatment, not wanting to change physicians, concerns about medication side-effects, limited health insurance reimbursement, mistrust of medical research, fear of stigma associated with a disorder/disease, etc.</li><li><strong>Investigator barriers:</strong> research teams lacking knowledge about the communities chosen for inclusion, ineffective guidance to study staff, recruitment based on convenience, ineffective informed consent processes, limited knowledge about methods to promote a study, limited knowledge of appropriate retention methods, etc.</li></ul><p><strong>Suggestions:</strong></p><ul><li>Create an FAQ sheet addressing potential concerns in order to clear up misconceptions.</li><li>Prepare recruitment documents using the first language of the target populations, such as Spanish. Take into consideration that the Spanish language differs between countries, thus translation must be performed by an individual who is familiar with the target community.</li></ul></td></tr><tr><td><p><strong>Informational materials</strong></p><ul><li>Have you designed your informational/study materials for your intended audience?</li><li>Have you considered working with community organizations that could help prepare, design, or distribute informational/study materials?</li><li>Will study materials (consent forms, study instruments) account for different levels literacy and cognitive abilities?</li></ul></td><td><p><strong>Suggestions:</strong></p><ul><li>Please see the <a href="/funding/clinical-research/clinical-research-toolbox/nimh-clinical-research-toolbox" data-entity-type="node" data-entity-uuid="ddcc871b-dc78-47b0-a142-5012df7ad159" data-entity-substitution="canonical">NIMH Clinical Research Toolbox</a> for NIH and NIMH policy and guidance documents, templates, sample forms, links to additional resources, and other materials to assist investigators in the development and conduct of high-quality clinical research studies. Also, check out the <a href="/get-involved/digital-shareables" data-entity-type="node" data-entity-uuid="6f34a495-dcfa-4808-b93d-00d7a2022a60" data-entity-substitution="canonical">NIMH Education and Awareness</a> materials and publications.</li><li>Use clear and simple language in informational materials.</li><li>Provide all materials in the first language of target populations.</li></ul><p>Besides NIMH resource materials, NIH has <a href="http://www.nih.gov/" rel="external">health information <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a> resources from all institutes as well as <a href="http://www.medlineplus.gov/" rel="external">MedlinePlus <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a> in <a href="http://www.medlineplus.gov/" rel="external">English <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a> and <a href="http://medlineplus.gov/spanish/" rel="external">Spanish <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a>.</p></td></tr><tr><td><p><strong>Planning and Timeline</strong></p><ul><li>What is a realistic recruitment timeline?</li><li>What is your timeline for protocol finalization, IRB approvals, development of treatment materials or experimental methods, piloting, staff training and certification, development of data collection instruments and systems, tools for quality control, acquisition of treatment products and matching placebo, etc.?</li><li>Do you plan to match resources to recruitment over the lifespan of the grant (i.e. funds, personnel)?</li></ul></td><td><p><strong>Suggestions:</strong></p><ul><li>Rebounding from recruitment shortfalls can be difficult as a study progresses. Thus, detailed planning of all aspects of study design and implementation is critical to the success of the study.</li><li>Personnel effort should be adjusted accordingly during periods of high/low recruitment.</li><li>Prior local studies may provide parameter estimates of the percent of eligible participants.</li><li>What resources will be required to retain participants after the recruitment phase is completed?</li><li>Have you considered using available local data to generate enrollment/retention estimates that are as accurate as possible?</li></ul><p>A Recruitment timeline considers the following critical time points:</p><ul><li>Enrollment start date</li><li>Enrollment end date</li><li>Intervention completion date (date last person will complete study intervention if patient completes the full protocol)</li><li>Data lock date (date when all data have been entered, queries resolved, data ready for analysis)</li><li>Paper Finalization date (date when outcome manuscript is ready for journal submission)</li></ul></td></tr><tr><td><p><strong>Recruitment Strategies</strong></p><ul><li>What mechanisms will you use to encourage recruitment?