  {"id":68301,"date":"2026-05-29T09:44:32","date_gmt":"2026-05-29T16:44:32","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=68301"},"modified":"2026-05-29T10:31:37","modified_gmt":"2026-05-29T17:31:37","slug":"apply-for-review-uw-reviewing-for-other-institutions","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/apply-for-review-uw-reviewing-for-other-institutions\/","title":{"rendered":"Apply for Review- 91爆料 Reviewing for Other Institutions"},"content":{"rendered":"<p><img decoding=\"async\" class=\"WP-PrintIcon\" src=\"https:\/\/www.washington.edu\/research\/wp-content\/plugins\/wp-print\/images\/printer_famfamfam.gif\"  alt=\"Print\" title=\"Print\" style=\"border: 2px;\">&nbsp;<a href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/apply-for-review-uw-reviewing-for-other-institutions\/print\/\" title=\"Print\" rel=\"nofollow\" target=\"_blank\">Print<\/a><\/p>\n<div class=\"table-of-contents\">\n<h2 id=\"toc\">Table of Contents<\/h2>\n<ul class=\"list-unstyled\">\n<li><a href=\"#1\">Before You Begin<\/a>\n<ul>\n<li><a href=\"#1a\">Is the project likely to be considered \u201cexempt\u201d from IRB review?<\/a><\/li>\n<li><a href=\"#1b\">What qualifies as another site or institution on my project?<\/a><\/li>\n<li><a href=\"#1c\">Have you consulted HSD&#8217;s Reliance Team to confirm that 91爆料 will review on behalf of another institution?<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#2\">How the Review Process Works- 2 Phases<\/a><\/li>\n<li><a href=\"#3\">Steps for Submitting- STUDY Application<\/a>\n<ul>\n<li><a href=\"#overview\">Overview<\/a><\/li>\n<li><a href=\"#step1\">Step 1: Set Up Zipline Access for 91爆料 Study Team (One Time Only)<\/a><\/li>\n<li><a href=\"#step2\">Step 2: Complete the IRB Protocol Form<\/a><\/li>\n<li><a href=\"#step3\">Step 3: Prepare Other Documents<\/a><\/li>\n<li><a href=\"#step4\">Step 4: Create Study Record in Zipline<\/a><\/li>\n<li><a href=\"#step5\">Step 5: Add Faculty Advisor Review (Students and Medical Residents Only)<\/a><\/li>\n<li><a href=\"#step6\">Step 6: Check Application for Completeness<\/a><\/li>\n<li><a href=\"#step7\">Step 7: Principal Investigator (PI) or PI Proxy Must Submit<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#4\">What to Expect After Submitting<\/a><\/li>\n<\/ul>\n<\/div>\n<h2 id=\"1\">Before You Begin<\/h2>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\" id=\"1a\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Is the project likely to be considered \u201cexempt\u201d from IRB review?<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>The 91爆料 does not typically rely on exempt determinations made by other institutions, nor does it usually allow other institutions to formally rely on 91爆料\u2019s exempt determinations. Reliance for exempt research may be permitted only in <strong>very limited circumstances<\/strong>, as determined by HSD leadership.<\/p>\n<p>If your research is exempt:<\/p>\n<ul>\n<li>Go to <a href=\"\/research\/hsd\/study-activities\/apply-for-review\/\">Apply for Review \u2013 91爆料 Reviewing for 91爆料 Only<\/a><\/li>\n<\/ul>\n<p>Resources:<\/p>\n<ul>\n<li><a href=\"\/research\/hsd\/do-i-need-irb-review\/is-your-human-subjects-research-exempt-from-regulations\/\">Is Your Human Subjects Research Exempt from Regulations?<\/a><\/li>\n<li>Contact <a href=\"mailto:hsdrely@uw.edu\">hsdrely@uw.edu<\/a> with questions<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\" id=\"1b\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">What qualifies as another site or institution on my project?<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>In Zipline, selecting <strong>\u201cMulti-site\/collaborative\u201d<\/strong> means that <strong>one or more non-91爆料 institutions are actively involved in conducting the research with human subjects<\/strong>.<\/p>\n<p>This is <strong>not<\/strong> about where 91爆料 researchers travel or recruit participants. It only applies when <strong>non-91爆料 investigators or study teams<\/strong> are performing research activities such as obtaining consent, conducting study procedures, or collecting identifiable data.