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menu-mlid-3926"><a href="/guidance">Guidance A to Z</a></li> </ul></li> </ul></div> </div> </div> </div> </div> </div> <div id="breadcrumb" class="row-full-width"><div class="inside"><h2 class="element-invisible">You are here</h2><div class="breadcrumb"><a href="/">Home</a> > <a href="/our-services">Our Services</a> > <a href="/working-other-institutions">Working with Other Institutions</a> > <span class="breadcrumb-page-title">Research at the SFVAHCS</span></div></div></div> <h1 class="title" id="page-title">Research at the SF VA Health Care System</h1> <div class="content-top"> </div> <div id="main-wrapper"> <div id="main" class="clearfix"> <div id="content" class="column"> <div class="inside"> <a id="main-content"></a> <div class="tabs"></div> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-357" class="node node-page slider-secondary clearfix" about="/research-sfvamc" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Research at the SF VA Health Care System" 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="#sfvamc">Research at the SFVAHCS</a></li> <li><a href="#hrppcovid19">HRPP COVID-19 Information</a></li> <li><a href="#approval">When is VA Approval Required?</a></li> <li><a href="#education">Required Education and Training</a></li> <li><a href="#submission">IRB and R&D Submission Process</a></li> <li><a href="#studyapplicationguidance">Study Application Guidance</a></li> <li><a href="#consentforms">Consent Forms</a></li> <li><a href="#vadocusign">VA Docusign</a></li> <li><a href="#vaprivacy">VA Privacy and Information Security Requirements</a></li> <li><a href="#sfvasubjectpayments">Restrictions on VA Research Subject Payments</a></li> <li><a href="#nonveteran">Non-Veteran Research Subjects</a></li> <li><a href="#researchpharmacy">VA Research Pharmacy</a></li> <li><a href="#radiationsafety">VA Radiation Safety Committee Forms</a></li> <li><a href="#researchcompliance">Research Compliance</a></li> <li><a href="#quicklinks">Quick Links</a></li> </ul> <p><strong>CLINICAL RESEARCH OFFICE</strong></p> <div class="webedit-clearfix">San Francisco VA Health Care System</div> <div class="webedit-clearfix">4150 Clement Street (CRO 151)</div> <div class="webedit-clearfix">Building 210, Room 100</div> <div class="webedit-clearfix"><a href="/cdn-cgi/l/email-protection#dbade9ea889d9893898b8b9badbaf5bcb4ad"><span class="__cf_email__" data-cfemail="ef99dddebca9aca7bdbfbfaf998ec1888099">[email protected]</span></a></div> <div class="webedit-clearfix"> </div> <div class="webedit-clearfix"> <p><strong>HRPP Team</strong></p> <h5>Gregory Green, MPH, CIP</h5> <div> <h5>Director of Operations</h5> <h5><a href="/cdn-cgi/l/email-protection#377045525058454e19704552525977415619505841"><span class="__cf_email__" data-cfemail="c582b7a0a2aab7bceb82b7a0a0ab85b3a4eba2aab3">[email protected]</span></a></h5> <h5>(415) 221-4810 ext. 22996</h5> <p> </p> <h5>Juliana Bondzie, MA, MA-C</h5> <h5>HRPP Manager</h5> <h5><a href="/cdn-cgi/l/email-protection#89c3fce5e0e8e7e8a7cbe6e7edf3e0ecc9ffe8a7eee6ff"><span class="__cf_email__" data-cfemail="511b243d38303f307f133e3f352b38341127307f363e27">[email protected]</span></a></h5> <h5>(415) 221-4810 x21058 </h5> <p> </p> <h5>Jade Ollison</h5> <h5>HRPP Coordinator</h5> <h5><a href="/cdn-cgi/l/email-protection#d399b2b7b6fd9cbfbfbaa0bcbd93a5b2fdb4bca5"><span class="__cf_email__" data-cfemail="6c260d080942230000051f03022c1a0d420b031a">[email protected]</span></a></h5> <h5>(415) 221-4810 x21071</h5> <p> </p> <h5>Nina Medoff, MPP, MSW</h5> <h5>HRPP Program Analyst</h5> <h5><a href="/cdn-cgi/l/email-protection#a8e6c1c6c986e5cdccc7cecee8dec986cfc7de"><span class="__cf_email__" data-cfemail="347a5d5a551a7951505b52527442551a535b42">[email protected]</span></a></h5> <h5>(415) 221-4810 ext. 23394</h5> <p> </p> <p>FWA number: FWA00000280</p> </div> </div> <h2 class="webedit-clearfix"><a id="sfvamc" name="sfvamc"></a>Research at the SFVAHCS</h2> <p>The San Francisco Veterans Affairs Health Care System (SFVAHCS) has an institutional affiliation with UCSF and provides opportunities for collaborative research. The UCSF IRB is the primary IRB of record for SFVAHCS, but there are additional requirements for research conducted at the VA. While SFVAHCS and UCSF are affiliated institutions, they are separate legal entities.</p> <h2><a id="hrppcovid19" name="hrppcovid19"></a>HRPP COVID-19 Information</h2> <p>Consideration should be taken to reduce COVID-19 transmission risk to research subjects and research staff as much as possible. Remote study procedures can and should be utilized when feasible. This may include, but is not limited to: obtaining consent remotely, remote study visits, and/or use of web-based surveys or mobile apps for data collection. Please refer to guidance documents below for more information, and to the CDC website for COVID-19 updates.</p> <h3>Additional COVID-19 VA research guidance</h3> <ul> <li><a href="https://dvagov.sharepoint.com/sites/vacovhacomm/admin/projects/covid19">ORD Covid-19 SharePoint site</a> (accessible only behind VA firewall)</li> <li><a href="https://www.research.va.gov/resources/policies/human_research.cfm">ORD Policies and Guidance</a></li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/sfva Remote consent and data collection guidance_rev 5-18-2021.pdf">SFVA remote consent and data collection guidance</a> - May 18, 2021</li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/bulletin No. 427 VA Research %26 Development Guidance for Securely Obtaining Informed Consent.pdf">Bulletin No. 427 VA Research & Development Guidance for Securely Obtaining Informed Consent</a> - December 22, 2020</li> <li><a href="https://www.research.va.gov/resources/policies/guidance/video-comm-covid19.pdf">VA Video Communication Technology Research Memorandum</a>—April 7, 2020</li> <li><a href="https://www.research.va.gov/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf">ORD Human Subject Protection Issues Related to COVID-19 Frequently Asked Questions</a>—April 6, 2020</li> <li><a href="https://www.research.va.gov/resources/policies/CRADO-memo-COVID19-biobank.pdf">VA COVID-19 Research Biorepositories/Biobanks</a>—May 1, 2020</li> <li><a href="https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf">ORD Guidance on VA Employee Participation in VA-Conducted COVID-19 Research Studies</a>—September 24, 2020</li> </ul> <h2><strong><a id="approval" name="approval"></a></strong>When is VA Approval Required?</h2> <p>VA research is research that is conducted by VA investigators (serving on compensated, <a href="https://irb.ucsf.edu/research-sfvamc#considerations">WOC</a>, or Intergovernmental Personnel Agreement appointments) while on VA time. If you wish to enroll patients or staff at the VA, or use VA personnel, facilities or medical records, you must secure prior approval of the SFVAHCS Research & Development Committee (R&DC). </p> <h3>VHA Directive 1200.05</h3> <p><a href="https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8171" target="_self">VHA Directive 1200.05</a> (new revision published January 8, 2021) is the national policy that describes the requirements for the protection of human subjects in VA research. Please review this policy if you are interested in engaging VA in your research project.