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</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="/submissions">Submissions</a> > <span class="breadcrumb-page-title">Modification</span></div></div></div> <h1 class="title" id="page-title">Modification</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-201" class="node node-page slider-secondary clearfix" about="/modification" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Modification" 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="#approval">What Modifications Need IRB Approval?</a></li> <li><a href="#types">Types of Modifications</a></li> <li><a href="#submitting">Submitting in iRIS</a></li> <li><a href="#continuing">Information for Continuing Subjects</a></li> <li><a href="#exempt">Exempt Research</a></li> <li>Adding or Updating: <a href="#personnel">Investigators or Staff</a>, <a href="#funding">Funding</a>, <a href="#sites">Study Sites</a>, <a href="#financial">Researchers' Financial Interests</a></li> </ul> <h2><a id="approval" name="approval"></a>What Modifications Need IRB Approval?</h2> <p><strong>All changes to your study, even minor ones, must receive IRB approval before you implement them<em>.</em> </strong>For example, changes in inclusion criteria, procedures, recruitment, advertisements, consent forms and questionnaires all require IRB review and approval.</p> <p><strong>NOTE</strong>:</p> <ul> <li>Considerable changes to the study’s research plan (e.g., Hypothesis; Aims/Objectives; Procedures; Study design; Scope; Intervention) require the submission of a new study. Modifications to an existing study must fit within the original aims of the study. For example, a No Subject Contact study cannot be modified and made into a Subject Contact study.</li> <li>Implementing changes without IRB approval is a violation of federal regulations and University policies and can lead to the suspension of IRB approval and other serious consequences for the participants, investigators and University.</li> <li>If the study has a protocol, and the changes affect the protocol (e.g., changes to inclusion/exclusion criteria, changes to procedures, etc.), you must submit the revised protocol within the Modification Form. Only submitting a Modification Form and revising the IRB application is not sufficient.</li> <li>Continue to submit protocol amendments until the study is closed by the sponsor. If enrollment is permanently closed and the new information doesn’t need to be relayed to the study participants, you do not need to submit a revised informed consent form. But you do need to revise the IRB application.</li> <li>The IRB <a href="/protocol-violation-or-incident#major-violation">does not approve</a> “planned deviations” i.e., planned departures from what the IRB has approved. Please see below for the only exceptions to this. You must follow the IRB-approved materials (e.g., IRB Study Application/protocol and informed consent forms). If you need to make changes, submit a Modification Form that includes the revised IRB Study Application, the revised protocol if the study has a protocol, and any other revised study documents such as the informed consent form. For studies in which the UCSF PI does not have protocol control (e.g., some multicenter trials), and the revised protocol has not yet been issued by the sponsor/lead site, you may submit a Modification Form and include a Letter of Amendment from the entity that has protocol control. The Letter of Amendment must describe the upcoming protocol change and when the revised protocol will be submitted to the IRB for review. If the changes described in the Letter of Amendment affect the IRB Study Application, informed consent form, or any other documents, you must make those changes when submitting the Letter of Amendment. </li> </ul> <h3>Exceptions: </h3> <h4>Changes “necessary to eliminate apparent immediate hazards to the subject”</h4> <p>The requirement for prior IRB review and approval is not required when the changes are “necessary to eliminate apparent immediate hazards to the subject” (<a href="http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.103" style="line-height: 1.538em;" target="_self">45 CFR 46.103.b.4</a>, <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.108" style="line-height: 1.538em;" target="_self">21 CFR 56.108.a</a>). In such rare cases, report the actions taken to the IRB within 10 working days using the <a href="/protocol-violation-or-incident" style="line-height: 1.538em;">Protocol Violation or Incident Reporting Form</a>. Seek approval for permanent changes to prevent the hazards in the future.