<\/p>\n<p>Examples:<\/p>\n<ul>\n<li><strong>91爆料-only study<\/strong>: A 91爆料 researcher recruits participants at Seattle Pacific University, but only 91爆料 personnel obtain consent and conduct study activities. No SPU staff are involved in the research. This is a single-site (91爆料-only) study.<\/li>\n<li><strong>Multi-site\/collaborative study<\/strong>: 91爆料 researchers collaborate with investigators at UCLA and Johns Hopkins. Each institution has its own study team conducting research activities under a shared protocol. This is a multi-site\/collaborative study.<\/li>\n<\/ul>\n<p>For more help deciding, review our <a href=\"\/research\/hsd\/guidance\/engagement\/\">Engagement Guidance<\/a> or contact <a href=\"mailto:hsdrely@uw.edu\">hsdrely@uw.edu<\/a>.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\" id=\"1c\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Have you consulted HSD\u2019s Reliance Team to confirm that 91爆料 will review on behalf of another institution?<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>91爆料 IRB review of multi-institutional research is <strong>not guaranteed<\/strong> unless HSD has been consulted in advance, or the collaboration is covered by an established cooperative agreement (for example, with Fred Hutch or Seattle Children\u2019s).<\/p>\n<p>Before selecting this review path, consult HSD\u2019s Reliance Team at <a href=\"mailto:hsdrely@uw.edu\">hsdrely@uw.edu<\/a> to determine whether 91爆料 IRB review is appropriate for a collaborating institution.<\/p>\n<p>For more information:<\/p>\n<ul>\n<li><a href=\"\/research\/hsd\/irb-reliances\/single-irb\/uw-irb-as-a-single-irb\/\">91爆料 IRB as a Single IRB<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<h2 id=\"2\">How the Review Process Works- 2 Phases<\/h2>\n<p>91爆料 IRB review of a multi-site or collaborative study happens in 2 phases. <strong>Phase 1 must be completed and approved before Phase 2 can begin.<\/strong><\/p>\n<ul>\n<li><strong>Phase 1- STUDY application:<\/strong> Submit a study application describing the overall protocol, any 91爆料 specific materials, and any generic materials that will be used across sites.<\/li>\n<li><strong>Phase 2- SITE applications:<\/strong> After the STUDY application is approved, HSD creates a separate SITE application for each non 91爆料 institution. Phase 2 includes additional researcher coordination with HSD, and each site is reviewed and approved individually. Learn more at <a href=\"\/research\/hsd\/study-activities\/add-relying-sites\/\">Add Relying Sites to Approved Study<\/a>.<\/li>\n<\/ul>\n<p>For more information:<\/p>\n<ul>\n<li><a href=\"\/research\/hsd\/irb-reliances\/single-irb\/uw-irb-as-a-single-irb\/steps-in-the-single-irb-review-process-for-initial-applications\/\">91爆料 as the Single IRB- Initial Application Process <\/a><\/li>\n<\/ul>\n<h2 id=\"3\">Steps for Submitting- Phase 1 STUDY Application<\/h2>\n<h3 id=\"overview\">Overview<\/h3>\n<p><strong>All applications must be submitted via Zipline, 91爆料\u2019s eIRB system.<\/strong> Zipline is a document management system where you upload your application form and other study documents and fill out a series of electronic SmartForms.<\/p>\n<p><strong>The order of the application steps is flexible.<\/strong> You may find it better to create the study record in Zipline and then complete the Word-based IRB application form, especially if you plan to be a PI proxy for a study.<\/p>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\" id=\"step1\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 1: Set Up Zipline Access (One Time Only)<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>91爆料 study team members who need access to the Zipline application must complete a one-time self-registration process in Zipline before they can be added to the application.<\/strong> Each person must be added to the application before they are able to access it.<\/p>\n<p>Individuals from non-91爆料 institutions cannot access Zipline.