513 lines
41 KiB
Text
513 lines
41 KiB
Text
<!DOCTYPE html>
|
||
<html class="no-js" lang="en" dir="ltr" prefix="content: http://purl.org/rss/1.0/modules/content/ dc: http://purl.org/dc/terms/ foaf: http://xmlns.com/foaf/0.1/ rdfs: http://www.w3.org/2000/01/rdf-schema# sioc: http://rdfs.org/sioc/ns# sioct: http://rdfs.org/sioc/types# skos: http://www.w3.org/2004/02/skos/core# xsd: http://www.w3.org/2001/XMLSchema#">
|
||
<head>
|
||
<title>Guiding Principles for Ethical Research | National Institutes of Health (NIH)</title>
|
||
<meta charset="utf-8" />
|
||
<script type="text/javascript">
|
||
//<![CDATA[
|
||
var usasearch_config = { siteHandle:"nih" };
|
||
|
||
var script = document.createElement("script");
|
||
script.type = "text/javascript";
|
||
script.src = "//search.usa.gov/javascripts/remote.loader.js";
|
||
document.getElementsByTagName("head")[0].appendChild(script);
|
||
|
||
//]]>
|
||
</script><link rel="shortcut icon" href="https://www.nih.gov/favicon.ico" type="image/vnd.microsoft.icon" />
|
||
<meta name="google-site-verification" content="rjIoO4vW0AYgltSYvxM1L_CzGIkq28kHf9gHIASKx8s" />
|
||
<link rel="profile" href="http://www.w3.org/1999/xhtml/vocab" />
|
||
<meta http-equiv="cleartype" content="on" />
|
||
<link rel="apple-touch-icon" href="https://www.nih.gov/sites/all/themes/nih/apple-touch-icon.png" />
|
||
<meta name="description" content="Researchers can take precautions to protect participants in research studies." />
|
||
<meta name="keywords" content="guiding principles, ethical, research" />
|
||
<meta name="robots" content="follow, index" />
|
||
<meta name="viewport" content="width=device-width, initial-scale=1.0" />
|
||
<meta name="generator" content="Drupal 7 (http://drupal.org)" />
|
||
<link rel="canonical" href="https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research" />
|
||
<link rel="shortlink" href="https://www.nih.gov/node/10006" />
|
||
<meta http-equiv="content-language" content="EN" />
|
||
<meta property="og:site_name" content="National Institutes of Health (NIH)" />
|
||
<meta property="og:type" content="article" />
|
||
<meta property="og:title" content="Guiding Principles for Ethical Research" />
|
||
<meta property="og:url" content="https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research" />
|
||
<meta property="og:description" content="Researchers can take precautions to protect participants in research studies." />
|
||
<meta property="og:updated_time" content="2016-03-16T16:31:39-04:00" />
|
||
<meta property="og:image" content="https://www.nih.gov/sites/default/files/health-info/clinical-trials/female-doctor-talking-to-senior-couple_0.jpg" />
|
||
<meta name="twitter:card" content="summary" />
|
||
<meta name="twitter:title" content="Guiding Principles for Ethical Research" />
|
||
<meta name="twitter:url" content="https://www.nih.gov/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research" />
|
||
<meta name="twitter:description" content="Researchers can take precautions to protect participants in research studies." />
|
||
<meta name="twitter:image" content="https://www.nih.gov/sites/default/files/health-info/clinical-trials/female-doctor-talking-to-senior-couple_0.jpg" />
|
||
<meta property="article:published_time" content="2015-06-03T14:26:50-04:00" />
|
||
<meta property="article:modified_time" content="2016-03-16T16:31:39-04:00" />
|
||
<meta name="owner" content="OD" />
|
||
<meta name="published_date" content="2015-06-03T14:26:50-04:00" />
|
||
<meta name="last_revision" content="2016-03-16T16:31:39-04:00" />
|
||
<link type="text/css" rel="stylesheet" href="https://www.nih.gov/sites/default/files/css/css_PfvPCWanzn7FjDwZqwAHhPoOxYKwkQP-RZSK1pFFG0s.css" media="all" />
|
||
<link type="text/css" rel="stylesheet" href="https://www.nih.gov/sites/default/files/css/css__mIWP9gcStq74isjZVoAAsiih8VXwJoN75Nyw_BXrj0.css" media="screen" />
|
||
<style media="print">#sb-container{position:relative;}#sb-overlay{display:none;}#sb-wrapper{position:relative;top:0;left:0;}#sb-loading{display:none;}
|
||
</style>
|
||
<link type="text/css" rel="stylesheet" href="https://www.nih.gov/sites/default/files/css/css_jENQOQqZCRFGZK__DTefxYiXR2RUf03k1ugj3_Vg7vk.css" media="all" />
|
||
<link type="text/css" rel="stylesheet" href="//cdn.jsdelivr.net/qtip2/3.0.3/jquery.qtip.min.css" media="all" />
|
||
<link type="text/css" rel="stylesheet" href="https://www.nih.gov/sites/default/files/css/css_3yt-b0M1HNJsvKsXwYjh5TEtX2lJGAvJvtmVAfORYZs.css" media="all" />
|
||
<link type="text/css" rel="stylesheet" href="//fonts.googleapis.com/css?family=Droid+Sans:700,regular|Droid+Serif:italic,regular&subset=latin" media="all" />
|
||
<link type="text/css" rel="stylesheet" href="https://www.nih.gov/sites/default/files/css/css_5rDMv37-JxnNA70cRr_1jlAjVs56DCb8EN4XB2QLl0c.css" media="all" />
