[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-164543-105":53,"doc-detail-164543-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","informed-consent-guidance-hrp-2633","Informed Consent Guidance - HRP-2633","","Informed consent is the voluntary confirmation by a subject to participate in a study after receiving complete, decision-relevant information. The study protocol must outline and document how informed consent is obtained, and the LSUHSC-NO IRB must approve the method. The guidance explains written informed consent requirements, including providing an IRB-approved form to the subject or LAR, allowing time for questions, obtaining signatures, and distributing signed copies. It also covers verbal informed consent, including allowable conditions, documentation approaches, and requirements for verbal consent information sheets and scripts.",{"@graph":63,"@context":118},[64,80,101],{"@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/informed-consent-guidance-hrp-2633/164543/",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/informed-consent-guidance-hrp-2633/164543.png","ImageObject",442,249,{"name":88,"@type":89},"Emma Wilson","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-23","2026-08-31",true,{"@type":98,"interactionType":99,"userInteractionCount":76},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is informed consent in research?","Question",{"text":108,"@type":109},"Informed consent is the voluntary confirmation that a subject is willing to participate after being informed of all aspects of the study relevant to the decision to participate.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What steps are required to obtain written informed consent?",{"text":113,"@type":109},"The investigator presents the consent form, allows ample time for questions, provides a copy for review, answers additional questions, and obtains signatures (and HIPAA documentation if applicable). Signed copies should then be given to the subject or LAR.",{"name":115,"@type":106,"acceptedAnswer":116},"When can verbal informed consent be used instead of written consent?",{"text":117,"@type":109},"Verbal consent is allowed only under specified conditions, such as when the only record linking the subject is the signed consent form and risks are limited, when research presents no more than minimal risk with no normally written-consent procedures, or when signing is not the norm for a distinct cultural group with an appropriate alternative documentation method.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},164543,1788155477,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":76,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"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":125,"read_time":76},3848291630094,"https://eur-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","A process by which a subject voluntarily confirms his or her willingness to participate in a particular study, after having been informed of all aspects of the study that are relevant to the subject’s decision to participate.  The method of obtaining and documenting informed consent must be outlined in the study protocol and approved by the LSUHSC-NO IRB.\n\u0013 HYPERLINK \\l \"ICF\" \u0014Written Informed Consent\u0015\n\u0013 HYPERLINK \\l \"Verbal\" \u0014Verbal Informed Consent\u0015\n\u0013 HYPERLINK \\l \"InfoSheet\" \u0014Information Sheets\u0015\n\u0013 HYPERLINK \\l \"Waiver\" \u0014Waiver of Informed Consent\u0015\n\u0013 HYPERLINK \\l \"NonEnglish\" \u0014Consenting Non-English-Speaking Subjects\u0015\nINFORMED CONSENT\nWhat is written informed consent?\nInformed consent is typically documented by means of a written, signed and dated informed consent form.\nWhat is the process for obtaining written informed consent from a subject?\nInvestigator or sub-investigator presents the consent form with the potential participant and allows ample time for the potential participant to ask questions.\nThe potential participant must be provided with a copy of the consent and given time to consider whether they want to participate.\nAfter allowing the participant time to decide, the Investigator or designee (e.g., coordinator) must answer any additional questions the subject may have.\nWhen the potential participant is ready, the Investigator or designee must obtain signatures on the consent (and HIPAA Authorization/Acknowledgement of Notice of Privacy and Practices (NPP), if applicable).\nWhat do you need to provide to the subject/LAR when consenting?\nThe IRB requires the investigator to provide the subject and/or their LAR with the IRB-approved informed consent form (and HIPAA Authorization/Acknowledgement of NPP, if applicable) during the consenting process. Upon execution, a copy of the signed documents should be made and given to the subject or their Legally Authorized Representative (LAR).\nWhat consent template do you use and when?\n\u0013 HYPERLINK \"https://www.lsuhsc.edu/administration/academic/ors/irb/consent_form_templates.aspx\" \u0014Standard Joint Consent/HIPAA Template [HRP-2250, 2251]\u0015: used for research activities conducted by LSUHSC personnel, with the exceptions listed below.\n\u0013 HYPERLINK \"https://www.lsuhsc.edu/administration/academic/ors/irb/consent_form_templates.aspx\" \u0014LSUHSC-UMC Joint Consent/HIPAA Template [HRP-2251UMC]\u0015: used when some/all research activities will be conducted at UMC.\n\u0013 HYPERLINK \"https://www.lsuhsc.edu/administration/academic/ors/irb/consent_form_templates.aspx\" \u0014LSUHSC-OLOL Joint Consent/HIPAA Template [HRP-2251OLOL]\u0015: used when some/all research activities will be conducted on an FMOLHS campus.\n\u0013 HYPERLINK \"https://www.lsuhsc.edu/administration/academic/ors/irb/consent_form_templates.aspx\" \u0014CHNOLA-LSUHSC Joint Consent Form\u0015: used when some/all research activities will be conducted at Children’s Hospital\nVERBAL INFORMED CONSENT (Waiver of Documentation of Informed Consent, Request for Verbal)\nWhat is verbal consent?\nVerbal informed consent occurs when a member of the research team and a potential subject verbally interact, and the subject gives their consent to participate verbally. The member of the research team and the subject can be in the same location or can be communicating over the phone or through some other electronic means (i.e. Zoom).\nWhen is verbal consent allowed?\nOne of the following must apply:\nThe only record linking the subject and the research would be the signed informed consent form, and the principal risk would be potential harm resulting from a breach in confidentiality. In this instance, you must give the subject or their LAR the opportunity to sign the Verbal Consent if they want to.\nThe research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.\nThe subject and/or their LAR are members of a distinct cultural group or community where signing forms is not the norm; th","cbCaidMWrzqqane9","https://ap.wps.com/l/cbCaidMWrzqqane9","docx",81865,8,"English","# Informed Consent\n## What is written informed consent?\n## Process for obtaining written informed consent\n## What is required to provide to the subject/LAR\n## Consent template options and when to use them\n## Verbal informed consent (waiver of documentation, request for verbal)\n### What is verbal consent?\n### When is verbal consent allowed?\n### Verbal consent form vs verbal consenting script\n### Process for obtaining verbal informed consent (in-person)","[{\"question\":\"What is informed consent in research?\",\"answer\":\"Informed consent is the voluntary confirmation that a subject is willing to participate after being informed of all aspects of the study relevant to the decision to participate.\"},{\"question\":\"What steps are required to obtain written informed consent?\",\"answer\":\"The investigator presents the consent form, allows ample time for questions, provides a copy for review, answers additional questions, and obtains signatures (and HIPAA documentation if applicable). Signed copies should then be given to the subject or LAR.\"},{\"question\":\"When can verbal informed consent be used instead of written consent?\",\"answer\":\"Verbal consent is allowed only under specified conditions, such as when the only record linking the subject is the signed consent form and risks are limited, when research presents no more than minimal risk with no normally written-consent procedures, or when signing is not the norm for a distinct cultural group with an appropriate alternative documentation method.\"}]","Informed Consent Guidance - HRP-2633 | DOCX"]