</p> <p>Special considerations may be found in the following sections:</p> <ul> <li>5g—VA Investigators' Responsibilities</li> <li>15 – Collaborative Research</li> <li>17 – General Requirements for Informed Consent (refer to <a href="/sites/g/files/tkssra6501/f/va%20ICF%20Checklist.docx" target="_self">VA Informed Consent Checklist</a>)</li> <li>18 – Documentation of Informed Consent</li> <li>19 – Research Involving Pregnant Women, Human Fetuses, and Neonates as Subjects (refer to ORD Memo: <a href="https://www.research.va.gov/resources/policies/guidance/Restriction-on-Use-of-Fetal-Tissue.pdf">Restriction on Use of Fetal Tissue for all VHA Research Studies</a>, dated August 28, 2019)</li> <li>20 – Research Involving Prisoners (restricted by the VA)</li> <li>23 – HIPAA Authorization</li> </ul> <p>Also refer to <a href="https://www.research.va.gov/resources/policies/faq-search.cfm">ORPP&E’s Policy and Guidance FAQs</a>.</p> <h3>What to do if VA is an administrative site only</h3> <p>Complete this <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/ucsf%20studies%20using%20SFVAMC%20resources%209-22-2016%20%28Non-engaged%29.pdf">form</a> for UCSF research projects where SFVAHCS is an administrative site only. SFVA is considered an administrative site when local VA resources such as SFVAHCS property, office, computer, server or email are used, and/or VA time is used, but:</p> <ul> <li>No VA patients or employees are enrolled,</li> <li>No identifiable data or specimens are collected from or used at SFVAHCS, <u>and</u></li> <li>No VA funding is used.</li> </ul> <h3>Quality Improvement Projects</h3> <p>Per <a href="https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.research.va.gov%2Fresources%2Fpolicies%2FProgramGuide-1200-21-VHA-Operations-Activities.pdf&data=04%7C01%7C%7C6f4183445b484227729808d8ab9b0857%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637448029634949509%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=qU8a2OWPIGo9qVsNqGKToMBxcKnZxDFQXCSoHo1ngyc%3D&reserved=0">VHA Program Guide 1200.21</a>, activities—including some involving collection of PHI/PII—do not constitute research if they are not designed to produce information that expands the knowledge base of a scientific discipline (or other scholarly field). This includes projects focused on quality improvement, program administration, and/or program evaluation that are not designed to answer a research question nor includes a hypothesis designed to contribute to generalizable scientific knowledge. Use the Research vs. Operations Decision Tool and Research or QA Chart to determine if the project meets the definition of research.</p> <p>Quality improvement (QI) projects do not require IRB approval, therefore <strong>do not</strong> submit an IRB application in iRIS. To determine if your proposed VA project is QI or Operations, go to the VA Electronic Determination Aid (VAEDA) <a href="https://vhacdwdwhvda01.vha.med.va.gov/vaeda/home#/">website tool</a> and fill out the checklist. Please submit the results to HRPP at <a href="/cdn-cgi/l/email-protection#d583e7e48693969d87858595a3b4fbb2baa3"><span class="__cf_email__" data-cfemail="50066261031613180200001026317e373f26">[email protected]</span></a>. If you need written determination that the project is not research (e.g., for publication), contact <a href="/cdn-cgi/l/email-protection#5c2a6e6d0f1a1f140e0c0c1c2a3d723b332a"><span class="__cf_email__" data-cfemail="d2a4e0e38194919a80828292a4b3fcb5bda4">[email protected]</span></a>.</p> <p>Please also consult with Education Service, Chief of Quality Management Service and your service chief for any additional approvals that may be needed to proceed with your project.</p> <p>Those who work only on QI projects are not required to complete VA CITI Human Subjects Protection training. </p> <h3>Advertising non-VA studies at SFVA</h3> <p>If you <em>only</em> wish to inform VA patients about a non-VA study by posting/distributing recruitment materials on the premises of a VA facility, R&DC approval is not required. Complete this form and return it to the VA Clinical Research Office (<a href="/cdn-cgi/l/email-protection#a3f59192f0e5e0ebf1f3f3e3d5c28dc4ccd5"><span class="__cf_email__" data-cfemail="287e1a197b6e6b607a7878685e49064f475e">[email protected]</span></a>) prior to advertising non-VA studies at SFVA.</p> <h3>Cooperative Research Provisions and Single IRB Implementation at VA</h3> <p>If SFVAHCS and any other Federal or Federally-funded institutions are engaged in a non-exempt research study which has been <i>approved or transitioned</i> to follow the 2018 Requirements of the Common Rule, the cooperative research provisions may apply. Per these provisions, the use of a single IRB (sIRB) or ORD-approved sIRB exception is required.</p> <p>When collaborating with other sites, take into consideration the single IRB requirement early in the grant writing stage, before submitting the project for IRB approval. If one or more other VA sites are engaged in your research study, first consider using VA Central IRB as your IRB of record. Contact <a href="/cdn-cgi/l/email-protection#e89e898b8d869c9a8984819a8aa89e89c68f879e"><span class="__cf_email__" data-cfemail="a5d3c4c6c0cbd1d7c4c9ccd7c7e5d3c48bc2cad3">[email protected]</span></a> or visit the <a href="https://www.research.va.gov/programs/orppe/vacentralirb/default.cfm">VA Central IRB</a> website for more information.</p> <p>If using a commercial IRB, refer to SFVA <a href="/sites/g/files/tkssra6501/f/Commercial%20IRB%20submission%20guidance%207-6-2023.pdf" target="_blank">Commercial IRB submission guidance</a> for our facility.The following <a href="https://www.research.va.gov/programs/orppe/irb_relationships.cfm">forms from ORD</a> will aid in ensuring your ICF and/or HIPAA documents are in compliance:</p> <ul> <li><a href="https://www.research.va.gov/programs/orppe/VA-Specific-and-Selected-2018-Common-Rule-Informed-Consent-Requirements-When-Using-an-Independent-Commercial-IRB.docx">VA ICD Requirements When Using an Independent Commercial IRB</a></li> <li><a href="https://www.research.va.gov/programs/orppe/VA-HIPAA-Authorization-Requirements-When-Using-an-Independent-Commercial-IRB.docx">VA HIPAA Authorization Requirements for and Independent Commercial IRB</a></li> <li><a href="https://www.research.va.gov/programs/orppe/Checklist-for-VA-Facilities-Using-Independent-Commercial-IRBs-ICDs-and-Combined-ICD-HIPAA-Authorization.docx">Checklist for VA Facilities Using Independent Commercial IRB’s (ICD & Combined ICD/HIPAA)</a></li> </ul> <p>For more information about cooperative research provisions requirements, refer to the <a href="https://www.research.va.gov/programs/orppe/single_irb.cfm">ORPP&E</a> website or email the VA Research Office at <a href="/cdn-cgi/l/email-protection#d385e1e28095909b81838393a5b2fdb4bca5"><span class="__cf_email__" data-cfemail="0c5a3e3d5f4a4f445e5c5c4c7a6d226b637a">[email protected]</span></a>.</p> <h2><a id="education" name="education"></a>Required Education and Training</h2> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>VA employment or WOC status required</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>All personnel engaged in research at the VA, including volunteers, must be paid by the VA or have completed a federal background check and have Worker Without Compensation (WOC) status. These personnel must be registered in the VA Research and Development Information System (<a href="http://vhasfcapprdis2.v21.med.va.gov:8080/va/pinsite" target="_blank">RDIS</a>) which is only accessible behind the VA firewall.