|
||
|
||
<!--[if lte IE 8]>
|
||
<link type="text/css" rel="stylesheet" href="https://www.nih.gov/sites/default/files/css/css_aLJB_yHt22A_mQek4IRDNsur5tEkCpqLe72j_w6QHQ0.css" media="all" />
|
||
<![endif]-->
|
||
<link type="text/css" rel="stylesheet" href="https://www.nih.gov/sites/default/files/css/css_KviiBystpJcQq4MplcQZvCFxnu9V763f5bPq_AKh4xM.css" media="all" />
|
||
<script src="https://www.nih.gov/sites/default/files/js/js_mQAv54bz2JVXcwS5QWlz0fVY9Os67zeu9bgNqtlVLPY.js"></script>
|
||
<script src="//code.jquery.com/jquery-2.2.4.min.js"></script>
|
||
<script>window.jQuery || document.write("<script src='/sites/all/modules/contrib/jquery_update/replace/jquery/2.2/jquery.min.js'>\x3C/script>")</script>
|
||
<script>jQuery.migrateMute=true;jQuery.migrateTrace=false;</script>
|
||
<script src="//code.jquery.com/jquery-migrate-1.4.1.min.js"></script>
|
||
<script>window.jQuery && window.jQuery.migrateWarnings || document.write("<script src='/sites/all/modules/contrib/jquery_update/replace/jquery-migrate/1.4.1/jquery-migrate.min.js'>\x3C/script>")</script>
|
||
<script src="https://www.nih.gov/sites/default/files/js/js_9sGTPBGcOGZjLiSLGrYEnuUf8VdvLmL_DEZNNNbnHXk.js"></script>
|
||
<script src="https://www.nih.gov/sites/default/files/js/js_hNnF7a_sbk6nZ2-mOamHzalYND7HBHDLRInsaU93HDk.js"></script>
|
||
<script>document.createElement( "picture" );</script>
|
||
<script src="https://www.nih.gov/sites/default/files/js/js_gHk2gWJ_Qw_jU2qRiUmSl7d8oly1Cx7lQFrqcp3RXcI.js"></script>
|
||
<script src="//cdn.jsdelivr.net/qtip2/3.0.3/jquery.qtip.min.js"></script>
|
||
<script defer="defer" src="//script.crazyegg.com/pages/scripts/0011/2616.js"></script>
|
||
<script src="https://www.nih.gov/sites/default/files/js/js_3s0l7MQ3oYmGkNAypyzCJq3a0wT85XX_P1SLgnph5K4.js"></script>
|
||
<script>
|
||
Shadowbox.path = "/sites/all/libraries/shadowbox/";
|
||
</script>
|
||
<script>jQuery.extend(Drupal.settings, {"basePath":"\/","pathPrefix":"","setHasJsCookie":0,"instances":"{\u0022default\u0022:{\u0022content\u0022:{\u0022text\u0022:\u0022\u0022},\u0022style\u0022:{\u0022tip\u0022:false,\u0022classes\u0022:\u0022\u0022},\u0022position\u0022:{\u0022at\u0022:\u0022bottom right\u0022,\u0022adjust\u0022:{\u0022method\u0022:\u0022\u0022},\u0022my\u0022:\u0022top left\u0022,\u0022viewport\u0022:false},\u0022show\u0022:{\u0022event\u0022:\u0022mouseenter \u0022},\u0022hide\u0022:{\u0022event\u0022:\u0022mouseleave \u0022}}}","qtipDebug":"{\u0022leaveElement\u0022:0}","shadowbox":{"animate":true,"animateFade":true,"animSequence":"wh","auto_enable_all_images":1,"auto_gallery":1,"autoplayMovies":true,"continuous":false,"counterLimit":10,"counterType":"default","displayCounter":true,"displayNav":true,"enableKeys":true,"fadeDuration":0.34999999999999998,"handleOversize":"resize","handleUnsupported":"link","initialHeight":160,"initialWidth":320,"language":"en","modal":false,"overlayColor":"#000","overlayOpacity":0.80000000000000004,"resizeDuration":0.55000000000000004,"showMovieControls":true,"slideshowDelay":0,"viewportPadding":20,"useSizzle":false},"picture":{"mappings":[["Sidebar media mappings","sidebar_media_mappings"],["Floated media mappings","floated_media_mappings"],["Not Set","not_set"]],"label":"Image size (required)"},"extlink":{"extTarget":"_blank","extClass":"ext","extLabel":"(link is external)","extImgClass":0,"extIconPlacement":0,"extSubdomains":1,"extExclude":"(.\\.nih\\.gov.)|(.\\.cancer\\.gov.)|(.\\.genome\\.gov.)|(.\\.drugabuse\\.gov.)|(locatorplus\\.gov.)|(.\\.govdelivery\\.com.)|(.\\.hatchbuck\\.com.)|(nihseniorhealth\\.gov.)|(clinicaltrials\\.gov.)|(search\\.usa\\.gov\\\/search\\?affiliate\\=hip.)|(search\\.gov\\\/search\\?affiliate\\=hip.)|(drugabuse\\.gov.)|(medlineplus\\.gov.)|(collegedrinkingprevention\\.gov.)|(smokefree\\.gov.)|(arpa-h\\.gov.)|(nih\\.sharepoint\\.com)","extInclude":"(.\\.pagefreezer\\.com.)","extCssExclude":".media, .emergency-message, .slideshow-main, .bean-home-slideshow-2l-block","extCssExplicit":"","extAlert":"_blank","extAlertText":"You are leaving the NIH website.\r\n\r\nThis external link provides additional information that is consistent with the intended purpose of this site. NIH cannot attest to the accuracy of a non-federal site.\r\n\r\nLinking to a non-federal site does not constitute an endorsement by NIH or any of its employees of the sponsors or the information and products presented on the site. You will be subject to the destination site\u2019s privacy policy when you follow the link.","mailtoClass":"mailto","mailtoLabel":"(link sends e-mail)","extUseFontAwesome":0}});</script>
|
||
|
||
<script type="application/javascript" id="uws-snippet">
|
||
// Verint Unified WebSDK Integration Snippet v2.3
|
||
//
|
||
// Instructions: please embed this snippet directly into every page of your website template.
