{"id":160,"date":"2018-09-07T15:06:31","date_gmt":"2018-09-07T15:06:31","guid":{"rendered":"http:\/\/www.montclair.edu\/institutional-review-board\/?page_id=160"},"modified":"2026-02-19T09:16:38","modified_gmt":"2026-02-19T14:16:38","slug":"cayuse-irb-submission-process","status":"publish","type":"page","link":"https:\/\/www.montclair.edu\/institutional-review-board\/cayuse-irb\/cayuse-irb-submission-process\/","title":{"rendered":"Cayuse IRB Submission Process"},"content":{"rendered":"<div class=\"prpl-drawer\"><div class=\"prpl-drawer-header\">New Study Submission<\/div><div class=\"prpl-drawer-content\">\n<h2>New Study Submission<\/h2>\n<p>NEW! View our\u00a0<a href=\"http:\/\/www.montclair.edu\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2025\/12\/Cayuse-Turtorial-2025.pdf\">Cayuse IRB Initial Submission Training PowerPoint<\/a>.<\/p>\n<p>To create a new study, click the\u00a0<strong>New Study<\/strong>\u00a0button in the upper right of either the Studies page or your Dashboard.<\/p>\n<figure class=\"responsive-image-holder wp-caption alignnone\"><img decoding=\"async\" class=\"mlt-responsive-image\" data-original-image=\"\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2019\/09\/New-Study2.jpg\" src=\"\/responsive-media\/cache\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2019\/09\/New-Study2.jpg.0.1x.generic.jpg\"\/><\/figure>\n<p>After creating the new study, you will be taken to the Study Details page for that study, which displays important information regarding the study.<\/p>\n<p>To begin working on your study, click\u00a0<strong>New Submission<\/strong>\u00a0to add the initial submission for your study.<\/p>\n<figure class=\"responsive-image-holder wp-caption alignnone\"><img decoding=\"async\" class=\"mlt-responsive-image\" data-original-image=\"\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2019\/09\/initiial.jpg\" src=\"\/responsive-media\/cache\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2019\/09\/initiial.jpg.0.1x.generic.jpg\"\/><\/figure>\n<p>The initial submission appears below the study details. The person who creates the study is added as the PC by default. You can change this when editing the submission, if needed. Click the\u00a0<strong>Edit<\/strong>\u00a0button to begin working on the initial submission.<\/p>\n<\/div><\/div>\n<div class=\"prpl-drawer\"><div class=\"prpl-drawer-header\">Making IRB Requested Changes<\/div><div class=\"prpl-drawer-content\">\n<ul>\n<li>You will likely have to make revisions to your initial submission based on comments from the IRB reviewer and\/or the IRB staff<\/li>\n<li>This may involve responding to comments within the submission sections<\/li>\n<li>Sections with unresolved\u00a0<span class=\"SearchHighlight SearchHighlight1\">comments<\/span>\u00a0have a comment bubble icon to their right indicating the total number of unresolved\u00a0<span class=\"SearchHighlight SearchHighlight1\">comments<\/span>\u00a0in that section\n<ul>\n<li>Questions with new\u00a0<span class=\"SearchHighlight SearchHighlight1\">comments<\/span>\u00a0show a gray comment bubble and the number of\u00a0<span class=\"SearchHighlight SearchHighlight1\">comments<\/span>\u00a0for that particular item underneath the question<\/li>\n<\/ul>\n<\/li>\n<li>Select the sections that are highlighted with comment boxes and search for &#8220;Expand comments&#8221;<\/li>\n<li>Click on the &#8220;Expand Comments&#8221;\u00a0to view the\u00a0<span class=\"SearchHighlight SearchHighlight1\">comments<\/span>\u00a0associated with each question<\/li>\n<li>Click &#8220;Reply&#8221;\u00a0to open a text box to write your comment<\/li>\n<li>Type in your comment<\/li>\n<li>Click &#8220;Save&#8221;<strong>\u00a0to save<\/strong>\u00a0your comment<\/li>\n<li>Once you have resolved an issue, change the status drop-down from &#8220;Not Addressed&#8221;\u00a0 to\u00a0&#8220;Addressed&#8221;. Addressed\u00a0<span class=\"SearchHighlight SearchHighlight1\">comments<\/span>\u00a0have a green sidebar and the comment count no longer appears on the comment bubble icon for that question (unless there are other unaddressed\u00a0<span class=\"SearchHighlight SearchHighlight1\">comments<\/span>\u00a0for that question). You must mark all\u00a0<span class=\"SearchHighlight SearchHighlight1\">comments<\/span>\u00a0as addressed before the submission can be re-certified.<\/li>\n<li>Your submission is ready to re-certify once all check marks appear as green next to each section<\/li>\n<li>The PI \u00a0will need to re-certify the submission to return it to the IRB Office<\/li>\n<\/ul>\n<\/div><\/div>\n<div class=\"prpl-drawer\"><div class=\"prpl-drawer-header\">Submitting Modifications<\/div><div class=\"prpl-drawer-content\">\n<p><strong>Step 1:<\/strong> Go to your study details page. \u00a0Click the blue &#8220;+ New Submission&#8221; button and select &#8220;Modification&#8221;<\/p>\n<div class=\"prpl-row\"><div class=\"prpl-column two-thirds\">\n<figure class=\"responsive-image-holder wp-caption alignnone\"><img decoding=\"async\" class=\"mlt-responsive-image\" data-original-image=\"\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2018\/09\/cayuse-mod1-640x480.png\" src=\"\/responsive-media\/cache\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2018\/09\/cayuse-mod1-640x480.png.0.1x.generic.jpg\" alt=\"Go to your study details page. Click the blue &quot;+ New Submission&quot; button and select &quot;Modification.