</p> <p>The VA PI (or designee) must complete a <strong>Scope of Practice</strong> for each RDIS user listing designated research duties. If users require access to the VA’s electronic medical record (CPRS) as part of their research duties, this must be indicated in the scope and the user must be listed in key study personnel on the IRB Study Application. It is the PI’s responsibility to ensure the new personnel are listed on the IRB Study Application either in real time or that the request to add new personnel is combined with the next future IRB submission. </p> <p>For assistance with RDIS or with obtaining a VA laptop and other VA equipment for research personnel, email the VA onboarding team at <a href="/cdn-cgi/l/email-protection#bceaf4fdeffaffe3fdf8ecfdffe3eed9cfd9ddcedfd4fccadd92dbd3ca"><span class="__cf_email__" data-cfemail="14425c554752574b55504455574b467167717566777c5462753a737b62">[email protected]</span></a>.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Mandatory VA-specific training for research staff</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>IRB approvals may be delayed if key study personnel listed in the Study Application are not up-to-date on the following VA research training at the time of submission:</p> <ul> <li><a href="https://about.citiprogram.org/"><strong>CITI</strong></a> (VA Human Subjects Protection)—CITI account must be affiliated with <strong>VA</strong> <strong>San Francisco, CA-662</strong>. This training must be renewed every three years. Review the <a href="https://www.research.va.gov/programs/orppe/education/ord_training/default.cfm">VA ORD website</a> and <a href="/citi-human-subjects-training" target="_self">CITI FAQs</a> for more information. Please email VA HRPP if further instruction is needed.</li> <li><strong>VA Privacy & HIPAA and VA Privacy & Information Security and Rules of Behavior</strong> must be updated annually via the <a href="https://www.tms.va.gov/SecureAuth35/">VA TMS</a> website. All researchers accessing identifiable VA data must complete these trainings. For assistance with TMS accounts or training requirements, contact <a href="/cdn-cgi/l/email-protection#6f39272e3c292c302e2b3f2e2c303d0a1c0a0e1d0c072f190e41080019"><span class="__cf_email__" data-cfemail="7a2c323b293c39253b3e2a3b3925281f091f1b0819123a0c1b541d150c">[email protected]</span></a>.</li> </ul> <p>Trainings are specific to the VA. UCSF training may not be substituted.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Additional training (not required)</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>VA Office of Research Protections, Policy, and Education (ORPP&E) webinar archive may be accessed <a href="https://www.research.va.gov/programs/orppe/education/webinars/archives.cfm">here</a>. It is highly recommended that VA research personnel review the topics listed and listen to any webinars that may pertain to your VA research activities.</p> <p>OHRP provides <a href="https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Feducation-and-outreach%2Fonline-education%2Fhuman-research-protection-training%2Findex.html&data=04%7C01%7C%7C22d7f4fb044c4e12386208d88fccfe3c%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637417457936932914%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=b4xYJKOP7iCL0UeaDYohnOujCKHbjkwVX28%2BkHXm7Ps%3D&reserved=0"><strong>Human Research Protection Training</strong></a> that includes foundational knowledge on protecting human subjects in research funded by the U.S. Department of Health and Human Services (HHS). The training is developed for the broad research community including IRBs, investigators and key personnel, and anyone interested in the Common Rule. Access is free.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Licensed Practitioners</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Licensed practitioners must have appropriate privileges from the VA’s Professional Standards Board or Nurse Credentialing Committee prior to working on research or prescribing research medications at SFVAHCS.</p> </div> </div> <h2><a id="submission" name="submission"></a>IRB and R&D Submission Process</h2> <p>The VA distinguishes between projects and protocols. A <strong>project</strong> is a cohesive body of work, usually tied to one major funding source, and is reviewed for safety before any research may begin. Projects may contain one or more <strong>Protocols</strong> (i.e., IRB, BUA, IACUC). </p> <p>IRB <strong><em>protocol </em></strong>approval and VA R&D Committee <strong><em>project</em></strong> approval are required for human subjects research. Protocol approval is not required for projects that are not considered human subjects research (e.g., QA/QI projects).</p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Protocol Approval</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Log into <a href="https://iris.ucsf.edu/">iRIS</a> and submit the appropriate submission packet (Initial Review or Modification Form, if adding SFVAHCS as a site) with a complete description of study procedures on the <a href="#studyapplicationguidance">Study Application</a>.</p> <p>Attach all required VA forms to your IRB submission:</p> <ul> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/va%2010-250.pdf">VA Form 10-250 Privacy Checklist</a> - complete Page 1 only</li> <li><a href="https://dvagov.sharepoint.com/sites/OITRSDResearchCybersecurity/RSD%20Documents/Forms/AllItems.aspx?RootFolder=%2Fsites%2FOITRSDResearchCybersecurity%2FRSD%20Documents%2FEnterprise%20Research%20Data%20Security%20Plan%20%28ERDSP%29%2FERDSP%20Template%20and%20User%20Guide&FolderCTID=0x012000A71201A05A749545A370DB74151D69D6&View=%7B49F2E741%2D4B47%2D429F%2DA7AC%2D91D187041478%7D">Enterprise Research Data Security Plan</a> (ERDSP)—This link is only accessible behind the VA firewall. The VA PI or designee must sign.</li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/va-request-for-approval.pdf">Request for R&D Approval (aka 'pink sheet')</a>—List all protocols attached to the funding source. You must obtain your Service Chief’s signature on this form. After VA PI signature, you must obtain your VA Service Chief’s signature on this form.</li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/va-rpss.pdf">Research Protocol Safety Survey (RPSS)</a>—Refer to <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/pi%20Instructions%20for%20RPSS%202021.pdf" target="_self">instructions for completing the RPSS</a>. The VA PI must sign.</li> </ul> <p><strong>Failure to attach the above required documents may result in delays in review and approval.</strong></p> <p>Attach the following study documents, if applicable. </p> <p>Consent Documents section: </p> <ul> <li><a href="#consentforms">VA consent form(s) </a></li> <li>Information sheet</li> <li>Verbal consent script</li> </ul> <p>Other Study Documents section</p> <ul> <li>VA HIPAA (VA Form 10-0493)</li> <li>Recruitment scripts</li> <li>Non-consent phone scripts</li> <li><a href="/sites/g/files/tkssra6501/f/Request-Non-Veteran-Approval.docx" target="_self">Request for Non-Veteran Approval</a> form, if enrolling non-Veteran subjects in research that involves VA outpatient or VA hospital treatment</li> <li>Single IRB exception approval letter: only required for non-exempt studies if there are collaborating engaged VA sites and/or other collaborating engaged sites which are Federal entities or Federally-funded</li> <li><a href="https://dvagov.sharepoint.com/sites/VHAORPPE/RecruitmentRequests">Proactive calling</a> approval letter issued by ORD</li> <li><a href="/sites/g/files/tkssra6501/f/DART%20HIPAA%20Waiver%281%29.pdf">HIPAA Waiver form</a> (for projects involving DART applications needing a waiver)</li> <li>Any other related materials– other documents such as Data Use Agreements, Authorization to Transport Sensitive Information may be obtained through the SFVA HRPP team.