[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-430792-105":59,"doc-detail-430792-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","irb-guidance-on-modifications-and-amendments-review","IRB Guidance on Modifications and Amendments Review","","Guidance explains when proposed changes to an existing approved protocol should be handled as a modification/amendment request rather than a new IRB application. It emphasizes that IRB review standards remain the same for modifications and amendments, and inadequate change descriptions, inconsistencies, or missing revised materials can slow review and trigger follow-up. The document provides decision factors including changes to research hypotheses, changes to procedures or methods, and how long ago approval was obtained, plus criteria suggesting the IRB would treat the change as a new study.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/irb-guidance-on-modifications-and-amendments-review/430792/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/irb-guidance-on-modifications-and-amendments-review/430792.png","ImageObject",300,407,{"name":92,"@type":93},"Marglet","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-05","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"When are proposed changes more appropriate as a modification/amendment request than a new IRB application?","Question",{"text":112,"@type":113},"If the basic research question or purpose remains intact and procedures/methods remain essentially the same, a new application may not be warranted. If changes are closely related to a longitudinal study, an amendment may also be appropriate.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Why can a modification/amendment request take longer than submitting a new application?",{"text":117,"@type":113},"A misconception is that modifications or amendments are easier and faster, but IRB must apply the same review and approval standards. Inadequate explanations of changes, inconsistencies, or missing appropriately revised materials can slow review and lead to follow-up communications.",{"name":119,"@type":110,"acceptedAnswer":120},"What criteria suggest the IRB would likely treat a modification as a new study requiring a new protocol?",{"text":121,"@type":113},"If the modification includes changes to two or more of the following criteria—study population, study procedures, and study purpose—the IRB would likely consider it a new study and ask the investigator(s) to submit a new protocol.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},430792,1791159752,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":8,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":81,"preview_page_count":4},2336477982702,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","| When do proposed changes warrant a modification or amendment request versus a new IRB  application? |  |  |\n| --- | --- | --- |\n| 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/amendment. It is a misconception that modification or amendment requests are easier and faster than submitting a new application. Xavier’s IRB must examine any modification/amendment using the same standards for review and approval as any other submission. A modification or amendment 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\u003Cbr>communications with the IRB. In some cases, a new application is easier to develop, review and approve. When deciding whether to submit a modification/amendment or a new protocol, consider the following: |  |  |\n| 1. | Do the proposed changes alter the research hypotheses? Is there a change in the study purpose and/or aims?\u003Cbr>• If the basic research question or purpose remains intact, then a new application may not be warranted.\u003Cbr>• If the research question has changed, even if it builds on the knowledge learned from a prior approved protocol, then a new application may be warranted. |  |\n| 2. | How will the procedures/methods change?\u003Cbr>• If the procedures/methods to be used remain essentially the same, then a new application may not be warranted.\u003Cbr>o For example, if the only changes involve substituting one questionnaire with another similar questionnaire or adding different stimuli of the same type, then submitting a modification/amendment may be appropriate.\u003Cbr>• If the new procedures/methods deviate from the original approved protocol, then a new application may be warranted.\u003Cbr>o If the changes to the procedures/methods result in a study that is different (e.g., asks a different research question) from the approved protocol, modifications/amendments can affect the quality of review and may not be appropriate. Submitting a new study may be necessary. |  |\n| 3. | How long ago was approval obtained?\u003Cbr>• If the approved protocol reflects a longitudinal study and if changes are otherwise closely related to the previously approved protocol (see item \\#2), then submitting an amendment may be appropriate.\u003Cbr>• If the approved protocol is not intended as longitudinal research and was approved in previous academic years, a new application may be appropriate. |  |\n| 4. | When might a modification or amendment really be a new IRB application?\u003Cbr>If the modification or amendment includes changes to two or more of the following criteria, the IRB would likely consider it to be a new study and the investigator(s) would be asked to submit a new protocol.\u003Cbr>• Study population\u003Cbr>• Study procedures\u003Cbr>• Study purpose\u003Cbr>[This guidance also applies when modifications/amendments are submitted to the same approved protocol successively across time.] |  |","cbCaijCHFl4SbCbj","https://ap.wps.com/l/cbCaijCHFl4SbCbj","pdf",92395,"English","# Decision Criteria for Modification vs. New IRB Application\n## Changes to Research Hypotheses and Study Purpose\n## Changes to Procedures and Methods\n## Time Since Approval\n## When Modifications Constitute a New IRB Study","[{\"question\":\"When are proposed changes more appropriate as a modification/amendment request than a new IRB application?\",\"answer\":\"If the basic research question or purpose remains intact and procedures/methods remain essentially the same, a new application may not be warranted. If changes are closely related to a longitudinal study, an amendment may also be appropriate.\"},{\"question\":\"Why can a modification/amendment request take longer than submitting a new application?\",\"answer\":\"A misconception is that modifications or amendments are easier and faster, but IRB must apply the same review and approval standards. Inadequate explanations of changes, inconsistencies, or missing appropriately revised materials can slow review and lead to follow-up communications.\"},{\"question\":\"What criteria suggest the IRB would likely treat a modification as a new study requiring a new protocol?\",\"answer\":\"If the modification includes changes to two or more of the following criteria—study population, study procedures, and study purpose—the IRB would likely consider it a new study and ask the investigator(s) to submit a new protocol.\"}]","IRB Guidance on Modifications and Amendments Review | PDF",1790653740]