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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-1841" class="node node-page slider-secondary clearfix" about="/submitting-covid-19-research-irb-new-studies-modifications" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="Submitting COVID-19 Research to the IRB (New Studies & Modifications)" 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="##priority">Priority Review for COVID-19-Related Research</a></li> <li><a href="#newcovid">New Consent Form Statement for COVID-19 Countermeasures</a></li> <li><a href="#submittingnewstudies">Submitting New COVID-19 Studies</a></li> <li><a href="##submissionrequirements">Submission Requirements for COVID-19-Related Modifications</a></li> </ul> <p> </p> <h2><a id="#priority" name="#priority"></a>Priority Review for COVID-19-Related Research</h2> <p>The HRPP has appointed a new COVID-19 Rapid Review Team (RRT) to ensure COVID-19-related research gets fast tracked to approval.</p> <p>The HRPP COVID-19 Rapid Review Team is led by two senior HRPP staff people: <a href="/cdn-cgi/l/email-protection#553f3a343b3b307b383c363e34393c343b15203626337b303120">Joanne Mickalian</a> (IRB Manager) and <a href="/cdn-cgi/l/email-protection#f99a919c8b90d79c8d8d9c8bb98c9a8a9fd79c9d8c">Cheri Etter</a> (Expedited/Exempt and GESCR Coordinator). Other HRPP Analysts, IRB Chairs, and IRB Members also conduct or participate in reviews, depending on the type of research, expertise needed, and level of review required.</p> <h3>Identification of COVID-Studies in iRIS</h3> <ul> <li>New COVID-19 studies should include ”(COVID-19)” in the Study Alias.</li> <li>Ongoing studies that are being modified to include COVID-19-related research components should have ‘(COVID-19)’ appended to the Study Alias. This requirement does not apply to studies being modified to accommodate restrictions on activities due to the COVID-19 pandemic.</li> <li>Including the ”(COVID-19)” tag in the Study Alias will ensure these studies are included in reports to UCSF leadership, the CTSI, and faculty advisory groups.</li> </ul> <h3>Priority Routing of COVID-19-Related Studies to the RRT</h3> <div>New COVID-19 questions have been added to the Study Application and Modification Form. The iRIS system will automatically route studies that indicate COVID-19-related activities to the RRT for priority review. If your Study Application includes questions about COVID-19 in Section 4: Initial Screening Questions, no additional communications are needed to alert the RRT that your COVID-19 study has been submitted.</div> <div> </div> <div>If your Study Application does not include COVID-19 questions in Section 4: Initial Screening Questions, you should close and re-open the Study Application and click ‘Convert to the New Form Version’ when prompted. Only submit your study after you have answered the COVID-19-related questions in the Study Application.</div> <div> </div> <div>If you have questions about your project prior to submission, please email <a href="/cdn-cgi/l/email-protection#2f45404e41414a0142464c444e43464e416f5a4c5c49014a4b5a">Joanne Mickalian</a> and <a href="/cdn-cgi/l/email-protection#6e0d060b1c07400b1a1a0b1c2e1b0d1d08400b0a1b">Cheri Etter</a>.</div> <div> </div> <h3><u><strong><a id="newcovid" name="newcovid"></a></strong></u>New COVID-19 Questions in the IRB Study Application and Modifications Forms</h3> <p>There are currently many types of COVID-19-related research being submitted to the IRB. Several clinical trials have been recently approved or are currently under review. Laboratory studies involving testing methodologies, transmissibility, antibody production and detection, immunity, and vaccine development are coming on line. Other types of research that are being approved are social and behavioral research, epidemiological research, and clinical outcomes studies.