</li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Project Approval</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Once your protocol documents are submitted to the IRB, VA Research Office personnel will facilitate R&DC approval. <strong>You may not begin a new research project without IRB <u>and</u> R&D Committee approval. When your project is approved, you will receive a signed ACOS/R&D memo giving you authorization to begin your project.</strong></p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>DART Research Requests</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Data Access Request Tracker (<b>DART</b>) is the submission request process to use any VA data resources associated with the VA Informatics and Computing Infrastructure (VINCI) system (or VA data warehouse). If you will be completing a DART research request and the IRB has approved a waiver of HIPAA Authorization for your study, the HRPP team will assist in completing the <a href="/sites/g/files/tkssra6501/f/DART%20HIPAA%20Waiver%281%29.pdf" target="_blank">Waiver of HIPAA Authorization (VA Form 10-0521)</a>. Please complete the <b>first page of the form to the orange line</b> and send it to <a href="/cdn-cgi/l/email-protection#aadc989bf9ece9e2f8fafaeadccb84cdc5dc" target="_blank"><span class="__cf_email__" data-cfemail="681e5a593b2e2b203a3838281e09460f071e">[email protected]</span></a>. <strong>Be sure to include your study number with your submission in the email to the HRPP team.</strong> Further information and a full list of required documents may be found at the website for the <a href="https://vaww.vhadataportal.med.va.gov/Data-Access/DART-Request-Process" target="_blank">DART Research Request Process</a>. </p> </div> </div> <h2><a id="studyapplicationguidance" name="studyapplicationguidance"></a>Study Application Guidance</h2> <p>Review the following for information that must be included in the IRB Study Application. Failure to include this information may result in delays in approval.</p> <p>If SFVA is engaged in the research, on the IRB Study Application, check “SF VA Medical Center (SF VAMC)” under UCSF and Affiliated Sites and ensure that all VA-specific sections of the application are completed.</p> <p>Note that if the UCSF Principal Investigator is not affiliated with SFVAHCS, a SFVAHCS-approved PI who will be responsible for the conduct of the work at the VA must be identified. For information about applying for VA PI status, contact <a href="/cdn-cgi/l/email-protection#7e28363f2d383d213f3a2e3f3d212c1b0d1b1f0c1d163e081f50191108"><span class="__cf_email__" data-cfemail="7e28363f2d383d213f3a2e3f3d212c1b0d1b1f0c1d163e081f50191108">[email protected]</span></a>.</p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Inclusion/Exclusion Criteria</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>If enrolling non-Veterans in VA research, include explicit justification. Refer to <a href="https://irb.ucsf.edu/research-sfvamc#nonveteran" target="_blank">Non-Veteran Research Subjects</a> section.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Qualifications of Key Study Personnel</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li>If the UCSF PI is not affiliated with VA, indicate who will serve as the VA PI.</li> <li>Clearly distinguish VA from non-VA personnel.</li> <li>Identify personnel who will interact with VA subjects and/or have access to identifiable VA data (not required if the study is conducted at VA only)</li> <li>Identify authorized study drug prescribers, if applicable.</li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Study Procedures</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li>Describe all study procedures to be conducted at VA. If any procedures are not being done at VA or any study populations are not included at the VA, describe in this section.</li> <li>Include all remote study procedures, if applicable.</li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Recruitment</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li>Distinguish which recruitment methods will occur at the VA and which methods will NOT be conducted at the VA.</li> <li>If there are multiple subject populations (e.g., Veterans and non-Veterans), distinguish how each group will be recruited.</li> <li>Proactive calling (sometimes referred to as “cold calling”) may be permitted in certain circumstances. Click <a href="https://dvagov.sharepoint.com/sites/VHAORPPE/RecruitmentRequests">here</a> to request ORD approval for proactive calling.</li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Confidentiality</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>1. For <strong>all</strong> VA studies, include the Required VA records retention language: <strong>VA research records will be retained and disposed in accordance with the VHA Records Control Schedule (RCS 10-1). </strong></p> <p>2. Describe:</p> <ul> <li>How VA data/specimens will be stored (e.g., de-identified, coded or identifiable). If biospecimens are collected and/or stored at SFVA, specify whether the specimens will be labeled with identifiable, coded or de-identified information.</li> <li>Where data will be stored (e.g., VA server, UCSF server), and</li> <li>Who will have access to the data.</li> </ul> <p>3. If the study involves collection or use of sensitive VA data (specifically drug abuse, alcoholism/alcohol abuse, HIV, or sickle cell anemia), include 38 USC 7332 language</p> <p>4. Specify whether non-VA personnel will have access to identifiable VA information.</p> <p>5. If you plan to transmit VA data outside the VA, describe how the data will be transferred (e.g., encrypted email) AND whether VA data will be combined with non-VA data. This information must also be included on the VA consent and VA HIPAA forms.</p> <p><em><em>Note that the complete record (original or copy) of all data obtained in VA research must be retained at VA.</em></em></p> </div> </div> <h2><a id="consentforms" name="consentforms"></a>VA Consent Forms</h2> <p>VA consent forms are the consent document used to obtain informed consent from participants in VA-approved research, including but not limited to research conducted at VA, using VA employees and time, funded by VA, etc. Please see the “When to use a VA consent form” section below for more information.</p> <p>All VA consent forms and verbal consent scripts must contain:</p> <ul> <li>The required elements of consent as described in <a href="https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8171" target="_blank">VHA Directive 1200.05</a></li> <li>VA treatment and compensation for research-related injury wording, if applicable.</li> <li>All 2018 Common Rule required language.</li> </ul> <p>When drafting your consent form(s), refer to UCSF <a href="https://irb.ucsf.edu/consent-form-guidelines-and-suggested-wording" target="_blank">consent form guidelines and suggested wording</a> and the <a href="/sites/g/files/tkssra6501/f/va%20ICF%20Checklist.docx">VA Informed Consent checklist</a>. You may use the VA consent form header (VA Form 10-1086) if desired, though use of the 10-1086 is not required.