|
||
// For optimal performance, this should be embedded directly into the template, not referenced as
|
||
// an external file.
|
||
//
|
||
// DO NOT MODIFY BELOW THIS LINE *****************************************
|
||
(function () {
|
||
var cookies = document.cookie.split("; ").reduce(function (o, i) { var p = i.split("="); o[p[0]] = p[1]; return o; }, {});
|
||
var containerValue = cookies.uws_container_override && JSON.parse(decodeURIComponent(cookies.uws_container_override));
|
||
var config = {
|
||
moduleHost: "ucm-us.verint-cdn.com",
|
||
configHost: "ucm-us.verint-cdn.com",
|
||
siteKey: "nih-gov",
|
||
container: containerValue || "live",
|
||
loadTime: Date.now()
|
||
};
|
||
var readyCallbacks = []; window.uwsReady = function (callback) { readyCallbacks.push(callback); };
|
||
var sdkPath = "//" + [config.moduleHost, "files/sites", config.siteKey, config.container, "sdk.js"].join("/");
|
||
var script = document.createElement("script"); script.src = sdkPath; script.async = true; script.type = "module";
|
||
script.addEventListener("load", function () { window.unifiedSDK.start(config, readyCallbacks); });
|
||
document.head.appendChild(script);
|
||
})();
|
||
// DO NOT MODIFY ABOVE THIS LINE *****************************************
|
||
</script>
|
||
|
||
</head>
|
||
<body class="html not-front not-logged-in page-node page-node- page-node-10006 node-type-nih-basic-page section navigation-nih-clinical-research-trials-and-you section-health-information">
|
||
<a href="#main-content" class="element-invisible element-focusable">Skip to main content</a>
|
||
<noscript aria-hidden="true"><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-5CBCNW2" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript>
|
||
<div class="l-page has-one-sidebar has-sidebar-first">
|
||
|
||
<div class="l-page-content">
|
||
|
||
<header class="l-header" role="banner">
|
||
<div class="l-ribbon-wrapper">
|
||
<ul class="l-ribbon">
|
||
<li><span class="ribbon-hhs"></span><a href="https://www.hhs.gov">U.S. Department of Health & Human Services</a><span class="ribbon-right"></span></li>
|
||
</ul>
|
||
</div> <div class="l-banner-wrapper">
|
||
<div class="l-banner">
|
||
<div class="l-branding">
|
||
<a class="nih-logo icon-nih-logo" href="/" title="National Institutes of Health (NIH) - Turning Discovery into Health" rel="home"><img src="/sites/all/themes/nih/images/nih-logo-color.png" width="390" height="60" alt="National Institutes of Health (NIH) - Turning Discovery into Health" /></a>
|
||
</div>
|
||
<!-- DigitalGov Search -->
|
||
<form accept-charset="UTF-8" action="https://search.nih.gov/search" id="search" class="search-form site-search" method="get">
|
||
<div style="margin:0;padding:0;display:inline"><input name="utf8" type="hidden" value="✓" /></div>
|
||
<input id="affiliate" name="affiliate" type="hidden" value="nih" />
|
||
<label for="query" class="hide">Search the NIH Website</label>
|
||
<input autocomplete="on" class="usagov-search-autocomplete form-field form-field-site-search" id="query" name="query" type="text" placeholder="Search NIH" /><input type="submit" name="commit" value="Search" class="form-button form-button-site-search" />
|
||
</form>
|
||
<ul class="banner-utilities">
|
||
<li><a href="/virtual-tour">Virtual Tour</a></li>
|
||
<li><a href="https://ned.nih.gov/">Staff Directory</a></li>
|
||
<li><a href="https://salud.nih.gov">En Español</a></li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</header>
|
||
|
||
<div class="l-navigation-wrapper">
|
||
<!-- ****************** SITE MENU ****************** -->
|
||
<h2 class="element-invisible">Site Menu</h2>
|
||
<nav class="l-menu-wrapper">
|
||
<ul class="l-menu">
|
||
<!-- ********* HOME TAB (Mobile view only) ********* -->
|
||
<li class="tab-wrapper tab-wrapper-home">
|
||
<div class="tab home"><a href="/"><span>Home</span></a></div>
|
||
</li>
|
||
<!-- ********* HEALTH INFO TAB ********* -->
|
||
<li class="tab-wrapper tab-wrapper-healthinfo tab-wrapper-left">
|
||
<div class="tab"><a href="/health-information"><span>Health Information</span></a></div>
|
||
<div class="megamenu">
|
||
<div class="megamenu-col megamenu-leftcol">
|
||
<ul class="sub-menu">
|
||
<li><a href="https://www.hhs.gov/programs/social-services/health-care-facilities/index.html">Health Care Providers & Facilities</a></li>
|
||
<li><a href="/health-information/health-info-lines">Health Info Lines</a></li>
|
||
<li><a href="https://www.healthcare.gov">HealthCare.gov</a></li>
|
||
<li><a href="/research-training/science-education">Science Education Resources</a></li>
|
||
<li><a href="/health-information/nih-clinical-research-trials-you">NIH Clinical Research Trials and You</a></li>
|
||
<li><a href="/institutes-nih/nih-office-director/office-communications-public-liaison/clear-communication/talking-your-doctor">Talking to Your Doctor</a></li>
|
||
<!--<li><a href="/institutes-nih/nih-office-director/office-communications-public-liaison/clear-communication/clear-health-nih" title="">Clear Health A–Z</a></li>-->
|
||
</ul>
|
||