</p> <h4>Minor (not significant) changes to exempt research</h4> <p>For <a href="#exempt">exempt research only</a>, you can make <a href="#exempt">minor changes</a> to the study without notifying the IRB. However, you must submit significant changes to the IRB. </p> <h2><a id="types" name="types"></a>Types of Modifications (Updated <a href="/news/now-iris-new-‘add-relying-site’-form-updated-modification-and-application-forms">November 2024</a>)</h2> <p>Evaluate whether the proposed changes constitute a major modification, minor modification, personnel change, addition of relying sites, or administrative modification using the definitions and examples below. Study changes are typically reviewed by the IRB panel that originally reviewed the study. </p> <p>OHRP and FDA guidance allows the IRB to use an expedited review procedure to review "minor changes in previously approved research." The IRB makes the final determination as to whether study changes qualify as “minor changes in previously approved research.”</p> <p>Below are definitions and examples to help guide the Principal Investigator in determining what form to submit in iRIS, based on the proposed study changes.</p> <p>If using the Modification Form, the Principal Investigator must determine if the changes alter the study’s overall risk/benefit ratio.</p> <p>IRB committee members identified barriers to efficiently reviewing modifications to complex trials (including <strong>umbrella trials </strong>and <strong>adaptive designs</strong>). “Umbrella trials” are studies that assign a particular treatment to a patient based on the type of cancer or unique tumor characteristics, such as molecular markers. Because there are often many treatment arms that come and go based on the study results or other data, the review of modifications can be very challenging. To facilitate IRB review, if you are submitting modifications to complex trials, in addition to completing all sections of the modification form, please ensure that the following information is included in the section where modifications are described. Please ensure this information is in lay language, understandable to non-scientists and scientists.</p> <ul> <li>Provide a brief general scientific rationale for submitting these changes</li> <li>Describe how the proposed changes fit into the overall progress of the study</li> <li>Describe any removals or additions of study treatment or patient populations</li> </ul> <p>Include citations for published articles that support these changes if available</p> <h3>Major Modifications</h3> <blockquote> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first bg--undefined bg--interactive-blue"> <h2>Definition</h2> <div class="vtab-content"> <p>1. Any increase in risk to participants is more than minimal;<strong> OR</strong>;</p> <p><br /> 2. Any additional activity or procedure would not be eligible for <a href="/levels-review">expedited review</a> if submitted as part of new research, <strong>OR </strong></p> <p><br /> 3. The research itself involves more than minimal risk and the changes significantly alter the study design. </p> </div> </div> <div class="wysiwyg_threecols--second bg--undefined bg--interactive-light-navy"> <h2>Examples</h2> <div class="vtab-content"> <p>1. Increasing major risks or discomforts </p> <p><br /> 2. Adding or deleting major procedures or diagnostic tests</p> <p><br /> 3. Restarting a study after a hold for safety concerns</p> <p><br /> 4. Changing, adding or deleting drugs, devices or other treatments being studied (substituting approved treatments being used in standard ways may be a minor modification)</p> </div> </div> <div class="wysiwyg_threecols--third bg--undefined bg--interactive-teal"> <h2>Process </h2> <p>Submit a Modification Form in iRIS.</p> <p>On the form, check the box for "Major Modification."</p> <p>Reviewed by the full committee at a convened meeting. Approval letter issued. </p> </div> </div> <h3>Minor Modifications</h3> </blockquote> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first bg--undefined bg--interactive-blue"> <h2>Definition</h2> <div class="vtab-content"> <p>1. Any increase in risk to participants is no more than minimal risk<strong style="font-size: 13px; line-height: 1.538em;">, AND </strong></p> <p><br /> 2. All additional activities or procedures would be eligible for <a href="/levels-review">expedited review</a> if submitted as part of new research, <strong style="font-size: 13px; line-height: 1.538em;">AND;</strong></p> <p><br /> 3. Either the research itself involves minimal riskor the changes do not significantly alter the study design.