</p> <p><strong>NOTE</strong>: You may include the Person Obtaining Consent signature block on VA consent forms if desired, however this is no longer a VA requirement.</p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>All risk studies</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p><strong>The following language regarding VA treatment and compensation for research-related injury must be included verbatim in VA consent</strong><strong>s forms for all VA studies:</strong></p> <p>If you are experiencing a medical emergency, please call 9-1-1. If you incur an injury or illness as a result of being in this study, the Department of Veterans Affairs (VA) will ensure that treatment is made available at a VA medical facility or non-VA facility, as appropriate. If you were following study instructions, the costs of such treatment will be covered by the VA or the study sponsor (if applicable). If you were NOT following study instructions, the costs of such treatment may be covered by the VA or the study sponsor (if applicable) or may be billed to you or your insurer just like any other medical costs, depending on a number of factors. The VA and a study sponsor do not normally provide any other form of compensation for injury or illness. For further information about this, call the study team at the number(s) provided.</p> <p><strong><u>NOTE</u></strong>: If the greater than minimal risk study is conducted at both UCSF and VA, include both VA and <a href="https://irb.ucsf.edu/treatment-and-compensation-injury#UCSF-wording">UCSF treatment and compensation for injury wording</a>.</p> <p> </p> </div> </div> <h4>When to use a VA consent form</h4> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Examples of when a VA consent document must be used:</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li>The study for which you are obtaining informed consent has VA funding of any type (including, but not limited to Career Development Awards, Merit Review Awards, Cooperative Studies Program). You must use the VA consent form for VA-funded studies even when informed consent is obtained at UCSF or other outside (non-VA) site.</li> <li>An individual from whom you are obtaining consent was identified by reviewing VA records (medical or research) and/or screened for study eligibility and consented at VA, but sent to UCSF for all subsequent study procedures. Note the participant <em>may need to sign both</em> VA and UCSF consents.</li> <li>Study procedures are conducted at both the VA and UCSF—participant signs a VA consent and a UCSF consent (as required by the IRB).</li> <li>VA or NCIRE employees (on their VA or NCIRE time) go to UCSF to obtain informed consent from UCSF patients for VA studies.</li> <li>You (or your study staff) are on your VA time when you obtain informed consent from an individual on UCSF premises.</li> <li>The participant typically receives care at UCSF, but study procedures are conducted at the VA.</li> <li>Informed consent is obtained at VA or on VA-leased property regardless of: <ul> <li>participant’s Veteran status</li> <li>the location(s) at which study procedures will be performed, or</li> <li>whether the individual obtaining informed consent is employed by VA, NCIRE, UCSF, or elsewhere. (Please note: Any individual who obtains informed consent on VA premises MUST be VA-employed or have WOC status.)</li> </ul> </li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Examples of when a VA consent document must NOT be used:</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li>VA clinician informs Veteran patient of a UCSF study, then refers patient directly to UCSF study team and consent process is conducted at UCSF.</li> <li>All data is UCSF data, obtained either through direct interaction or records review, and the VA is serving as an administrative site (e.g., the role of VA is limited to data analysis).</li> <li>A prospective participant contacts a researcher about a UCSF study and discloses that he/she happens to be a Veteran</li> </ul> </div> </div> <h2><a id="vadocusign" name="vadocusign"></a>VA Docusign</h2> <p>DocuSign may be used to obtain signatures on VA forms (VA consent, VA HIPAA Authorization Form and other VA forms requiring subject signature). ORD has purchased a supply of envelopes to be used in research studies requiring documentation of informed consent. All requests are considered but studies requiring the creation of <100 envelopes (100 subjects) will need to provide justification. Inpatient studies are generally not appropriate for DocuSign and study teams should consider the use of iMedConsent<sup>TM</sup> for inpatient studies.</p> <p><strong>Requesting Use of VA DocuSign</strong></p> <p>For more information, <a href="http://www.research.va.gov/resources/policies/human_research.cfm#docusign">visit instructions for requesting the use of VA DocuSign</a>. Please also refer to the <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/sfva%20Remote%20consent%20and%20data%20collection%20guidance_rev%205-18-2021.pdf">SFVA remote consent and data collection guidance</a>. </p> <p><strong>If approved to use VA DocuSign</strong></p> <ul> <li>Review DocuSign <a href="https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign/SitePages/Post-Approval-Instructions.aspx">Post-Approval Instructions</a> (only accessible behind VA firewall).</li> <li>Submit a Modification Form for your study in iRIS.</li> <li>On the IRB Study Application: <ul style="list-style-type:circle;"> <li>Clearly indicate that VA DocuSign will be used to recruit VA subjects only.</li> <li>In CONSENT METHODS item, select “Sign an electronic consent form using DocuSign (signed consent)”</li> <li>In CONSENT PROCESS section, describe the procedures for obtaining consent remotely. </li> </ul> </li> <li>Attach a PDF copy of the approval correspondence from ORD.</li> <li>Attach 1) email script and 2) consent phone script as needed—see email script template and phone script template.</li> </ul> <p> </p> <p style="margin-left:.25in;">NOTE: Do not list VA DocuSign in the Disclosure section of the VA HIPAA form.</p> <p><strong>After IRB approval is granted, questions should be directed to </strong><a href="/cdn-cgi/l/email-protection#b8eef0f9fbf7f7eafceadddfcdd4d9ccd7cac1f8ced996dfd7ce"><span class="__cf_email__" data-cfemail="a1f7e9e0e2eeeef3e5f3c4c6d4cdc0d5ced3d8e1d7c08fc6ced7">[email protected]</span></a>.</p> <h2><a id="vaprivacy" name="vaprivacy"></a>VA Privacy and Information Security Requirements</h2> <p><strong>Enterprise Research Data Security Plan (ERDSP)</strong></p> <p><em>This form must be completed and attached to all initial submissions and to any modifications that affect the study’s data and security plan.