[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-170788-105":3,"detail-sidebar-cat-1-en-105":85,"doc-detail-170788-en":130},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":78,"head_meta":80,"extra_data":82,"updated_unix":84},105,"en","retrospective-data-or-biospecimen-review-protocol-template-request-for-an-exemption","Retrospective Data or Biospecimen Review Protocol Template - Request for an Exemption","","Retrospective data or biospecimen review protocol template outlining requirements for requesting an exemption from NIH IRB review under Exemption Category 4. Specifies eligibility conditions, including use of identifiable data or biospecimens without recording or retaining identifiers for analyses, and emphasizes secondary research rather than primary use. Includes rules on project scope restrictions (e.g., prisoner data), necessity of a blank data collection sheet, identifiability considerations, and guidance for using CRIS with de-identified data and required correspondence uploads.",{"@graph":14,"@context":77},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/template/forms/","Forms",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/template/retrospective-data-or-biospecimen-review-protocol-template-request-for-an-exemption/170788/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/retrospective-data-or-biospecimen-review-protocol-template-request-for-an-exemption/170788.png","ImageObject",442,249,{"name":42,"@type":43},"Mason","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/octet-stream","2026-10-25","2026-09-01",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",12,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69,73],{"name":60,"@type":61,"acceptedAnswer":62},"What eligibility criteria allow an exemption for a retrospective review under Exemption Category 4?","Question",{"text":63,"@type":64},"The protocol must use identifiable biospecimens and/or data, but it must not record or retain identifiers for analysis. The work must be secondary research rather than primary use, and the submission must not involve prisoner data.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"Why is a blank data collection sheet required for this type of submission?",{"text":68,"@type":64},"The data collection sheet must list every data point that will be recorded and maintained for analysis. Projects submitted without this sheet will not be reviewed.",{"name":70,"@type":61,"acceptedAnswer":71},"When is an IRB exemption likely not possible due to identifiers?",{"text":72,"@type":64},"If personal identifiers or links to identifiers will remain accessible to the research team throughout the project, an exemption is likely not possible. De-identified or non-linkable data may reduce the need for an exemption, depending on circumstances.",{"name":74,"@type":61,"acceptedAnswer":75},"What steps are required to use CRIS for an exempt retrospective project?",{"text":76,"@type":64},"Contact the BTRS team to determine feasibility with de-identified data or to obtain and de-identify data. If CRIS is the only option and the subjects come from known IRB-approved protocols, obtain PI(s) confirmation by email, save responses as PDFs, and upload them as correspondence in iRIS.","https://schema.org",{"og:url":32,"og:type":79,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":81,"canonical":32},"index,follow",{"doc_id":83,"site_id":7},170788,1790954520,{"code":4,"msg":86,"data":87},"success",[88,93,97,102,107,112,116,121,126],{"id":89,"doc_module":22,"doc_module_name":25,"category_name":90,"show_sort_weight":91,"slug":92},11,"Presentations",90,"presentations",{"id":55,"doc_module":22,"doc_module_name":25,"category_name":94,"show_sort_weight":95,"slug":96},"Resumes",80,"resumes",{"id":98,"doc_module":22,"doc_module_name":25,"category_name":99,"show_sort_weight":100,"slug":101},14,"Invoices",70,"invoices",{"id":103,"doc_module":22,"doc_module_name":25,"category_name":104,"show_sort_weight":105,"slug":106},15,"Posters",60,"posters",{"id":108,"doc_module":22,"doc_module_name":25,"category_name":109,"show_sort_weight":110,"slug":111},16,"Social Media",50,"social-media",{"id":113,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":114,"slug":115},17,40,"forms",{"id":117,"doc_module":22,"doc_module_name":25,"category_name":118,"show_sort_weight":119,"slug":120},18,"Letters",30,"letters",{"id":122,"doc_module":22,"doc_module_name":25,"category_name":123,"show_sort_weight":124,"slug":125},21,"Paper Templates",5,"papers-templates",{"id":127,"doc_module":22,"doc_module_name":25,"category_name":128,"show_sort_weight":4,"slug":129},158,"General","general-158",{"code":4,"msg":86,"data":131},{"doc_id":83,"user_id":132,"nickname":42,"user_avatar":133,"doc_module":22,"category_id":113,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":124,"language":139,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":12,"update_tm":143,"read_time":26},5909887256941,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","PROTOCOL TEMPLATE FOR A RETROSPECTIVE DATA OR BIOSPECIMEN REVIEW (REQUEST FOR AN EXEMPTION)\nThis preface contains clarification about the protocol template and required supporting materials.  Remove the preface before finalizing the protocol.\nTo be eligible of an exemption from IRB review for a retrospective review at NIH, you must be using identifiable biospecimens and/or data, but not recording or retaining any identifiers to be used for the analyses (Exemption Category 4).  