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Inclusion of Women and Minorities in Clinical Research | RePORT
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accept-charset="UTF-8" action="https://search.usa.gov/search" id="search_form" method="get" name="search"><div style="margin:0;padding:0;display:inline"><input name="utf8" type="hidden" value="?"></div> <fieldset class="serch_forcast"> <legend> <input id="affiliate" name="affiliate" type="hidden" value="ds_report"> <input autocomplete="off" class="usagov-search-autocomplete search high_off" id="query" name="query" type="text" data-bs-com.agilebits.onepassword.user-edited="yes"> <label for="query" class="visually-hidden">Search</label> <input name="commit" type="image" value="Search" alt="Search Icon" src="/sites/report/themes/custom/report-cms/images/icon-search.svg"> </legend> </fieldset> </form> </li> </ul> </nav> </div> </nav> </div> <div class="container-fluid"> <div data-drupal-messages-fallback class="hidden"></div> </div> <div class="container-fluid"> <div class="row"> <div class="col-12 pt-3"> <div id="block-report-page-title"> <h1 class="page-title"><span>Inclusion of Women and Minorities in Clinical Research</span> </h1> </div> </div> </div> </div> <div id="content"> <div class="container-fluid"> <div class="row row-content"> <div class="col-12"> <div class="main-content"> <div id="block-report-content"> <article data-history-node-id="12"> <div> <div class="layout layout--onecol"> <div class="layout__region layout__region--content"> <div> </div> <div> <div><p>NIH has examined and reported aggregate inclusion enrollment information for its portfolio of NIH-funded clinical research since fiscal year 1994. These reports are one component of NIH's policy on <a href="https://grants.nih.gov/grants/funding/women_min/women_min.htm" title="Inclusion of Women and Minorities as Subjects in Clinical Research">Inclusion of Women and Minorities as Subjects in Clinical Research</a>.</p> <p>Inclusion reports are produced with all NIH enrollment information and for each NIH Institute and Center (IC) that supports clinical research. Formally biennial, the 21st Century Cures Act changed the frequency of inclusion data reporting to triennial reporting. Each report provides some analysis of the data. FY 2018 inclusion data are also available by research, condition, and disease categories (RCDC) using the link below. However, caution should be used in interpreting these figures as analyses of aggregate data has limits.</p> <ul> <li>Enrollment figures should not be compared directly to national census figures when considering inclusion data or evaluating policy implementation.</li> <li>The goal of NIH's inclusion policy is not to endorse or enforce quotas for proportional representation based on census data, but rather to support biomedical and behavioral research that produces scientific knowledge that is generalizable to the population under study and ultimately applicable to the entire population of the United States.</li> <li>The appropriate number of women, men, and/or representatives of racial/ethnic groups included in a particular study depends upon a number of factors, including but not limited to the scientific question(s) being addressed, the prevalence of the disease, disorder, or condition among women, men, and/or racial/ethnic groups, and potential gaps in scientific knowledge.</li> <li>The scientific missions of different Institutes and Centers are distinct. This includes the amount of clinical research and NIH-defined Phase III clinical trials that are the IC portfolio. For example, some ICs support only a limited number of clinical trials, particularly late stage trials such as Phase III trials.</li> <li><a href="/funding/categorical-spending/rcdc" title="RCDC categories">RCDC categories</a> are not mutually exclusive; individual projects can be included in multiple categories.</li> </ul> <h2>NIH Reports</h2> <div class="my-3"><a href="https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH_Biennial%20Report_121823_1516_F_508c_Optimized.pdf" title="Report of the Advisory Committee for Research on Women’s Health: Fiscal Years 2021 – 2022">Report of the Advisory Committee for Research on Women’s Health: Fiscal Years 2021 – 2022</a><br> Previous Women’s Health reports can be found on the <a href="https://orwh.od.nih.gov/research/funded-research-and-programs/research-reports/biennial-report">Office of Research on Women’s Health Biennial Reports website</a>.</div> <div class="mb-1"><a href="/RISR/#/" title="NIH RCDC Inclusion Statistics Report">NIH RCDC Inclusion Statistics Report</a><br> This report displays the typical representation of the sex or gender, race, and ethnicity of participants in human subject studies enrolled in projects associated with the listed research, condition, or disease category. Data on enrollment by age are available below.</div> <div class="mb-4"> <ul> <li><a href="/reportweb/web/displayreport?rid=1020">Inclusion Enrollment by Age Groups in Research, Condition, and Disease Categorization (RCDC) Categories Fiscal Year 2023</a></li> <li><a href="/reportweb/web/displayreport?rid=1019">Inclusion Enrollment by Age Groups in Research, Condition, and Disease Categorization (RCDC) Categories Fiscal Year 2022</a></li> <li><a href="/reportweb/web/displayreport?rid=1008">Inclusion Enrollment by Age Groups in Research, Condition, and Disease Categorization (RCDC) Categories Fiscal Year 2021</a></li> </ul> </div> <div class="panel panel-default"> <div class="panel-heading" id="headingOne" role="tab"> <h4 class="panel-title"><button aria-controls="collapseOne" aria-expanded="false" class="panel-title-button collapsed" data-bs-toggle="collapse" href="#collapseOne" role="button">Archived Reports <img alt="expand content" class="panel-heading-icon" 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class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=1016" title="Fiscal Years 2008 & 2009 (PDF – 2.8 MB)">Fiscal Years 2008 & 2009 (PDF – 1.2 MB)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=1017" title="Fiscal Years 2007 & 2008 (PDF – 2.8 MB)">Fiscal Years 2007 & 2008 (PDF – 2.8 MB)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file 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src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=909">National Human Genome Research Institute (NHGRI)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=910">National Heart, Lung, and Blood Institute (NHLBI)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=911">National Institute on Aging (NIA)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=912">National Institute on Alcohol Abuse and Alcoholism (NIAAA)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=913" title="National Institute of Allergy and Infectious Diseases (NIAID)">National Institute of Allergy and Infectious Diseases (NIAID)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=914" title="National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)">National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=915" title="National Institute of Biomedical Imaging and Bioengineering (NIBIB)">National Institute of Biomedical Imaging and Bioengineering (NIBIB)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=916" title="Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)"><em>Eunice Kennedy Shriver</em> National Institute of Child Health and Human Development (NICHD)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=917" title="National Institute on Deafness and Other Communication Disorders (NIDCD)">National Institute on Deafness and Other Communication Disorders (NIDCD)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=918" title="National Institute of Dental and Craniofacial Research (NIDCR)">National Institute of Dental and Craniofacial Research (NIDCR)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=919" title="National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)">National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=920" title="National Institute on Drug Abuse 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src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" href="/reportweb/web/displayreport?rid=923" title="National Institute of Mental Health (NIMH)">National Institute of Mental Health (NIMH)</a></p> <p><a href="#"><img class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a href="/reportweb/web/displayreport?rid=924" title="National Institute on Minority Health and Health Disparities (NIMHD)"> National Institute on Minority Health and Health Disparities (NIMHD)</a></p> <p><a href="#"><img alt class="format_icon" height="17" src="/sites/report/themes/custom/report-cms/images/icon-adobe-acrobat.png" style="margin-bottom: -5px;" width="18" loading="lazy"></a> <a class="file file--mime-application-pdf file--application-pdf" 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