</em></p> <p>ORD has mandated that Information Security Officers use the <a href="https://dvagov.sharepoint.com/sites/OITRSDResearchCybersecurity/RSD%20Documents/Forms/AllItems.aspx?RootFolder=%2Fsites%2FOITRSDResearchCybersecurity%2FRSD%20Documents%2FEnterprise%20Research%20Data%20Security%20Plan%20%28ERDSP%29%2FERDSP%20Template%20and%20User%20Guide&FolderCTID=0x012000A71201A05A749545A370DB74151D69D6&View=%7B49F2E741%2D4B47%2D429F%2DA7AC%2D91D187041478%7D">ERDSP</a> (accessible only behind the VA firewall) to facilitate protocol reviews. Once you select the Purpose of Submission, the form will branch out with questions and will continue to branch based on your responses. Refer to ERDSP <a href="https://dvagov.sharepoint.com/sites/OITRSDResearchCybersecurity/RSD%20Documents/Forms/AllItems.aspx?RootFolder=%2Fsites%2FOITRSDResearchCybersecurity%2FRSD%20Documents%2FEnterprise%20Research%20Data%20Security%20Plan%20%28ERDSP%29%2FERDSP%20Template%20and%20User%20Guide&FolderCTID=0x012000A71201A05A749545A370DB74151D69D6&View=%7B49F2E741%2D4B47%2D429F%2DA7AC%2D91D187041478%7D">Guide and FAQs</a> for further information, or contact <a href="/cdn-cgi/l/email-protection#7a0c484b091c19332935290e1b1c1c3a0c1b541d150c"><span class="__cf_email__" data-cfemail="1167232062777258425e42657077775167703f767e67">[email protected]</span></a>.</p> <p>If you plan to share VA research data (electronic and/or hard copy) with another VA or non-VA entity/institution, refer to the <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/vaData%20Transfer%20Methods%20Table%202-28-2021.pdf" target="_blank">VA Data Transfer Methods Table</a> for VA-approved methods for secure data transfer. </p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>VA Form 10-250 (required by VHA Directive 1605.03</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p><em>This form must be completed and attached to all initial submissions as well as to any modification that result in changes to: data collection/use/storage/transmission/disposition, VA informed consent, VA HIPAA Authorization form, Data Use Agreement (DUA), or when the modification impacts waiver of HIPAA Authorization.</em></p> <p>Complete the Study Information section (Page 1 only) of the <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/va%2010-250.pdf">VA Form 10-250</a> and upload in the Other Study Documents section of your iRIS submission. Include all relevant information in the Study Application for consistency.</p> <p>Unless it’s determined that Privacy Officer review is not required, the VA Privacy Officer will email a signed copy of the form to the study team documenting the final privacy review. Please visit this <a href="https://vaww.visn21.portal.va.gov/sanfrancisco/privacy/default.aspx/R01SFCHSM03.r01.med.va.gov/homedir$/vhasfccoleb/My%20Documents/Attachmate">website</a> for more information about VA Privacy requirements (only accessible behind VA firewall).</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><strong>VA HIPAA </strong></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/sfvamc-hipaa-authorization.pdf">Authorization for Use & Release of Protected Health Information for Research Form 10-0493</a>. <strong>This pdf works best with Internet Explorer. </strong>The VA HIPAA form must be used when written HIPAA authorization is required for a VA study. <em>SFVAHCS Privacy Officer must review and approve the VA HIPAA form for each study prior to implementation (this applies to new and revised versions of the HIPAA). </em>If you have questions, contact the VA Privacy Officer at <a href="/cdn-cgi/l/email-protection#077135365441445748747366616147716629606871"><span class="__cf_email__" data-cfemail="7a0c484b293c392a35090e1b1c1c3a0c1b541d150c">[email protected]</span></a>.</p> <p>Attach the HIPAA form to your IRB submission in the Other Study Documents section—DO NOT upload in the Consent Documents section.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><strong>Required VA records retention language</strong></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>For all VA studies, include the following statement verbatim in the Confidentiality section of the Study Application: <strong>VA research records</strong> <strong>will be retained and disposed in accordance with the VHA Records Control Schedule (RCS 10-1).</strong></p> <p>Refer to VHA Records Control Schedule (<a href="https://www.va.gov/vhapublications/RCS10/rcs10-1.pdf">RCS 10-1</a>) Section 8300.6 Research Investigator Files for VA research records maintenance. Contact the Research Office for assistance with off-site records storage.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><strong>Required 38 USC 7332 language</strong></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>38 U.S.C. Section 7332 makes all VA records that contain the identity, diagnosis, prognosis or treatment of VA patients or research subjects for drug abuse, alcoholism or alcohol abuse, infection with human immunodeficiency virus (HIV/AIDS), or Sickle Cell Anemia strictly confidential. This statute applies to information regardless of whether it is recorded in a document or a Department record.</p> <p>If a study collects or uses individually identifiable patient health information covered under 38 U.S.C. 7332 (DRUG, ALCOHOL, HIV AND SICKLE CELL ANEMIA INFORMATION), <strong>include the following statement verbatim in the Study Application:</strong></p> <p>This study includes collection of information covered under 38 U.S.C. 7332 (drug, alcohol, HIV and/or sickle cell information). The purpose of the data is to conduct scientific research. No personnel involved in the study will identify, directly or indirectly, any individual patient or subject in any report of such research, e.g. manuscript or publication.</p> <p>For VA Information Systems Security Officer requirements, refer to Confidentiality section of the <a href="https://irb.ucsf.edu/research-sfvamc#studyapplicationguidance" target="_blank">Study Application table</a>. For additional guidance, refer to ORPP&E’s <a href="https://www.research.va.gov/programs/orppe/education/tools.cfm">Research Information Security & Cybersecurity Toolkit</a>.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><b>External disclosure of patient information for non-VA research (Form 10-5345 required)</b></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>If VA staff will obtain VA patients’ contact information from the VA medical record and provide it to UCSF staff (e.g., for recruitment into a non-VA study), this is considered an external disclosure which requires the VA patient’s signed authorization. This disclosure of identifiable information must be documented using VA Form 10-5345 (Release of Information Form).</p> <p>The 10-5345 must be collected by the VA employee and sent to HIMS for scanning into the patients’ medical records. Information may be pre-filled for the patient (except for the section related to authorizing disclosure of 7332-protected information), then the patient must review and sign it. Electronic signatures are not accepted. The 10-5345 must be filled out completely to be valid. If you plan to pre-fill the form for patients, the Privacy Officer must review the form prior to use. Email the pre-filled form to <a href="/cdn-cgi/l/email-protection#bacc888bc9dcd9eaf5e9cedbdcdcfaccdb94ddd5cc"><span class="__cf_email__" data-cfemail="bcca8e8dcfdadfecf3efc8dddadafccadd92dbd3ca">[email protected]</span></a> for review.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><strong>Reporting Privacy and Information Security Incidents</strong></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>To report privacy incidents, email the VA Privacy Office at <a href="/cdn-cgi/l/email-protection#9beda9aac8ddd8cbd4e8effafdfddbedfab5fcf4ed"><span class="__cf_email__" data-cfemail="661054573520253629151207000026100748010910">[email protected]</span></a> or call 415-750-2135. To report data security incidents, email the VA Information Security Office at <a href="/cdn-cgi/l/email-protection#9debafaccedbded4ced2eee9fcfbfbddebfcb3faf2eb"><span class="__cf_email__" data-cfemail="1e682c2f4d585d574d516d6a7f78785e687f30797168">[email protected]</span></a>.