[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-172266-105":53,"doc-detail-172266-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","nih-informed-consent-template-for-expanded-access-including-single-patient-at-the-nih-clinical-center-version-9-use-instructions","NIH INFORMED CONSENT TEMPLATE FOR EXPANDED ACCESS (including single patient) AT THE NIH CLINICAL CENTER - Version 9 - Use instructions","","NIH informed consent template for expanded access protocols, including single-patient use, for the NIH Clinical Center, aligned with NIH policies and the revised Common Rule (rCR). Provides required NIH language, section headers, document headers/footers, and optional sections, with specific rules on what cannot be changed without clearance from OHSRP and OGC and how to update investigator-highlighted areas before IRB submission. Includes guidance on consent readability, proofreading, signature page block selection, and required footer/version and IRB numbering updates.",{"@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/nih-informed-consent-template-for-expanded-access-including-single-patient-at-the-nih-clinical-center-version-9-use-instructions/172266/",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/nih-informed-consent-template-for-expanded-access-including-single-patient-at-the-nih-clinical-center-version-9-use-instructions/172266.png","ImageObject",442,249,{"name":88,"@type":89},"Sage","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-25","2026-09-01",true,{"@type":98,"interactionType":99,"userInteractionCount":40},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is this template intended for?","Question",{"text":108,"@type":109},"It is intended for expanded access protocols (including single patient) conducted at the NIH Clinical Center, and is built to meet NIH-required consent language and structure.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Which parts of the required NIH language can be changed?",{"text":113,"@type":109},"Changes to required NIH language cannot be made without clearance from the Office of Human Subjects Research Protections (OHSRP) and the NIH Office of the General Counsel (OGC).",{"name":115,"@type":106,"acceptedAnswer":116},"How should investigators handle the signature page and optional blocks?",{"text":117,"@type":109},"Keep only the signature blocks applicable to the study, always leaving the “Investigator” block and following study enrollment rules for adult participants, legally authorized representatives, parents/guardians, and assent as applicable. Include the “Witness” block only under the stated eligibility restrictions.","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},172266,1788290947,{"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":40,"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":79},687197207057,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","NIH INFORMED CONSENT TEMPLATE FOR EXPANDED ACCESS (including single patient) AT THE NIH CLINICAL CENTER\nVersion 9: 01-26-2026\nGENERAL INSTRUCTIONS FOR USE OF THIS TEMPLATE\nThis template must be used for expanded access protocols (including single patient) conducted at the NIH Clinical Center. The template comprises NIH required language, document headers, document footers, and section headings, as well as optional section headings and instructional language, and is consistent with NIH policies and the revised Common Rule (rCR).\nRequired NIH Language:\nChanges to required language cannot be made without clearance from the Office of Human Subjects Research Protections (OHSRP) and the NIH Office of the General Counsel (OGC).\nRequired NIH Language is included throughout the consent template and is colored in blue for the purposes of this template. Change all font to black when you submit to the NIH IRB.\nNote that in this version the language regarding the storage of data for future use and sharing is now in blue.\nThe document header and footer may not be revised except for areas highlighted in yellow; these highlighted sections must be updated by the investigator prior to submission to the IRB.\nSection Headings:\n12-point, Times New Roman is the preferred font. Use one font throughout the document.\nAll section headings are required unless the section heading is highlighted (e.g., (As applicable)).\nAdditional section headings and content may be added at the discretion of the investigator and the IRB.\nRemove (As applicable) from the optional section headings if using the optional section; remove the entire optional section heading if not using the optional section.\nOther text:\n12-point, Times New Roman is the preferred font. Use one font throughout the document. Text should be justified or aligned left. Larger font size may be used for visually-impaired populations.\nItalicized or bolded font may be used to emphasize certain information. Bullets and other spacing are encouraged to facilitate readability.\nEnsure that incorrect, instructional, and non-applicable language is removed from the body of the consent form prior to review by the IRB.\nItalicized, and/or highlighted instructional language below should be removed and replaced with the consent language as applicable.\nLanguage that is in regular black font is not required NIH language but is standard consent language that the NIH IRB would like to be used in all consent documents as applicable.\nUse the “Consent Library” for suggested procedure descriptions and risks.\nSignature Page:\nPlease keep only the signature blocks that are applicable to your study.  Delete the blocks which are not applicable.\nIf your study is enrolling people over the age of 18, or the consent will also be used to consent minors when they reach the age of 18, keep the “Adult Research Participant” block.\nIf your study allows for enrollment of cognitively impaired adult subjects or would allow cognitively impaired subjects to remain on study should they lose capacity after enrollment, keep the “Legally Authorized Representative” block.\nIf your study is enrolling minors, keep the “Parent/Guardian of a Minor Participant” block\nIf your study is enrolling older minors, and you do not have a separate assent form for minors to sign and are using this form as the assent, then keep the “Assent” block.\nALWAYS leave the “Investigator” block\nInclude the “Witness” block if there are no eligibility restrictions in the protocol based on language that would prohibit enrollment of a non-English speaking participant or if you may enroll blind and/or illiterate subjects. Otherwise, remove this block.\nReading Level and Proof Reading:\nThe preferred reading level is 8th grade or lower if possible.\nProofread, and spell check the final clean document.  Please ensure:\nNo section headings are separated from the section text across page breaks\nThere are no blank pages\nAny tables you have inserted are within the document margins\nThe protoc","cbCaiqKZgAou8KPg","https://ap.wps.com/l/cbCaiqKZgAou8KPg","docx",62968,10,"English","# GENERAL INSTRUCTIONS FOR USE OF THIS TEMPLATE\n## Required NIH Language\n## Section Headings and Document Formatting\n## Optional Section Headings\n## Other Text and Consistency Rules\n# Signature Page\n## Applicable Signature Blocks\n## Witness Block Guidance\n# Reading Level and Proof Reading\n## Proofreading Checklist\n## Nomenclature for Clean Consent Documents\n# PRINCIPAL INVESTIGATOR and Study Details\n## Consent Version and Contact Information\n# KEY INFORMATION ABOUT THIS TREATMENT\n## Understanding the Treatment Choice\n## Language Adjustments for Special Consent Contexts","[{\"question\":\"What is this template intended for?\",\"answer\":\"It is intended for expanded access protocols (including single patient) conducted at the NIH Clinical Center, and is built to meet NIH-required consent language and structure.\"},{\"question\":\"Which parts of the required NIH language can be changed?\",\"answer\":\"Changes to required NIH language cannot be made without clearance from the Office of Human Subjects Research Protections (OHSRP) and the NIH Office of the General Counsel (OGC).\"},{\"question\":\"How should investigators handle the signature page and optional blocks?\",\"answer\":\"Keep only the signature blocks applicable to the study, always leaving the “Investigator” block and following study enrollment rules for adult participants, legally authorized representatives, parents/guardians, and assent as applicable. Include the “Witness” block only under the stated eligibility restrictions.\"}]","NIH INFORMED CONSENT TEMPLATE FOR EXPANDED ACCESS (including single patient) AT THE NIH CLINICAL CENTER - Version 9 - Use instructions | DOCX"]