</p> </div> </div> <div class="wysiwyg_threecols--second bg--undefined bg--interactive-light-navy"> <h2>Examples</h2> <div class="vtab-content"> <p>1. Changing minor procedures or activities without adding more-than-minimal risks </p> <p><br /> 2. Reducing risks or adding minor risks</p> <p><br /> 3. Changing wording in the consent form, application or other documents</p> <p><br /> 4. Adding a new advertisement</p> </div> </div> <div class="wysiwyg_threecols--third bg--undefined bg--interactive-teal"> <h2>Process</h2> <p>Submit a Modification Form in iRIS. </p> <p>On the form, check the box for "Minor Modification."</p> <p>Reviewed by a small number of IRB members using <a href="/levels-review">expedited review</a> procedures. Approval letter sent.</p> </div> </div> <h3>Personnel Changes</h3> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first bg--undefined bg--interactive-blue"> <h2>Definition</h2> <p>Additions or removals of Key Study Personnel (KSP)</p> </div> <div class="wysiwyg_threecols--second bg--undefined bg--interactive-light-navy"> <h2>Examples</h2> <div class="vtab-content"> <p>1. Change in Principal Investigator (PI)</p> <p><br /> 2. Change in Investigators or staff who are Key Study Personnel (KSP)</p> </div> </div> <div class="wysiwyg_threecols--third bg--undefined bg--interactive-teal"> <h2>Process</h2> <p>Submit a Personnel Changes Form in iRIS.</p> <p>Reviewed by a small number of IRB members or staff. Approval letter sent for all Key Study Personnel changes.</p> </div> </div> <h3>Add Relying Site </h3> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first bg--undefined bg--interactive-blue"> <h2>Definition</h2> <p>Addition of outside sites (sites that are not at UCSF and are not a UCSF-affiliate) that are seeking to rely on the UCSF IRB.</p> <p>Note: Advance agreement for UCSF to serve as the IRB of record is required before you submit this form. If you have not yet had a consultation with a UCSF IRB Analyst about this, review the <a href="https://irb.ucsf.edu/when-ucsf-can-serve-irb-record" target="_blank"><strong>Reliance Request page</strong></a> and submit the appropriate consultation request form. </p> </div> <div class="wysiwyg_threecols--second bg--undefined bg--interactive-light-navy"> <h2>Example</h2> <div class="vtab-content"> <p>Adding an outside study site that will rely on UCSF as the IRB of Record for that site.</p> </div> </div> <div class="wysiwyg_threecols--third bg--undefined bg--interactive-teal"> <h2>Process</h2> <p>Submit an Add Relying Site form in iRIS.</p> <p>Reviewed by a small number of IRB members or staff. IRB approval letter sent.</p> </div> </div> <h3>Administrative Modifications</h3> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first bg--undefined bg--interactive-blue"> <h2>Definition</h2> <p>Minor changes that do not affect study participants in any way.</p> <p> </p> </div> <div class="wysiwyg_threecols--second bg--undefined bg--interactive-light-navy"> <h2>Examples</h2> <div class="vtab-content"> <p>1. Changing procedures that do not affect participants (e.g., method of shipping samples)</p> <p><br /> 2. Fixing typographical, grammatical or spelling errors</p> </div> </div> <div class="wysiwyg_threecols--third bg--undefined bg--interactive-teal"> <h2>Process</h2> <p>Submit a Modification Form in iRIS.</p> <p>On the form, check the box for "Administrative" changes.</p> <p>Reviewed by a small number of IRB members or staff using expedited review procedures. Approval letter sent; however,<em> no letter</em> is sent for <a href="#personnel">optional modifications</a> to change research support staff or study contacts who are not Key Study Personnel.</p> </div> </div> <h2><a id="submitting" name="submitting"></a>Submitting in iRIS</h2> <p>Follow these steps to submit a modification after your study is approved. For additional assistance, read the quick guide called "Submitting Post-approval Forms" in the Help section of iRIS or on the <a href="https://iris-help.ucsf.edu/irb-iris" target="_self">iRIS Help webpage</a>.</p> <p>1. Open the study via IRB Study Assistant (Go to My Studies under the <strong>IRB Study Assistant</strong>. Open the active study you want to modify.)