<p class="more-wrapper"><a class="button gold" href="/health-information" title="More Health Information">More »</a></p>
|
||
</div>
|
||
<div class="megamenu-col megamenu-rightcol">
|
||
<form id="hipsearch" accept-charset="UTF-8" action="https://search.nih.gov/search" method="get" class="search-form">
|
||
<p class="subhead"><label for="query2">Search Health Topics</label></p>
|
||
<div class="input-wrapper">
|
||
<div style="margin:0;padding:0;display:inline"><input name="utf8" type="hidden" value="✓" /></div>
|
||
<input id="affiliate" name="affiliate" type="hidden" value="hip" />
|
||
<input type="hidden" name="dc" value="940" />
|
||
<input autocomplete="on" maxlength="50" class="usagov-search-autocomplete form-field form-field-search" id="query2" name="query" type="text" />
|
||
<input name="commit" type="submit" value="Go" id="searchbutton" class="form-button" />
|
||
</div>
|
||
</form>
|
||
<p class="subhead">Quick Links</p>
|
||
<ul class="sub-menu">
|
||
<li><a class="minibadge minibadge-medlineplus" href="https://medlineplus.gov/"><span class="minibadge-text">MedlinePlus Health Info</span></a></li>
|
||
<li><a class="minibadge minibadge-newsinhealth" href="https://newsinhealth.nih.gov/"><span class="minibadge-text">NIH News in Health</span></a></li>
|
||
<li><a class="minibadge minibadge-wellnesstoolkits" href="/health-information/your-healthiest-self-wellness-toolkits"><span class="minibadge-text">Wellness Toolkits</span></a></li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
<!-- ********* GRANTS TAB ********* -->
|
||
<li class="tab-wrapper tab-wrapper-grants tab-wrapper-left">
|
||
<div class="tab"><a href="/grants-funding"><span>Grants & Funding</span></a></div>
|
||
<div class="megamenu">
|
||
<div class="megamenu-col megamenu-leftcol">
|
||
<ul>
|
||
<li><a href="https://grants.nih.gov">Grants Home Page</a></li>
|
||
<li><a href="https://grants.nih.gov/funding/index.htm">Find Funding</a></li>
|
||
<li><a href="https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm">Due Dates</a></li>
|
||
<li><a href="https://grants.nih.gov/grants/how-to-apply-application-guide.html">How to Apply</a></li>
|
||
<li><a href="https://grants.nih.gov/grants/about_grants.htm">About Grants</a></li>
|
||
<li><a href="https://grants.nih.gov/policy/index.htm">Policy & Compliance</a></li>
|
||
<li><a href="https://nexus.od.nih.gov/all/">Grants News/Blog</a></li>
|
||
<li><a href="https://grants.nih.gov/funding/contracts.htm">Contracts</a></li>
|
||
<li><a href="https://www.lrp.nih.gov/">Loan Repayment</a></li>
|
||
</ul>
|
||
<p class="more-wrapper"><a class="button gold" href="/grants-funding" title="More Grants & Funding Information">More »</a></p>
|
||
</div>
|
||
<div class="megamenu-col megamenu-rightcol">
|
||
<p class="subhead">Quick Links</p>
|
||
<ul>
|
||
<li><a class="minibadge minibadge-report" href="https://report.nih.gov/"><span class="minibadge-text">RePORT</span></a></li>
|
||
<li><a class="minibadge minibadge-era" href="https://commons.era.nih.gov/commons/"><span class="minibadge-text">eRA Commons</span></a></li>
|
||
<li><a class="minibadge minibadge-commonfund" href="https://commonfund.nih.gov/"><span class="minibadge-text">NIH Common Fund</span></a></li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
<!-- ********* NEWS TAB ********* -->
|
||
<li class="tab-wrapper tab-wrapper-news tab-wrapper-left">
|
||
<div class="tab"><a href="/news-events"><span>News & Events</span></a></div>
|
||
<div class="megamenu">
|
||
<div class="megamenu-col megamenu-leftcol">
|
||
<ul>
|
||
<li><a href="/news-events/news-releases">News Releases</a></li>
|
||
<li><a href="/news-events/digital-media-kits">Digital Media Kits</a></li>
|
||
<li><a href="/news-events/media-resources">Media Resources</a></li>
|
||
<li><a href="/news-events/media-contacts">Media Contacts</a></li>
|
||
<li><a href="/news-events/images-b-roll">Images and B-roll</a></li>
|
||
<li><a href="/news-events/events">Events</a></li>
|
||
<li><a href="/news-events/social-media-outreach">Social Media</a></li>
|
||
</ul>
|
||
<p class="more-wrapper"><a class="button gold" href="/news-events" title="More News & Events">More »</a></p>
|
||
</div>
|
||
<div class="megamenu-col megamenu-rightcol">
|
||
<p class="subhead">Quick Links</p>
|
||
<ul>
|
||
<li><a class="minibadge minibadge-newsinhealth" href="https://newsinhealth.nih.gov/"><span class="minibadge-text">NIH News in Health</span></a></li>
|
||
<li><a class="minibadge minibadge-researchmatters" href="/news-events/nih-research-matters"><span class="minibadge-text">NIH Research Matters</span></a></li>
|
||
<li><a class="minibadge minibadge-nihrecord" href="https://nihrecord.nih.gov/"><span class="minibadge-text">NIH Record</span></a></li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
<!-- ********* RESEARCH TAB ********* -->
|
||
<li class="tab-wrapper tab-wrapper-research tab-wrapper-right">
|
||
<div class="tab"><a href="/research-training"><span>Research & Training</span></a></div>
|
||
<div class="megamenu">
|
||
<div class="megamenu-col megamenu-leftcol">
|
||
<ul>
|
