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<title>Common Rule</title>

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<span id="openzim-page-title" class="mw-page-title-main"><span class="mw-page-title-main">Common Rule</span></span>

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</style><div role="note" class="hatnote navigation-not-searchable">This article is about US rule of ethics. For the Australian industry award, see <a href="Common_rule_awards" title="Common rule awards">common rule awards</a>.</div>

<p>The <b>Common Rule</b> is a 1991 rule of ethics in the <a href="United_States" title="United States">United States</a> regarding biomedical and behavioral research involving human subjects. A significant revision became effective July 2018.<sup id="cite_ref-1" class="reference"><a href="#cite_note-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> It governed <a href="Institutional_Review_Board" class="mw-redirect" title="Institutional Review Board">Institutional Review Boards</a> for oversight of human research and followed the 1975 revision of the <a href="Declaration_of_Helsinki" title="Declaration of Helsinki">Declaration of Helsinki</a>; it is encapsulated in the 1991 revision to the <a href="U.S._Department_of_Health_and_Human_Services" class="mw-redirect" title="U.S. Department of Health and Human Services">U.S. Department of Health and Human Services</a> Title 45 <a href="Code_of_Federal_Regulations" title="Code of Federal Regulations">CFR</a> 46 (Public Welfare) Subparts A, B, C and D. Subpart A. The Common Rule is the baseline standard of ethics by which any government-funded research in the US is held; nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding.

</p>

<div class="mw-heading mw-heading2"><h2 id="Background">Background</h2></div>

<p>The Common Rule is a 1991 rule of ethics (revised in 2018)<sup id="cite_ref-2" class="reference"><a href="#cite_note-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> regarding biomedical and behavioral research involving human subjects in the <a href="United_States" title="United States">United States</a>. The regulations governing <a href="Institutional_Review_Board" class="mw-redirect" title="Institutional Review Board">Institutional Review Boards</a> for oversight of human research followed the 1975 revision of the <a href="Declaration_of_Helsinki" title="Declaration of Helsinki">Declaration of Helsinki</a>, and are encapsulated in the 1991 revision to the <a href="U.S._Department_of_Health_and_Human_Services" class="mw-redirect" title="U.S. Department of Health and Human Services">U.S. Department of Health and Human Services</a> Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D. Subpart A. The Common Rule is the baseline standard of ethics by which any government-funded research in the US is held; nearly all academic institutions hold their researchers to these statements of rights regardless of funding.<sup id="cite_ref-3" class="reference"><a href="#cite_note-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup>

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<div class="mw-heading mw-heading2"><h2 id="Main_elements">Main elements</h2></div>

<p>The main elements of the Common Rule include:<sup id="cite_ref-4" class="reference"><a href="#cite_note-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup>

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<ul><li>Requirements for assuring compliance by research institutions</li>

<li>Requirements for researchers' obtaining, waiving, and documenting informed consent</li>

<li>Requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping.</li></ul>

<p>The Common Rule includes additional <b>protections for certain vulnerable research subjects</b>:

</p>

<ul><li>Subpart B provides additional protections for pregnant women, in vitro fertilization, and fetuses</li>

<li>Subpart C contains additional protections for prisoners</li>

<li>Subpart D does the same for children.</li></ul>

<div class="mw-heading mw-heading2"><h2 id="Signatories">Signatories</h2></div>

<p>The list below displays the 20 agencies and departments that have signed onto the Common Rule and their CFR numbers for those with published statutes.

</p>

<ol><li><a href="United_States_Department_of_Agriculture" title="United States Department of Agriculture">Department of Agriculture</a> (7 CFR Part 1c)</li>

<li><a href="United_States" title="United States">Department of Commerce</a>, <a href="National_Institute_of_Standards_and_Technology" title="National Institute of Standards and Technology">National Institute of Standards and Technology</a> (15 CFR Part 27)</li>

<li><a href="United_States_Department_of_Energy" title="United States Department of Energy">Department of Energy</a> (10 CFR Part 745)</li>

<li><a href="United_States_Department_of_Education" title="United States Department of Education">Department of Education</a> (34 CFR Part 97)</li>