</p> <p>2. Start a new form (see tables above for which form to use, based on the proposed study changes.)</p> <p>3. Complete the Form (This is a dynamic form that will build automatically based on how you answer each question.)</p> <p>4. Attach new or revised documents or applications (<strong>Attach</strong> any new or revised documents or applications in the appropriate section (e.g. attach the revised IRB Application in the "Revisions to the Application Form" section). Do NOT track your changes. See the <a href="/sites/g/files/tkssra6501/f/initial-submission-checklist%202023.pdf" target="_self">Initial Submission Checklist</a> for a list of documents that require IRB review. <strong>Reminder</strong>: If you are changing study personnel, revise and attach the IRB Application Form.)</p> <p>5. Submit the form (Anyone listed on the study can <strong>sign off</strong> <strong>and submit </strong>the Modification Form.)</p> <p><strong>Reminders: </strong></p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="accordion" href="#">You can combine several changes to your study in one modification request, but only submit one Modification Form at a time</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>You can make several changes to your study at one time — describe each change in detail on the Modification Form. However, in general, do not submit more than one Modification Form at a time, particularly if both modifications involve the IRB Application form or the same document. Hold additional modifications until the first request has been approved. <a href="/contact-us">Contact</a> the analyst assigned to the modification with que</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="accordion" href="/#">Submit modifications resulting from an adverse event, violation, incident or other safety report at the same time as that report, when possible</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Some modifications are required based on a report of an adverse event, protocol violation or incident; a DSMB or DMC report; an action letter from a sponsor; or other safety report. Submit the modification at the same time as the report, whenever possible. If the report and the modification are not submitted concurrently, explain in both the report and modification why it is/was necessary to delay the modification submission to a later date.</p> </div> </div> <h2><a id="continuing" name="continuing"></a>Information for Continuing Subjects</h2> <p>Per federal regulations, research participants must be informed when there is a significant new finding during the course of research that may affect their willingness to participate [<a href="http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" target="_self">45 CFR 46.116 (b) (5)</a>]. Examples of significant new findings include:</p> <ul> <li>New risks or previously described risks that are now found to occur with greater frequency or severity.</li> <li>Changes to the protocol that may affect a subject’s willingness to participate in the research.</li> </ul> <p>If any significant new findings or protocol changes are included in your modification request:</p> <ul> <li>Describe how you propose to inform current subjects of this information.</li> <li>Attach any additional consent forms (see our <a href="/sites/g/files/tkssra6501/f/addendum%20general.docx" target="_self">consent form addendum template</a>) or contact letters that will be used for this purpose.</li> </ul> <p>The level of urgency will determine how the information is communicated to participants. See the <a href="/adverse-event#what">Adverse Event Reporting Requirements</a> for additional information.</p> <h2><a id="exempt" name="exempt"></a>Exempt Research</h2> <p><strong>Only for studies that the IRB has <a href="/levels-review">certified as exempt</a>, </strong>researchers can make <em>minor</em> changes to the study without notifying the IRB. However, significant changes must be submitted to the IRB. See the examples below.</p> <p>All changes must follow UCSF guidance, and <a href="/exempt-consent-templates-and-guidance">some changes are not allowed in the consent materials</a>.