<\/p>\n<p>A 91爆料 NetID is required to register. For more information:<\/p>\n<ul>\n<li><a href=\"\/research\/hsd\/training\/zipline-online-help-library\/account-creation-and-management\/\">Account Creation and Management<\/a><\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\" id=\"step2\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 2: Complete the IRB Protocol Form<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>All applications must include an IRB Protocol Form. Use the most recent version available on the HSD website or in Zipline and upload the form in Microsoft Word format. <a href=\"https:\/\/it.uw.edu\/uware\/microsoft-office-for-desktop\/\">91爆料 students, faculty, and staff can access Microsoft Office at no cost<\/a>.<\/p>\n<p>Two versions of the form are available:<\/p>\n<ul>\n<li><a href=\"\/research\/forms-and-templates\/zipline-application-irb-protocol\/\">IRB Protocol Form<\/a>: Standard form for most studies.<\/li>\n<li><a href=\"\/research\/forms-and-templates\/zipline-application-irb-protocol-no-contact-with-subjects\/\">IRB Protocol Form, No Contact<\/a>: A shortened form for studies that involve no interaction with subjects in any format (for example, in person, email, or online).<\/li>\n<\/ul>\n<p><strong>Tips for multi-site and collaborative studies<\/strong><\/p>\n<ul>\n<li>Indicate in Section 1.9 that 91爆料 IRB review is being requested on behalf of non-91爆料 individuals or institutions.<\/li>\n<li>Describe the overall study and research activities across all participating institutions.<\/li>\n<li>Where possible, describe the range of procedures across sites in the STUDY application.<\/li>\n<\/ul>\n<p>For more guidance, go to <a href=\"\/research\/hsd\/irb-reliances\/single-irb\/uw-irb-as-a-single-irb\/steps-in-the-single-irb-review-process-for-initial-applications\/#prep\">Preparing and Submitting the sIRB Application<\/a>.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\" id=\"step3\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 3: Prepare Other Documents<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>We recommend preparing all other required study documents before creating your application in Zipline. Whenever possible, upload documents in Microsoft Word format.<\/p>\n<p><strong>Required Supplements<\/strong><\/p>\n<p>Your application must include one or both of the following supplements, as applicable:<\/p>\n<ul>\n<li><a href=\"\/research\/forms-and-templates\/supplement-multi-site-or-collaborative-research\/\">SUPPLEMENT Multi-site or Collaborative Research<\/a>:\u00a0 Required for studies involving other institutions, including those with standing reliance agreements with 91爆料 (for example, Fred Hutch and Seattle Children\u2019s).<\/li>\n<li><a href=\"\/research\/forms-and-templates\/supplement-non-uw-individual-investigators\/\">SUPPLEMENT Non-91爆料 Individual Investigators<\/a>: Required for investigators who are unaffiliated with an institution, or who are affiliated with an institution that does not have a Federalwide Assurance (FWA).<\/li>\n<\/ul>\n<p><strong>Planning Consent Materials for Multi-site and Collaborative Studies<\/strong><\/p>\n<p>For multi-institutional research, consent materials are typically developed using a study-wide template created by the overall study team, which sites then adapt to local requirements. <strong>HSD does not create this template<\/strong>. You may need to coordinate with investigators at other institutions to develop it.<\/p>\n<p>When submitting the STUDY application in Zipline, you will need:<\/p>\n<ul>\n<li>Template consent, assent, and parental permission forms (for multi-site studies where sites will create site specific versions based on a shared template)<\/li>\n<li>91爆料 specific consent, assent, and parental permission forms<\/li>\n<\/ul>\n<p>For more information, go to <a href=\"\/research\/hsd\/guidance\/consent\/design\/#6\">Designing the Consent Process: Considerations for Multi-institutional Research<\/a>.<\/p>\n<p><strong>Other Required Documents<\/strong><\/p>\n<p>You may also need to prepare other required study documents and 91爆料 site specific documents, as applicable. A full list is included in the table under Step 4.<\/p>\n<p><strong>Keep documents specific to non-91爆料 sites for later<\/strong>. These materials will be submitted as part of the SITE application process.