||
<li><a href="/research-training/medical-research-initiatives">Medical Research Initiatives</a></li>
|
||
<li><a href="/research-training/science-highlights">Science Highlights</a></li>
|
||
<li><a href="/research-training/science-education">Science Education</a></li>
|
||
<li><a href="/research-training/research-nih-labs-clinics">Research in NIH Labs & Clinics</a></li>
|
||
<li><a href="/research-training/training-opportunities">Training Opportunities</a></li>
|
||
<li><a href="/research-training/library-resources">Library Resources</a></li>
|
||
<li><a href="/research-training/research-resources">Research Resources</a></li>
|
||
<li><a href="/research-training/clinical-research-resources">Clinical Research Resources</a></li>
|
||
<li><a href="/research-training/safety-regulation-guidance">Safety, Regulation and Guidance</a></li>
|
||
</ul>
|
||
<p class="more-wrapper"><a class="button gold" href="/research-training" title="More Research & Training">More »</a></p>
|
||
</div>
|
||
<div class="megamenu-col megamenu-rightcol">
|
||
<p class="subhead">Quick Links</p>
|
||
<ul>
|
||
<li><a class="minibadge minibadge-pubmed" href="https://pubmed.ncbi.nlm.nih.gov"><span class="minibadge-text">PubMed</span></a></li>
|
||
<li><a class="minibadge minibadge-stemcell" href="https://stemcells.nih.gov"><span class="minibadge-text">Stem Cell Information</span></a></li>
|
||
<li><a class="minibadge minibadge-oppnet" href="https://oppnet.nih.gov"><span class="minibadge-text">OppNet</span></a></li>
|
||
<li><a class="minibadge minibadge-nidb" href="https://intramural.nih.gov"><span class="minibadge-text">NIDB</span></a></li>
|
||
<li><a class="minibadge minibadge-nihblueprint" href="https://neuroscienceblueprint.nih.gov"><span class="minibadge-text">NIH Blueprint for Neuroscience Research</span></a></li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
<!-- ********* INSTITUTES TAB ********* -->
|
||
<li class="tab-wrapper tab-wrapper-institutes tab-wrapper-right">
|
||
<div class="tab"><a href="/institutes-nih"><span>Institutes at NIH</span></a></div>
|
||
<div class="megamenu">
|
||
<div class="megamenu-col megamenu-leftcol">
|
||
<ul>
|
||
<li><a href="/institutes-nih/list-institutes-centers">List of Institutes and Centers</a></li>
|
||
<li><a href="/institutes-nih/nih-office-director">NIH Office of the Director</a></li>
|
||
<li><a href="/institutes-nih/directors-nih-institutes-centers">Directors of NIH Institutes and Centers</a></li>
|
||
<li><a href="/institutes-nih/nih-institute-center-contact-information">NIH Institute and Center Contact Information</a></li>
|
||
</ul>
|
||
<p class="more-wrapper"><a class="button gold" href="/institutes-nih" title="More About the Institutes at NIH">More »</a></p>
|
||
</div>
|
||
<div class="megamenu-col megamenu-rightcol">
|
||
<p class="subhead">Quick Links</p>
|
||
<ul class="ic-acronymn-list">
|
||
<li><a href="https://www.cancer.gov" title="National Cancer Institute">NCI</a></li>
|
||
<li><a href="https://nei.nih.gov" title="National Eye Institute">NEI</a></li>
|
||
<li><a href="https://www.nhlbi.nih.gov" title="National Heart, Lung, and Blood Institute">NHLBI</a></li>
|
||
<li><a href="https://www.genome.gov" title="National Human Genome Research Institute">NHGRI</a></li>
|
||
<li><a href="https://www.nia.nih.gov" title="National Institute on Aging">NIA</a></li>
|
||
<li><a href="https://www.niaaa.nih.gov" title="National Institute on Alcohol Abuse and Alcoholism">NIAAA</a></li>
|
||
<li><a href="https://www.niaid.nih.gov" title="National Institute of Allergy and Infectious Diseases">NIAID</a></li>
|
||
<li><a href="https://www.niams.nih.gov" title="National Institute of Arthritis and Musculoskeletal and Skin Diseases">NIAMS</a></li>
|
||
<li><a href="https://www.nibib.nih.gov" title="National Institute of Biomedical Imaging and Bioengineering">NIBIB</a></li>
|
||
<li><a href="https://www.nichd.nih.gov" title="Eunice Kennedy Shriver National Institute of Child Health and Human Development">NICHD</a></li>
|
||
<li><a href="https://www.nidcd.nih.gov" title="National Institute on Deafness and Other Communication Disorders">NIDCD</a></li>
|
||
<li><a href="https://www.nidcr.nih.gov" title="National Institute of Dental and Craniofacial Research">NIDCR</a></li>
|
||
<li><a href="https://www.niddk.nih.gov" title="National Institute of Diabetes and Digestive and Kidney Diseases">NIDDK</a></li>
|
||
<li><a href="https://nida.nih.gov" title="National Institute on Drug Abuse">NIDA</a></li>
|
||
<li><a href="https://www.niehs.nih.gov" title="National Institute of Environmental Health Sciences">NIEHS</a></li>
|
||
<li><a href="https://www.nigms.nih.gov" title="National Institute of General Medical Sciences">NIGMS</a></li>
|
||
<li><a href="https://www.nimh.nih.gov" title="National Institute of Mental Health">NIMH</a></li>
|
||
<li><a href="https://www.nimhd.nih.gov" title="National Institute on Minority Health and Health Disparities">NIMHD</a></li>
|
||
<li><a href="https://www.ninds.nih.gov" title="National Institute of Neurological Disorders and Stroke">NINDS</a></li>
