{"id":730,"date":"2018-05-02T10:25:06","date_gmt":"2018-05-02T10:25:06","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/standard-informed-consent-template\/"},"modified":"2026-11-06T13:43:50","modified_gmt":"2026-11-06T18:43:50","slug":"standard-informed-consent-template","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/templates\/standard-informed-consent-template\/","title":{"rendered":"Standard Informed Consent Template"},"template":"","categories":[24],"tags":[],"content-type":[25],"topic":[26],"update-type":[95,94],"class_list":["post-730","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-templates","topic-informed-consent-assent","update-type-action-may-be-required","update-type-review-recommended"],"acf":{"use_legacy_editor":true,"updated_date":"2026-11-06 17:00:00","update_notice":true,"author":"IRBMED","summary":"New IRBMED studies should most often use the latest Standard Informed Consent template available on this webpage.\r\n\r\n<a href=\"\/medschool\/templates\/specialty-informed-consent-templates\" target=\"_blank\" rel=\"noopener\">Specialty Consent Templates<\/a> may be appropriate for low-risk studies with simpler study methodologies.","button_links":null,"related_content":[733,892,775,902,906],"legacy_path":"standard-informed-consent-template","legacy_node_id":259,"legacy_related_nids":"262, 1626, 317, 1665, 1685","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Downloadable Standard Informed Consent Template","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"The <strong>working version<\/strong> template containing blue and orange text boxes is updated with additional instructions and required language. IRBMED recommends using the working version template for creating the consent document. If using the <strong>outline version<\/strong> (without the blue-box instructions), always use the working version as a companion document for additional information and as-applicable required language.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"link_button","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":[{"legacy_button":{"title":"Working Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20240410-workingStandardConsentTemplate_0_0.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Outline Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_oor_irbmed_standard_informed_consent_template_outline_20240410_0.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"Changes to the Standard Consent Template","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"November 2026","legacy_section_text":"<h4>Section 9.2<\/h4>\r\nIn the bulleted list of reasons participants' personal information may be shared:\r\n<ul>\r\n \t<li>The item regarding information collection for payment processing has been updated, consistent with the <a href=\"https:\/\/hrpp.umich.edu\/hsip-threshold-change-faqs\/\">new HSIP threshold change<\/a>.<\/li>\r\n \t<li>A new set of bullets has been added explaining in detail the sharing of PHI with external entities when another hospital may need the information to provide care\/safety coordination<\/li>\r\n<\/ul>\r\n<h4>Sections 9 and 12<\/h4>\r\nThe introductory sentences in Section 9 have been expanded to clarify that while Section 9 describes storing and sharing of information during the study, Section 12 relates to retention and potential sharing after the study is complete.\r\n<h4>Typographical corrections and minor updates<\/h4>\r\nMinor changes such as typographical corrections, grammar in blue box instructions, and URL updates are sprinkled throughout the document.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"April 2024","legacy_section_text":"<strong>Extensive revisions, including a new section<\/strong>\r\n\r\nChange history available upon request.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"When uploading your informed consent form in eResearch","legacy_subheading":"Changes to instructions and as-applicable template text (blue\/orange boxes)","legacy_section_text":"<ul>\r\n \t<li>All but one orange box formerly containing information specific to research subject to <a href=\"\/medschool\/guidance\/international-council-harmonisation-good-clinical-practice-ich-gcp\/\">ICH-GCP standards<\/a> have been revised to pertain to all research as applicable; this takes either of two forms:\r\n<ul>\r\n \t<li>The orange box has been changed to blue and references to ICH-GCP\u00a0have been removed<\/li>\r\n \t<li>The text of a former orange ICH-GCP box has been incorporated into body text<\/li>\r\n<\/ul>\r\nThe one box that remains orange and remains confined to ICH-GCP studies is the directive above the witness signature box, instructing researchers to characterize witnesses as impartial.<\/li>\r\n \t<li>In section 1.1 (key information), sample descriptions of clinical trial phases have been rewritten.<\/li>\r\n \t<li>Also in section 1.1, new help text guides researchers in choosing which study risks represent key information and which needn\u2019t be included in this section.<\/li>\r\n \t<li>In section 4.1, guidance on blinded studies has been narrowed to apply only to certain scenarios.<\/li>\r\n \t<li>Sub-studies: Help text in section 4.1 (study procedures) now directs researchers to describe their sub-study(-ies) in one of several parts of the consent document:\r\n<ul>\r\n \t<li>Sub-studies that involve factors, such as procedures or risks, that are similar to those in the main study, or that involve only storage and\/or use of samples and information gathered in the main study,\u00a0appear in section 4.1 or the new section 12. These instances are expected to be the most common.<\/li>\r\n \t<li>Sub-studies that involve factors, such as procedures or risks, that differ significantly from those in the main study should now appear in an appendix added to very end of the template. These instances are expected to be relatively uncommon.<\/li>\r\n<\/ul>\r\nRecommended language for use in sub-study descriptions has also been condensed and revised.<\/li>\r\n \t<li>In section 5.1 (risks), help text pertaining to efforts to mitigate study risk has been rewritten.<\/li>\r\n \t<li>Also in 5.1, risk language regarding COVID-19 vaccination has been inserted.