</p> <p>If the privacy or data incident also involves UCSF participants, contact the UCSF Privacy Office at 415-353-2750. </p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><strong>Certificates of Confidentiality</strong></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>For general information about Certificates of Confidentiality, refer to the UCSF IRB website: <a href="https://irb.ucsf.edu/certificate-confidentiality-nih">https://irb.ucsf.edu/certificate-confidentiality-nih</a>.</p> <p>When requesting a Certificate of Confidentiality, you may find more details about how to respond to the specific sections of the request <a href="https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fera.nih.gov%2Ferahelp%2FCoc_Ext%2F%23C-Procedure%2FRequesting.htm&data=04%7C01%7C%7C35b59ce1ad8f426680c208d8be47a675%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637468562222123396%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=%2Fe0Z0Ms0lrA9tuLJRkm3rx5yL4L4q3QyxulGsmRV37g%3D&reserved=0">here</a>. Further questions should be directed to the NIH CoC Coordinator at <a href="/cdn-cgi/l/email-protection#84cacdcca9c7ebc7a9c7ebebf6e0edeae5f0ebf6c4e9e5ede8aaeaedecaae3ebf2"><span class="__cf_email__" data-cfemail="7c323534513f133f513f13130e1815121d08130e3c111d151052121514521b130a">[email protected]</span></a>.</p> <p> </p> </div> </div> <h2><a id="sfvasubjectpayments" name="sfvasubjectpayments"></a>Research Subject Payments</h2> <p>SFVAHCS subjects may not be paid for participation in research when the research is integrated with the patient’s medical care and makes no special demands on the patient.</p> <p>Payment is permissible in the following circumstances:</p> <ul> <li>When the research is not directly intended to enhance the diagnosis or treatment of the medical condition for which the subject is being treated, and when the standard of practice in affiliated non-VA institutions is to pay subjects.</li> <li>If subjects at a collaborating non-VA institution are being paid for the same participation, in the same study, at the same rate proposed.</li> <li>In comparable situations when, in the opinion of the IRB, payment of subjects is appropriate.</li> <li>When the subject incurs transportation expense that would not be incurred in the normal course of treatment which are not reimbursed by another mechanism.</li> </ul> <h2><a id="nonveteran" name="nonveteran"></a>Non-Veteran Research Subjects</h2> <p>Per VA Directive 1200.01, non-Veterans may be entered into a VA-approved research study that involves VA outpatient or VA hospital treatment, but only when there are insufficient Veteran patients suitable for the study. Non-Veteran subjects include students, fellows, clinical staff, caregivers or any other research subject who is not a Veteran. In addition to IRB approval, you must obtain R&D approval before enrolling non-Veterans (by obtaining consent, written or verbal). Complete the <a href="/sites/g/files/tkssra6501/f/Request-Non-Veteran-Approval.docx" target="_blank">Request for Non-Veteran Approval Form</a> and attach in Other Study Documents section of the IRB submission.</p> <p><strong>VHA Notice of Privacy Practices for Non-Veterans</strong></p> <p>Some non-Veteran research participants must be provided the VHA Notice of Privacy Practices (<a href="/sites/g/files/tkssra6501/f/Notices_of_Privacy_Practices-_dated%2009302022.pdf">NoPP</a>) in accordance with VHA Handbook 1605.04. VHA health care facilities must provide the Notice of Privacy Practices when a non-Veteran patient attends their first research visit associated with an episode of care. Only pharmacy medication pick-up, laboratory appointments and Tuberculosis screening, are <u>not</u> considered episodes of care. </p> <p>In some circumstances (i.e., if a medical record is created), the non-Veteran participant must sign <a href="/sites/g/files/tkssra6501/f/10-0483-fill%20Acknowledgement%20of%20the%20Notice%20of%20Privacy%20Practices.pdf">VA Form 10-0483</a> (Acknowledgment of the Notice of Privacy Practices) and the form must be scanned into the non-Veteran’s medical record.</p> <p>If you must provide the NoPP or obtain the VA Form 10-0483, note this in the Study Application.</p> <p>For additional guidance, click <a href="https://dvagov.sharepoint.com/sites/vacovetsprivacy/vhapo/Pages/default.aspx" target="_blank">here</a> or contact the VA Privacy Office at <a href="/cdn-cgi/l/email-protection#fb8dc9caa8bdb8abb4888f9a9d9dbb8d9ad59c948d"><span class="__cf_email__" data-cfemail="f187c3c0a2b7b2a1be8285909797b18790df969e87">[email protected]</span></a></p> <p> </p> <h3><a id="researchpharmacy" name="researchpharmacy"></a>VA Research Pharmacy</h3> <p><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/va-idir-10-9012.doc">VA Investigational Drug Information Report (10-9012)</a></p> <p>The <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/va-idir-10-9012.doc">VA form 10-9012</a> is required for studies involving investigational drugs. An investigational drug is defined as a new chemical compound, which has not been approved by the FDA, or an approved drug that is being studied in a clinical investigation for an approved or unapproved use, dose, dosage form, administration schedule, or under an IND application.</p> <p>The 10-9012 must indicate who may prescribe the research medications and include any safety information that may not be available in published references. Please ensure this form is signed by the VA PI, IRB Chair, and R&DC Chair. The study IRB approval letter may be used in lieu of the actual signature of the IRB chair if it is attached to the VA Form 10-9012.</p> <p>Per VHA Handbook 1108.04, VA Form 10-9012 is not required if a package insert is available (for studies involving approved drugs used according to FDA-approved labeling). Identify authorized study drug prescribers listed on the 10-9012 in the qualifications of key study personnel section of the Study Application.</p> <p><strong>Research pharmacy requirements</strong></p> <p>All investigational drugs and devices used at the SFVAHCS MUST be shipped directly to the VA Research pharmacy, not to the PI or study staff. If your research needs do not permit participants to obtain medications directly from the pharmacy, this must be addressed in your application. The pharmacy charges researchers a modest fee for its services. Researchers are encouraged to discuss dispensing issues and fees with the research pharmacist (<a href="/cdn-cgi/l/email-protection#9fccebfaeff7fef1f6fab1c8f0f1f8dfe9feb1f8f0e9"><span class="__cf_email__" data-cfemail="481b3c2d38202926212d661f27262f083e29662f273e">[email protected]</span></a>) before the budget is finalized.</p> <p>When the study is conducted at SFVAHCS, the following additional obligations must be met by the researcher:</p> <ul> <li>The research pharmacy must be provided: <ul> <li>A copy of <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/va-idir-10-9012.doc" target="_blank">VA Form 10-9012</a> (if applicable).</li> <li>A copy of the consent document for each participant with all appropriate signatures.