{"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":"2026-04-08T10:53:21","modified_gmt":"2026-04-08T14:53:21","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":"2024-04-15 09:00:00","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","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<strong>April 2024: Extensive revisions, including a new section<\/strong>","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":"Changes to note throughout the document","legacy_section_text":"<ul>\r\n \t<li>All appearances of the term \u201csubject\u201d have been replaced with \u201cparticipant.\u201d<\/li>\r\n \t<li>Most orange boxes indicating <a href=\"\/medschool\/guidance\/international-council-harmonisation-good-clinical-practice-ich-gcp\/\">ICH-GCP<\/a>-specific instructions have been\u00a0revised to pertain to all research as applicable.<\/li>\r\n \t<li>Office of Technology Transfer\u2019s name change to <a href=\"https:\/\/innovationpartnerships.umich.edu\/\">Innovation Partnerships<\/a>\u00a0has been incorporated.<\/li>\r\n \t<li>IRBMED has developed new approach to addressing participation in sub-studies, depending on whether the substudy\/ies involve factors,\u00a0such as procedures or risks, that differ significantly from those in the main study.<\/li>\r\n \t<li>To better organize consent document information by clearly separating main study information from all information about data and biospecimen storage, future use, and sharing, this document contains a new section, which is numbered section 12.<\/li>\r\n \t<li>The signature section (formerly section 12) is shifted down to a new section 13.<\/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_with_subheading","legacy_heading":"","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_with_subheading","legacy_heading":"","legacy_subheading":"Changes to document body text","legacy_section_text":"<ul>\r\n \t<li>In section 1.1 (key information), language regarding duration of study participation has been revised.<\/li>\r\n \t<li>Section 4.1 (procedures): This template instructs researchers to mark any procedures or risks included in the consent document but completed as part of standard clinical treatment with a \u201c[not research]\u201d tag.\u00a0This is not required for all studies but can be used when research and standard clinical procedures overlap.<\/li>\r\n \t<li>Section 5.1: The passage beginning \u201cAdditionally, there may be a risk of loss of confidentiality or privacy\u201d is new.<\/li>\r\n \t<li>Section 5.1 also now includes language pertaining to the risks associated with premedications.<\/li>\r\n \t<li>Section 7.2: The three-paragraph passage beginning \u201cYou are free to partially or completely end your participation in the study\u201d is new.<\/li>\r\n \t<li>Language in section 7.2 regarding the risks of discontinuing study participation has undergone revision.<\/li>\r\n \t<li>Section 8.3 (\u201cWho could benefit financially from information learned in the study?\u201d) now contains prompt language researchers should use to disclose the source of funding for the University of Michigan study.<\/li>\r\n \t<li>Language about basic (non-HIPAA) privacy and confidentiality measures in section 9.1 have been added.<\/li>\r\n \t<li>Language to be added if adult or child abuse may be revealed during the study has been updated.<\/li>\r\n \t<li>9.2: In the list of entities that may see subjects\u2019 data, the bullet addressing use of research data by federal agencies and other entities for safety oversight purposes now closes with the phrase: \u201cand for quality improvement purposes.\u201d<\/li>\r\n \t<li>9.2: In the list of entities that may see subjects\u2019 data, the bullet about collecting subjects\u2019 Social Security numbers has been revised by the <a href=\"https:\/\/finance.umich.edu\/treasury\/hsip\">Human Subjects Incentives Program (HSIP)<\/a> to reflect\u00a0their <a href=\"https:\/\/finance.umich.edu\/resource\/policy-document-social-security-number-ssn-collection-and-distribution-procedure-human\">new expectations and policies<\/a>. See also Research A-Z <a href=\"\/medschool\/guidance\/payment-research-participants\/\">Payment to Research Participants<\/a>, heading \"Incentive,\" subheading \"HSIP.\"<\/li>\r\n \t<li>The statement in section 9.2 about the expiration or termination of HIPAA Authorization has been revised. Representatives of the <a href=\"https:\/\/www.med.umich.edu\/u\/compliance\/hipaa\/index.html\">Compliance Office<\/a> reviewed and approved these changes.<\/li>\r\n \t<li>Section 11: Language from a\u00a0former orange box has been added indicating participants will receive a copy of the\u00a0<strong>signed and dated<\/strong> informed consent document.<\/li>\r\n \t<li>The template\u2019s signature section, formerly section 12, is now numbered Section 13.<\/li>\r\n \t<li>Signature boxes pertaining to optional aspects, such as unspecified future use and participation in sub-studies, were altered to contain yes\/no boxes, but with a note instructing researchers to collect subjects\u2019 signatures only when they select the yes box.<\/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_with_subheading","legacy_heading":"","legacy_subheading":"New section: data and biospecimen storage, future use, and sharing","legacy_section_text":"To better organize consent document information by clearly separating main study information from all information about data and biospecimen storage, future use, and sharing, this document contains a new section. The new\u00a0section 12\u00a0shifts the signature section to a new section 13.