|
||
<li><a href="https://www.ninr.nih.gov" title="National Institute of Nursing Research">NINR</a></li>
|
||
<li><a href="https://www.nlm.nih.gov" title="National Library of Medicine">NLM</a></li>
|
||
<li><a href="https://www.cc.nih.gov" title="NIH Clinical Center">CC</a></li>
|
||
<li><a href="https://www.cit.nih.gov" title="Center for Information Technology">CIT</a></li>
|
||
<li><a href="https://www.csr.nih.gov" title="Center for Scientific Review">CSR</a></li>
|
||
<li><a href="https://www.fic.nih.gov" title="Fogarty International Center">FIC</a></li>
|
||
<li><a href="https://ncats.nih.gov" title="National Center for Advancing Translational Sciences">NCATS</a></li>
|
||
<li><a href="https://nccih.nih.gov" title="National Center for Complementary and Integrative Health">NCCIH</a></li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
<!-- ********* ABOUT TAB ********* -->
|
||
<li class="tab-wrapper tab-wrapper-about tab-wrapper-right">
|
||
<div class="tab"><a href="/about-nih"><span>About NIH</span></a></div>
|
||
<div class="megamenu">
|
||
<div class="megamenu-col megamenu-leftcol">
|
||
<ul>
|
||
<li><a href="/about-nih/who-we-are">Who We Are</a></li>
|
||
<li><a href="/about-nih/what-we-do">What We Do</a></li>
|
||
<li><a href="https://hr.nih.gov/jobs">Jobs at NIH</a></li>
|
||
<li><a href="/about-nih/visitor-information">Visitor Information</a></li>
|
||
<li><a href="/about-nih/frequently-asked-questions">Frequently Asked Questions</a></li>
|
||
<li><a href="/about-nih/contact-us">Contact Us</a></li>
|
||
<!--<li><a href="/about-nih/explore-nih">Explore NIH</a></li>-->
|
||
</ul>
|
||
<p class="more-wrapper"><a class="button gold" href="/about-nih" title="More About NIH">More »</a></p>
|
||
</div>
|
||
<div class="megamenu-col megamenu-rightcol">
|
||
<p class="subhead">Quick Links</p>
|
||
<ul>
|
||
<li><a href="/about-nih/who-we-are/nih-director">The NIH Director</a></li>
|
||
<li><a href="/virtual-tour">Take the Virtual Tour</a></li>
|
||
<li><a href="/about-nih/what-we-do/nih-turning-discovery-into-health">NIH…Turning Discovery Into Health<sup>®</sup></a></li>
|
||
<li><a href="/about-nih/what-we-do/impact-nih-research">Impact of NIH Research</a></li>
|
||
<li><a href="/about-nih/what-we-do/science-health-public-trust">Science, Health, and Public Trust</a></li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</li>
|
||
</ul>
|
||
<div class="tab-bkgnd"></div><!-- For pixel rounding issue -->
|
||
</nav>
|
||
<!-- ****************** END SITE MENU ****************** -->
|
||
</div>
|
||
|
||
<div class="l-main-wrapper">
|
||
<div class="l-main" id="page-content">
|
||
<h2 class="element-invisible">You are here</h2><div class="breadcrumb"><a href="/">Home</a> » <a href="/health-information">Health Information</a> » <a href="/health-information/nih-clinical-research-trials-you">NIH Clinical Research Trials and You</a></div> <div class="l-region l-region--section-header">
|
||
<div id="block-block-111" class="block block--block sectionheader block--block-111" id="block-block-111" class="block block--block sectionheader block--block-111">
|
||
|
||
|
||
<div class="content" class="block__content">
|
||
<h2><a href="/health-information/nih-clinical-research-trials-you">NIH Clinical Research Trials and You</a></h2> </div>
|
||
</div>
|
||
</div>
|
||
<aside class="l-region l-region--sidebar-first">
|
||
<nav id="block-menu-block-8" role="navigation" class="block block--menu-block subnav block--menu-block-8">
|
||
<h3 class="block__title"><a href="/health-information/nih-clinical-research-trials-you" title="NIH Clinical Research Trials and You" class="active-trail">NIH Clinical Research Trials and You</a></h3>
|
||
|
||
<div class="menu-block-wrapper menu-block-8 menu-name-main-menu parent-mlid-1246 menu-level-1">
|
||
<ul class="menu"><li class="first leaf menu-mlid-12421"><a href="/health-information/nih-clinical-research-trials-you/basics">The Basics</a></li>
|
||
<li class="leaf menu-mlid-12431"><a href="/health-information/nih-clinical-research-trials-you/finding-clinical-trial">Finding a Clinical Trial</a></li>
|
||
<li class="leaf menu-mlid-12436"><a href="/health-information/nih-clinical-research-trials-you/list-registries">List of Registries</a></li>
|
||
<li class="leaf menu-mlid-12451"><a href="/health-information/nih-clinical-research-trials-you/personal-stories">Personal Stories</a></li>
|
||
<li class="leaf menu-mlid-12751"><a href="/health-information/nih-clinical-research-trials-you/parents-children">For Parents and Children</a></li>
|
||
<li class="leaf menu-mlid-12756"><a href="/health-information/nih-clinical-research-trials-you/health-care-providers">For Health Care Providers</a></li>
|
||
<li class="leaf menu-mlid-12441"><a href="/health-information/nih-clinical-research-trials-you/researchers-trial-sites">For Researchers and Trial Sites</a></li>
|
||
<li class="leaf menu-mlid-12761"><a href="/health-information/nih-clinical-research-trials-you/educational-resources">Educational Resources</a></li>
|
||