For guidance on identifiability and a list of identifiers, please see Guidance for Determining Whether Data Constitutes Individually Identifiable Information under 45 CFR 46 on the OHSRP website. The use of these materials must be secondary research rather than primary. Secondary Research is the research use of information or biospecimens collected for research studies other than the proposed research, or for non-research purposes. Please note that if your project involves data from prisoners, it is not eligible for an exemption.\nThis type of submission also requires a blank data collection sheet be created and submitted as a part of the application as well. The data collection sheet must show every data point that you will record and maintain for use as part of the analysis.  Projects that are submitted without the data collection sheet will not be reviewed.\nIf personal identifiers or links to identifiers will be accessible to the research team throughout the research project, an exemption from IRB review is likely not possible. One exception is if the biospecimens and/or data meet the definition of publicly available or the project only involves government-generated or government-collected information that was obtained for non-research activities.\nIf the biospecimens and/or data that you plan to use for the project do not currently contain personal identifiers and the research team will have no way to link back to identifiers or if the human sources of the materials are all confirmed to be deceased, submission of a request for an exemption from IRB review is likely not necessary.\nIf the purpose of the project is only to conduct quality assessment (QA), quality improvement (QI), a program evaluation or evidence-based practice (EBP) and not also to conduct research or is to create a single case report (i.e. discussing the clinical trajectory of one patient), submission of a protocol for a determination of \"exempt from IRB review\" is not required.  If you wish, you can request a determination of “Not Research” through submission of the Not Human Subjects Research Application form.\nUse of CRIS\nIf you are conducting a retrospective chart review and wish to use CRIS (the electronic medical record) for your project, you are expected to first contact the Office of Biomedical Translational Research Informatics (BTRS) team (BTRISSupport@nih.gov) to determine whether it would be possible to conduct the study using de-identified data in BTRIS or if the BTRIS staff can help obtain and de-identify data for the study team. Once you determine that CRIS is your only option: If the subjects whose data you will access are a part of known IRB-approved protocols, you will need to contact the PIs and explain that you plan to access data from their protocols and ensure that they have no concerns.  Please email the PI(s) and ask them to respond to your email confirming their knowledge and approval of your planned project.  Then save the response email(s) as PDF(s) and upload them as correspondence into your iRIS submission. Please note that after receiving your exemption you also will have to submit documentation to the medical records department (HIMD), prior to moving forward with your project.  Please review and complete the “Access to CRIS for Exempt Research” form which can be found on the IRBO website.\nIf it is determined that your study does not meet the review level of exempt, you will need to submit a protocol or an amendment to a protocol for IRB review and approval","cbCaimsu8RDTv2IS","https://ap.wps.com/l/cbCaimsu8RDTv2IS","doc",68608,"English","# Protocol Eligibility and Supporting Materials\n## Identifiability, Secondary Research, and Exemption Category 4\n## Data Collection Sheet Requirement\n## When Exemption Is Not Possible\n## Not Research and Non-IRB Alternatives\n# CRIS Guidance and Required Correspondence\n## Contacting BTRS Team and De-Identification Steps\n## PI(s) Approval and iRIS Uploads\n## HIMD Documentation Before Project Start\n# Protocol Sections to Complete\n## Title, Investigators, and Collaborators\n## Background\n## Study Objectives and Hypotheses\n## Biospecimens and/or Data to Be Used","[{\"question\":\"What eligibility criteria allow an exemption for a retrospective review under Exemption Category 4?\",\"answer\":\"The protocol must use identifiable biospecimens and/or data, but it must not record or retain identifiers for analysis. The work must be secondary research rather than primary use, and the submission must not involve prisoner data.\"},{\"question\":\"Why is a blank data collection sheet required for this type of submission?\",\"answer\":\"The data collection sheet must list every data point that will be recorded and maintained for analysis. Projects submitted without this sheet will not be reviewed.\"},{\"question\":\"When is an IRB exemption likely not possible due to identifiers?\",\"answer\":\"If personal identifiers or links to identifiers will remain accessible to the research team throughout the project, an exemption is likely not possible. De-identified or non-linkable data may reduce the need for an exemption, depending on circumstances.\"},{\"question\":\"What steps are required to use CRIS for an exempt retrospective project?\",\"answer\":\"Contact the BTRS team to determine feasibility with de-identified data or to obtain and de-identify data. If CRIS is the only option and the subjects come from known IRB-approved protocols, obtain PI(s) confirmation by email, save responses as PDFs, and upload them as correspondence in iRIS.\"}]","Retrospective Data or Biospecimen Review Protocol Template - Request for an Exemption | DOC",1788275524]