</li><li>Will you need different recruitment strategies tailored to different racial/ethnic populations?</li><li>Do you have a Public Affairs or Media Relations Department at your university that can help you to promote the study to your local media and community?</li><li>Does your Public Affairs or Media Relations Department have connections to all of the communities chosen for the study?</li><li>Do you have a detailed and piloted plan for community outreach for each group chosen?</li><li>How long does it take your IRB to review and approve advertising?</li><li>Will you have a dedicated telephone number and/or email address for potential participants to learn more about the study and a response system in place?</li><li>Have you determined if there are conditions in the local community that might affect participant support of your project (e.g. the effects of numerous studies and over-sampling, or community activists seeking to influence research projects)?</li></ul></td><td><p><strong>Recruitment tools:</strong> Radio ads, newspaper ads, flyers, newsletter articles, FAQ sheets, web sites, public service announcements, press releases, letters to the editor, Op-Ed articles, interviews on TV or radio, etc.</p><p><strong>Suggestions:</strong></p><ul><li>Match the recruitment tool to the target audience (potential participant vs. caregiver vs. community referral source) and conduct pilot tests.</li><li>Make sure all staff who communicate with potential participants receive proper training.</li><li>Enter information about your clinical trial on <a href="http://www.ClinicalTrials.gov" rel="external">ClinicalTrials.gov <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a>.</li></ul></td></tr><tr><td><p><strong>Retention Strategies</strong></p><ul><li>How will you retain participants?</li><li>How will you monitor retention?</li></ul></td><td><p><strong>Suggestions:</strong></p><ul><li>Communicate your long-term commitment to the individual and community.</li><li>Clearly explain to participants the requirements of the study. For example, “I will need you to see you again one year from now. What is the best way for me to contact you?”</li><li>Be flexible when scheduling appointments.</li><li>Obtain several phone numbers (home, work, cell) for participants so that you can follow up with them easily.</li><li>Send participants small tokens of appreciation that will remind them of the study: birthday cards, refrigerator magnets, pens, etc.</li><li>Send out newsletters that report the progress of the study.</li><li>Provide services for the participant separate from the research study.</li><li>Report research results in formats most useful to the different communities involved, such as participants, families of participants, and referring practitioners. For participants, explain how the findings may ultimately improve their health. To accommodate the busy schedules of health care practitioners, provide a handout that summarizes the findings more succinctly than a journal publication.</li></ul></td></tr><tr><td><p><strong>Representativeness</strong></p><ul><li>Do you have realistic recruitment and retention strategies for all populations?</li><li>Do you have an adequate mix of diversity in your community from which to recruit participants?</li><li>Do the backgrounds of senior study staff reflect the communities that you wish to engage for participation in the study?</li><li>Are you aware that some communities are mistrustful of medical research? How do you plan to address these concerns?</li><li>Will your research team work with peers who are knowledgeable about the community?</li><li>Are you planning to work with organizations that interact or advocate for diverse populations?</li></ul></td><td><p><strong>Suggestions:</strong></p><ul><li>Research staff should reflect the groups desired for enrollment and a diversity of scientific discipline and research experience.</li><li>Establish relationships with respected members of the communities chosen for inclusion.</li><li>Work with a representative/liaison of specific communities to obtain ideas for enhancing communication.</li><li>Work with local churches, community centers, etc.</li><li>Offer all study materials in relevant languages.