[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-168476-105":53,"doc-detail-168476-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","addendum-to-the-informed-consent-document-template","Addendum to the Informed Consent Document - Template","","This addendum template supports informing research participants about newly available or changed information after initial consent. It guides addendum preparation, clarifies when participant signatures are required, and describes acceptable methods for delivering the addendum (e.g., letter, email, REDCap, or at the next visit). It emphasizes IRB review and documentation of delivery and receipt, and provides participant-facing wording covering voluntary participation, withdrawal rights, and updated study information.",{"@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/addendum-to-the-informed-consent-document-template/168476/",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/addendum-to-the-informed-consent-document-template/168476.png","ImageObject",442,249,{"name":88,"@type":89},"Theodore","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-23","2026-09-01",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},"When should an addendum be used instead of a revised consent form?","Question",{"text":108,"@type":109},"Use an addendum when information becomes available after initial consent and the change can be communicated without extensive revisions; if changes are extensive, a revised consent form is required.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Is a participant signature always required for the addendum?",{"text":113,"@type":109},"No. Whether a signature is required depends on the nature of the new information; new risks and addition of procedures generally require a participant signature.",{"name":115,"@type":106,"acceptedAnswer":116},"How should the research team provide the addendum to participants?",{"text":117,"@type":109},"The addendum can be provided through formats aligned with the study’s communication approach, such as a letter, email, REDCap, or handed out at the participant’s next visit. If signature is required, instructions for returning the signed document must be included.","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},168476,1788232251,{"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":73,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":125,"read_time":9},7971461740886,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","ADDENDUM TO THE INFORMED CONSENT DOCUMENT\nInstructions for Addendum Preparer\nThis template can be used to prepare an addendum to the consent form to communicate information that becomes available after participants have initially consented to participate in a research study. If the changes are extensive, a revised consent form rather than an addendum is required.\nSignature of the participants is not always required. It will depend on the nature of the new information to be communicated (e.g. communication of new risks and addition of procedures would generally require the signature of the participant). If a signature is not required, the statement of consent can be omitted.\nThe addendum with the new information can be provided to the participants in various ways, depending on the nature of the study and the manner in which the study team usually communicates with the participants, e.g., in a letter, by email, via Redcap, or handed out at the time of their next visit. If a signature is required, instructions for returning the signed document should be provided with the addendum. The plan to inform participants of new information and proposed use of the addendum to the consent form should be submitted to the IRB for review and approval before use. Research records should document when and how the addendum was provided to each participant and, when a signature is required, when the signed form was received.\nComplete all green-highlighted fields, update the footer, and remove all instructions in this document including the statement: “LEAVE SPACE (minimum 1”) FOR IRB STAMP” in the footer before submitting the addendum to the IRB.\nProtocol: IRB-AAA___\nIRB Protocol Title: ________\nDate:\nDear Study Participant:\nThe purpose of this document is to notify you of a change to information in the [insert as relevant: Consent Form/Consent Form and HIPAA Authorization/Parental Permission to participate in a Research Study/Parental Permission to participate in a Research Study and HIPAA Authorization] that you read and signed at the beginning of this study.\nNew Information:\nEnter a description of the new information. Specify whether it is new information or a change to previous information that was provided.\nAll other information in the consent form that you signed remains unchanged.\nYour participation continues to be voluntary. You may refuse to participate or may withdraw your consent to participate at any time, and for any reason, without affecting your future care at this institution or your relationship with your study doctor.\nYou can talk to the Principal Investigator about any questions or concerns you have about this study. You may contact (PI’s name) at (telephone number).\nIf you have questions about your rights as a research subject while taking part in this study, you should call the\nColumbia University Institutional Review Board\n154 Haven Avenue, second floor\nNew York, NY 10032\nTelephone: (212) 305-5883\nEmail: \u0013 HYPERLINK \"mailto:irboffice@columbia.edu\" \u0014irboffice@columbia.edu\u0015\nAn Institutional Review Board is a committee organized to protect the rights and welfare of human subjects in research.\nIf this information will be communicated via letter not requiring the subject signature:\nPlease keep this communication for future reference.\nThank you for your participation.\nName and Signature of the Principal Investigator\nIf signature is required:\nStatement of consent:\nI have read the information provided above. I voluntarily agree to continue to participate in this research study. I understand that I will receive and may keep a copy of this signed and dated Addendum to the consent form. By signing and dating this addendum, I have not waived any of the legal rights that I would have if I were not a participant in the study.\nParticipant\nPrint Name________________________Signature__________________________ Date ________\nPerson obtaining consent\nPrint Name_________ _______________Signature___________________________Date________","cbCaimpdOqWKmGo5","https://ap.wps.com/l/cbCaimpdOqWKmGo5","docx",32794,"English","# Instructions for Addendum Preparer\n## Signature and delivery requirements\n## IRB submission and documentation\n# Addendum Notification Letter\n## New Information section\n## Participant rights and contact information\n## Principal Investigator name and signature\n# Signature of the Participant (If required)","[{\"question\":\"When should an addendum be used instead of a revised consent form?\",\"answer\":\"Use an addendum when information becomes available after initial consent and the change can be communicated without extensive revisions; if changes are extensive, a revised consent form is required.\"},{\"question\":\"Is a participant signature always required for the addendum?\",\"answer\":\"No. Whether a signature is required depends on the nature of the new information; new risks and addition of procedures generally require a participant signature.\"},{\"question\":\"How should the research team provide the addendum to participants?\",\"answer\":\"The addendum can be provided through formats aligned with the study’s communication approach, such as a letter, email, REDCap, or handed out at the participant’s next visit. If signature is required, instructions for returning the signed document must be included.\"}]","Addendum to the Informed Consent Document - Template | DOCX"]