&quot;\"\/><\/figure>\n<\/div><\/div>\n<p><strong>Step 2:<\/strong> Select Edit on the Submission details page to begin the submission<\/p>\n<p><strong>Step 3:<\/strong> Answer the Modification type question and make your requested changes directly in the corresponding section of the submission<\/p>\n<div class=\"prpl-row\"><div class=\"prpl-column two-thirds\"><div class='inset lt-gray'>\n<figure class=\"responsive-image-holder wp-caption alignnone\"><img decoding=\"async\" class=\"mlt-responsive-image\" data-original-image=\"\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2019\/09\/mod-choice2.jpg\" src=\"\/responsive-media\/cache\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2019\/09\/mod-choice2.jpg.0.1x.generic.jpg\" alt=\"Answer the Modification type question and make your requested changes directly in the corresponding section of the submission.\"\/><\/figure>\n<\/div><\/div><\/div>\n<p><strong>Step 4:<\/strong> Complete and certify your submission<\/p>\n<div class=\"prpl-row\"><div class=\"prpl-column one-fourth\">\n<figure class=\"responsive-image-holder wp-caption alignnone\"><img decoding=\"async\" class=\"mlt-responsive-image\" data-original-image=\"\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2018\/09\/modification1.png\" src=\"\/responsive-media\/cache\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2018\/09\/modification1.png.0.1x.generic.jpg\" alt=\"Complete and certify your submission.\"\/><\/figure>\n<\/div>\n<div class=\"prpl-column three-fourths\">\n<figure class=\"responsive-image-holder wp-caption alignnone\"><img decoding=\"async\" class=\"mlt-responsive-image\" data-original-image=\"\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2018\/09\/modification2.png\" src=\"\/responsive-media\/cache\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2018\/09\/modification2.png.0.1x.generic.jpg\" alt=\"Complete and certify your submission.\"\/><\/figure>\n<\/div><\/div>\n<p><strong>Note:\u00a0<\/strong>Remember you can compare your current submission to the immediately preceding version by selecting &#8220;Compare&#8221; at the top of the page<\/p>\n<\/div><\/div>\n<div class=\"prpl-drawer\"><div class=\"prpl-drawer-header\">Submitting Modifications vs&period; New Initial Protocol<\/div><div class=\"prpl-drawer-content\">\n<p><span style=\"font-weight: 400\">When proposing changes to an existing approved protocol, it is important to consider whether the changes may warrant submission of a new protocol rather than a modification. Please consider the following:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Did the study aims, research questions, or hypotheses change?<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Are there more than just 1 or 2 changes to the procedures or method?<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">When was your initial approval? Was your study designed as a longitudinal study?<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Did your compensation change (i.e., you gave out the first 100 gift cards and now you are using a different type of compensation strategy)?<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">If one or more of these apply to your modification, it is likely you should submit a new application for a new proposed study. <strong>If you are still unsure, please review the checklist below regarding when to submit a modification versus a new application.<\/strong>\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">Modification submissions are not necessarily easier or faster for you as the PI than submitting a new application.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">Montclair\u2019s IRB must examine any modification using the same standards for review and approval as any other submission. A modification that does not adequately explain changes, includes inconsistencies, or does not provide the appropriately revised materials will slow the review process and result in follow-up communications with the IRB.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">Please note, if you do need to submit a new application, you will also need to submit a closure for the original study.\u00a0<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<th colspan=\"3\"><strong>Submitting Modifications vs. New Initial Protocol Checklist<\/strong><\/th>\n<\/tr>\n<tr>\n<td><b>Do the proposed changes alter the research hypothesis? Is there a change in the study purpose and\/or aims?