Protection of Human Subjects | Agency for Healthcare Research and Quality

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A final rule was published in the Federal Register (FR) on January 19, 2017, and was amended to delay the effective and compliance dates on January 22, 2018, and June 19, 2018." /> <meta name="keywords" content="Grants" /> <link rel="canonical" href="https://www.ahrq.gov/funding/policies/human-subjects/index.html" /> <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, shrink-to-fit=no" /> <meta http-equiv="x-ua-compatible" content="ie=edge" /> <link rel="icon" href="/themes/custom/ahrq_bootstrap_barrio/favicon-swoosh.ico" type="image/vnd.microsoft.icon" /> <link rel="alternate" hreflang="en" href="https://www.ahrq.gov/funding/policies/human-subjects/index.html" /> 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col-sm-8 col-md-9"> <div id="main-content"></div> <article about="/funding/policies/human-subjects/index.html" typeof="schema:WebPage" class="node node--type-page node--view-mode-full clearfix"> <div class="node__content clearfix"> <div class="main-content-with-sb2"> <h1 class="node__title"> <span property="schema:name" class="field field--name-title field--type-string field--label-hidden">Protection of Human Subjects</span> </h1> <div class="pager-wrap"> </div> <div property="schema:text" class="clearfix text-formatted field field--name-body field--type-text-with-summary field--label-hidden field__item"><h3>Revised Common Rule</h3> <p>The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). A final rule was published in the <em>Federal Register</em> (FR) on January 19, 2017, and was amended to delay the effective and compliance dates on January 22, 2018, and June 19, 2018. The revised Common Rule is effective July 19, 2018. A Final Rule was issued on June 18, 2018 to delay the general compliance date of the Revised Common Rule until January 21, 2019. The Final Rule provides regulated entities with the option to implement three burden-reducing provisions during the delay period (July 19, 2018, through January 20, 2019). Go to the <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-HS-18-014.html">AHRQ Guide Notice</a>.</p> <p>The general compliance date of the revised Common Rule remains January 21, 2019. This means that HHS-conducted or supported research initiated on or after January 21, 2019, and studies that voluntarily implemented the three burden-reducing provisions during the delay period (July 19, 2018, through January 20, 2019), are expected to comply with all Revised Common Rule requirements.</p> <p>View an official version of the 2018 Requirements in 45 CFR 46 of the July 19, 2018, edition of the <a href="https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML">e-Code of Federal Regulations</a>.</p> <p><a href="https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html">Revised Common Rule Q&As</a>.</p> <p><a href="https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/2018-requirements-faqs/index.html">2018 Requirements FAQs</a>.</p> <h3>Posting Clinical Trial Informed Consent Form (45 CFR 46.116(h))</h3> <p>The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available Federal website within a specific time frame. The consent form must have been used in enrolling participants in order to satisfy this new provision.</p> <p>Refer to the Office for Human Research Protections (OHRP)鈥檚 guidance on <a href="https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/index.html">Clinical Trial Informed Consent Form Posting (45 CFR 46.116(h))</a>.</p> <p><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-023.html">AHRQ Guidance on Posting Informed Consent Forms for AHRQ-Funded Clinical Trials</a>.</p> <h3>Single IRB Requirement</h3> <p>The Revised Common Rule, at 45 CFR 46.114 (b) (cooperative research), requires all institutions located in the United States that are engaged in cooperative research conducted or supported by a Common Rule department or agency rely upon approval by a single IRB for the portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. Reliance on a single IRB of record in cooperative research is required beginning January 20, 2020, unless the study meets the criteria for an exception described in 搂46.114(b)(2) of the Revised Common Rule.</p> <p>For more information on exceptions that apply to HHS supported or conducted research protocols, refer to <a href="https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/114b-exception1/index.html">HHS' exception determinations</a>.</p> <p><a href="/sites/default/files/wysiwyg/funding/policies/single-IRB-plan-elements.pdf">The Single IRB Plan Elements</a> (PDF, 102 KB)</p> <p><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-HS-21-002.html">AHRQ Guide Notice on Exception to the Use of the Single IRB Review Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency</a>.