{"id":3616,"date":"2024-01-04T15:31:38","date_gmt":"2024-01-04T20:31:38","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=3616"},"modified":"2026-09-09T17:52:02","modified_gmt":"2026-09-09T21:52:02","slug":"submission-checklist","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-checklist\/","title":{"rendered":"IRB Submission Checklist"},"content":{"rendered":"<p>In accordance with <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_502_Types_of_RSRB_Submissions.pdf\">OHSP Policy 502: Types of RSRB Submissions<\/a>, reference the following checklist of information\/documents for inclusion in your study submission to the University of Rochester\u2019s Institutional Review Board. You can also <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/QuickReferenceGuide_IRBSubmissionChecklist.pdf\">save a PDF version of this guidance<\/a> for your records.<\/p>\n<p><a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/QuickReferenceGuide_IRBSubmissionChecklist.pdf\">Download the submission checklist<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In accordance with OHSP Policy 502: Types of RSRB Submissions, reference the following checklist of information\/documents for inclusion in your study submission to the University of Rochester\u2019s Institutional Review Board.&hellip;<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":356,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-3616","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"","subtitle":"","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"accordion_new","anchor_id":"","classes":"","title":"<h2>Submission requirements checklist<\/h2>","description":"","background":"decorative","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Basic information","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/templates\/#protocol\/\">Study protocol<\/a> and any applicable site-specific supplements and\/or addendums\r\n<ul>\r\n \t<li>A <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-preparation\/#sitespecificprotocoladdendum\">site-specific protocol addendum<\/a> maybe be required if the sponsor provided protocol does not provide specific information about the conduct of the research at the University. Specifically, to address how subjects will be recruited and consented. If <a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/non-english-speaking-subjects\/\">non-English speaking subjects<\/a> will be recruited and if not, what is the rationale for excluding, etc.<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Study team members\r\n<ul>\r\n \t<li>For guidance on who should be added as research personnel, reference our <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/team-members\/\">Identifying Study Team Members in IRB Submissions page<\/a>.<\/li>\r\n \t<li>For each study team member, verify whether they have a financial interest related to the research. If yes, obtain a copy of their <a href=\"http:\/\/www.rochester.edu\/orpa\/_assets\/pdf\/compl_COIPolicyFaculty.pdf\">Conflict of Interest Management Plan and\/or Transparency Checklist<\/a>.<\/li>\r\n \t<li>For external study team members, obtain documentation of their current <a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/required-human-subject-protection-training\/external\/\">human subject protection training<\/a>.<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Funding sources<\/li>\r\n \t<li>Research locations (i.e., non-University locations [e.g., Rochester City School District] and 糖心传媒-affiliated sites [e.g., Highland Hospital, FF Thompson] where research activities will be conducted by University faculty\/staff or by University faculty\/staff in collaboration with non-University staff)<\/li>\r\n \t<li>ClinicalTrials.gov registration number, if applicable<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Study and local site documents","icon":"","row_content":"<ul>\r\n \t<li>All <a href=\"https:\/\/www.rochester.edu\/ohsp\/templates\/#consent\">consent, permission, and assent forms<\/a>, as applicable\r\n<ul>\r\n \t<li>All consent, permission, and assent forms should be submitted with the first page on University letterhead.<\/li>\r\n \t<li>For studies undergoing review by an External IRB, ensure all consent and permission forms have been edited to include local, site-specific information. Minimally this includes local site contact information and template University language (e.g., HIPAA authorization and compensation for injury). For additional information, see the <a href=\"https:\/\/www.rochester.edu\/ohsp\/templates\/#relying\">Relying Consent Language Reference<\/a>.<\/li>\r\n \t<li>For multi-site research undergoing single IRB review where the URochester IRB is the Reviewing IRB, include all <em>model<\/em> consent forms that will be distributed for use at participating sites on the study submission under the <em>Study-Related Documents<\/em>. For participating site submissions, ensure all consent and permission forms have been edited to include local, site-specific information.<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>All recruitment materials (i.e., all direct advertising materials that may been seen\/heard by potential subjects), as applicable\r\n<ul>\r\n \t<li>For studies undergoing review by an External IRB, ensure all recruitment materials have been edited to include local, site-specific information (as appropriate).<\/li>\r\n \t<li>For multi-site research undergoing single IRB review where the URochester IRB is the Reviewing IRB, include all <em>model<\/em> recruitment materials that will be distributed for use at participating sites on the study submission under the <em>Study-Related Documents<\/em>. For participating site submissions, ensure all recruitment materials have been edited to include local, site-specific information (as appropriate).