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\" id=\"step4\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 4: Create Study Record in Zipline<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>Once your documents are ready, login to Zipline to create a new study record, complete the SmartForm application, and upload the study documents.<br \/>\n<\/strong><\/p>\n<p>To create a new study record, select Create New Study from the menu:<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"wp-img wp-image-40954 alignnone\" src=\"\/research\/wp-content\/uploads\/Submitting-a-Study-Filling-Out-Application-Create-New-Study.png\" alt=\"create new study\" width=\"360\" height=\"231\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Submitting-a-Study-Filling-Out-Application-Create-New-Study.png 826w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Submitting-a-Study-Filling-Out-Application-Create-New-Study-300x192.png 300w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Submitting-a-Study-Filling-Out-Application-Create-New-Study-768x493.png 768w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Submitting-a-Study-Filling-Out-Application-Create-New-Study-375x241.png 375w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/Submitting-a-Study-Filling-Out-Application-Create-New-Study-750x481.png 750w\" sizes=\"auto, (max-width: 360px) 100vw, 360px\" \/><\/p>\n<h4>General Tips<\/h4>\n<ul class=\"general-tips\">\n<li><strong>Use the help bubbles<\/strong> throughout Zipline for additional context if you\u2019re unsure how to answer a question.<br \/>\n<figure><img loading=\"lazy\" decoding=\"async\" class=\"wp-img alignnone\" src=\"\/research\/wp-content\/uploads\/help-bubble-300x24.png\" alt=\"Zipline help bubble icon showing contextual help\" width=\"338\" height=\"27\" \/><\/figure>\n<\/li>\n<li><strong>Navigate through the application sequentially<\/strong> by selecting <em>Continue<\/em> at the bottom of each page.<br \/>\n<figure><img loading=\"lazy\" decoding=\"async\" class=\"wp-img alignnone\" src=\"\/research\/wp-content\/uploads\/2019\/11\/Managing-Study-Access-Change-Study-PI-Continue-300x46.png\" alt=\"Screenshot of the Continue button in Zipline\" width=\"267\" height=\"41\" \/><\/figure>\n<\/li>\n<li><strong>Jump between pages<\/strong> using the left\u2011hand navigation menu when you need to review or update specific sections.<br \/>\n<figure><img loading=\"lazy\" decoding=\"async\" class=\"wp-img alignnone\" src=\"\/research\/wp-content\/uploads\/2019\/12\/Zipline-Basics-Navigating-Studies-Lefthand-Navigator-156x300.png\" width=\"164\" height=\"316\" \/><\/figure>\n<\/li>\n<li><strong>Save your progress<\/strong> and return later by selecting <em>Save and Edit Study<\/em> if you need to complete the application in multiple sessions.<br \/>\n<figure><img loading=\"lazy\" decoding=\"async\" class=\"wp-img alignnone\" src=\"\/research\/wp-content\/uploads\/2019\/11\/Submitting-New-Studies-Check-For-Errors-Edit-Study-300x262.png\" alt=\"Edit Study button under Next Steps in Zipline\" width=\"232\" height=\"203\" \/><\/figure>\n<\/li>\n<\/ul>\n<h4>SmartForm Instructions for 91爆料 Reviewing for Other Institutions<\/h4>\n<table>\n<thead>\n<tr>\n<th scope=\"col\">SmartForm Page &amp; Attachments<\/th>\n<th scope=\"col\">Tips &amp; Guidance<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Basic Information SmartForm Page<\/strong><br \/>\nAttachments:<\/p>\n<ul>\n<li>IRB Protocol Form (Item 8) \u2013 <strong>Required<\/strong><\/li>\n<\/ul>\n<\/td>\n<td>The Basic Information page should indicate that:<\/p>\n<ul>\n<li>The study is\u00a0<strong>multi\u2011site or collaborative<\/strong> (Question 4)<\/li>\n<li>You are <strong>not<\/strong> requesting authorization for an external IRB to conduct the review (Question 5)<\/li>\n<li>The 91爆料 IRB will act as the IRB for other sites or institutions (Question 6)<\/li>\n<\/ul>\n<p><strong>The IRB Protocol must be uploaded in <a href=\"https:\/\/it.uw.edu\/uware\/microsoft-office-for-desktop\/\">Microsoft Word<\/a> format.<\/strong><\/p>\n<p>No other documents should be uploaded in this question. An attachment is required to save the application.