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The policy defines documentation of consent, signatures, written-in-person and electronic signatures, and how investigators must provide participants adequate opportunity to read, ask questions, and sign. It also outlines conditions where the IRB may waive the signed documentation requirement and the compliance needs for cases involving student educational records under FERPA.",{"@graph":14,"@context":73},[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/irb-documentation-of-informed-consent-purpose-and-policy-for-waivers-and-signatures/307142/",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/irb-documentation-of-informed-consent-purpose-and-policy-for-waivers-and-signatures/307142.png","ImageObject",442,249,{"name":42,"@type":43},"Bulrr","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-23","2026-09-19",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",13,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What does documentation of informed consent require?","Question",{"text":63,"@type":64},"Documentation requires providing participants with a written version of the required consent elements and obtaining their signature (or other mark) on a written document as verification of their decision to participate.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"When is an electronic signature considered acceptable?",{"text":68,"@type":64},"Electronic signatures are acceptable if they are legally valid in the jurisdiction of the research. Examples include attaching or inserting a scanned handwritten signature, using an e-signature service, typing a name with intent to sign, or signing with a stylus or touchscreen method.",{"name":70,"@type":61,"acceptedAnswer":71},"Under what conditions may the IRB waive the requirement to obtain a signed consent form?",{"text":72,"@type":64},"The IRB may waive signed documentation when specific criteria are met, such as when the only record linking the participant to the research would be the consent document and the principal risk is confidentiality harm, when the research presents no more than minimal risk and no procedures normally require written consent outside the research context, or when participants and/or LARs are from a cultural group where signing forms is not normative and an appropriate alternative mechanism is used.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},307142,1790434013,{"code":4,"msg":82,"data":83},"success",[84,89,94,99,104,109,113,118,123],{"id":85,"doc_module":22,"doc_module_name":25,"category_name":86,"show_sort_weight":87,"slug":88},11,"Presentations",90,"presentations",{"id":90,"doc_module":22,"doc_module_name":25,"category_name":91,"show_sort_weight":92,"slug":93},12,"Resumes",80,"resumes",{"id":95,"doc_module":22,"doc_module_name":25,"category_name":96,"show_sort_weight":97,"slug":98},14,"Invoices",70,"invoices",{"id":100,"doc_module":22,"doc_module_name":25,"category_name":101,"show_sort_weight":102,"slug":103},15,"Posters",60,"posters",{"id":105,"doc_module":22,"doc_module_name":25,"category_name":106,"show_sort_weight":107,"slug":108},16,"Social Media",50,"social-media",{"id":110,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":111,"slug":112},17,40,"forms",{"id":114,"doc_module":22,"doc_module_name":25,"category_name":115,"show_sort_weight":116,"slug":117},18,"Letters",30,"letters",{"id":119,"doc_module":22,"doc_module_name":25,"category_name":120,"show_sort_weight":121,"slug":122},21,"Paper Templates",5,"papers-templates",{"id":124,"doc_module":22,"doc_module_name":25,"category_name":125,"show_sort_weight":4,"slug":126},158,"General","general-158",{"code":4,"msg":82,"data":128},{"doc_id":79,"user_id":129,"nickname":42,"user_avatar":130,"doc_module":22,"category_id":110,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":136,"language":137,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":12,"update_tm":141,"read_time":26},5909892115043,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","|  |  |  |  |  |\n| --- | --- | --- | --- | --- |\n\n1. PURPOSE  \n1.1. Federal regulations for human research generally require that informed consent be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the research participant or the participant’s legally authorized representative (LAR) . This policy describes the process to document the informed consent and the conditions and considerations under which the investigators may seek a waiver from the requirement to document informed consent.  \n2. DEFINITIONS  \n2.1. Documentation of informed consent: means providing participants with a written version of the required elements of consent and obtaining their signature (or other mark) on a written document as verification of their decision to participate in the research. Documentation of informed consent generally occurs during the consent process after the elements of informed consent have been presented to the prospective participant and the investigator has responded to any questions or concerns from the prospective participant.  \n2.2. Signature: is a participant's name written by him or her in a characteristic way as a form of identification or authentication.  \n2.3. Written or in writing: refers to writing on a tangible medium (e.g., paper) or in an electronic format.  \n2.4. Electronic signature: means an electronic or digital method executed or adopted by a party with the intent to be bound by or to authenticate a record. According to the Uniform Electronic Transactions Act, this means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record. Also e-signature.  \n3. POLICY  \n3.1. This policy applies only to non-exempt human research that is not FDA regulated. See Policy and Procedure: Exempt Review.  \n3.2. Federal regulations require the documentation of informed consent by the use of a written consent form approved by the IRB and signed by the participant or the participant's LAR, unless the IRB has approved a waiver of the requirement to document informed consent per 45 CFR 46. 117(c) . A written copy must be given to the person signing the form.  \n3.3. For the purposes of this policy, both written signatures and electronic signatures are  \n\n| UGAHRP-091-4 | 10/4/2021 | HSO | HRPP Policy Committee | Page 2 of 6 |\n| --- | --- | --- | --- | --- |\n\nacceptable forms of documentation.  \n3.4. The form of electronic signature must be legally valid within the jurisdiction where the research is to be conducted. Examples of electronic signature include: attaching or inserting a scanned handwritten signature, using an e-signature service like Adobe, typing a name with an accompanying statement of intent to affix a legal signature, signing with a stylus or other touchscreen method. All constitute “signatures” and a waiver of documentation of informed consent is not required for these processes.  \n3.5. Where informed consent is documented in accordance with 46 . 117(b)(1), the written consent document embodies the basic and required additional elements of informed consent (See CHECKLIST: Informed Consent Elements.) This form may be read by the participant, to the participant or to the participant's LAR, but in any event, the investigator must give either the participant or the LAR adequate opportunity to read and ask questions about it before it is signed.  \n3.6. Alternatively, the investigator may provide an oral presentation of informed consent information in conjunction with a written short-form consent document stating that the required elements of informed consent have been presented orally to the participant or the participant’s legally authorized representative.  \n3.6.1. When this method is used, there must be a witness to the oral presentation.  \n3.6.2. The IRB must approve a written summary of what is to be presented orally to the participant or the LAR. ","cbCaijUAhbIUgmno","https://ap.wps.com/l/cbCaijUAhbIUgmno","pdf",666306,6,"English","# Purpose\n# Definitions\n# Policy\n## Applies To\n## Consent Form and Signing Requirements\n## Electronic Signature Acceptability\n## Waiver of Signed Documentation\n## FERPA Requirements","[{\"question\":\"What does documentation of informed consent require?\",\"answer\":\"Documentation requires providing participants with a written version of the required consent elements and obtaining their signature (or other mark) on a written document as verification of their decision to participate.\"},{\"question\":\"When is an electronic signature considered acceptable?\",\"answer\":\"Electronic signatures are acceptable if they are legally valid in the jurisdiction of the research. Examples include attaching or inserting a scanned handwritten signature, using an e-signature service, typing a name with intent to sign, or signing with a stylus or touchscreen method.\"},{\"question\":\"Under what conditions may the IRB waive the requirement to obtain a signed consent form?\",\"answer\":\"The IRB may waive signed documentation when specific criteria are met, such as when the only record linking the participant to the research would be the consent document and the principal risk is confidentiality harm, when the research presents no more than minimal risk and no procedures normally require written consent outside the research context, or when participants and/or LARs are from a cultural group where signing forms is not normative and an appropriate alternative mechanism is used.\"}]","IRB Documentation of Informed Consent - Purpose and Policy for Waivers and Signatures | PDF",1789844821]