</li></ul><p><strong>More information is contained in:</strong></p><ul><li><a href="http://orwh.od.nih.gov/research/inclusion/pdf/Outreach-Notebook-021315.pdf" rel="external">NIH Outreach Notebook for the Inclusion, Recruitment and Retention of Women and Minority Subjects in Clinical Research <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li><li><a href="https://accrualnet.cancer.gov/sites/accrualnet.cancer.gov/files/ResourceGuide_Book_m.pdf" rel="external">Cancer Clinical Trials: a Resource Guide for Outreach, Education, and Advocacy (NCI) <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon"></i></a></li></ul></td></tr><tr><td><p><strong>Staff</strong></p><ul><li>How do you plan to train your staff to perform the study protocol?</li><li>How will you train staff to assume greater responsibility/independence?</li><li>How will you replace key staff, if other staff members are not sufficiently experienced and/or trained to assume those responsibilities?</li><li>How will you maintain "staff balance" for this study/trial (i.e. assigning staff among various trials)?</li></ul></td><td><p><strong>Considerations:</strong></p><ul><li>Staff training directly impacts recruitment and retention.</li><li>Because of the lengthy commitment to complete a clinical study, there will likely be turnover in staff.</li><li>Plan for ongoing training for the replacement staff as well as refresher training for all staff.</li></ul></td></tr><tr><td><p><strong>Multi-site considerations</strong></p><ul><li>What is the maximum number of participants that your site has the capacity to screen, enroll, and follow up with at the same time?</li><li>Have you chosen sites that can access the target populations and have a realistic likelihood of recruitment success?</li><li>How will you train and certify staff at all clinical sites?</li><li>How will you ensure that your sites will adhere to a common protocol?</li><li>Are there plans for ensuring and monitoring fidelity to the protocol?</li><li>Do you have plans for “backup” sites, should they become necessary?</li><li>Have you considered the impact of potential unbalanced enrollment across sites?</li><li>Have you specified conditions under which a site may be terminated?</li></ul></td><td><p><strong>Considerations:</strong></p><ul><li>Multiple sites are used because the topic being studied requires a large and diverse sample size that is beyond what one site can achieve alone. However, many sites fail to enroll their target sample sizes, leaving the total sample inadequate.</li><li>As a study progresses, sites tend to fall into the categories of strong and weak enrollers. As enrollment goals slip behind, study leaders often decide to allow the strong enrollers to “over-recruit” in order to meet the overall sample size goal. However, because part of the site selection involves balance of geography, type of clinic, and racial/ethnic diversity, the post-design imbalance in enrollment across sites often impacts statistical analysis in a manner rarely considered.</li></ul></td></tr><tr><td><p><strong>Coordinating center for multi-site studies</strong></p><ul><li>Does the coordinating center(s) have expertise in multi-site leadership?</li><li>Do the coordinating center leaders have a clear mandate from site investigators?</li><li>Have the leaders demonstrated a capacity to make decisions and keep the project moving forward?</li><li>Does the coordinating center senior research team have the ability to assess and advise in matters concerning racial and ethnic diversity?</li><li>Have you outlined the organizational structure (e.g. committees) of the coordinating center?</li><li>Has the administrative structure and function been clearly defined?</li><li>Do you have processes for resolving disputes and disagreements?</li></ul></td><td><p><strong>Considerations:</strong></p><ul><li>Problems may arise when the coordinating center is located at one of the participating data collection sites. The coordinating center must ensure a clear line of responsibility, confidentiality of data, and a strong firewall to prevent cross-talk.</li><li>The study leader must have a clear mandate from colleagues to assume a position of authority. The leader must have the experience and confidence to be able to consider all points of view and to make a decision in spite of disagreement.</li><li>During study implementation, the coordinating investigators need to review data without allowing their knowledge to influence decision-making at a site level.