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It outlines required submission steps, including a written protocol, IRB application through an information portal, IRB review and approval, consent and authorization waivers, and an approval letter for record custodians. It specifies approval conditions for confidentiality, data use limits, de-identification for journal publication, identifier protection, chart coding, and destruction timing, with waiver criteria grounded in 45CFR46.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/loyola-university-chicago-health-sciences-division-institutional-review-board-retrospective-chart-andor-material-review-studies-template/170789/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/loyola-university-chicago-health-sciences-division-institutional-review-board-retrospective-chart-andor-material-review-studies-template/170789.png","ImageObject",442,249,{"name":88,"@type":89},"Connor ","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/octet-stream","2026-10-22","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",8,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What are the key requirements to submit a retrospective chart and/or material review study request?","Question",{"text":109,"@type":110},"Submission requires a written protocol using the attached template, an IRB application through the information portal, IRB review and approval, waivers of consent and authorization, and an approval letter provided to the keeper of the records.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"What conditions of IRB approval govern confidentiality and data use?",{"text":114,"@type":110},"The study must follow customary medical, legal, and ethical confidentiality requirements. Collected data may not be sold or shared outside the submission scope unless de-identified for journal publication, and identifiers must be handled and protected as required.",{"name":116,"@type":107,"acceptedAnswer":117},"What criteria must the IRB find to waive consent and to waive authorization?",{"text":118,"@type":110},"For consent waiver, the IRB must determine minimal risk and that the research cannot practicably be done without the waiver without adversely affecting rights, and without information needing to be provided. For authorization waiver, the IRB must determine minimal risk to individuals, no adverse effect on privacy rights and welfare, practicable inability without protected health information access, and reasonable privacy risks relative to anticipated benefits and knowledge importance, plus adequate plans for protecting and destroying identifiers and assurances against reuse or disclosure.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},170789,1788275536,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":76,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":126,"read_time":9},687207022233,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Loyola University Chicago\nHealth Sciences Division\nInstitutional Review Board for the Protection of Human Subjects\nRetrospective Chart and/or Material Review Studies\nThe following information and template are to be used when submitting a request to conduct retrospective chart and/or material review studies.\nRetrospective chart/existing materials reviews require:\na written protocol (use the attached template),\nan IRB application through the information portal,\nIRB review and approval,\nwaivers of consent and authorization,\nan approval letter provided to the keeper of the records.\nConditions of approval will be:\nYou are bound by the usual and customary medical, legal and ethical considerations governing the confidentiality of the medical record.\nThe data you collect may not be sold or given to any third party outside the scope of this submission unless it is to a journal for publication.  Data to a journal for publication must be de-identified.\nThe chart reviewed is to be identified on the data collection form by a unique code number and the master list kept under lock and key.  If you are not collecting data elements that can directly or indirectly identify the chart reviewed then this requirement is not relevant.\nThe link of the patient to the project is to be destroyed when it is no longer necessary.\nTo waive consent, the IRB must find:\nThe study is of minimal risk and qualifies for expedited review 45CFR46.110, b-1, HHS Secretary Category).\nThe requirement for consent is waived if:\nthe research could not practicably be done without the waiver;\nthe waiver does not adversely affect the rights of the individual;\nthe research involves no more than minimal risk;\nthere is no information that would need to be provided to the individual.\n(45CFR46.116, d1-4)\nTo waive authorization, the IRB must find:\nThe use or disclosure of protected health information involves no more than minimal risk to the individuals;\nThe alteration or waiver will not adversely affect the privacy rights and the welfare of the individuals;\nThe research could not practicably be conducted without the alteration or waiver;\nThe research could not practicably be conducted without access to and use of the protected health information;\nThe privacy risks to individuals whose protected health information is to be used or disclosed are reasonable in relation to 1) the anticipated benefits (if any) to the individuals, and 2) the importance of the knowledge that may reasonably be expected to result from the research.\nThere is an adequate plan to protect the identifiers from improper use and disclosure;\nThere is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law;\nThere are adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart.\n\u000f\nLOYOLA UNIVERSITY CHICAGO\nHEALTH SCIENCES DIVISION\nMAYWOOD, ILLINOIS\nProject Title:\nPrincipal Investigator:\nCo-Investigator:\nClinical Research Nurse:\n1.  Purpose / Rationale (appropriately referenced):\n2.  Objectives:\n3.  Methods and Material:  [Indicate:  a) what will be reviewed, b) the criteria for pulling the charts for review, c) the dates for the chart review (for example: January 1, 2000 to January 1, 2020), and d) how you will know what charts to review.  Examples:  ICD-9 diagnostic codes, departmental database, etc.]\n4.  Data Collected: [Specify the data/samples that will be collected and where the data is originating; LUMC and/or an outside institution.  Note samples or data from Epic Medical Records CANNOT be collected from Gottlieb and/or MacNeal.]\n5.  Plan to Protect Patient Identifi","cbCaijAdeICm5LCF","https://ap.wps.com/l/cbCaijAdeICm5LCF","doc",46592,"English","# Retrospective Chart and/or Material Review Studies Submission Requirements\n## Approval conditions and confidentiality rules\n## Waiver of consent and waiver of authorization criteria\n# Retrospective Review Study Project Template\n## Purpose and objectives\n## Methods and materials\n## Data collection and identifier protection plan","[{\"question\":\"What are the key requirements to submit a retrospective chart and/or material review study request?\",\"answer\":\"Submission requires a written protocol using the attached template, an IRB application through the information portal, IRB review and approval, waivers of consent and authorization, and an approval letter provided to the keeper of the records.\"},{\"question\":\"What conditions of IRB approval govern confidentiality and data use?\",\"answer\":\"The study must follow customary medical, legal, and ethical confidentiality requirements. Collected data may not be sold or shared outside the submission scope unless de-identified for journal publication, and identifiers must be handled and protected as required.\"},{\"question\":\"What criteria must the IRB find to waive consent and to waive authorization?\",\"answer\":\"For consent waiver, the IRB must determine minimal risk and that the research cannot practicably be done without the waiver without adversely affecting rights, and without information needing to be provided. For authorization waiver, the IRB must determine minimal risk to individuals, no adverse effect on privacy rights and welfare, practicable inability without protected health information access, and reasonable privacy risks relative to anticipated benefits and knowledge importance, plus adequate plans for protecting and destroying identifiers and assurances against reuse or disclosure.\"}]","Loyola University Chicago - Health Sciences Division - Institutional Review Board Retrospective Chart and/or Material Review Studies Template | DOC"]