</p> <div>Several new questions have been added to the Initial Screening Questions section of the Study Application to facilitate tracking, metrics, and reporting on the various types of COVID-19-related research being conducted by UCSF faculty and affiliates. They will also be used to trigger automated notifications to the HRPP COVID-19 Rapid Review Team and the Biosafety Committee when a BUA is required.</div> <div>COVID-19-related questions have also been added to the Modification Form to assist with triage and prioritization.</div> <h3>New Consent Form Statement for COVID-19 Countermeasures</h3> <div>The Secretary HHS issued a <a href="https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05484.pdf">Public Readiness and Emergency Preparedness (PREP) Act Declaration</a> for certain COVID-19 countermeasures on March 10, 2020. The Declaration covers covered countermeasures (described below).</div> <div> </div> <div>As an example, the PREP Act applies to UCSF when it initiates a clinical trial studying therapeutic treatment of COVID-19 using a drug under an IND. When the PREP Act applies, the Declaration limits participants’ legal right to sue covered persons.</div> <div>Covered persons in these situations includes the federal government, manufacturers, trial sponsors, healthcare providers engaged in countermeasures, or others.</div> <div> </div> <div>While study participants’ right to sue for significant injuries (including death) is restricted under the Declaration, U.S.-located or other certain participants with a U.S. nexus may be able to seek compensation from HRSA’s Countermeasure Injury Compensation Program (CICP) for certain serious physical injuries.</div> <div> </div> <div>Human subjects protection regulations require that participants be informed if any of their legal rights are affected, and what recourse is available, so it is important for IRBs to be informed about the PREP Act. To comply with this, the University of California has provide an additional statement to include in the <em>Treatment and Compensation for Injury</em> section consent forms for studies that involve the use of a “covered countermeasure” (see <a href="#CoveredCountermeasure">definition</a> below).</div> <div>If your study uses a COVID-19 covered countermeasure, substitute the following language in the research injury section of the informed consent document:</div> <blockquote> <p><em>If you are injured as a result of being in this study, the University of California will provide necessary medical treatment. The costs of the treatment may be billed to you or your insurer just like any other medical costs, or covered by the study sponsor or another entity, depending on a number of factors.</em></p> <p><em>Due to the coronavirus public health crisis, the federal government issued a Declaration under the Public Readiness and Emergency Preparedness (PREP) Act. If the Declaration applies, it limits your right to sue and recover for losses from the researchers, healthcare providers, any study sponsor or manufacturer or distributor involved with the study, including the University of California, while participating in this COVID-19 clinical study. However, the federal government has a program that may provide compensation to you or your family for certain claims if you experience serious physical injuries or death and these costs are not covered by other payors. To find out more about this “Countermeasures Injury Compensation Program” go to </em><a href="https://urldefense.proofpoint.com/v2/url?u=https-3A__www.hrsa.gov_cicp_about_index.html&d=DwMF-g&c=iORugZls2LlYyCAZRB3XLg&r=I2oJwBqX9w7DybaC_CIJburLz6HHKqG683WfrJQOYqI&m=W9NJJlaGtZfinBicKwx9Q4oaJRiEd5ra1dr0LHgY1HA&s=ltntFGFNKJQCIYmxSeqoY1yeqO5D7wpM_dlSJwnJdjk&e="><em>https://www.hrsa.gov/cicp/about/index.html</em></a><em> or call 1-855-266-2427. </em></p> </blockquote> <h3>Resources/Definitions:</h3> <div>The CICP program is explained on the HRSA CICP Program page</div> <div><a href="https://urldefense.proofpoint.com/v2/url?u=https-3A__www.federalregister.gov_documents_2020_03_17_2020-2D05484_declaration-2Dunder-2Dthe-2Dpublic-2Dreadiness-2Dand-2Demergency-2Dpreparedness-2Dact-2Dfor-2Dmedical-2Dcountermeasures&d=DwMF-g&c=iORugZls2LlYyCAZRB3XLg&r=I2oJwBqX9w7DybaC_CIJburLz6HHKqG683WfrJQOYqI&m=W9NJJlaGtZfinBicKwx9Q4oaJRiEd5ra1dr0LHgY1HA&s=C4hHvUazEV8NYJDSta7ju4D1c5ik2U6GUrYR_i74ufM&e=">COVID-19 - Medical Countermeasures (effective February 4, 2020)</a></div> <div><a href="https://urldefense.proofpoint.com/v2/url?u=https-3A__www.federalregister.gov_documents_2020_04_15_2020-2D08040_amendment-2Dto-2Ddeclaration-2Dunder-2Dthe-2Dpublic-2Dreadiness-2Dand-2Demergency-2Dpreparedness-2Dact-2Dfor-2Dmedical&d=DwMF-g&c=iORugZls2LlYyCAZRB3XLg&r=I2oJwBqX9w7DybaC_CIJburLz6HHKqG683WfrJQOYqI&m=W9NJJlaGtZfinBicKwx9Q4oaJRiEd5ra1dr0LHgY1HA&s=h10VCfUU7yVgpFFfxM_s8am3mNUHUDYU2w7iIXkouKs&e=">Amended April 10, 2020 to add countermeasures pursuant to the CARES Act</a></div> <div><a href="https://urldefense.proofpoint.com/v2/url?u=https-3A__www.hhs.gov_sites_default_files_prep-2Dact-2Dadvisory-2Dopinion-2Dapril-2D14-2D2020.pdf&d=DwMF-g&c=iORugZls2LlYyCAZRB3XLg&r=I2oJwBqX9w7DybaC_CIJburLz6HHKqG683WfrJQOYqI&m=W9NJJlaGtZfinBicKwx9Q4oaJRiEd5ra1dr0LHgY1HA&s=O1sTKh2Ou9WFsO9BEftYSv4x8ff8sZsgoROTB-URpSY&e=">OGC Advisory Opinion on PREP Act Declaration</a></div> <div> </div> <h3>Definition of a "covered countermeasure" (42 U.S.C 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)</h3> <div> <p>Covered Countermeasures are any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating there from, or any device used in the administration of any such product, and all components and constituent materials of any such product.</p> <div>Covered Countermeasures must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.</div> <h3>Resources for help determining PREP Act applicability</h3> <div>If you are not sure if the PREP Act Declaration is applicable, please check with the study sponsor or funding agency. For PI-initiated research, contact the <a href="https://compliance.ucsf.edu/fda-support">UCSF Regulatory Support</a> program.</div> <div> </div> <h2><a id="submittingnewstudies" name="submittingnewstudies"></a>Submitting New COVID-19 Studies</h2> <h3>Instructions for Submitting New COVID-19 Studies</h3> <p>Step 1<strong>: </strong>Start a new study. Review the <a href="https://courses.learning.ucsf.edu/?eCourse=347469">online interactive tutorial</a> if you need step-by-step instructions for submitting a new study. Fill the application out as you normally would and follow these COVID-19-specific instructions:</p> <ol> <li>In the <strong>General Information</strong> section, include ”(COVID-19)” in the <em><b>Study Alias.</b></em></li> <li>In the <em><b>Initial Screening Questions</b></em> section explain in the ‘Project Summary’ how the study design and objectives relate to COVID-19.</li> <li>In the <em><b>Initial Screening Questions</b></em> section, answer the coronavirus and COVID-19-specific questions.</li> </ol> <p>In the <em><b>Other Approvals and Registrations</b></em> section, a BUA number may be required if the research involves collection of or use of COVID-19 biospecimens. If your application involves laboratory use of COVID-19 biospecimens, you’ll be asked if you’ll be working with live viral cultures (requires BSL-3 facility and a consult with EH&S).</p> <p>Step 2: Save and Continue at the end of the application form to begin the Initial Review Submission Packet Form.</p> <ol> <li>Verify that ”(COVID-19)” is included in the <em><b>Study Alias.</b></em></li> <li>Attach the study consent forms and study documents, as appropriate.</li> </ol> <p>Step 3: Submit the study. The HRPP COVID-19 Rapid Review Team (RRT) will receive an automated email from the iRIS system notifying them that your study has been submitted. No further action is required to ensure priority processing. </p> <h3>Submitting COVID-19-Related Research Activities as a New Study Using an Existing Cohort</h3> <div>If you would like to add COVID-19-specific activities to an active study because the cohort has already been recruited and there are ongoing study visits planned, but there’s no relationship between the original study aims and the proposed COVID-19 activities, the HRPP suggests submitting the COVID-19 research as a new study of an existing cohort. If you choose to do so, please reference the existing IRB Study Number(s) in the new application and explain in the recruitment section how you plan to approach ongoing participants for enrollment in the new COVID-19 study.