<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>All study measures that will be completed by, or include questions that will be asked to, subjects (e.g., surveys\/questionnaires, interview\/focus group scripts, behavioral assessments, diaries)\r\n<ul>\r\n \t<li>If the research involves a secondary analysis, include a data collection sheet that identifies all data points that will be collected<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>All supplemental educational materials that will be provided to potential or enrolled subjects, including any instructions\/information sheets (e.g., concerning drug administration)\r\n<ul>\r\n \t<li>Educational materials developed by OHSP do not need to be uploaded (i.e., OHSP\u2019s <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2023\/12\/Participating-in-Research-Flyer.pdf\">Participating in Research: What You Need to Know<\/a> and <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2023\/12\/Informed-Consent-Flyer.pdf\">Informed Consent: What You Need to Know<\/a>)<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/certificates-of-confidentiality\/\">Certificate of Confidentiality (CoC)<\/a>, if applicable, for research funded via a mechanism other than the National Institute of Health (NIH).<\/li>\r\n \t<li>Translator Declaration, if applicable (for additional information, reference our <a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/non-english-speaking-subjects\/\">Enrolling Non-English Speaking Subjects page<\/a>).<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Ancillary review documents","icon":"","row_content":"<ul>\r\n \t<li>Completed <a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_on_HSR_Research_Electronic_Data_Security_Assessment_Form.doc\">Data Security Assessment Form [icon name=\"file-word\" prefix=\"fas\"]<\/a><\/li>\r\n \t<li>Completed <a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Surgical_Pathology_Request_Form.docx\">Surgical Pathology Request for Human Tissues Form [icon name=\"file-word\" prefix=\"fas\"]<\/a>, if fresh, banked, or archived human tissue will be obtained from Surgical Pathology<\/li>\r\n \t<li>Completed <a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/HURC_Review_Form.docx\">Human Use of Radiation Committee Research Form [icon name=\"file-word\" prefix=\"fas\"]<\/a>, if radioisotopes or radiation-generating devices will be used for research purposes (i.e., non-clinical purposes)<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Drug details (if applicable)","icon":"","row_content":"<ul>\r\n \t<li>Drug name<\/li>\r\n \t<li>Package insert or investigators brochure<\/li>\r\n \t<li>Drug management and accountability plan, if not included in the study protocol<\/li>\r\n \t<li>Randomization plan, if applicable and not included in the study protocol<\/li>\r\n \t<li>Sample of drug label<\/li>\r\n \t<li>Temperature log (for storage location)<\/li>\r\n \t<li>If the study is being conducted under an IND (Investigational New Drug):\r\n<ul>\r\n \t<li>IND number, IND holder<\/li>\r\n \t<li>Verification from the FDA (or sponsor) of the IND<\/li>\r\n \t<li>If the local PI is the IND holder, documentation of required IND training via the <a href=\"https:\/\/www.urmc.rochester.edu\/clinical-translational-science-institute\/services-and-support\/investigational-drugs.aspx#Get%20Training\">CTSI Office of Regulatory Support<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Device details (if applicable)","icon":"","row_content":"<ul>\r\n \t<li>Device name<\/li>\r\n \t<li>Manufacturers brochure\/device instructions<\/li>\r\n \t<li>Device management and accountability plan, if not included in the study protocol<\/li>\r\n \t<li>Randomization plan, if applicable and not included in the study protocol<\/li>\r\n \t<li>If the study is being conducted under an IDE (Investigational Device Exemption)\/HDE (Humanitarian Device Exemption):\r\n<ul>\r\n \t<li>IDE\/HDE number, IDE\/HDE holder<\/li>\r\n \t<li>Verification from the FDA (or sponsor) of the IDE\/HDE<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>If the local PI is the IDE holder, documentation of required IDE training via the <a href=\"https:\/\/www.urmc.rochester.edu\/clinical-translational-science-institute\/services-and-support\/investigational-devices.aspx#Get%20Training\">CTSI Office of Regulatory Support<\/a><\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"card_grid","anchor":"","css_class":"pt-0","title":"","description":"","background_color":"#FFFFFF","width":"width-medium","columns":"1","cards":[{"card_title":"<h5>Important note about file types<\/h5>","card_text":"To facilitate reviews, limit document uploads to Microsoft Word files, when feasible. <strong><em>DO NOT<\/em> upload Rich Text or Publisher Files. <\/strong>When Microsoft Word files are unavailable, PDF files may be used.