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Education: IRB Training & Opportunities | Human Research Protection Program (HRPP)
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property="dc:title" content="Education: IRB Training & Opportunities" 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-body field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><ul> <li><a href="#education">Education Opportunities</a></li> <li><a href="#cititraining">CITI Training</a></li> <li><a href="#inservicetraining">In-service Education Training</a></li> <li><a href="#irbchecklists">IRB Research Tools and Checklists</a></li> <li><a href="#cirt">Community Training (CIRT)</a></li> <li><a href="#past">Past Classes and Slides</a></li> <li><a href="#resources">Other Education Resources</a></li> </ul> <h2><a id="education" name="education"></a>Education Opportunities</h2> <p><a href="https://hub.ucsf.edu/research-coordinator">UCSF Clinical Research Resource HUB's Suggested Training for Clinical Research</a>: The HUB has published a <a href="http://hub.ucsf.edu//sites/hub.ucsf.edu/files/cr-training.pdf">useful checklist</a> for both onboarding and ongoing training for Clinical Research Coordinators, PIs, and other research support staff at UCSF.</p> <p>iRIS Interactive Tutorials: Visit the<strong><a href="http://iris-help.ucsf.edu/irb-iris"> <em>iRIS Help</em></a></strong> website (MyAccess login required) to access a comprehensive suite of resources for working in iRIS. This includes interactive online tutorials, quick guides, and exemplary IRB applications to assist with your submission process.</p> <h2><a id="cititraining" name="cititraining"></a>CITI Training</h2> <p>All <a href="https://irb.ucsf.edu/citi-human-subjects-training">Key Personnel</a> at UCSF or affiliated sites involved in Human Subjects Research are required to complete CITI training in human subjects protection (HSP). This requirement applies to Key Study Personnel on Exempt, Expedited, and Full Board studies. To check your CITI training status and for <a href="https://irb.ucsf.edu/citi-human-subjects-training">detailed instructions on completing or updating your training</a>, please refer to the following lists:</p> <p><strong>Human Subjects Protection (HSP)</strong></p> <ul> <li><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/ucsf%20citi%20training%20list.pdf" target="_blank">UCSF completion list</a></li> <li><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/va%20citi%20training%20list_0.pdf">SFVAHCS completion list</a></li> </ul> <p><strong>Good Clinical Practice (GCP)</strong></p> <ul> <li><font color="sky blue"><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/ucsfgcp%20training%20list.pdf">UCSF completion list</a></font></li> </ul> <h2><a id="inservicetraining" name="inservicetraining"></a>In-service Education Training</h2> <p>Need an in-service for your department? In-Services are a great way to educate a team or department for specific topics and assure all attendees hear the same information. <strong> To request an in-service training session please fill out this <a href="https://ucsf.co1.qualtrics.com/jfe/form/SV_73g8ftcFukhinqt">form</a>. </strong></p> <p><strong>Questions? </strong>We encourage you to submit your questions to us using the <strong><a href="https://ucsf.co1.qualtrics.com/jfe/form/SV_06qk41JwVXpOdMx">"</a></strong><strong><a href="https://ucsf.co1.qualtrics.com/jfe/form/SV_06qk41JwVXpOdMx">Ask Andy" Analyst of the Day</a></strong> form.</p> <h2><a id="irbchecklists" name="irbchecklists"></a>IRB Research Tools and Checklists</h2> <p>These tools and checklists are designed to support compliance and streamline study processes:</p> <p>Submission and Reporting:</p> <ul> <li><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/initial-submission-checklist%202023.pdf">Initial Submission Checklist</a> <em>(Last updated Oct 2023)</em></li> <li><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/post-approval-reporting-summary-sheet.pdf">Post Approval Reporting Requirements</a> <em>(Last updated Mar 2024)</em></li> </ul> <p>Consent:</p> <ul> <li><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/wysiwyg/checklist%20non%20ucsf%20checklist.pdf">Consent Form Checklist for Using a Non-UCSF Consent Form</a> <em>(Last updated Apr 2024)</em></li> <li><a href="http://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/gds-checklist.pdf">NIH GDS Policy Consent Checklist</a> <em>(Last updated Jul 2015)</em></li> </ul> <p>Study-Specific Documents:</p> <ul> <li><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/device-checklist.pdf">UCSF Investigator Checklist for IDE Exempt, Non-Significant, and Significant Risk Device Studies</a> <em>(Last Updated Oct 2018)</em></li> <li><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/Routine%20Site%20Visit%20Report.pdf">UCSF Routine On-Site Review Form</a></li> </ul> <p>Quality and Compliance Documentation:</p> <ul> <li><a