</div> <div> </div> <h2><a id="#submissionrequirements" name="#submissionrequirements"></a>Submission Requirements for COVID-19 Related Modifications</h2> <div> <h3>Modifications to Add COVID-19 Research Activities</h3> <div><strong>Relevance of COVID-19-Related Research Activities to the Original Study</strong></div> <div>Please carefully consider whether there is a scientific rationale for adding COVID-19 research elements to an existing IRB-approved study (i.e. as a modification) vs. submitting it as a brand new COVID-19 study. The study team should provide adequate information supporting the addition of a COVID-19 research component; the enrolled participants should not serve as a population of convenience for new aims.</div> <div> </div> <div>The IRB may reject your modification if the new COVID-19-related research activities are not clearly relevant to or supporting of the original study aims. In this case, you will be asked to submit a new study.</div> <div>A substantive change to an existing greater than minimal risk protocol will need to undergo full board review even if the new procedures are all minimal risk. In contrast, the same activities submitted as a new minimal risk study can undergo expedited review. Avoid extra work and needless delays by submitting COVID-19-related investigations as new stand-alone studies.</div> <div> </div> <h3>COVID-19 Alias Tag</h3> </div> <div>All ongoing studies that are being modified to include COVID-19-related research activities should also include a reference to ‘COVID-19’ in the Study Alias to facilitate tracking, metrics, and reporting.</div> <div> </div> <aside> <h3>COVID-19 Questions</h3> </aside> <aside> <div>Several new questions have been added to the <em>Initial Screening Questions</em> section of the IRB <strong>Study Application</strong> to identify the kinds of COVID-19-related research activities that will be carried out under the approval. The answers in the new questions in the Study Application will feed into the <strong>Modification Form</strong>, as long as the <strong>Study Application</strong> has been converted to the April 2020 version.</div> </aside> <aside> <div>The new COVID-19-related questions in the <strong>Study Application</strong> and <strong>Modification Form</strong> will be used for triage, reviewer assignment, IRB review, and reporting of research activities relating to COVID-19.</div> </aside> <h3>Requirement to Convert to the Current IRB Study Application Version</h3> <div>Research involving any of the following COVID-19-specific activities will require conversion of the <strong>Study Application</strong> to the new ‘<em>April 2020 Study Application Form</em>’ version.</div> <ul> <li>Testing and diagnostics for COVID-19</li> <li>Randomized controlled trial of treatments for COVID-19</li> <li>Other treatment or intervention for COVID-19-infected patients</li> <li>Observation of patients with COVID-19</li> <li>Post-COVID-19-infection assessments relating to antibodies and immunity or long-term effects</li> <li>COVID-19 specimen collection for research purposes (not clinical)</li> <li>COVID-19 specimen analysis (clinical or research specimens)</li> <li>Chart review of COVID-19 patients</li> </ul> <p><strong>The HRPP suggests submitting a new COVID-19-specific study rather than modifying an existing study. Turnaround times for new COVID-19 studies are currently 2-5 days for minimal risk research.</strong></p> <p><strong>Application conversion is not recommended for studies approved prior to 2016 or studies that are only adding a minor COVID-19-related scope, such as Quality of Life indices or a questionnaire about impact of infection or infection reduction protocols. </strong></p> <h3>Preparing the Modification Form</h3> <div>The IRB recommends revising the <strong>Study Application</strong> prior to preparing the <strong>Modification Form</strong> because many of the COVID-19-related questions in the <strong>Modification Form</strong> populate from the <strong>Study Application</strong>.