</li><li>Conflict may arise if a clinical site is under-recruiting, and the site is also the coordinating center.</li></ul></td></tr><tr><td><p><strong>Sample Size</strong></p><ul><li>Is the design flexible enough to permit enrollment of a diverse sample?</li><li>Are the inclusion criteria too narrow, such that you will have unusual difficulty finding people who qualify for the study?</li></ul></td><td><p><strong>Considerations:</strong></p><ul><li>Strict inclusion criteria restrict the eligible number of participants and increase the amount of time and resources dedicated to screening.</li><li>Studies may require that people are screened at successive stages, requiring significant time and expenditure of resources on subjects who never enter the study.</li></ul></td></tr><tr><td><p><strong>Institutional Review Board (IRB) and Data & Safety Monitoring</strong></p><ul><li>Are the risks to participants minimized as much as possible through sound research design and the use of safety-focused procedures?</li><li>Are participants selected fairly?</li><li>Is a plan in place for seeking and documenting participants’ informed consent? Are consent documents culturally and developmentally appropriate for all study populations?</li><li>Is the informed consent document both legally and ethically sound?</li><li>Have provisions been made for monitoring the data collected to ensure the safety of participants as the trial progresses?</li><li>Have provisions been made to protect the privacy of participants and the confidentiality of data collected during the study?</li></ul></td><td><p><strong>Considerations:</strong></p><ul><li>IRBs consist of people who are qualified to evaluate new and ongoing clinical studies on the basis of scientific, legal, and ethical merit.</li><li>The IRB determines whether the risks involved in a study are reasonable with respect to the potential benefits.</li><li>The IRB has the authority to approve, require modification, or disapprove of research to ensure protection of human subjects.</li><li>IRBs monitor the ongoing progress of a study, from beginning to end.</li><li>Most institutions that carry out clinical studies have their own IRBs.</li><li>Failure to obtain IRB approval will delay the progression of a study.</li><li>All institutions carrying out a NIMH funded intervention study must establish a data monitoring system commensurate with the risks, complexity, and nature of the trial. For more information, see the <a href="/funding/clinical-research/nimh-policy-governing-the-monitoring-of-clinical-trials" data-entity-type="node" data-entity-uuid="17e69009-1f1f-4eb1-9a56-c448d8afb785" data-entity-substitution="canonical">NIMH website on Data and Safety Monitoring</a>.</li></ul></td></tr><tr><td><p><strong>Pilot studies</strong></p><ul><li>Have you piloted all relevant aspects of the methodology including recruitment, screening, assessment, randomization procedures (if required), treatment and experimental methods, data entry, etc.?</li><li>Has retention of participants been achieved for pilot studies? For how long?</li></ul></td><td><p><strong>Considerations:</strong></p><ul><li>Complex designs are often needed to answer important questions that cannot be addressed with simple designs, but pilot studies may be required to develop an achievable recruitment plan.</li></ul></td></tr><tr><td><p><strong>When the study has been completed</strong></p><ul><li>How will you thank participants?</li><li>How will you disseminate the research results to all communities involved?</li><li>How will you maintain the relationships that you have forged with the communities?</li></ul></td><td><p><strong>Suggestions:</strong></p><ul><li>Send thank you notes to participants and other communities that were involved in the study.</li><li>Report research results in formats most useful to the different communities involved, such as participants, families of participants, and referring practitioners. For participants, explain how the findings may ultimately improve their health. To accommodate the busy schedules of health care practitioners, provide a handout that summarizes the findings more succinctly than a journal publication.</li><li>Maintain contact with your established community-based research advisory board and other community representatives/liaisons.</li><li>Establishing and maintaining positive relationships with your community may facilitate your future research studies, as well as the studies of your colleagues.</li></ul></td></tr></tbody></table></div>