<li><a href="United_States_Department_of_Defense" title="United States Department of Defense">Department of Defense</a> (32 CFR Part 219)</li>

<li><a href="Department_of_Health_and_Human_Services" class="mw-redirect" title="Department of Health and Human Services">Department of Health and Human Services</a> (45 CFR Part 46)</li>

<li><a href="Department_of_Homeland_Security" class="mw-redirect" title="Department of Homeland Security">Department of Homeland Security</a> (6 CFR Part 46)</li>

<li><a href="Department_of_Housing_and_Urban_Development" class="mw-redirect" title="Department of Housing and Urban Development">Department of Housing and Urban Development</a> (24 CFR Part 60)</li>

<li><a href="United_States_Department_of_Justice" title="United States Department of Justice">Department of Justice</a>, <a href="National_Institute_of_Justice" title="National Institute of Justice">National Institute of Justice</a> (28 CFR Part 46)</li>

<li><a href="Department_of_Labor" class="mw-redirect" title="Department of Labor">Department of Labor</a> (29 CFR Part 21)</li>

<li><a href="United_States_Department_of_Transportation" title="United States Department of Transportation">Department of Transportation</a> (49 CFR Part 11)</li>

<li><a href="United_States_Department_of_Veterans_Affairs" title="United States Department of Veterans Affairs">Department of Veterans Affairs</a>, Office of Research Oversight, Office of Research and Development (38 CFR Part 16)</li>

<li><a href="Agency_for_International_Development" class="mw-redirect" title="Agency for International Development">Agency for International Development</a> (USAID) (22 CFR Part 225)</li>

<li><a href="Central_Intelligence_Agency" title="Central Intelligence Agency">Central Intelligence Agency</a></li>

<li><a href="Consumer_Product_Safety_Commission" class="mw-redirect" title="Consumer Product Safety Commission">Consumer Product Safety Commission</a> (16 CFR Part 1028)</li>

<li><a href="United_States_Environmental_Protection_Agency" title="United States Environmental Protection Agency">Environmental Protection Agency</a>, Research and Development (40 CFR Part 26)</li>

<li><a href="National_Aeronautics_and_Space_Administration" class="mw-redirect" title="National Aeronautics and Space Administration">National Aeronautics and Space Administration</a> (14 CFR Part 1230)</li>

<li><a href="National_Science_Foundation" title="National Science Foundation">National Science Foundation</a> (45 CFR Part 690)</li>

<li><a href="Office_of_the_Director_of_National_Intelligence" class="mw-redirect" title="Office of the Director of National Intelligence">Office of the Director of National Intelligence</a></li>

<li><a href="Social_Security_Administration" title="Social Security Administration">Social Security Administration</a> (20 CFR 431)</li></ol>

<div class="mw-heading mw-heading2"><h2 id="References">References</h2></div>

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</style><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/index.html">"Regulations"</a>. 16 February 2016.</cite></span>

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<li id="cite_note-2"><span class="mw-cite-backlink"><b><a href="#cite_ref-2">^</a></b></span> <span class="reference-text"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html">"Federal Policy for the Protection of Human Subjects ('Common Rule')"</a>. <a href="United_States_Department_of_Health_and_Human_Services" title="United States Department of Health and Human Services">United States Department of Health and Human Services</a><span class="reference-accessdate">. Retrieved <span class="nowrap">July 10,</span> 2024</span>.</cite></span>

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<li id="cite_note-3"><span class="mw-cite-backlink"><b><a href="#cite_ref-3">^</a></b></span> <span class="reference-text"><cite id="CITEREFU.S._Department_of_Health_and_Human_Services" class="citation web cs1">U.S. Department of Health and Human Services. <a rel="nofollow" class="external text" href="https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html">"Code of Federal Regulations - Title 45 Public Welfare CFR 46"</a><span class="reference-accessdate">. Retrieved <span class="nowrap">2014-07-25</span></span>.</cite></span>