<\/li>\r\n \t<li>Recommended language regarding study benefit (section 5.2) has been revised.<\/li>\r\n \t<li>In section 8.1, which addresses costs of study participation, help text regarding costs of treatment for study-related injury has been revised by the<a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/calendar-review-analysis-office\/billing-calendar-study-applications\"> Calendar Analysis and Review Office (CRAO)<\/a> to reflect changes in university policy. These policy changes affect investigator-initiated and federally sponsored research only.<\/li>\r\n \t<li>The blue box guiding researchers on explaining mitigation of confidentiality risk in section 9.1 has been augmented with new language about protecting electronic data, including data stored on cloud servers.<\/li>\r\n \t<li>Language in section 9.1 regarding <a href=\"https:\/\/hrpp.umich.edu\/certificates-of-confidentiality\/\">Certificates of Confidentiality<\/a> has been revised.<\/li>\r\n \t<li>Language in Section 9.1 regarding adult and child abuse has been revised to clarify who required reporters will include, for what Michigan law requires reporting, and a revision to the policies linked in the blue boxes.<\/li>\r\n \t<li>Help text on HIV testing has been both condensed and moved from what was formerly 11.2 (Which documents will I receive?) to section 4.1 (study procedures). The move was prompted by changes in Michigan law that no longer require researchers to provide subjects undergoing HIV testing with an informational pamphlet.<\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"Changes to document body text","legacy_section_text":"<ul>\r\n \t<li>New Applications:\u00a0 Please make sure to delete all instruction boxes, comments, and headers from the original working template. Also be sure to proofread the document for spelling, grammar, and formatting errors.<\/li>\r\n \t<li>Amendments: Per the IRBMED\u00a0<a href=\"\/medschool\/policies\/statement-practice-document-revision-guidance-naming-convention-and-version\/\">Document Revision Guidance, Naming Convention, and Version Control<\/a>\u00a0statement of practice, as part of an amendment modifying the consent(s)\r\n<ul>\r\n \t<li>Edit the most recent version of the\u00a0CLEAN informed consent document found in 10-1.1.<\/li>\r\n \t<li>Turn on \u201cTrack Changes\u201d feature in Word.<\/li>\r\n \t<li>Save \u201cTrack Changes\u201d version in .docx or .doc format.<\/li>\r\n \t<li>Upload ONLY \"Track Changes\" document on the previous tracked-changes stack in 10-1.1 using the ellipsis (three dots) next to the version number column.<\/li>\r\n \t<li>Use the standard naming conventions for stacks from the\u00a0<a href=\"\/medschool\/policies\/statement-practice-document-revision-guidance-naming-convention-and-version\/\">Document Revision Guidance, Naming Convention, and Version Control<\/a>\u00a0statement of practice.\u00a0Also be sure to proofread the document for spelling, grammar, and formatting errors.<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>For informed consent documents that are uploaded in eResearch but are no longer in use, please simply change the document file name by adding the phrase \u201cX - Not in use\u201d or \"X - Out of Date\" to the file name. Do not delete these documents from the eResearch application.<\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[95],"update_notice_start":"2026-11-06 17:00:00","update_notice_end":"2027-01-03 17:00:00","update_notice_text_blocks":[{"update_notice_text":"On November 7, 2026, IRBMED has issued a revised standard informed consent template. Changes include:\r\n<ul>\r\n \t<li>URL and address corrections.<\/li>\r\n \t<li>information collection for payment processing, consistent with the <a href=\"https:\/\/hrpp.umich.edu\/hsip-threshold-change-faqs\/\">new HSIP threshold change<\/a>.<\/li>\r\n \t<li>sharing of PHI with external entities.<\/li>\r\n \t<li>distinguishing record retention and sharing for the current study from potential re-use of information and\/or biospecimens for later studies.<\/li>\r\n<\/ul>\r\nIRBMED has also issued revised versions of the <a href=\"\/medschool\/templates\/specialty-informed-consent-templates\/\">specialty templates<\/a> with corresponding updates, as applicable..\r\n\r\nConsent documents in review at and after November 7 should include all new language, as applicable. IRBMED approved consent documents still in use should be updated at next convenient Amendment, no later than November 2027, as explained at the <a href=\"https:\/\/hrpp.umich.edu\/hsip-threshold-change-faqs\/\">HRPP FAQ regarding the HSIP changes<\/a>."}],"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"Contact us at\u00a0<a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/a>\u00a0or 734-763-4768 \/ (Fax 734-763-1234)\r\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\nA list of <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\" target=\"_blank\" rel=\"noopener\">IRBMED staff<\/a> is available through our website.\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: November 6, 2026 1:45 PM","global_contact_block_select":null},"permalink_manager":null,"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/730","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/document"}],"version-history":[{"count":7,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/730\/revisions"}],"predecessor-version":[{"id":2090,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/730\/revisions\/2090"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/95"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/906"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/902"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/775"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/892"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/733"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=730"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=730"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=730"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=730"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=730"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=730"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}