\r\n\r\nIf you have questions about what types of files can be uploaded, contact your <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/coordinator\/\">IRB Coordinator<\/a>.","card_background_color":"#f4f4f4","card_hover_color":"transparent","card_link":"","card_hover_arrow":"","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]},{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"<h2 style=\"text-align: center;\">Related resources<\/h2>","description":"","background_color":"#f4f4f4","width":"width-large","columns":"3","cards":[{"card_title":"<h5>Templates<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Templates","url":"https:\/\/www.rochester.edu\/ohsp\/templates\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Click IRB resources<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Click IRB Resources","url":"https:\/\/www.rochester.edu\/ohsp\/click-irb\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Preparing your submission<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-preparation\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Getting started guide<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Getting Started Guide","url":"https:\/\/www.rochester.edu\/ohsp\/getting-started\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>IRB overview<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"IRB and RSRB Overview","url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>A<span class=\"ILfuVd\" lang=\"en\"><span class=\"hgKElc\">\u2013<\/span><\/span>Z resources<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Resources","url":"https:\/\/www.rochester.edu\/ohsp\/resources\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IRB Submission Checklist - Office for Human Subject Protection - 糖心传媒<\/title>\n<meta name=\"description\" content=\"View and download a checklist of requirements for IRB submissions. Guidance issued by OHSP at the University of Rochester.\" \/>\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.rochester.edu\/ohsp\/irb-review\/submission-checklist\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IRB Submission Checklist - Office for Human Subject Protection - 糖心传媒\" \/>\n<meta property=\"og:description\" content=\"View and download a checklist of requirements for IRB submissions. Guidance issued by OHSP at the University of Rochester.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-checklist\/\" \/>\n<meta property=\"og:site_name\" content=\"Office for Human Subject Protection\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-09T21:52:02+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/irb-review\\\/submission-checklist\\\/\",\"url\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/irb-review\\\/submission-checklist\\\/\",\"name\":\"IRB Submission Checklist - Office for Human Subject Protection - 糖心传媒\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/#website\"},\"datePublished\":\"2024-01-04T20:31:38+00:00\",\"dateModified\":\"2026-09-09T21:52:02+00:00\",\"description\":\"View and download a checklist of requirements for IRB submissions. Guidance issued by OHSP at the University of Rochester.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/irb-review\\\/submission-checklist\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/irb-review\\\/submission-checklist\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/irb-review\\\/submission-checklist\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"IRB\",\"item\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/irb-review\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"IRB Submission Checklist\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/#website\",\"url\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/\",\"name\":\"Office for Human Subject Protection\",\"description\":\"糖心传媒\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.rochester.edu\\\/ohsp\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"IRB Submission Checklist - Office for Human Subject Protection - 糖心传媒","description":"View and download a checklist of requirements for IRB submissions. Guidance issued by OHSP at the University of Rochester.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-checklist\/","og_locale":"en_US","og_type":"article","og_title":"IRB Submission Checklist - Office for Human Subject Protection - 糖心传媒","og_description":"View and download a checklist of requirements for IRB submissions. Guidance issued by OHSP at the University of Rochester.","og_url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-checklist\/","og_site_name":"Office for Human Subject Protection","article_modified_time":"2026-09-09T21:52:02+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-checklist\/","url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-checklist\/","name":"IRB Submission Checklist - Office for Human Subject Protection - 糖心传媒","isPartOf":{"@id":"https:\/\/www.rochester.edu\/ohsp\/#website"},"datePublished":"2024-01-04T20:31:38+00:00","dateModified":"2026-09-09T21:52:02+00:00","description":"View and download a checklist of requirements for IRB submissions. Guidance issued by OHSP at the University of Rochester.","breadcrumb":{"@id":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-checklist\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-checklist\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/submission-checklist\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.rochester.edu\/ohsp\/"},{"@type":"ListItem","position":2,"name":"IRB","item":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/"},{"@type":"ListItem","position":3,"name":"IRB Submission Checklist"}]},{"@type":"WebSite","@id":"https:\/\/www.rochester.edu\/ohsp\/#website","url":"https:\/\/www.rochester.edu\/ohsp\/","name":"Office for Human Subject Protection","description":"糖心传媒","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.rochester.edu\/ohsp\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/3616","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/users\/36"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/comments?post=3616"}],"version-history":[{"count":15,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/3616\/revisions"}],"predecessor-version":[{"id":18056,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/3616\/revisions\/18056"}],"up":[{"embeddable":true,"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/pages\/356"}],"wp:attachment":[{"href":"https:\/\/www.rochester.edu\/ohsp\/wp-json\/wp\/v2\/media?parent=3616"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}