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<li id="cite_note-4"><span class="mw-cite-backlink"><b><a href="#cite_ref-4">^</a></b></span> <span class="reference-text">Korenman, S.G., Teaching the Responsible conduct of Research in humans (RCRH) <a rel="nofollow" class="external text" href="https://ori.hhs.gov/education/products/ucla/chapter2/page04b.htm">Common Rule</a>, Office of Research Integrity, US Department of Health and Human Services</span>

</li>

</ol></div></div>

<div class="mw-heading mw-heading2"><h2 id="External_links">External links</h2></div>

<ul><li><a rel="nofollow" class="external text" href="https://ori.hhs.gov/education/products/ucla/chapter2/page04b.htm">government page on Common Rule</a></li></ul>

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</style><div id="Research_participant_rights152" style="font-size:114%;margin:0 4em"><a href="Research_participant" title="Research participant">Research participant</a> rights</div></th></tr><tr><th scope="row" class="navbox-group" style="width:1%">Rights</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em">

<ul><li><a href="Beneficence_(ethics)" title="Beneficence (ethics)">Beneficence</a></li>

<li><a href="Justice_(ethics)" class="mw-redirect" title="Justice (ethics)">Justice</a></li>

<li><a href="Respect_for_persons" title="Respect for persons">Respect for persons</a></li>

<li><a href="Privacy_for_research_participants" title="Privacy for research participants">Privacy for research participants</a></li>

<li><a href="Right_to_withdraw" title="Right to withdraw">Right to withdraw</a></li>

<li><a href="Return_of_results" title="Return of results">Return of results</a></li>

<li><a href="Informed_consent" title="Informed consent">Informed consent</a></li></ul>

</div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="Human_subject_research" title="Human subject research">Human subject research</a></th><td class="navbox-list-with-group navbox-list navbox-even hlist" style="width:100%;padding:0"><div style="padding:0 0.25em">

<ul><li><a href="Clinical_research" title="Clinical research">Clinical research</a></li>

<li><a href="Biobank" title="Biobank">Biobank</a></li>

<li><a href="Social_research" title="Social research">Social research</a></li></ul>

</div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%">Ethical systems</th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em">

<ul><li><a href="Research_ethics" title="Research ethics">Research ethics</a></li>

<li><a href="Medical_ethics" title="Medical ethics">Medical ethics</a></li>

<li><a href="Bioethics" title="Bioethics">Bioethics</a></li>

<li><a href="Clinical_research_ethics" class="mw-redirect" title="Clinical research ethics">Clinical research ethics</a></li>

<li><a href="Biobank_ethics" title="Biobank ethics">Biobank ethics</a></li></ul>

</div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="Guidelines_for_human_subject_research" title="Guidelines for human subject research">Guidelines for human subject research</a></th><td class="navbox-list-with-group navbox-list navbox-even hlist" style="width:100%;padding:0"><div style="padding:0 0.25em">

<ul><li><a href="List_of_medical_ethics_cases" title="List of medical ethics cases">List of medical ethics cases</a></li>

<li><a href="Nuremberg_Code" title="Nuremberg Code">Nuremberg Code</a></li>

<li><a href="Declaration_of_Helsinki" title="Declaration of Helsinki">Declaration of Helsinki</a></li>

<li><i><a href="Belmont_Report" title="Belmont Report">Belmont Report</a></i></li>

</ul>

</div></td></tr><tr><th scope="row" class="navbox-group" style="width:1%"><a href="Monitoring_in_clinical_trials" title="Monitoring in clinical trials">Monitoring in clinical trials</a></th><td class="navbox-list-with-group navbox-list navbox-odd hlist" style="width:100%;padding:0"><div style="padding:0 0.25em">

<ul><li><a href="Ethics_committee" title="Ethics committee">Ethics committee</a></li>

<li><a href="Institutional_review_board" title="Institutional review board">Institutional review board</a></li>

<li><a href="Data_monitoring_committee" title="Data monitoring committee">Data monitoring committee</a></li>

<li><a href="Community_advisory_board" title="Community advisory board">Community advisory board</a></li></ul>

</div></td></tr></tbody></table></div></div><div><div class="zim-footer">

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