</li> <li>Copies of Sponsor-related correspondence specific to the drug(s) if applicable.</li> <li>Copies of all correspondence addressed to the Researcher from the FDA related to the investigational drugs or devices.</li> </ul> </li> <li>Inform the chief of pharmacy service, the research pharmacy, and the IRB in writing when a study involving investigational drugs or devices has been suspended, terminated, or closed.</li> <li>Comply with all documentation requirements and make relevant records accessible to the research pharmacist when requested.</li> </ul> <h3><a id="radiationsafety" name="radiationsafety"></a>VA Radiation Safety Committee Forms</h3> <p>If using radiation in your study, once the initial review submission has been submitted in iRIS, email the following forms and documents to <a href="/cdn-cgi/l/email-protection#16456273667e7378385079787156607738717960"><span class="__cf_email__" data-cfemail="7d2e09180d151813533b12131a3d0b1c531a120b">[email protected]</span></a>.</p> <ul> <li>Application form—<a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/rsc%20Human%20Use%20X-ray%20Application%20template.docx">Application for the Use of X-rays in Human Research</a> and/or <a href="/sites/g/files/tkssra6501/f/rsc%20Human%20Use%20RADIONUCLIDE%20Application%20template%20%281%29.doc">Application for Radionuclide Utilization in Human Use Research</a></li> <li><a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/radiation%20Exposure%20Form%20for%20Skin%20Dose%20Calculation%20and%20Reporting_%20rev%202021-08-03.docx">Radiation Exposure Form for Skin Dose Calculation and Reporting</a> form</li> <li>Copy of the IRB Study Application</li> <li>Clinical Investigation Plan (Protocol)</li> <li>Informed Consent Form</li> </ul> <p>For more information, visit the <a href="https://dvagov.sharepoint.com/sites/SFC/research/safety-rad/SitePages/Home.aspx">Radiation Safety Committee</a> website (accessible behind the VA firewall only) or email <a href="/cdn-cgi/l/email-protection#f5a68190859d909bdbb39a9b92b58394db929a83"><span class="__cf_email__" data-cfemail="5d0e29382d353833731b32333a1d2b3c733a322b">[email protected]</span></a>.</p> <h3><a id="researchcompliance" name="researchcompliance"></a>Research Compliance</h3> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Research Audits</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Informed consent audits are completed by the VA Research Compliance Officer (RCO) annually. Regulatory audits are conducted every three years depending on IRB status of study. Contact the VA RCO, Rakesh Singh (<a href="/cdn-cgi/l/email-protection#3765565c52445f19645e59505f0577415619505841"><span class="__cf_email__" data-cfemail="4a182b212f3922641923242d22780a3c2b642d253c">[email protected]</span></a>), for more information.</p> <p>For essential documents templates and good clinical practice documentation guidance, refer to the VA Site Monitoring, Auditing and Resource Team (<a href="https://vaww.abq.csp.va.gov/csp/smart/default.cfm">SMART</a>) website.</p> <p>Research guidance and templates are also available on the <a href="https://www.research.va.gov/programs/orppe/default.cfm" target="_blank">ORPP&E</a> website.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Adverse Events/Incident Reports/Unanticipated Problems</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>The VA has a shorter timeline (<strong>5 business days</strong>) and different definitions than UCSF for reporting certain categories of post-approval events. See <a href="https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=9082">VHA Directive 1058.01</a> (revised October 22, 2020) for specific examples. Note that reporting requirements for research subject deaths are shorter than 5 business days—see 1058.01 for more information related to reporting requirements.</p> <p>Please consult with the VA Research Office and review the following VA decision charts to determine if your adverse event report or protocol violation or incident needs to be reported to the IRB.</p> <p><a href="https://www.va.gov/ORO/Docs/Guidance/1058_01_Examples_App_Serious_Cont_NonCom_HumanRsch_03_08_21.pdf">Examples of Noncompliance in VA Human Subjects Research that ORO Typically Considers to Meet the Definition of Serious or Continuing Noncompliance</a> (March 8, 2021)</p> <p><a href="https://www.va.gov/ORO/Docs/Guidance/Reporting_Human_Deaths_Unanticipated_Problems_and_Accident_Injury_Illness_and_Exposure_in_VA_Research.pdf">Decision Chart: Reporting Human Deaths, Unanticipated Problems and Accident, Injury, Illness or Exposure in VA Research</a> (March 12, 2021)</p> <p>Note: Some types of <em>apparent</em> serious or continuing noncompliance be reviewed at a convened IRB meeting for determination of whether they constitute <em>actual</em> serious or continuing noncompliance.</p> <p>Refer to <a href="https://www.va.gov/ORO/oropubs.asp">VA ORO Publications and Guidance</a> for more information.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Monitoring Visits</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>All outside monitors visiting SFVA must register with VA Police Services for a badge. Monitors must also email the <a href="/research-sfvamc">Clinical Research Office</a> at <a href="/cdn-cgi/l/email-protection#742246452732373c2624243402155a131b02"><span class="__cf_email__" data-cfemail="134521224055505b4143435365723d747c65">[email protected]</span></a> and provide a brief report at the conclusion of the visit.</p> <p>For information related to remote monitoring visits, refer to <a href="http://www.research.va.gov/programs/orppe/education/webinars/orppe-061820.cfm">remote monitoring</a> guidance. </p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p>Additional VA Research Guidance</p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>There are additional requirements in VHA Handbooks/Directives <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/vha%20Directive%201058_01%202020-10-22.pdf" target="_blank">1058.01</a>, <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/vha%20Directive%201200.01%20-%20Technical%20Amendment%20-%20January%208%2C%202021.pdf" target="_blank">1200.01</a>,<a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/vha%20Directive%201605_01%202016-08-31.pdf">1605.1</a>, and <a href="https://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/vha%20Handbook%206500%202021-02-24.pdf">6500</a> and <a href="/sites/g/files/tkssra6501/f/sFVA%20MCM%2011-19%20rev%208-20-2021.pdf" target="_blank">SFVAMC MCM 11-19</a>. The full list of VHA Publications may be found <a href="https://www.va.gov/vhapublications/">here</a>. Contact the SFVAHCS Clinical Research Office for assistance in interpretation of these policies.</p> </div> </div> <p> </p> <h3><a id="quicklinks" name="quicklinks"></a>Quick Links </h3> <ul> <li><a href="http://vhasfcapprdis2.v21.med.va.gov:8080/va/pinsite">RDIS</a></li> <li><a href="https://www.research.va.gov/resources/policies/human_research.cfm">ORD Policies and Guidance</a></li> <li><a href="https://www.va.gov/ORO/oropubs.asp">Office of Research Oversight (ORO) Publications and Guidance</a></li> <li><a href="https://www.research.va.gov/resources/policies/faq-search.cfm">ORPP&E Policy and Guidance FAQs</a></li> <li><a href="https://dvagov.sharepoint.com/sites/VHAORPPE/Field/SitePages/Welcome!.aspx">ORPP&E Communication Page for VHA Researchers</a>. 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