<\/td>\n<\/tr>\n<tr>\n<td><strong>Study Funding Sources SmartForm Page<\/strong><br \/>\nAttachments:<\/p>\n<ul>\n<li>Grants, contracts, and other funding information (Item 4)<\/li>\n<\/ul>\n<\/td>\n<td><strong>For funding administered through 91爆料:<\/strong><\/p>\n<ul>\n<li>Include the e\u2011GC1 number as the Grants Office ID (Item 3). This makes it much easier and faster for the Office of Sponsored Programs (OSP) to release funds for human subjects research.<\/li>\n<\/ul>\n<p><a href=\"\/research\/hsd\/training\/zipline-online-help-library\/zipline-faqs\/#funding\">Zipline Funding FAQs<br \/>\n<\/a><\/td>\n<\/tr>\n<tr>\n<td><strong>Local Study Team Members SmartForm Page<\/strong><br \/>\nNo attachments<\/td>\n<td><strong>Can\u2019t find someone on the list?<\/strong> Make sure they are registered in Zipline.<\/p>\n<p><strong>Add everyone who needs access to the application<\/strong>, including anyone who should be designated as a PI proxy. People must be listed on this page in order for the PI to designate them as a proxy.<\/p>\n<p><strong>Students\/medical residents:<\/strong> Do not list your faculty advisor. Adding your faculty advisor on this page prevents them from completing faculty advisor review of your application.<\/td>\n<\/tr>\n<tr>\n<td><strong>Study Scope SmartForm Page<\/strong><br \/>\nNo attachments<\/td>\n<td>Questions should be answered as they apply to the overall study, not just the 91爆料 site. If you are unsure how to respond to a question, use the help text for more information.<\/td>\n<\/tr>\n<tr>\n<td><strong>Local Research Locations<\/strong><br \/>\nNo attachments<\/td>\n<td>If your research location is not listed, select <strong>Other<\/strong>.<\/p>\n<p>If your research consists solely of obtaining records, specimens, or other information without interacting with participants, select <strong>No direct interaction with participants<\/strong>.<\/td>\n<\/tr>\n<tr>\n<td><strong>Drugs SmartForm Page (if applicable)<\/strong><br \/>\nAttachments:<\/p>\n<ul>\n<li>Documents related to a specific study drug, such as documentation of the IND,<br \/>\nInvestigator\u2019s Brochure, or Package Insert (Item 3 in the Add Drug Information window)<\/li>\n<li>Any related documents not specific to a study drug, such as correspondence from the FDA<br \/>\nor study sponsor (Item 3)<\/li>\n<\/ul>\n<\/td>\n<td>Identify all drugs to be used on human subjects as part of this study, including all investigational new drugs (INDs). An IND number is assigned by the FDA to a drug that the FDA allows to be transported across state lines for use in clinical studies prior to marketing approval.For each IND number, attach one of the following:<\/p>\n<ul>\n<li>Sponsor protocol with the IND number<\/li>\n<li>Communication from the FDA or sponsor that includes the IND number<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<td><strong>Devices SmartForm Page (if applicable)<\/strong><br \/>\nAttachments:<\/p>\n<ul>\n<li>Documents related to a specific study device, such as documentation of the IDE or HDE, the Package Insert, or other device\u2011specific communication (Item 3 in the Add Device window)<\/li>\n<li>Any related documents not specific to a study device, such as correspondence from the FDA or study sponsor (Item 3)<\/li>\n<\/ul>\n<\/td>\n<td>Identify all devices to be evaluated for safety and effectiveness or used as an HUD on human subjects. Include all information the IRB needs to identify and evaluate any device with exemptions or claimed exemptions. Also, attach information from the study sponsor or the FDA verifying the exemption status of each exempt device.<\/td>\n<\/tr>\n<tr>\n<td><strong>Study Related Documents Page<\/strong><br \/>\nAttachments:<\/p>\n<ul>\n<li>Generic Templates for Consent Forms, Assent Forms, and Parental Permission Forms that will be supplied to other sites for adaptation or use<\/li>\n<li>Generic Templates for Recruitment Materials<\/li>\n<li>Other documents that apply to the study as a whole and not just the 91爆料 site, such as the study protocol, data collection forms, and any required supplements\n<ul>\n<li>SUPPLEMENT Multi-site or Collaborative Research<\/li>\n<li>SUPPLEMENT Diversity Plan for Clinical Trials (if applicable)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/td>\n<td><strong>Only attach documents that apply to the overall study and are not specific to the 91爆料 site<\/strong>, such as generic study consent templates that will be adapted for each site. Documents specific to the 91爆料 site should be attached on the Local Site Documents Page.