href="http://hub.ucsf.edu/quality-management-practices">Quality Management Plans</a></li> <li><a href="https://hub.ucsf.edu/virtual-regulatory-binder">Regulatory Binder Requirements</a></li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/delegation-of-authority-documentation-log.doc">Delegation of Authority Documentation Log</a></li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/investigational-agent-accountability-record.doc">Drug or Biologic Dispensing / Accountability Log</a></li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/screening-enrollment-withdrawal-log.doc">Screening / Enrollment / Withdrawal Log</a></li> <li><a href="https://irb.ucsf.edu/sites/g/files/tkssra6501/f/UCSF%20CAPA%20Training_log.doc">UCSF Corrective and Preventative Action (CAPA) Training Log</a></li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/investigational-device-accountability-log.doc">Device Dispensing / Accountability Log</a> <ul> <li>Example: <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/example-study-events-tracking-form.doc">Study Events Tracking Form</a></li> <li>Example: <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/example-tracking-system-for-deadlines-reporting.xls">Tracking System for Deadlines and Reporting</a></li> </ul> </li> <li>On-site assessment assessment and training for researchers: <a href="https://ucsf.co1.qualtrics.com/jfe/form/SV_4UgMc7sj8jieX2K">Routine Site Audit Request</a></li> <li>FDA and OHRP Inspections: Please notify UCSF upon receiving the call or letter to schedule the inspection. See the <a data-once="isExternalLink" href="http://hub.ucsf.edu/fda-and-ohrp-inspections" tabindex="-1" target="_blank">UCSF Clinical Research HUB</a> for more information about whom to contact and how to prepare for the inspection.</li> </ul> <ul> </ul> <h2><a id="cirt" name="cirt"></a>Community Training Involvement in Research Training (CIRT)</h2> <p>The <strong>Community Involvement in Research Training (CIRT) Certification</strong>, developed by the University of Illinois Chicago (UIC), introduces the ethical principles of research to individuals without academic or scientific backgrounds. Designed for community-based research contexts, this program offers an accessible way for non-academic participants to engage with research practices responsibly and effectively.</p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Who Is the CIRT Certification For?</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li>Community members participating in research initiatives.</li> <li>Staff from non-profit organizations or community groups collaborating with academic researchers.</li> <li>Individuals <strong>without formal academic training</strong> who wish to learn about research ethics and processes.</li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Key Points to Note</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li>The <strong>CIRT Certification</strong> is specifically tailored for non-academic audiences and does <b>NOT</b> replace the <strong>CITI Training</strong> required for academic researchers and students.</li> <li>Researchers and students affiliated with academic institutions <strong>MUST</strong> complete the <a href="https://irb.ucsf.edu/citi-human-subjects-training"><strong>CITI Program Training</strong></a> for certification to meet institutional and federal requirements.</li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>What Does CIRT Cover?</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li>Recruitment and informed consent procedures.</li> <li>Best practices for collecting and protecting data.</li> <li>Addressing challenges during participant interactions.</li> <li>An overview of research terminology, people, and methods.</li> <li>The history of research abuses and the ethical principles that guide current rules and regulations.</li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Available Languages</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li>CIRT Certification Online is available in English, Spanish, and Haitian Creole.</li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Getting Started</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>To explore CIRT and access training materials, visit the <strong><a href="http://training.ccts.uic.edu/" rel="noopener">CIRT Training Portal</a></strong>. The program provides a clear path for community members to gain confidence and understanding in their research roles.</p> <ol> <li>Go to <a href="https://training.ccts.uic.edu/"><strong>CIRT Training Portal</strong></a> </li> <li>Click "Register" (top right hand corner. Select "I am not from UIC")</li> <li>Complete the registration form. When asked to select a site, select "<strong>University of California, San Francisco</strong>".</li> <li>Click "Register" to finish.</li> <li>Visit the Course Catalog. Scroll until you find information about CIRTification. Click "Learn More" and "Enroll" to enroll in CIRTification.