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class="tabs"></div> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-1426" class="node node-page slider-secondary clearfix" about="/clinical-trial-consent-development" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Consent Development" class="rdf-meta element-hidden"></span><span property="sioc:num_replies" content="0" datatype="xsd:integer" class="rdf-meta element-hidden"></span> <div class="content"> <div class="field field-name-field-last-revised field-type-datetime field-label-inline inline"><div class="field-label">Last revised<span class="colon">:</span> </div><div class="field-items"><div class="field-item even"><span property="dc:date" datatype="xsd:dateTime" content="2015-03-02T00:00:00-08:00" class="date-display-single">03/02/2015</span></div></div></div><div class="field field-name-field-body field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><p>With few <a href="http://irb.ucsf.edu/research-needing-irb-review">exceptions</a>, researchers must obtain and document prospective consent from the research subject before initiating any screening or study procedures. Any exceptions must be reviewed and approved by the IRB beforehand. For additional guidance on the informed consent process, please refer to <a href="http://irb.ucsf.edu/consent-guidelines">UCSF policy</a>.</p> <p><strong>UCSF consent form templates</strong><br /> When developing a consent document, you should start with a <a href="http://irb.ucsf.edu/consent-and-assent-form-templates">UCSF Consent and Assent Template</a>. These templates include <a href="http://irb.ucsf.edu/consent-guidelines#federal">required regulatory elements </a>and UCSF-specific wording. Please <a href="/cdn-cgi/l/email-protection#eb829989ab9e88988dc58e8f9ed4989e89818e889fd6a88485988e859fced9dbaa989882989f8a85888e">contact the IRB</a> for assistance developing consent documents.</p> <h4>Choosing a consent form template</h4> <p>It is important to use the <a href="http://irb.ucsf.edu/consent-and-assent-form-templates">template</a> that best fits the type of research you are conducting. For example, if you are conducting a study that involves the use of investigational or approved drugs, devices, diagnostics, or therapeutics; or studies that may be considered interventional research, use the <a href="http://irb.ucsf.edu/consent-and-assent-form-templates#consent-templates">Biomedical</a><a href="http://irb.ucsf.edu/consent-and-assent-form-templates#consent-templates"> </a>consent form template.</p> <p>Need assistance? Please <a href="/cdn-cgi/l/email-protection#fe978c9cbe8b9d8d98d09b9a8bc18d8b9c949b9d8ac3af8b9b8d8a979190dbccce988c9193dbccceb6abbcdbccce899b9c8d978a9b">email the IRB </a>or call 415-476-1814.</p> </div></div></div> </div> </div> </div> </div> </div> </div> </div> <div id="sidebar" class="column"> <div class="sidebar"> <div class="section"> <div class="region region-sidebar"> <div id="block-menu-block-3" class="block block-menu-block"> <h3><a href="/clinical-trial-consent-development" class="active-trail active">Consent Development</a></h3> <div class="content"> <div class="menu-block-wrapper menu-block-3 menu-name-main-menu parent-mlid-0 menu-level-3"> <ul class="menu"><li class="first leaf menu-mlid-2526"><a href="/irb-guidance">IRB Guidance for All Research Studies</a></li> <li class="leaf menu-mlid-2506"><a href="/consent-format">Formatting Guidelines</a></li> <li class="last leaf menu-mlid-2391"><a href="/consent-tools">Guidance, Tools & Templates</a></li> </ul></div> </div> </div> </div> </div> </div> </div> </div></div> <div id="footer"> <div class="section"> <div class="region region-footer"> <div id="block-block-6" class="block block-block"> <div class="content"> <style type="text/css"> <![CDATA[/* ><!]]>*/ </style> <div class="quickref"> <h2 style="color:#000;font-size:22px;margin:0;padding: 0 0 6px;">Quick Reference</h2> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first"> <ul> <li><a href="http://policies.ucsf.edu/" target="_blank">Campus Policies</a></li> <li><a href="http://cancer.ucsf.edu/" target="_blank">Cancer Center (HDFCCC)</a></li> <li><a href="http://accelerate.ucsf.edu/research/crs" target="_blank">Clinical Research Services</a></li> <li><a href="http://ctsi.ucsf.edu" target="_blank">Clinical & Translational Science Institute (CTSI)</a></li> </ul> </div> <div class="wysiwyg_threecols--second"> <ul> <li><a href="http://coi.ucsf.edu/" target="_blank">Conflicts of Interest (COI)</a></li> <li><a href="http://accelerate.ucsf.edu/consult" target="_blank">Consultation Services</a></li> <li><a href="http://accelerate.ucsf.edu/cores/" target="_blank">Cores Search</a></li> <li><a href="https://ehs.ucsf.edu/" target="_blank">Environment, Health and Safety</a></li> <li><a href="http://compliance.ucsf.edu/" target="_blank">Ethics & Compliance</a></li> </ul> </div> <div class="wysiwyg_threecols--third"> <ul> <li><a href="http://globalhealthsciences.ucsf.edu/" target="_blank">Global Health Sciences</a></li> <li><a href="http://ita.ucsf.edu/" target="_blank">Innovation, Technology & Alliances</a></li> <li><a href="http://irb.ucsf.edu" target="_blank">IRB / Human Research Protection Program</a></li> <li><a href="https://osr.ucsf.edu/" target="_blank">Office of Sponsored Research</a></li> <li><a href="http://profiles.ucsf.edu" target="_blank">UCSF Profiles</a></li> </ul> </div> </div> </div> <p style="float: right; margin: 1.2em 30px -1.5em; text-align: right; width: 6em;"><a href="/cdn-cgi/l/email-protection#723a273032071101145c171607" style="color:#FFF"><span class="__cf_email__" data-cfemail="f4bca1b6b481978792da919081">[email protected]</span></a></p> </div> </div> </div> <div class="footer-bottom"> <nav aria-label="Footer Navigation" class="footer--navigation"> <ul> <li><a href="/cdn-cgi/l/email-protection#672f3225271204140149020312">Contact Us</a></li> <li><a href="https://www.ucsf.edu/accessibility-resources">Accessibility</a></li> <li><a href="https://www.ucsf.edu/website-privacy-policy">Privacy Policy</a></li> <li><a href="https://websites.ucsf.edu/website-terms-use">Terms of Use </a></li> <li><a href="https://websites.ucsf.edu/azlist">A-Z Website List</a></li> </ul> </nav> <div class="footer--copyright"> <p>© 2024 The Regents of the University of California</p> </div> </div> </div> </div> </div> </div> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script type="text/javascript"> /*<![CDATA[*/ (function() { var sz = document.createElement('script'); sz.type = 'text/javascript'; sz.async = true; sz.src = '//siteimproveanalytics.com/js/siteanalyze_8343.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(sz, s); })(); /*]]>*/ </script> </body> </html>