<\/td>\n<\/tr>\n<tr>\n<td><strong>Local Site Documents Page<\/strong><br \/>\nAttachments:<\/p>\n<ul>\n<li>91爆料 Specific Consent Forms, Assent Forms, and Parental Permission Forms (Item 1)<\/li>\n<li>91爆料 Specific Recruitment materials (Item 2)<\/li>\n<li>PI\u2019s Curriculum Vitae or biosketch (Item 3)<\/li>\n<li><a href=\"\/research\/hsd\/training\/required-training\/irb-101-online-tutorial\/\">IRB 101<\/a> Training Certificate- Required for student and medical resident principal investigators (Item 3)<\/li>\n<li>Other documents specific to the site that have not already been provided (Item 3)<\/li>\n<\/ul>\n<\/td>\n<td><strong>Consent forms:<\/strong><\/p>\n<ul>\n<li>Consent materials must be uploaded to Item 1 to be watermarked<\/li>\n<\/ul>\n<p><strong>Recruitment materials:<\/strong><\/p>\n<ul>\n<li>HSD encourages uploading descriptions of recruitment and screening materials instead of the materials themselves to allow flexibility for minor changes without submitting a modification for IRB approval.<\/li>\n<\/ul>\n<p><strong>Other documents:<\/strong><\/p>\n<ul>\n<li>Student and medical resident PIs must attach their <a href=\"\/research\/hsd\/training\/required-training\/irb-101-online-tutorial\/\">IRB 101<\/a> training certificate in Item 3.<\/li>\n<li>Any data collection forms, study instruments, surveys, and application supplements specific to 91爆料 should be attached in Item 3.<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<div class=\"card\" id=\"step5\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 5: Add Faculty Advisor Review (Students and Medical Residents Only)<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>The Manage Ancillary Review activity is used to obtain and document faculty advisor review when a student or medical resident is the principal investigator (PI) for the IRB application. Do not add the faculty advisor to the study team on the Zipline application before the faculty advisor has submitted the faculty advisor review.<\/strong> The system will not allow a member of the study team to submit an ancillary review for the study.<\/p>\n<p>The faculty advisor review may occur concurrently with HSD or IRB review of an application. However, final IRB approval will not be issued until the required faculty advisor review is completed.<\/p>\n<p>Your faculty advisor will receive an email notification when the application is submitted to HSD. For more information:<\/p>\n<ul>\n<li><a href=\"\/research\/hsd\/getting-started\/#6\">FAQ: What are the additional requirements for student and medical resident researchers?<\/a><\/li>\n<li><a href=\"\/research\/hsd\/training\/zipline-online-help-library\/add-faculty-advisor-review\/\">Add Faculty Advisor Review steps<\/a><\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-30749 size-full\" src=\"\/research\/wp-content\/uploads\/2019\/11\/Submitting-New-Studies-Add-Faculty-Advisor-Review-Manage-Ancillary-Reviews.png\" alt=\"screenshot of the Manage Ancillary Reviews activity\" width=\"265\" height=\"358\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/11\/Submitting-New-Studies-Add-Faculty-Advisor-Review-Manage-Ancillary-Reviews.png 265w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/11\/Submitting-New-Studies-Add-Faculty-Advisor-Review-Manage-Ancillary-Reviews-222x300.png 222w\" sizes=\"auto, (max-width: 265px) 100vw, 265px\" \/><\/p>\n<\/div>\n<\/div>\n<div class=\"card\" id=\"step6\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 6: Check Application for Completeness<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>Checking the application for errors and omissions helps you to include all the relevant information, which is essential for receiving a timely review of your study.