<\/b><span style=\"font-weight: 400\">\u00a0<\/span>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">If the focus or research question has changed, even if it builds on the knowledge learned in an existing study, this would be considered a substantial change and a new protocol would be warranted.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">If the original study was a pilot study and now you are ready to implement a full scale study, this would be considered a substantial change and would warrant a new protocol.<\/span><\/li>\n<\/ul>\n<\/td>\n<td><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td><b>Did the procedures\/methods change substantially?<\/b>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">If the only changes involve substituting one questionnaire for another similar questionnaire or adding different stimuli of the same type, this would not be considered a substantial change.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">If the study now has multiple new arms, you are changing from a quantitative method to a qualitative method, you have added a new participant group that has significantly different recruitment strategies, this would be considered a substantial change in method and would warrant a new protocol.<\/span><\/li>\n<\/ul>\n<\/td>\n<td><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td><b>Was the initial study submitted more than 3 years ago?\u00a0<\/b>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">If the study was intended to be a longitudinal study, this question may not be valid for use in determining if a new application is needed.<\/span><\/li>\n<\/ul>\n<\/td>\n<td><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td><b>Will the study utilize a new compensation structure?<\/b>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">For example, if your initial study had the \u201cfirst 100 people get a gift card\u201d or \u201cwill be entered into a raffle,\u201d these studies are somewhat time sensitive, as the awarding of these amounts should take place within a semester or one academic year.\u00a0<\/span><\/li>\n<\/ul>\n<\/td>\n<td><\/td>\n<td><\/td>\n<\/tr>\n<tr>\n<td><b>Is this a new grant?\u00a0<\/b>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Have you received a new grant number even if it is a continuation of a previously approved protocol with the same funder?<\/span><\/li>\n<\/ul>\n<\/td>\n<td><\/td>\n<td><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 200\">Adapted from University of Oregon IRB<\/span><\/p>\n<p><span style=\"font-weight: 400\"><strong>If you answered yes to one or more of the questions above, then you will need to submit a new application for your study.<\/strong> Please note you will also need to submit a closure to the previous study as well.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">If you have any questions or concerns please email us at <\/span><a href=\"mailto:ReviewBoard@montclair.edu\"><span style=\"font-weight: 400\"><strong>reviewboard@montclair.edu<\/strong><\/span><\/a><span style=\"font-weight: 400\">.<\/span><\/p>\n<\/div><\/div>\n<div class=\"prpl-drawer\"><div class=\"prpl-drawer-header\">Changing Study Title<\/div><div class=\"prpl-drawer-content\">\n<ol>\n<li>Go to your Study Details page<\/li>\n<li>Hover over your study title\n<figure class=\"responsive-image-holder wp-caption alignnone\"><img decoding=\"async\" class=\"mlt-responsive-image\" data-original-image=\"\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2018\/09\/studyname1.png\" src=\"\/responsive-media\/cache\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2018\/09\/studyname1.png.0.1x.generic.jpg\" alt=\"Hover over study title\"\/><\/figure><\/li>\n<li>Click and type in new study title<\/li>\n<li>Click the blue check\n<figure class=\"responsive-image-holder wp-caption alignnone\"><img decoding=\"async\" class=\"mlt-responsive-image\" data-original-image=\"\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2018\/09\/studyname2.png\" src=\"\/responsive-media\/cache\/institutional-review-board\/wp-content\/uploads\/sites\/179\/2018\/09\/studyname2.png.0.1x.generic.jpg\" alt=\"Click blue check\"\/><\/figure><\/li>\n<\/ol>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":539,"parent":156,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-160","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/pages\/160","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/comments?post=160"}],"version-history":[{"count":39,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/pages\/160\/revisions"}],"predecessor-version":[{"id":3065,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/pages\/160\/revisions\/3065"}],"up":[{"embeddable":true,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/pages\/156"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/media\/539"}],"wp:attachment":[{"href":"https:\/\/www.montclair.edu\/institutional-review-board\/wp-json\/wp\/v2\/media?parent=160"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}