|
||
|
||
</div>
|
||
</div>
|
||
</body></html>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</article>
|
||
</main>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
<footer id="footer-contact">
|
||
<div class="footer-container container">
|
||
<div>
|
||
<div id="block-contactusfooter" class="block block-block-content block-block-contentc7a9e7bc-56ff-41ac-8678-60f3a9a54eeb">
|
||
|
||
|
||
<div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><h2>NIMH Information Resource Center</h2><div><span class="small">Available in English and español</span></div><div class="row"><div class="col-xl-6 col-lg-6 col-md-6 col-sm-6 col-xs-12"><p class="phone"><em><i class="fas fa-phone" aria-hidden="true"> </i></em> <strong>Phone: </strong> <a href="tel:1-866-615-6464">1-866-615-6464</a> <br><em><i class="far fa-comments" aria-hidden="true"> </i></em> <strong>Live Online Chat: </strong> <a href="https://infocenter.nimh.nih.gov">Talk to a representative</a> <br><em><i class="far fa-envelope" aria-hidden="true"> </i></em> <strong>Email: </strong> <a href="mailto:nimhinfo@nih.gov">nimhinfo@nih.gov</a> <br><em><i class="far fa-clock" aria-hidden="true"> </i></em><strong>Hours:</strong> 8:30 a.m. – 5 p.m. ET, M-F</p></div><div class="col-xl-6 col-lg-6 col-md-6 col-sm-6 col-xs-12"><p><strong>Mail: </strong> National Institute of Mental Health <br>Office of Science Policy, Planning, and Communications <br>6001 Executive Boulevard, MSC 9663 <br>Bethesda, MD 20892-9663</p></div></div></div>
|
||
|
||
</div>
|
||
<div id="block-nimhtheme-linkdisclaimer" class="block block-block-content block-block-content43e6eaa7-a06a-4a06-9eff-b06d3dded90d">
|
||
|
||
|
||
<div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><div id="footer-disclaimer"><h2>Disclaimer</h2><p>We link to external websites for informational purposes only, but we do not endorse or guarantee their accuracy. Once you leave our site, you will be subject to the new website’s privacy policy. Read NIMH’s <a href="/site-info/policies#part_2717"><u>full external linking policy</u></a> for more information.</p></div></div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</footer>
|
||
|
||
<footer id="footer-social">
|
||
<div class="footer-container container">
|
||
<div>
|
||
<div id="block-followusfooter" class="block block-block-content block-block-contentcafb1a66-d0fb-4772-b5c2-5c7d0773f849">
|
||
|
||
|
||
<div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="row"><div class="col-lg-8 col-md-7 col-sm-12 followus"><h3>Follow Us</h3><p><a class="external-disclaimer" href="https://www.instagram.com/nimhgov/" title="NIMH Instagram" rel="external"><span class="hidden">Instagram</span><em><i class="fab fa-instagram" style="background:#005395;" aria-hidden="true"> </i></em></a> <a class="external-disclaimer" href="https://www.facebook.com/nimhgov" title="NIMH Facebook" rel="external"><span class="hidden">Facebook</span><em><i class="fab fa-facebook-f" style="background:#005395;" aria-hidden="true"> </i></em></a> <a class="external-disclaimer" href="https://www.linkedin.com/company/national-institute-of-mental-health-nimh" title="NIMH LinkedIn" rel="external"><span class="hidden">Linkedin</span><em><i class="fab fa-linkedin-in" style="background:#005395;" aria-hidden="true"> </i></em></a><a class="external-disclaimer" href="https://twitter.com/nimhgov" title="NIMH Twitter" rel="external"><span class="hidden">Twitter</span><em><i class="fab fa-x-twitter" style="background:#005395;" aria-hidden="true"> </i></em></a> <a class="external-disclaimer" href="https://www.youtube.com/nimhgov" title="NIMH YouTube" rel="external"><span class="hidden">YouTube</span><em><i class="fab fa-youtube" style="background:#005395;" aria-hidden="true"> </i></em></a><a href="/news/email-updates" title="NIMH Newsletters" data-entity-type="node" data-entity-uuid="72c6d25b-a844-48b0-be68-5c85cf5df771" data-entity-substitution="canonical"> <em><i class="far fa-file-alt" style="background:#005395;" aria-hidden="true"> </i></em></a><a href="/news/web-channels" title="NIMH News Feeds" data-entity-type="node" data-entity-uuid="26a1cafd-738b-443d-920f-c491f872d6d9" data-entity-substitution="canonical"> <em><i class="fas fa-rss" style="background:#005395;" aria-hidden="true"> </i></em></a></p></div><div class="col-lg-4 col-md-5 col-sm-12"><h3 class="mb-0">Subscribe to NIMH Email Updates</h3><form class="subscribe-in-banner" accept-charset="UTF-8" action="https://public.govdelivery.com/accounts/USNIMH/subscribers/qualify" method="get" name="Subscribe"><p><label><span class="hidden">Type email address...</span> <input class="subscribe_box" aria-label="Type email address..." name="email" placeholder="Type email address..." size="30" type="text"> </label><input type="submit" value="Subscribe"> </p></form></div></div><style>