<\/strong> Automatic system error checking identifies any omitted answers to questions that are required for every application. A red asterisk (*) indicates required questions.<\/p>\n<p>HSD also recommends looking over the forms to see what you may have missed, especially:<\/p>\n<ul>\n<li>Questions that are relevant to your study but are not required for all studies (no asterisks)<\/li>\n<li>Documents that should be attached<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div class=\"card\" id=\"step7\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Step 7: Principal Investigator (PI) or PI Proxy Must Submit<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><strong>The Submit activity must be completed once the application is ready to go to HSD.<\/strong> This activity:<\/p>\n<ul>\n<li><strong>Must be completed by the PI or the <a href=\"\/research\/hsd\/training\/zipline-online-help-library\/assign-pi-proxy\/\">PI Proxy<\/a><\/strong><\/li>\n<li>Changes the application state from Pre-Submission to Pre-Review<\/li>\n<li>Sends the item to HSD for review<\/li>\n<li>Removes the study team\u2019s ability to make edits while the study is in review unless HSD requests more information or a change to the study<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-30758 size-full\" src=\"\/research\/wp-content\/uploads\/2019\/11\/Submitting-New-Studies-Submit-Study-Submit.png\" alt=\"Screenshot of the submit button\" width=\"271\" height=\"425\" srcset=\"https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/11\/Submitting-New-Studies-Submit-Study-Submit.png 271w, https:\/\/www.washington.edu\/research\/wp-content\/uploads\/2019\/11\/Submitting-New-Studies-Submit-Study-Submit-191x300.png 191w\" sizes=\"auto, (max-width: 271px) 100vw, 271px\" \/><\/p>\n<\/div>\n<\/div>\n<\/div>\n<h2 id=\"4\">What to Expect After Submitting<\/h2>\n<p>An HSD staff member will be assigned to your application as the IRB coordinator. <strong>The PI, any PI proxies, and the primary contact will receive email notifications<\/strong>:<\/p>\n<ul>\n<li>If HSD staff need additional information or changes to complete the review<\/li>\n<li>To inform you about the outcome of the review, including a formal determination letter with more information<\/li>\n<\/ul>\n<p>You can check the application status in the study workspace in Zipline at any time.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-30757 size-full\" src=\"\/research\/wp-content\/uploads\/pre-review-study.png\" alt=\"Screenshot of the review diagram with Pre-Review highlighted\" width=\"979\" height=\"170\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>Once the STUDY is approved, HSD will work with you to begin adding relying SITES and site specific information, including documents such as consent materials.<\/p>\n<p>For more information:<\/p>\n<ul>\n<li><a href=\"\/research\/hsd\/study-activities\/add-relying-sites\/\">Add Relying Sites to Approved Study<\/a><\/li>\n<li><a href=\"\/research\/hsd\/irb-reliances\/single-irb\/uw-irb-as-a-single-irb\/steps-in-the-single-irb-review-process-for-initial-applications\/#approval\">Responsibilities after initial approval<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Table of Contents Before You Begin Is the project likely to be considered \u201cexempt\u201d from IRB review? What qualifies as another site or institution on my&#8230;<\/p>\n","protected":false},"author":15,"featured_media":0,"parent":11143,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-68301","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Apply for Review- 91爆料 Reviewing for Other Institutions - 91爆料 Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.washington.edu\/research\/hsd\/study-activities\/apply-for-review-uw-reviewing-for-other-institutions\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Apply for Review- 91爆料 Reviewing for Other Institutions - 91爆料 Research\" \/>\n<meta property=\"og:description\" content=\"Table of Contents Before You Begin Is the project likely to be considered \u201cexempt\u201d from IRB review? 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