</li> </ol> </div> </div> <ol> </ol> <h2>Past Classes and Slides</h2> <ul> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/routine-site-visit-class.pdf" target="_blank">Findings From Routine Site Visits Conducted by the Quality Improvement Unit (QIU)</a></li> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/post-approval-event-class.pdf" target="_blank">Post-Approval Event Reporting</a> and <a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/subject-injury-program-class.pdf" target="_blank">Overview of UCSF's Subject Injury Program</a></li> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/consent-class.pdf" target="_blank">Preparing Consent and Assent Forms and the Consent Process</a></li> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/recruitment-class.pdf" target="_blank">Recruitment: Ethics, Regulations and Practical Solutions</a> and <a href="http://www.slideshare.net/CTSIatUCSF/chr-workshop-may20121">Technology and Best Practices for Recruitment</a></li> <li><a href="http://hrpp.ucsf.edu/sites/hrpp.ucsf.edu/files/modification-continuing-review-class.pdf" target="_blank">Submitting Modifications and Continuing Reviews</a></li> </ul> <p>Currently Unavailable: </p> <ul> <li>IRB Introductory Training Archived Webinar/Slides</li> <li>Preparing a New IRB Application</li> </ul> <p>Note: The IRB was formerly known as the Committee on Human Research (CHR), which is the term used in some of these presentations.</p> <h2><a id="resources" name="resources"></a>Other Education Resources</h2> <p><strong>UCSF</strong></p> <ul> <li><a href="http://hub.ucsf.edu//sites/hub.ucsf.edu/files/cr-training.pdf" target="_blank">Suggested Training for Clinical Research</a>: The UCSF Clinical Research Training document provides essential and supplementary training resources for Clinical Research Coordinators (CRCs), covering areas like HIPAA, informed consent, Good Clinical Practice, and data security. Each training component includes links, requirements, and estimated completion times.</li> <li><a href="https://ctsi.ucsf.edu/programs/clinical-trials-operations">Clinical Trials Operations (CTO)</a>:The Clinical Trials Operations (CTO)<strong> </strong>Unit serves as an institutional representative and advocate for the UCSF clinical trials community. The CTO aims to identify, assess and prioritize barriers for inclusive and efficient trials, and steward solutions to challenges that adversely impact clinical trials operations. <a href="https://ctsi.ucsf.edu/programs/clinical-trials-operations/events">View upcoming and past events. </a></li> <li><a href="https://rcr.ucsf.edu/">Responsible Conduct of Research</a>: A guide for RCR training for UCSF learners and researchers at all levels — graduate students, postdocs, and faculty — and a resource for NIH training grant faculty and administrators. </li> <li><a href="https://hub.ucsf.edu/training">UCSF Clinical Research Resource HUB: Training</a></li> <li><a href="http://ctsi.ucsf.edu/">Clinical and Translational Science Institute</a> (CTSI) </li> </ul> <p><strong>Other Groups or Institutions</strong></p> <ul> <li><a href="http://www.centerwatch.com/" target="_blank">Center Watch Resources</a></li> <li><a href="http://cbssm.med.umich.edu/how-we-can-help/tools-and-resources/informed-consent" target="_blank">University of Michigan Online Course: Valid Consent/Refusal to Participate in Research </a></li> </ul> <p><strong>Federal Government</strong></p> <ul> <li><a href="http://www.hhs.gov/ohrp/education-and-outreach/upcoming-educational-events/index.html" target="_blank">Office of Human Research Protections (OHRP): Education Resources (Includes In-Person Events and Online Educational Opportunities)</a></li> <li><a href="http://www.nih.gov/health/clinicaltrials/resources.htm" target="_blank">NIH: Educational Materials About Clinical Trials</a></li> </ul> <p><strong>National Conferences and Workshops</strong></p> <ul> <li><a href="http://www.socra.org/html/SoCRA_Ed_Calendar.htm" target="_blank">Society of Clinical Research Associates (SoCRA) Educational Opportunities Calendar</a></li> <li><a href="http://www.primr.org/" target="_blank">Public Responsibility in Medicine and Research (PRIM&R) Conferences</a></li> </ul> </div></div></div> </div> </div> </div> </div> <div id="block-views-last-updated-block" class="block block-views"> <div class="content"> <div class="view view-last-updated view-id-last_updated view-display-id-block view-dom-id-c21cbfee6912c8ce634c517a403d87ce"> <div class="view-content"> <div> <p class="updated-date"> <span>Last updated: </span> January 27, 2025 </p> </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-block-16" class="block block-block"> <h3>Quicklinks </h3> <div class="content"> <p><a class="btn--large btn--more--reverse btn--full-width" href="https://ucsf.co1.qualtrics.com/jfe/form/SV_06qk41JwVXpOdMx"><font color="yellow">Questions? 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