[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-168944-en":3,"doc-seo-168944-105":29,"detail-sidebar-cat-1-en-105":91},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":11,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":15,"update_tm":28,"read_time":11},168944,962084925636,"Sophia Brooks","https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d",1,17,"Forms","NIMH Documentation of Informed Consent Template - Version 2026","A structured template for recording the informed consent process for research studies under NIMH guidance. It supports documenting each consent encounter, including initial consent and re-consent, and collecting required accountability details such as date and time, trained delegated staff, presence of LAR or interpreters, witness documentation, capacity and comprehension assessment, and confirmation that subjects had time to review and ask questions. The template also captures IRB-approved version or date, signature verification, provision of signed copies, eConsent delivery checks, and the documented reason for re-consent, aligning storage with site SOPs and institutional policy.","NIMH Documentation of Informed Consent Template\nPurpose: This template may be used to document the informed consent process.\nAudience/User: Principal Investigators and study team members who are delegated to obtain informed consent.\nHow to Use This Template: Use this template to document each consent encounter (initial consent and re-consent), and file it with the signed consent/assent documents per site Standard Operating Procedure (SOP).\nBest Practice Recommendations:\nVerify that you are using the most current Institutional Review Board (IRB) approved consent and/or assent form before each consent encounter.  This may be indicated with the IRB-stamp and/or approved version/date.\nEnsure the full consent process is documented, including:\nDate & time.\nWho conducted the consent process (name & role); ensure the individual obtaining consent is appropriately trained and delegated (per Delegation of Authority [DOA] log/site SOP).\nIf a Legally Authorized Representative (LAR) or interpreter was present.\nIf a translated consent is used, document the language and that an IRB-approved translated version (or approved process) was used.\nIf a witness is required (per protocol/IRB/institutional policy), ensure witness name/signature/date are documented.\nHow capacity and comprehension were assessed.\nConfirmation that the subject had time to review the form and ask questions.\nThe IRB-approved consent/assent version date (or version number) used for the consent.\nVerify all required signatures and fields and ensure signature dates match.\nProvide the subject/LAR with a signed and dated copy of the consent/assent, as applicable, and document that a copy was provided. For eConsent, verify the system supports automatic delivery and/or download per site SOP.\nStore signed forms in accordance with site SOPs/institutional policy.\nDocument the reason for any re-consent.  Re-consenting is required when protocol amendments change risks/benefits, new findings may affect willingness to continue, or IRB mandates re-consent.\nFor eConsent, ensure system is compliant with \u0013 HYPERLINK \"https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11\" \u001421 CFR Part 11\u0015.\nFor telephone or remote consent (if applicable):\nFollow IRB-approved remote process\nDocument that subject or LAR received the consent form in advance (save all email confirmations, courier logs, or scanned forms as applicable)\n[Site Name] Documentation of Informed Consent\nSubject ID:  ______________________________________________________________________\nGrant #: _________________________________________________________________________\nStudy Title: ______________________________________________________________________\nPrincipal Investigator(s): ____________________________________________________________\nConsent obtained by (name/role): ____________________________________________________\nConsent/Assent (if applicable) version/date (IRB-approved): _______________________________\nDate of Consent/Assent (if applicable): ________________________________________________\nSignature/Initials: _________________________________\tDate: _____________________\nSpecific consent discussions (use as needed):","cbCaihH8ZWszpX4w","https://ap.wps.com/l/cbCaihH8ZWszpX4w","docx",37352,3,"English","en",105,"# Purpose and Audience\n## Purpose\n## Audience/User\n# How to Use This Template\n## Documenting each consent encounter\n# Best Practice Recommendations\n## IRB form verification\n## Required consent process elements\n## Signatures, copies, and storage\n## Re-consent documentation\n## eConsent and remote consent considerations\n# Site Documentation Form Fields","[{\"question\":\"Who should use the NIMH Informed Consent documentation template?\",\"answer\":\"Principal Investigators and study team members delegated to obtain informed consent should use it to document each consent encounter.\"},{\"question\":\"What must be documented for each consent encounter?\",\"answer\":\"Record date and time, who conducted the consent (name and role, confirming delegation and training), whether an LAR or interpreter was present, whether a translated consent was used, any required witness details, capacity and comprehension assessment, confirmation the subject had time to review and ask questions, the IRB-approved consent/assent version/date, and ensure required signatures and signature dates match.\"},{\"question\":\"When is re-consent required and what should be documented?\",\"answer\":\"Re-consent is required when protocol amendments change risks/benefits, new findings may affect willingness to continue, or the IRB mandates re-consent. The reason for the re-consent must be documented in the template.\"}]","NIMH Documentation of Informed Consent Template - Version 2026 | DOCX",1788239804,{"code":4,"msg":30,"data":31},"ok",{"site_id":24,"language":23,"slug":32,"title":14,"keywords":33,"description":15,"schema_data":34,"social_meta":86,"head_meta":88,"extra_data":90,"updated_unix":28},"nimh-documentation-of-informed-consent-template-version-2026","",{"@graph":35,"@context":85},[36,52,68],{"@type":37,"itemListElement":38},"BreadcrumbList",[39,43,47,49],{"item":40,"name":41,"@type":42,"position":11},"https://docshare.wps.com","Home","ListItem",{"item":44,"name":45,"@type":42,"position":46},"https://docshare.wps.com/template/","Template",2,{"item":48,"name":13,"@type":42,"position":21},"https://docshare.wps.com/template/forms/",{"item":50,"name":14,"@type":42,"position":51},"https://docshare.wps.com/template/nimh-documentation-of-informed-consent-template-version-2026/168944/",4,{"url":50,"name":14,"@type":53,"author":54,"headline":14,"publisher":56,"fileFormat":59,"inLanguage":23,"description":15,"dateModified":60,"datePublished":61,"encodingFormat":59,"isAccessibleForFree":62,"interactionStatistic":63},"DigitalDocument",{"name":9,"@type":55},"Person",{"url":40,"name":57,"@type":58},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-05","2026-09-01",true,{"@type":64,"interactionType":65,"userInteractionCount":67},"InteractionCounter",{"@type":66},"ViewAction",6,{"@type":69,"mainEntity":70},"FAQPage",[71,77,81],{"name":72,"@type":73,"acceptedAnswer":74},"Who should use the NIMH Informed Consent documentation template?","Question",{"text":75,"@type":76},"Principal Investigators and study team members delegated to obtain informed consent should use it to document each consent encounter.","Answer",{"name":78,"@type":73,"acceptedAnswer":79},"What must be documented for each consent encounter?",{"text":80,"@type":76},"Record date and time, who conducted the consent (name and role, confirming delegation and training), whether an LAR or interpreter was present, whether a translated consent was used, any required witness details, capacity and comprehension assessment, confirmation the subject had time to review and ask questions, the IRB-approved consent/assent version/date, and ensure required signatures and signature dates match.",{"name":82,"@type":73,"acceptedAnswer":83},"When is re-consent required and what should be documented?",{"text":84,"@type":76},"Re-consent is required when protocol amendments change risks/benefits, new findings may affect willingness to continue, or the IRB mandates re-consent. 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