\r\n<ul>\r\n \t<li>12.1: Explaining\u00a0the concepts of storage, use, and sharing.<\/li>\r\n \t<li>12.2: Detailed description of each possible type of storage, use, and sharing, each enclosed in its own blue help text box, as follows.<\/li>\r\n \t<li>12.2-A: Storage, future use, and sharing of information permitted by the revised Common Rule and applicable to most research under IRBMED oversight\r\nThe language (previously in Section 4.4) has been updated to include a selection for industry sponsored or investigator-initiated research; all research submitted to IRBMED must include one of these two statements.\r\nThis segment alerts potential participants that any data that have been used, placed in the medical record, or, in the majority of cases, shared with others cannot be retrieved and destroyed even if consent to their storage and use is withdrawn. See also Research A-Z <a href=\"\/medschool\/guidance\/retention-research-databiospecimens\/\">Retention of Research Data\/Biospecimens<\/a>, heading \"C. Retention for Future Research.\"<\/li>\r\n \t<li>12.2-B: Storage, use, and sharing of data per NIH policy\u2014both the <a href=\"https:\/\/research.umich.edu\/research-data-stewardship\/research-data-stewardship-nih-dmsp\/\">data management and sharing (DMS)<\/a> policy and the <a href=\"\/medschool\/guidance\/nih-genomic-data-sharing-policy\/\">genomic data sharing (GDS)<\/a> policy\r\nLanguage relating to the new DMS policy is new whereas language relating to the GDS policy was previously found in Section 4.1.<\/li>\r\n \t<li>12.2.C: Storage, future use, and sharing of subjects\u2019 data and\/or biospecimens as a necessary condition of participation in the main study\r\nThis language includes the caution that data may not be retrievable or destructible under certain circumstances.\r\nIt also clarifies that subjects who withdraw consent to storage, future use, and sharing will be withdrawn from the main study.\r\nThis language was previously found in Section 4.1.<\/li>\r\n \t<li>12.2-D: Genomic data sharing in non-NIH-sponsored research\r\nThis covers scenarios in which researchers are not obliged by policy to share genomic data but choose to do so.\r\nThis language was previously found in Section 4.1.<\/li>\r\n \t<li>12.2-E: Optional storage, unspecified future use, and sharing of subjects\u2019 data and\/or biospecimens\r\nThe guidance prompts researchers to caution subjects that if they withdraw their consent to this optional activity, the researchers will attempt but may be unable to retrieve and destroy data and specimens that have been shared with other researchers.\r\nIt also states that data and materials that have already been used in research, or data that has been placed within the medical record, cannot be retrieved and destroyed.\r\nThis language was previously found in Section 4.1.<\/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":"heading","legacy_heading":"When uploading your informed consent form in eResearch","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":"<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":[94,95],"update_notice_start":"2024-04-15 05:45:00","update_notice_end":"2024-06-14 14:00:00","update_notice_text_blocks":[{"update_notice_text":"<p>On April 15, 2024, IRBMED has issued a revised standard informed consent template. A&nbsp;list of changes is available, including the <a href=\"https:\/\/finance.umich.edu\/resource\/policy-document-social-security-number-ssn-collection-and-distribution-procedure-human\">HSIP (Human Subject Incentive Program) policy on collecting Social Security Numbers<\/a> when distributing payments to participants and adding a new Section 12 which consolidates all future storage, use, and sharing language into one section and has language to satisfy the NIH Data Management Sharing Policy.<\/p>\r\n\r\n<p>The <a href=\"\/file\/1553\">working version template<\/a> 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 <a href=\"\/file\/1555\">outline version<\/a> (without the blue-box instructions), always use the working version (with blue-box instructions) as a companion document for additional information and required language.<\/p>\r\n\r\n<p>IRBMED has also issued revised versions of the eligibility, survey, and blood draw <a href=\"\/node\/262\">specialty templates<\/a> containing updates relating to the <a href=\"https:\/\/finance.umich.edu\/resource\/policy-document-social-security-number-ssn-collection-and-distribution-procedure-human\">new HSIP compensation policy<\/a>.<\/p>\r\n\r\n<p>IRBMED will continue to review unapproved consent documents created in the previous template if submitted prior to June 1, 2024.&nbsp;<strong>Consent documents submitted on or after June 1st&nbsp;must be created in the newly revised template.<\/strong> IRBMED approved consent documents using the previous template do not need to be amended to update to the revised template.<\/p>\r\n\r\n<p>Contact the IRBMED office with questions, either by email (<a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/a>) or telephone (734-763-4768).<\/p>"}],"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: April 8, 2026 10:55AM","global_contact_block_select":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":2,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/730\/revisions"}],"predecessor-version":[{"id":1956,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/730\/revisions\/1956"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/95"},{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/94"}],"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}]}}