</div> <div> </div> <div>I<strong>f your study was approved prior to 2016 and includes COVID-19-related activities beyond questionnaires and instruments, you should submit a new COVID-19 study instead.</strong></div> <div><strong>Instructions</strong>The instructions are written for users who are familiar with revising active studies in iRIS. If you need step-by-step guidance, please review the online interactive tutorial ‘<a href="https://courses.learning.ucsf.edu/?eCourse=347472">Making Changes to Approved IRB Studies</a>’</div> <div><strong><u>Step 1</u>: </strong>Open your study and go to the <strong><em>Study Management Dashboard</em></strong><em>.</em></div> <div><strong><u>Step 2</u>: </strong>Under <strong><em>Protocol Items</em></strong>, open the <strong><em>IRB Study Application</em></strong> section and click ‘Add Revision’ in the right-most column of the latest approved version.</div> <div><strong><u>Step 3</u>: </strong>When asked if you want to convert to the new form version, choose the ‘Convert’ option.</div> <div><strong><u>Step 4</u>: </strong>Revise the Study Application with the following COVID-19-specific details:</div> <ol> <li> <div>In the <strong><em>General Information</em></strong> section, add ‘(COVID-19)’ to the end of the <strong><em>Study Alias</em></strong>.</div> </li> <li> <div>In the <strong><em>Initial Screening Questions</em></strong> section, add a brief statement at the end of the ‘Project Summary’ describing how the new activities relate to COVID-19 and what research objectives they will support, then answer the new coronavirus/COVID-19-specific questions.</div> </li> <li> <div>If you are adding COVID-19 biospecimen handling for the first time, add the new Biological Use Authorization (BUA) number in the <strong><em>Other Approvals and Registrations</em></strong> section at the end of the form. (Please note UCSF requires all biospecimens procured from COVID-19 patients to be managed in Biosafety Level 2 (BSL-2) or above laboratories.) An existing BUA number most likely cannot be used for new COVID-19-related biospecimen activities.</div> </li> <li> <div>Revise all other sections and questions affected by the proposed modifications. Include details in the Procedures, Risks and other sections as appropriate, then click ‘Save and Continue’ through the end of the application.</div> </li> </ol> <div><strong><u>Step 5</u>: </strong>Click ‘Back’ to return to the <strong><em>Study Management Dashboard</em></strong><em>.</em></div> <div><strong><u>Step 6</u>: </strong>Under <strong><em>IRB Submission Forms, </em></strong>open the <strong><em>Modification Form</em></strong> area.</div> <div><strong><u>Step 7</u>: </strong>Click ‘Add New Form’ and complete the <strong>Modification Form.</strong></div> <ol> <li> <div>Answer all questions in the <em>COVID-19-Related Questions</em> subsection in Q1.13. Most of the questions are programmed to populate from the <strong>Study Application</strong> form. If the information is not displaying correctly you will need to fix it in the Study Application.</div> </li> <li> <div>Add details about any other proposed modifications.</div> </li> <li> <div>Attach the revised Study Application in Q1.27. If you need to edit the application, you can open it from here.</div> </li> <li> <div>Attach any new or revised consent forms or documents in Q1.28.</div> </li> </ol> <div><strong><u>Step 8</u>: </strong>Click ‘Save and Continue,’ then ‘Signoff and Submit.’ </div> <div> </div> <div><strong>Studies Initially Approved Prior to 2016 That Are ONLY Adding COVID-19-Related Scales or Questionnaires (no form conversion required)</strong></div> <div> <div>The only COVID-19-related research activities that can currently be added to an ongoing study without converting the Study Application are adding or changing questionnaires, surveys, and instruments to collect data relating to the COVID-19 pandemic.