</p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="accordion" href="#">Examples of significant changes </a><a class="accordion" href="#">to <strong>Exempt Research</strong>: <strong>Submit</strong> to the IRB</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li>Adding a new subject population</li> <li>Adding new procedures</li> <li>Adding a new funding source</li> <li>Adding new collaborators or outside sites (each site must obtain their own Exempt Certification or IRB Approval)</li> <li>Adding questions about sensitive aspects of the subjects’ behavior – such as illegal conduct, drug use, sexual behavior or use of alcohol – to a survey or interview</li> <li>Change in PI (use the <a href="/modification">Personnel Changes form</a>)</li> <li>Disclosing a new financial interest</li> <li>Any change that makes the study no longer eligible for <a href="/levels-review">exemption</a></li> <li>Revising aims</li> <li>Changes to payment (adding, revising, or removing)</li> </ul> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="accordion" href="#">Examples of minor changes to <strong>Exempt Research: Submit to the IRB?</strong></a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <ul> <li>Editorial or administrative revisions to consent documents or other study documents</li> <li>Adding non-sensitive questions to a survey or interview or revising current questions</li> <li>Adding a new <a href="/advertising-and-recruitment-letter-guidelines">recruitment material</a> that follows IRB guidelines</li> <li>Increasing or decreasing the number of subjects, unless you are adding a new subject population</li> <li>Study team/personnel changes (except a change in PI) — follow the <a href="#personnel">steps below</a> in iRIS to grant access to new study team members.</li> </ul> </div> </div> <h2 class="accordian-content"><a id="personnel" name="personnel"></a>Changing or Adding Investigators or Staff</h2> <p>Some of these changes require submission of a modification or Personnel Changes form. Click on the role of the individual you are changing for more info.</p> <ul> <li><a href="#ucsfpi">UCSF Principal Investigator</a></li> <li><a href="#ucsfinvestigators">UCSF Investigators and Staff</a></li> <li><a href="#affiliatedstaff">Staff from a UCSF-Affiliated Institution</a></li> <li><a href="#vastaff">Staff from the SFVAHCS</a></li> <li><a href="#visitingfaculty">Visiting Faculty</a></li> <li><a href="#students">Students</a></li> <li><a href="#volunteers">Volunteers</a></li> </ul> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p><a id="ucsfpi" name="ucsfpi"></a>UCSF Principal Investigator</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Principal Investigator must have active <a href="/citi-human-subjects-training">CITI Human Subjects Protection Training</a>.</p> <p>Submit a <a href="https://irb.ucsf.edu/news/new-irb-form-key-study-personnel-changes">Personnel Changes</a> form if the <u>only</u> changes being made are to the study personnel, or submit a <a href="/modification">Modification</a> form if you are making personnel changes <em><u>and additional changes</u></em>. Attach these items to your submission:</p> <ol> <li>A letter signed by the <em>outgoing</em> PI requesting the change</li> <li>Revised IRB Application Form: Revise the "Grant Key Study Personnel (KSP) Access to the Study" and "Qualifications of Key Study Personnel" sections to reflect the personnel changes</li> <li>Revised consent forms and other participant-contact documents that name the PI</li> </ol> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p><a id="ucsfinvestigators" name="ucsfinvestigators"></a>UCSF Investigators and Staff</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <div class="accordian-content"> <p><strong><a id="UCSFIS" name="UCSFIS"></a>Researchers and staff who are Key Study Personnel:</strong></p> <p>UCSF personnel should be listed in the IRB application if they meet the <a href="https://irb.ucsf.edu/news/guidance-updates#ksp">UCSF definition of Key Study Personnel</a>. Key Study Personnel must have active <a href="/citi-human-subjects-training">CITI Human Subjects Protection Training</a>.</p> <p>Submit a <a href="https://irb.ucsf.edu/news/new-irb-form-key-study-personnel-changes">Personnel Changes</a> form if the <u>only</u> changes being made are to the study personnel, or submit a <a href="https://irb.ucsf.edu/modification">Modification</a> form if you are making personnel changes <em><u>and additional changes</u></em>. Attach these items to your submission:</p> <p>1. Revised IRB Application Form: Revise the "Grant Key Study Personnel (KSP) Access to the Study" and "Qualifications of Key Study Personnel" sections to reflect the personnel changes</p> <p>2. Revised consent forms and otehr particpant-contact documents that name the individuals being changed (if applicable)</p> <p><strong>Research support staff or study contacts who are NOT Key Study Personnel:</strong></p> <p>You do <em><strong>not</strong></em> need to submit a personnel changes for individuals who do not meet the definition of <a href="https://irb.ucsf.edu/news/guidance-updates#ksp">Key Study Personnel</a>. Instead, someone already listed on the study should follow these steps:</p> <ol> <li>Open the study via My Studies.