|
||
.followus p a {
|
||
margin: .1rem;
|
||
}
|
||
.followus i.fab:hover, .followus i.far:hover, .followus i.fas:hover{
|
||
background-color: #00335e !important;
|
||
}
|
||
</style></div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</footer>
|
||
|
||
<footer id="footer-siteInfo">
|
||
<div class="footer-container container">
|
||
<div>
|
||
<div id="block-siteinfofooter" class="block block-block-content block-block-content7adf2027-35bd-4389-9dd4-330dcc3d17c4">
|
||
|
||
|
||
<div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><div class="row" id="block-footer"><div class="col-xl-4 col-lg-4 col-md-4 col-sm-4 col-xs-12"><h5>NIMH Resources</h5><p><a href="/health/topics" data-entity-type="node" data-entity-uuid="f7e048e4-f68f-4b7f-afb8-6fb95336f6b3" data-entity-substitution="canonical">Health Topics</a> <br><a href="/health/publications" data-entity-type="node" data-entity-uuid="3a6321c0-9c96-45b6-8d5c-5f4eab17632b" data-entity-substitution="canonical">Brochures and Fact Sheets</a> <br><a href="/site-info/contact-nimh" data-entity-type="node" data-entity-uuid="3b82dd34-6040-4763-a9ff-db0c3d5b6a38" data-entity-substitution="canonical">Contact Us</a> <br><a href="/health/topics/espanol" data-entity-type="node" data-entity-uuid="d6df42f3-6876-496e-918c-cc34cc7681f7" data-entity-substitution="canonical">Información en español</a></p></div><div class="col-xl-4 col-lg-4 col-md-4 col-sm-4 col-xs-12"><h5>Policies and Notices</h5><p><a href="/site-info/privacy-policy" data-entity-type="node" data-entity-uuid="f9084068-f15e-4322-b69b-eb250f301bf4" data-entity-substitution="canonical">Privacy Policy</a> <br><a href="/site-info/policies" data-entity-type="node" data-entity-uuid="e7a9f3b0-b458-4dcd-84aa-2c373b217d3f" data-entity-substitution="canonical">Website Policies</a> <br><a href="http://www.nih.gov/icd/od/foia/index.htm" rel="external">FOIA <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a> <br><a href="/site-info/accessibility" data-entity-type="node" data-entity-uuid="35acaa5a-b4a3-4061-b0b9-018d0e02b011" data-entity-substitution="canonical">Accessibility</a> <br><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" rel="external">HHS Vulnerability Disclosure <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a></p></div><div class="col-xl-4 col-lg-4 col-md-4 col-sm-4 col-xs-12"><h5>Federal Resources</h5><p><a href="http://www.nih.gov/" rel="external">National Institutes of Health (NIH) <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a> <br><a href="https://www.nih.gov/virtual-tour/" rel="external">NIH Virtual Tour <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a> <br><a href="https://www.hhs.gov" rel="external">U.S. Department of Health and Human Services <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a> <br><a href="http://www.usa.gov/" rel="external">USA.gov <i class="fa-solid fa-arrow-up-right-from-square ext-link-icon" aria-hidden="true"></i></a></p></div></div><p class="institute_boilerplate">The National Institute of Mental Health (NIMH) is part of NIH, a component of the U.S. Department of Health and Human Services.</p></div>
|
||
|
||
</div>
|
||
<div id="block-backtotop" class="block block-block-content block-block-content2fd64a46-6d78-4c08-8260-bf3aad9aa46d">
|
||
|
||
|
||
<div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><p class="hidden-sm hidden-xs" id="backtotop"><a href="#skipnav"><span class="bt-img"> </span><span>Top</span></a>
|
||
</p></div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</footer>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
|
||
<script src="/sites/default/files/js/js_Ar12EQc0ItFgOVOiA7ch7vfF-NWs4pUi1kGBcM1-7rw.js?scope=footer&delta=0&language=en&theme=nimhtheme&include=eJzLy8zNKMlIzU3VT8vPK0ksTy3Oz02NN9PJg4un5-QnJeboFicXZRaUFAMA0TwS7A"></script>
|
||
<script src="//kit.fontawesome.com/1ea3372bd6.js" crossorigin="anonymous"></script>
|
||
<script src="/sites/default/files/js/js_uIBU-5fuvQZZvnNDo5BMVNRXUN7VE0SzzMMTrzW1miA.js?scope=footer&delta=2&language=en&theme=nimhtheme&include=eJzLy8zNKMlIzU3VT8vPK0ksTy3Oz02NN9PJg4un5-QnJeboFicXZRaUFAMA0TwS7A"></script>
|
||
|
||
</body>
|
||
</html>
|