</div> <div>If you plan to add COVID-19-related surveys, scales or questionnaires but <strong>NO OTHER</strong> COVID-19-specific research activities <strong>AND</strong> your study was approved prior to 2016, you will <strong>not be</strong> required to convert to the April 2020 Study Application version. Adding questions to existing questionnaires or instruments is also permitted.</div> <div> </div> <div><strong>Instructions for modifying studies approved prior to 2016 that are ONLY adding COVID-19-related scales or questionnaires</strong>. The instructions are written for users who are familiar with revising active studies in iRIS. If you need step-by-step guidance, please review the online interactive tutorial ‘<a href="https://courses.learning.ucsf.edu/?eCourse=347472">Making Changes to Approved IRB Studies</a>’</div> <div><strong><u>Step 1</u>: </strong>Open your study and go to the <strong><em>Study Management Dashboard</em></strong><em>.</em></div> <div><strong><u>Step 2</u>: </strong>Under <strong><em>Protocol Items</em></strong>, open the <strong><em>IRB Study Application</em></strong> section and click ‘Add Revision’ in the right-most column of the latest approved version.</div> <div><strong><u>Step 3</u>: </strong>When asked if you want to convert to the new form version, choose the ‘Do Not Convert’ option.</div> <div><strong><u>Step 4</u>: </strong>Revise the <strong>Study Application</strong> with the following COVID-19-specific details:</div> <ol> <li> <div>In the <strong><em>General Information</em></strong> section, add ‘(COVID-19)’ to the end of the Study Alias.</div> </li> <li> <div>In the <strong><em>Initial Screening Questions</em></strong> section, add a brief statement at the end of the ‘Project Summary’ describing how the new activities relate to COVID-19 and what research objectives they will support and answer the new coronavirus/COVID-19 questions.</div> </li> <li> <div>Revise all other sections and questions affected by the proposed modifications. Include details in the Procedures, Risks and other sections as appropriate, then click ‘Save and Continue’ through the end of the application.</div> </li> </ol> <div><strong><u>Step 5</u>: </strong>Click ‘Back’ to return to the <strong><em>Study Management Dashboard</em></strong><em>.</em></div> <div><strong><u>Step 6</u>: </strong>Under <strong><em>IRB Submission Forms, </em></strong>open the <strong><em>Modification Form</em></strong> area.</div> <div><strong><u>Step 7</u>: </strong>Click ‘Add New Form’ and complete the <strong>Modification Form.</strong></div> <ol> <li> <div>Answer all questions in the <em>COVID-19-Related Questions</em> subsection in Q1.13. In the ‘COVID-19-Specific Research Activities’ question, the only box checked should be ‘Questionnaires, surveys and/or Quality of Life assessments (QOL).’ The iRIS system will not allow you to proceed without converting to the <em>April 2020 Study Application</em> version if other activities are checked.</div> </li> <li> <div>Add details about any other proposed modifications.</div> </li> <li> <div>Attach the revised Study Application in Q1.27. If you need to edit the application, you can open it from here.</div> </li> <li> <div>Attach any new or revised consent forms or documents in Q1.28.</div> </li> </ol> <div><strong><u>Step 8</u>: </strong>Click ‘Save and Continue,’ then ‘Signoff and Submit.’ You can check the status of your submission review in the iRIS system by following these <a href="/sites/g/files/tkssra6501/f/where%20is%20my%20study_0.pdf">instructions</a>, but you should allow a couple of days for the team to work on it.</div> </div> </div> </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-fe273e1b6b099c71fc9f489b47110fde"> <div class="view-content"> <div> <p class="updated-date"> <span>Last updated: </span> July 1, 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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