NHLBI Policy for the Inclusion of Women, Minorities, and Participants Across the Lifespan in Clinical Research

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class="breadcrumbs"><ul> <li class='breadcrumb-home'><a href='/'>Home</a></li><li class='breacrumb-break'>/</li><li class='breadcrumb-grandparent'><a href='/node/80073'>Grants and Training</a></li><li class='breacrumb-break'>/</li><li class='breadcrumb-parent'><a href='/node/80570'><span class='back-to'> < Back To </span>Policies, Procedures, and Guidelines</a></li><li class='breacrumb-break'>/</li><li class='breadcrumb-current'>NHLBI Policy for the Inclusion of Women, Minorities, and Participants Across the Lifespan in Clinical Research</li></ul></div></div> <article class="node node--type-general node--view-mode-full" data-title="NHLBI Policy for the Inclusion of Women, Minorities, and Participants Across the Lifespan in Clinical Research" data-type="general" data-format="" data-audience="" data-campaign="" > <div class="standard"> <div class="field field--name-field-top-texture-banner field--type-list-string field--label-hidden field__item"> <div class="pageBanner"> <div class="banner-new-dark-blue"></div> </div> </div> <div class="secondary-grey-background"> <div class="responsive-container responsive-container-constrained"> <div class="content-container-constrained"> <div class="node__content"> <div class="flexcontainer general-header-container"> <div class="flexItemText flexTextWithoutImage "> <h1 class=""> <span>NHLBI Policy for the Inclusion of Women, Minorities, and Participants Across the Lifespan in Clinical Research</span> </h1> <div class="calloutdescription"> </div> <div class="subtitle-text"> </div> <div class="bodytext"> <div class="field field--name-field-introduction field--type-text-long field--label-hidden field__item"> <h2> </h2> </div> </div> </div> </div> </div> </div> </div> </div> <div class="responsive-container responsive-container-constrained"> <div class="node__content"> <div class="content-container-constrained content-container-margin"> <div class="bodytext"> <div class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><h2><span><span><strong><span lang="EN"><span><span>PURPOSE</span></span></span></strong></span></span></h2> <p><span><span><span><span>The </span></span><a href="https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm" rel="noreferrer"><span><span>NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research</span></span></a><span><span> (amended in 2001 and 2018) explains that all NIH-funded clinical research will be carried out in a manner sufficient to elicit information about individuals of all sexes/genders, races, and ethnicities, and (particularly in </span></span><a href="https://grants.nih.gov/grants/glossary.htm#NIHDefinedPhaseIIIClinicalTrial" rel="noreferrer"><span><span>NIH-defined Phase III clinical trials</span></span></a><span><span>) to examine differential effects on such groups.</span></span></span></span></p> <p><span><span><span><span>The </span></span><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-116.html" rel="noreferrer"><span><span>NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects</span></span></a><span><span><span> explains that principal investigators (PIs) must make efforts to include all age groups, especially </span></span></span><a href="https://grants.nih.gov/grants/glossary.htm#Child" rel="noreferrer"><span><span>children</span></span></a> <span><span><span>(<18 years) and </span></span></span><a href="https://grants.nih.gov/grants/glossary.htm#OlderAdult" rel="noreferrer"><span><span>older adults</span></span></a><span><span><span> (≥65 years), so that study populations are representative of the target patient population.</span></span></span></span></span></p> <p><span><span><span lang="EN"><span><span>The goal of this effort is to ensure that the clinical research supported by NHLBI is both diverse and inclusive, where the principles of beneficence and justice lead to generalizable, evidence-based medicine.</span></span></span></span></span></p> <h2><span><span><strong><span lang="EN"><span><span>POLICY DETAILS</span></span></span></strong></span></span></h2> <p><span><span><span lang="EN"><span><span>Prior to making awards, NHLBI will examine each grant application to ensure that it complies with the NIH policies and guidelines. The expectation for NHLBI-funded studies is that </span></span></span><span lang="EN"><span>the proposed study population is appropriate for the scientific aims of the study. The </span></span><span lang="EN"><span><span>targeted study population will reflect the age/gender/race/ethnic distribution of the population affected by the disease/condition under study, or if such information is not available, the study population should reflect the composition of the overall U.S. population (51% women, 30% minorities). Exceptions are permitted only when a valid scientific justification for limited inclusion exists; the law states explicitly that cost is not a permissible justification.</span></span></span></span></span></p> <h2><span><span><strong><span lang="EN"><span><span>REFERENCES AND RESOURCES</span></span></span></strong></span></span></h2> <ul> <li><span><a href="https://grants.nih.gov/policy/inclusion.htm" rel="noreferrer"><span><span>NIH Inclusion Policies for Research Involving Human Subjects</span></span></a></span></li> <li><span><a href="https://grants.nih.gov/faqs#/inclusion-basic-on-sex-gender-and-race-ethnicity.htm" rel="noreferrer"><span lang="EN"><span>NIH Frequently Asked Questions (FAQs) – Inclusion on the Basis of Sex/Gender and Race/Ethnicity</span></span></a></span></li> <li><span><a href="https://grants.nih.gov/faqs#/inclusion-across-the-lifespan.htm" rel="noreferrer"><span lang="EN"><span>NIH Frequently Asked Questions (FAQs) – Inclusion Across the Lifespan</span></span></a></span></li> <li><span><span><span><a href="https://orwh.od.nih.gov/toolkit/recruitment" rel="noreferrer"><span><span>NIH Inclusion Outreach Toolkit: How to Engage, Recruit, and Retain Women in Clinical Research</span></span></a></span></span></span></li> </ul> <h2><span><span><strong><span lang="EN"><span><span>NHLBI CONTACT</span></span></span></strong></span></span></h2> <p><span><span><span lang="EN"><span><span>Katie Kavounis, MPH<br> National Heart, Lung, and Blood Institute<br> 6705 Rockledge Drive, Room 308-D<br> Bethesda, MD 20892<br> Tel: 301-594-1369<br> Email: </span></span></span><a href="mailto:katherine.kavounis@nih.gov" rel="noreferrer"><span lang="EN"><span>katherine.kavounis@nih.gov</span></span></a></span></span></p> <p> </p> <p><strong><em><span><span><span lang="EN"><span><span>Last Updated: July 2020</span></span></span></span></span></em></strong></p> <p> </p></div> </div> </div> </div> </div> <div class="responsive-container 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