</li> <li>From the Submissions page, click on the “Study Management” tab.</li> <li>Click on the “Key Study Personnel” link.</li> <li>Add or remove the study staff and save.</li> </ol> <table border="0" cellpadding="0" cellspacing="0" style="width:601px;" width="601"> <tbody> <tr> <td> <p><strong>Reminder: </strong>Only add or remove <strong>individuals who are <u>not</u> Key Study Personnel i</strong>n the Study Management tab. DO NOT add or remove the PI, Other Investigators or other Key Study Personnel here. Making such changes without submitting a modification may result in a <strong>PROTOCOL VIOLATION.</strong></p> <p><strong>Exception</strong>: As <a href="/modification#exempt">explained</a>, <u>for exempt studies only</u>, you can change Other Investigators or Key Study Personnel (not the PI) in the Study Management tab without submitting a modification.</p> </td> </tr> </tbody> </table> </div> </div> </div> <div class="accordian-content"> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p><a id="affiliatedstaff" name="affiliatedstaff"></a>Staff from a UCSF-Affiliated Institution</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Please review our list of <a href="/ucsf-affiliated-institutions">UCSF-affiliated institutions</a>.</p> <p>UCSF-affiliated personnel should be listed in the IRB application if they meet the <a href="https://irb.ucsf.edu/news/guidance-updates#ksp">UCSF definition of Key Study Personnel</a>. Key Study Personnel must have active <a href="/citi-human-subjects-training">CITI Human Subjects Protection Training</a>.</p> <p>UCSF-affiliated personnel who are not Key Study Personnel do not need to be added to the IRB application.</p> <p><strong><u>If the affiliated KSP needs access to iRIS or other UC Network programs: </u></strong></p> <p>If the individual needs access to iRIS (e.g., to assist with IRB submissions, access study documents such as approved consent forms, the Sponsors Protocol, or IRB approval letters, or to carry out financial oversight responsibilities for studies in iRIS) or to any other UCSF Programs which are only accessible via MyAccess, they will need to be granted "affiliate access" to the UCSF network through the PI’s department. Please review <a href="http://irb.ucsf.edu/iris-accounts-and-access#affiliates">our guidance on obtaining affiliate access</a>.</p> <p>Once affiliate access is granted, submit a <a href="https://irb.ucsf.edu/news/new-irb-form-key-study-personnel-changes">Personnel Changes</a> form if the only changes being made are to the study personnel, or submit a <a href="/modification">Modification</a> form if you are making personnel changes <em><u>and additional changes</u></em>.</p> <p>Attach these items to your submission:</p> <ol> <li>Revised IRB Application Form: Revise the "Grant Key Study Personnel (KSP) Access to the Study" and "Qualifications of Key Study Personnel" sections to reflect the personnel changes</li> <li>Revised consent forms and other participant-contact documents that name the individuals being changed (if applicable)</li> </ol> <p><strong><u>If the affiliated KSP does NOT need access to iRIS or other UC Network programs: </u></strong></p> <p>If the individual does NOT need access to iRIS or any other UCSF Programs which are only accessible via the UCSF MyAccess Landing Page, they do not need to request affiliate access.</p> <p>Submit a <a href="https://irb.ucsf.edu/news/new-irb-form-key-study-personnel-changes">Personnel Changes</a> form if the only changes being made are to the study personnel, or submit a <a href="/modification">Modification</a> form if you are making personnel changes <em><u>and additional changes</u></em>.</p> <p>Attach these items to your submission:</p> <ol> <li>Revised IRB Application Form: Do <u>not</u> list the individual in the “Grant Key Study Personnel (KSP) Access to the Study” section. Instead, list them in the “Affiliated Personnel” table within the “Qualifications of Key Study Personnel” section.