</p> <p><a href="https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-exception-determinations/october-2020-exception-determination/index.html">OHRP/HHS Exception to the Single IRB Review Requirements for Certain HHS-Conducted or -Supported Cooperative Research Activities Subject to the 2018 Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency</a>.</p> <p><a href="https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/114b-exception1/index.html">OHRP鈥檚 determination of exception for two categories of research from the required use of a single institutional review board (IRB)</a>.</p> <p><a href="https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/index.html">OHRP's guide on the single IRB requirement</a>.</p> <p><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html">AHRQ Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46.114 (b)</a>.</p> <h3>AHRQ Guide Notices</h3> <p><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-008.html">AHRQ Implementation of Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule)</a>.</p> <p><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-HS-18-014.html">AHRQ Implementation of the Burden-Reducing Provisions of the 2018 Common Rule</a>.</p> <p><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html">AHRQ Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46.114 (b)</a>.</p> <p><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-023.html">AHRQ Guidance on Posting Informed Consent Forms for AHRQ-Funded Clinical Trials</a>.</p> <h3>Pre-2018 Requirements</h3> <p><a href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/regulatory-text/index.html">Pre-2018 Requirements</a>.</p> <h3>OHRP Guidance on the Federal Policy for the Protection of Human Subjects </h3> <p><a href=" https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/index.html">OHRP Guidance on the Federal Policy for the Protection of Human Subjects (the Common Rule)</a>.</p> <p><a href="https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html">OHRP Issues Guidance for Application of the Human Subjects Protection Regulations to Actions Taken in Response to the COVID-19 Pandemic</a></p> <p>On April 9, 2020, OHRP issued "OHRP Guidance on COVID-19." The guidance responds to questions OHRP received from the research community regarding how the Department of Health and Human Services (HHS) human subjects protection regulations (45 CFR part 46) apply to actions taken by institutions and investigators in response to the COVID-19 outbreak. OHRP offers guidance on the following topics: (i) Public Health and Clinical Activities; (ii) Excluded Public Health Surveillance Activities; (iii) Legally Required Reporting; (iv) Research Changes to Eliminate Apparent Immediate Hazards; (v) Proposing and Reviewing Study Changes; and (vi) Whether Suspensions of Research Must be Reported. Access <a href="https://www.hhs.gov/ohrp/regulations-and-policy/guidance/ohrp-guidance-on-covid-19/index.html">the guidance document</a>.</p> </div> <div class="pager-wrap"> </div> </div> <div class="sb2-layout"> <aside class="sidebar-second-wrapper"> <div class="sb2-content"> <div class="clearfix text-formatted field field--name-field-main-callout field--type-text-long field--label-hidden field__item"><h3>Education Resources</h3> <p><strong>OHRP Educational Resources for Investigators </strong>(<a href="https://www.hhs.gov/ohrp/sites/default/files/educational-resources-for-investigators.pdf">PDF</a>, 1.7 MB)</p> <p><strong>OHRP Research Participation resource library</strong></p> <p><a href="https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/index.html" title="About Research Participation"><img alt="About Research Participation: What you need to know before you decide" data-entity-type="file" data-entity-uuid="4f0ff355-05b4-4c30-99b1-feed369b08d9" src="/sites/default/files/wysiwyg/funding/policies/ohrp-arp-web-button-1_0.png" width="300" height="150" loading="lazy"></a></p> </div> </div> </aside> </div> </div> </article> </div> </div> </div> <div class="row"> <div class="col-md-12 col-sm-12 text-right"> <section class="row region region-citation"> <div id="block-citation" class="block block-ahrq block-citation"> <div class="content"> <div id="created-reviewed-citation" class="pad-bottom-sections"> <div id="page-reviewed" class="body-copy-italic">Page last reviewed June 2022 </div> <div id="page-created" class="body-copy-italic">Page originally created May 2019</div> </div> <div id="citation"> <div class="twocolordiv"> <div class="twocolordiv-content"> <p> <span class="citation-hdr">Internet Citation:</span> Protection of Human Subjects. 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