<li class="leaf menu-mlid-12426"><a href="/health-information/nih-clinical-research-trials-you/glossary-common-terms">Glossary of Common Terms</a></li>
|
||
<li class="leaf menu-mlid-13956"><a href="/health-information/nih-clinical-research-trials-you/if-you-have-question">If You Have a Question</a></li>
|
||
<li class="last leaf menu-mlid-12766"><a href="/health-information/nih-clinical-research-trials-you/news">In the News</a></li>
|
||
</ul></div>
|
||
</nav>
|
||
</aside>
|
||
<div class="l-content-wrapper">
|
||
<div class="l-content" role="main">
|
||
<a id="main-content"></a>
|
||
<div about="/health-information/nih-clinical-research-trials-you/guiding-principles-ethical-research" typeof="sioc:Item foaf:Document" class="ds-1col node node--nih-basic-page featured-media-floated view-mode-full node--full node--nih-basic-page--full clearfix">
|
||
|
||
|
||
<div class='syndicate'><h1>Guiding Principles for Ethical Research</h1><p class="subtitle">Pursuing Potential Research Participants Protections</p><div class="featured-media"><div class="ds-1col file file-image file-image-jpeg view-mode-featured_media clearfix">
|
||
|
||
|
||
<picture title="Female doctor talking to a senior couple">
|
||
<!--[if IE 9]><video style="display: none;"><![endif]-->
|
||
<source srcset="https://www.nih.gov/sites/default/files/styles/featured_media_breakpoint-large-extra/public/health-info/clinical-trials/female-doctor-talking-to-senior-couple_0.jpg?itok=gO9nEBPW&timestamp=1433355842 1x" media="screen and (min-width: 1100px)" />
|
||
<source srcset="https://www.nih.gov/sites/default/files/styles/featured_media_breakpoint-large/public/health-info/clinical-trials/female-doctor-talking-to-senior-couple_0.jpg?itok=wxqBbW2-&timestamp=1433355842 1x" media="screen and (min-width: 960px)" />
|
||
<source srcset="https://www.nih.gov/sites/default/files/styles/featured_media_breakpoint-medium/public/health-info/clinical-trials/female-doctor-talking-to-senior-couple_0.jpg?itok=yfAZRsak&timestamp=1433355842 1x" media="screen and (min-width: 800px)" />
|
||
<source srcset="https://www.nih.gov/sites/default/files/styles/featured_media_breakpoint-medium-small/public/health-info/clinical-trials/female-doctor-talking-to-senior-couple_0.jpg?itok=stcPK9BD&timestamp=1433355842 1x" media="screen and (min-width: 600px)" />
|
||
<source srcset="https://www.nih.gov/sites/default/files/styles/featured_media_breakpoint-small/public/health-info/clinical-trials/female-doctor-talking-to-senior-couple_0.jpg?itok=eqqdk5zA&timestamp=1433355842 1x" media="screen and (min-width: 480px)" />
|
||
<source srcset="https://www.nih.gov/sites/default/files/styles/featured_media__breakpoint-tiny_/public/health-info/clinical-trials/female-doctor-talking-to-senior-couple_0.jpg?itok=4N8Qo5aZ&timestamp=1433355842 1x" media="screen and (min-width: 0)" />
|
||
<!--[if IE 9]></video><![endif]-->
|
||
<img src="https://www.nih.gov/sites/default/files/styles/featured_media_breakpoint-medium/public/health-info/clinical-trials/female-doctor-talking-to-senior-couple_0.jpg?itok=yfAZRsak&timestamp=1433355842" alt="Female doctor talking to a senior couple at her desk." title="Female doctor talking to a senior couple" />
|
||
</picture></div>
|
||
|
||
</div><div><p>“When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are,” said Dr. Christine Grady, chief of the NIH Clinical Center Department of Bioethics, to Clinical Center Radio in a podcast.</p>
|
||
|
||
<p>Clinical research advances the understanding of science and promotes human health. However, it is important to remember the individuals who volunteer to participate in research. There are precautions researchers can take – in the planning, implementation and follow-up of studies – to protect these participants in research. Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the science.</p>
|
||
|
||
<p>NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:</p>
|
||
|
||
<ul class="spaced">
|
||
<li><strong>Social and clinical value</strong></li>
|
||
<li><strong>Scientific validity</strong></li>
|
||
<li><strong>Fair subject selection</strong></li>
|
||
<li><strong>Favorable risk-benefit ratio</strong></li>
|
||
<li><strong>Independent review</strong></li>
|
||
<li><strong>Informed consent</strong></li>
|
||
<li><strong>Respect for potential and enrolled subjects</strong></li>
|
||
</ul>
|
||
|
||
<h3>Social and clinical value</h3>
|
||
|
||
<p>Every research study is designed to answer a specific question. The answer should be important enough to justify asking people to accept some risk or inconvenience for others. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research.</p>
|
||
|
||
<h3>Scientific validity</h3>
|
||
|
||
<p>A study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose</p>
|
||
|
||
<h3>Fair subject selection</h3>
|
||
|
||
<p>The primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits. Specific groups of participants (for example, women or children) should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to risk.</p>
|
||
|
||
<h3>Favorable risk-benefit ratio</h3>
|
||
|
||