</li> <li>Revised consent forms and other participant-contact documents that name the individuals being changed (if applicable)</li> <li><a href="/citi-human-subjects-training">CITI</a> completion certificates for all individuals added to the “Affiliated Personnel” table</li> </ol> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p><a id="vastaff" name="vastaff"></a>Staff from the San Francisco Veterans Affairs Medical Center (SFVAHCS)</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>VA staff must be up to date on their UCSF-VA CITI training. The <a href="/research-sfvamc">SFVAHCS requires regular training</a> for all individuals engaged in research with human subjects, their tissue or data. If you are working at the SFVAMC, we recommend completion of the VA CITI training, which will meet UCSF’s requirements.</p> <p>If the individual is also a UCSF employee (dual appointment at SFVAHCS and UCSF), follow the instructions above for adding <strong>UCSF Investigators and Staff</strong>.</p> <p>If the individual is not also a UCSF employee, follow the instructions above for adding <strong>Staff from a UCSF-Affiliated Institution</strong>. <a> </a></p> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p><a id="visitingfaculty" name="visitingfaculty"></a>Visiting Faculty</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Visiting faculty should be listed in the IRB application if they meet the <a href="https://irb.ucsf.edu/news/guidance-updates#ksp">UCSF definition of Key Study Personnel</a>. Key Study Personnel must have active <a href="https://irb.ucsf.edu/citi-human-subjects-training">CITI Human Subjects Protection Training</a>.</p> <p>Consult with your Human Resources representative for guidance about setting up a visiting faculty member. Once they are established with HR, follow the above instructions for <strong>UCSF Investigators and Staff</strong>. </p> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p><a id="students" name="students"></a>Students</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Students may join a research team for the specific purpose of gaining academic credit or professional advancement. Students are not considered volunteers, per <a href="https://rmis.ucsf.edu/campus-volunteer-guidelines">Campus Volunteer Guidelines</a>, and therefore their work on a study team must be guided by an appropriate affiliation or professional service agreement.</p> <p>Students should be listed in the IRB application if they meet the <a href="https://irb.ucsf.edu/news/guidance-updates#ksp">UCSF definition of Key Study Personnel</a>. Key Study Personnel must have active <a href="https://irb.ucsf.edu/citi-human-subjects-training">CITI Human Subjects Protection Training</a>.</p> <p><strong><u>UCSF Students</u></strong></p> <p>UCSF students should follow the <a href="http://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/getting%20access%20to%20iris%202020.pdf">guidance for getting access to iRIS</a> within MyAccess (Note: follow the instructions in the guidance; When requesting an iRIS account, the student must indicate their school or graduate program). Once iRIS access is established, follow the above instructions for <strong>UCSF Investigators and Staff</strong>. </p> <p><strong><u>Non-UCSF Students </u></strong></p> <p>The UCSF PI’s department must work with Human Resources to provide an academic appointment, UCSF ID card, and other required documentation for a new employee. Once they have a UCSF ID, the student should follow the <a href="http://irb.ucsf.edu/sites/hrpp.ucsf.edu/files/getting%20access%20to%20iris%202020.pdf">guidance for getting access to iRIS</a> within MyAccess (Note: follow the instructions in the guidance; When requesting an iRIS account, the student must indicate which school or graduate program the PI is affiliated with). Once iRIS access is established, follow the above instructions for <strong>UCSF Investigators and Staff</strong>. </p> </div> </div> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p><a id="volunteers" name="volunteers"></a>Volunteers</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>UCSF: Volunteers are not permitted to work on research studies at UCSF, per <a href="https://riskadvisory.ucsf.edu/campus-volunteer-guidelines">UCSF Campus Volunteer Guidelines</a>. </p> <p>SFVAHCS: Volunteers can work on research studies at the SF Veterans Affairs Health Care System. To add a volunteer to the study application, follow the instructions above for adding <strong>Staff from a UCSF-Affiliated Institution</strong>.