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Submit all amendment materials to IRB staff, and follow email instructions regarding whether ROB review is needed.",{"name":70,"@type":61,"acceptedAnswer":71},"What protocol versions must be included in an amendment application?",{"text":72,"@type":64},"Include both a “tracked changes” version and a “clean” version without comments or markings of the protocol.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},283692,1790412485,{"code":4,"msg":82,"data":83},"success",[84,88,93,98,103,108,112,117,122],{"id":55,"doc_module":22,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Presentations",90,"presentations",{"id":89,"doc_module":22,"doc_module_name":25,"category_name":90,"show_sort_weight":91,"slug":92},12,"Resumes",80,"resumes",{"id":94,"doc_module":22,"doc_module_name":25,"category_name":95,"show_sort_weight":96,"slug":97},14,"Invoices",70,"invoices",{"id":99,"doc_module":22,"doc_module_name":25,"category_name":100,"show_sort_weight":101,"slug":102},15,"Posters",60,"posters",{"id":104,"doc_module":22,"doc_module_name":25,"category_name":105,"show_sort_weight":106,"slug":107},16,"Social Media",50,"social-media",{"id":109,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":110,"slug":111},17,40,"forms",{"id":113,"doc_module":22,"doc_module_name":25,"category_name":114,"show_sort_weight":115,"slug":116},18,"Letters",30,"letters",{"id":118,"doc_module":22,"doc_module_name":25,"category_name":119,"show_sort_weight":120,"slug":121},21,"Paper Templates",5,"papers-templates",{"id":123,"doc_module":22,"doc_module_name":25,"category_name":124,"show_sort_weight":4,"slug":125},158,"General","general-158",{"code":4,"msg":82,"data":127},{"doc_id":79,"user_id":128,"nickname":42,"user_avatar":129,"doc_module":22,"category_id":109,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":33,"language":135,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":12,"update_tm":139,"read_time":26},18829141979164,"https://eur-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","Department of Public Health Institutional Review Board 313 N. Figueroa St., Room 127  \nLos Angeles, CA 90012  \nPhone: (213) 288-8675 [Email: irb@ph.lacounty.gov](Email: irb@ph.lacounty.gov)  \n[http://publichealth.lacounty.gov/irb/](http://publichealth.lacounty.gov/irb/)  \nChecklist of Items You Will Need to Submit an Amendment Application  \nREMEMBER: Changes to project activities cannot be implemented until an official approval letter from the IRB has been obtained.  \nBefore you submit an amendment application   \n• For projects originating in DPH, involving DPH staff/clients, or funded by DPH:  \no We are no longer requiring surveys to be reviewed by Office of Health Assessment and Epidemiology (OHAE) Rapid Assessment, Training and Evaluation unit (RATE) . If you are adding a survey to your project and/or making changes to a previously approved survey, please ensure your survey has been reviewed and approved by program leadership and subject matter experts in your program. If your program does not have this expertise and you would like help at any point in the creation of your survey, please contact OHAE Director, Dr. Megha Shah, who will determine the best team in OHAE to assist you.  \n• If you are adding a DHS site, a DHS dataset, or DHS patients/staff to your project:  \nYour amendment application may need to undergo review by DHS’ Research Oversight Board (ROB) . Please submit all amendment materials, including a revised protocol, to [irb@ph.lacounty.gov](irb@ph.lacounty.gov. IRB)[. IRB](irb@ph.lacounty.gov. IRB)[ ](irb@ph.lacounty.gov. IRB)[staff will work with the ROB liaison to determine whether ROB review is needed. If ROB review is](staff will work with the ROB liaison to determine whether ROB review is needed. If ROB review is)[ ](staff will work with the ROB liaison to determine whether ROB review is needed. If ROB review is)required, no further action is required on your part and you will receive the result of the review via email -include a PDF of the email (including the assigned category number) with your amendment application in IRBManager. If the ROB decides that their review is not required, you will be notified via email-please include a PDF of the email confirmation with your amendment application.  \nRevised 07/30/2026  \nPlease note that it is your responsibility to also obtain approval from the director/leadership of the specific DHS site(s)/program(s) that will be involved in your project (documentation of approval from site(s)/program(s) does not need to be included with your IRB application) .  \n• If you are proposing to add minors, prisoners, and/or pregnant persons to your project:  \nYou will need to apply for IRB review as a new study (i.e., a separate study with a new IRB \\#) . Please submit a new IRB application and ensure that adequate protections for the inclusion of vulnerable populations are described in your application and supporting documents.  \nAmendment application checklist  \n□ Signatures  \nThe Principal Investigator(PI)/project lead and DPH/DHS liaison (if applicable) will need  \nto provide their signature throughout the amendment application process similar to the process for submitting a new IRB application. Please ensure they check their email account (including spam/junk folders) for any notifications and provide their signatures promptly to avoid any delays in the review process.  \n□ Summary of changes  \nThe amendment application will require a summary of all changes that are being requested as part of the amendment application (300 word limit) .  \n□ Protocol  \nInclude both “tracked changes” and “clean”(i.e., without any comments or markings) versions of your protocol. If your protocol does not require any modification from the previously approved version, you may upload the“clean” version of the previously approved protocol in both spaces.  \n□ New documents  \nYou will need to provide with your application any new documents you are adding to your project (for new documents only includ","cbCaictGaiN6EWzs","https://ap.wps.com/l/cbCaictGaiN6EWzs","pdf",515452,"English","# Amendment application checklist\n## Before you submit an amendment application\n## Checklist of items you will need to submit\n## Signatures\n## Summary of changes\n## Protocol\n## New documents\n## Modified versions of IRB-approved documents\n## HIPAA individual authorization (if applicable)\n## New personnel credentials","[{\"question\":\"When can project activity changes begin after submitting an IRB amendment request?\",\"answer\":\"Project activities cannot be implemented until an official approval letter from the IRB has been obtained.\"},{\"question\":\"What additional review may be required when adding a DHS site, DHS dataset, or DHS patients/staff?\",\"answer\":\"The amendment application may need review by the DHS Research Oversight Board (ROB). Submit all amendment materials to IRB staff, and follow email instructions regarding whether ROB review is needed.\"},{\"question\":\"What protocol versions must be included in an amendment application?\",\"answer\":\"Include both a “tracked changes” version and a “clean” version without comments or markings of the protocol.\"}]","IRB Amendment Application Checklist - Revised 07/30/2026 | PDF",1789617365]