<p>Uncertainty about the degree of risks and benefits associated with a clinical research study is inherent. Research risks may be trivial or serious, transient or long-term. Risks can be physical, psychological, economic, or social. Everything should be done to minimize the risks and inconvenience to research participants to maximize the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the risks.</p>
|
||
|
||
<h3>Independent review</h3>
|
||
|
||
<p>To minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: Are those conducting the trial sufficiently free of bias? Is the study doing all it can to protect research participants? Has the trial been ethically designed and is the risk–benefit ratio favorable? The panel also monitors a study while it is ongoing.</p>
|
||
|
||
<h3>Informed consent</h3>
|
||
|
||
<p>Potential participants should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate.</p>
|
||
|
||
<h3>Respect for potential and enrolled participants</h3>
|
||
|
||
<p>Individuals should be treated with respect from the time they are approached for possible participation — even if they refuse enrollment in a study — throughout their participation and after their participation ends. This includes:</p>
|
||
|
||
<ul class="spaced">
|
||
<li>respecting their privacy and keeping their private information confidential</li>
|
||
<li>respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without a penalty</li>
|
||
<li>informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating</li>
|
||
<li>monitoring their welfare and, if they experience adverse reactions, unexpected effects, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study</li>
|
||
<li>informing them about what was learned from the research</li>
|
||
</ul>
|
||
|
||
<p><a href="http://www.cc.nih.gov/recruit/ethics.html">More information on these seven guiding principles and on bioethics in general</a></p>
|
||
</div></div>
|
||
|
||
</div>
|
||
|
||
<div class="lastupdated">
|
||
<p>This page last reviewed on March 16, 2016</p> </div> </div>
|
||
</div>
|
||
<div class="l-connect-wrapper">
|
||
<div class="l-connect">
|
||
<h2 class="element-invisible">Connect with Us</h2>
|
||
<ul>
|
||
<li><a class="contactus-monochrome" href="/about-nih/contact-us"><span class="icon"></span>Contact Us</a></li>
|
||
<li><a class="twitter-monochrome" href="https://twitter.com/NIH"><span class="icon"></span>X</a></li>
|
||
<li><a class="facebook-monochrome" href="https://www.facebook.com/nih.gov"><span class="icon"></span>Facebook</a></li>
|
||
<li><a class="instagram-monochrome" href="https://www.instagram.com/nihgov/"><span class="icon"></span>Instagram</a></li>
|
||
<li><a class="youtube-monochrome" href="https://www.youtube.com/user/nihod"><span class="icon"></span>YouTube</a></li>
|
||
<li><a class="flickr-monochrome" href="https://www.flickr.com/photos/nihgov/"><span class="icon"></span>Flickr</a></li>
|
||
<li><a class="social-monochrome" href="/news-events/social-media-outreach"><span class="icon"></span>More Social Media from NIH</a></li>
|
||
</ul>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="l-footer-wrapper">
|
||
<footer class="l-footer" role="contentinfo">
|
||
<h2 class="element-invisible">Footer</h2>
|
||
<ul>
|
||
<li><a href="/">NIH Home</a></li>
|
||
<li><a href="/virtual-tour">Virtual Tour</a></li>
|
||
<li><a href="https://salud.nih.gov">En Español</a></li>
|
||
<li><a href="/about-nih/visitor-information">Visitor Information</a></li>
|
||
<li><a href="/about-nih/frequently-asked-questions">Frequently Asked Questions</a></li>
|
||
<li><a href="/privacy-policy">Privacy Policy</a></li>
|
||
<li><a href="/disclaimers">Disclaimers</a></li>
|
||
<li><a href="/accessibility">Accessibility</a></li>
|
||
<li><a href="/nih-website-archives">NIH Website Archives</a></li>
|
||
</ul>
|
||
<ul>
|
||
<li><a href="/nondiscrimination-notice">Nondiscrimination Notice</a></li>
|
||
<li><a href="/institutes-nih/nih-office-director/office-communications-public-liaison/freedom-information-act-office">Freedom of Information Act</a></li>
|
||
<li><a href="https://www.edi.nih.gov/no-fear-act">No Fear Act</a></li>
|
||
<li><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html">HHS Vulnerability Disclosure</a></li>
|
||
<li><a href="https://oig.hhs.gov">Office of Inspector General</a></li>
|
||
<li><a class="lastTab" href="https://www.usa.gov/">USA.gov</a></li>
|
||
</ul>
|
||
<p>NIH…Turning Discovery Into Health<sup>®</sup></p>
|
||
<p>National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892</p>
|
||
<p><a href="https://www.hhs.gov">U.S. Department of Health and Human Services</a></p>
|
||
</footer>
|
||
</div>
|
||
|
||
<div class="back-to-top"><a href="#"><span class="icon-arrow-up"></span><span class="text">Back to Top</span></a></div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
<script src="https://www.nih.gov/sites/default/files/js/js_7Ukqb3ierdBEL0eowfOKzTkNu-Le97OPm-UqTS5NENU.js"></script>
|
||
<script src="https://www.nih.gov/sites/default/files/js/js_E9yUYWK8EMydR0HMIp2PahVxPAClXyH0Cnh782A15UM.js"></script>
|
||
</body>
|
||
</html>
|
||
|