</p> </div> </div> <h2><a id="funding" name="funding"></a>Changing or Adding Funding Info </h2> </div> <p>You must submit a modification to the IRB to add a new funding source to an approved study. The IRB must approve the modification before the Office of Sponsored Research (OSR) may accept the new award. OSR administrators have access to iRIS and can verify approval of the new funding source.</p> <p>Submit a Modification Form and describe the new funding source. Attach the following items:</p> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="accordion">1. A revised IRB Application </a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p><strong>"Funding" section:</strong></p> <ol> <li>Indicate "Yes" for the federal funding question if your study receives any federal funds, even if they come through a subcontract or another source from the prime awardee.</li> <li>Add the new funding source. If your study includes a subcontract, specify the prime sponsor, such as the NIH.</li> <li>For all studies with funding through UCSF, either the Award Number (A Number) OR the Proposal Number (P Number) is required. The A Number should be added when other changes are being submitted.</li> <li>If applicable, list the grant title and PI, and explain any significant discrepancies between the IRB application and the grant or contract.</li> </ol> <p><strong>Key Study Personnel sections: </strong>The PI of the award must be listed as an investigator on the IRB Application, so update sections 3 and 4, if necessary.</p> </div> </div> <div class="collapse-item"> <div aria-expanded="true" class="header-text" role="button" tabindex="0"> <p><a class="accordion">2. Consent documents (if applicable)</a></p> </div> <div aria-hidden="false" class="content-text" role="region" tabindex="-1"> <p>Update the consent document(s) if the sponsor info needs to be changed.</p> </div> </div> <div class="accordian-content"> <p><strong>Removing a Funding Source: </strong>Please <em>do not remove a funding source</em> from the IRB Application if funding has ended. You can remove a sponsor if the study was never funded (e.g. a grant was submitted, but not funded).</p> <p><strong>Changing RAS Proposal numbers (P#) to Award numbers (A#):</strong><b><i> </i></b><i>The IRB requires either a P# or an A# at the time the funding source is added, not both, but the A Number is needed at the time of the next Modification. Do <b>not</b> submit a Modification only to add the A Number but please include it at the time that other changes are being made. </i></p> <h2><a id="sites" name="sites"></a>Changing or Adding Sites</h2> </div> <p>Most site additions require changes in the consent form and the Application — especially the "Sites," "Procedures," "Sample Size and Eligibility" and "Recruitment" sections — and completion of an "Outside Site Information" subform. You may also need to change your recruitment documents.</p> <p>In general, the IRB at the new site must approve the study before work can begin there. See the <a href="/working-other-institutions">Working With Other Institutions</a> page for more info. </p> <p>If you are adding a site that is affiliated with UCSF, see the <a href="/ucsf-affiliated-institutions">UCSF Affiliated Institutions</a> page.</p> <h2><a id="Changing Locations within UCSF" name="Changing Locations within UCSF"></a>Changing Locations within UCSF</h2> <p>If you move to another UCSF campus (e.g., from Parnassus to Mission Bay), the study site and address need to be updated in the consent form. A modification form needs to be submitted, but can be batched with your next, upcoming submission. A separate modification form does not have to be submitted solely to update the address.</p> <h2><a id="financial" name="financial"></a>Changes in Researchers’ Financial Interests</h2> <p>Report any changes the researchers’ financial interests related to the study to the <a href="http://coi.ucsf.edu/" target="_self">Conflict of Interest Advisory Committee (COIAC)</a>. The COIAC will advise the PI and the IRB if modifications in the study are needed.</p> <p>If there are changes in researchers’ financial interests that have not yet been reported to the IRB at the time of a modification, update the IRB Application and describe the change in the Modification Form. </p> </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-db0b769cf07ced12a9bc9c7eda2d6fc5"> <div class="view-content"> <div> <p class="updated-date"> <span>Last updated: </span> November 4, 2024 </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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