{"id":733,"date":"2018-05-02T12:28:59","date_gmt":"2018-05-02T12:28:59","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/specialty-informed-consent-templates\/"},"modified":"2026-04-08T14:26:17","modified_gmt":"2026-04-08T18:26:17","slug":"specialty-informed-consent-templates","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/templates\/specialty-informed-consent-templates\/","title":{"rendered":"Specialty Informed Consent Templates"},"template":"","categories":[24],"tags":[80,79,77,78,57],"content-type":[25],"topic":[40,30,26,66,65,75,67],"update-type":[95,94],"class_list":["post-733","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","tag-participant-management","tag-principal-investigator","tag-regulatory","tag-study-coordinator","tag-study-teams","content-type-templates","topic-clinical-research","topic-clinical-trial","topic-informed-consent-assent","topic-investigator-study-team-responsibilities","topic-records","topic-regulations-policies-federal-state-local","topic-subject-populations","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":"<a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/informed-consent-assent-templates\">Obtaining the consent of a participant<\/a> is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if they are to make an informed decision. We ensure respect for persons by providing information needed for thoughtful consent for a voluntary act.\r\n\r\nBelow is an overview of the Specialty Informed Consent Templates currently offered.","button_links":null,"related_content":[730,892,775],"legacy_path":"specialty-informed-consent-templates","legacy_node_id":262,"legacy_related_nids":"259, 1626, 317","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Informed Consent Builder Pilot","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":"Protocol Builder\/Informed Consent Builder is a third-party, web-based tool developed by BRANY available for the U-M human research community. HRPP is piloting making some consent and written assent templates\u00a0available through the <a href=\"https:\/\/hrpp.umich.edu\/informed-consent-builder-pilot\/\">Informed Consent Builder<\/a> tool.","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":"Biorepository 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":[{"legacy_button":{"title":"Central Biorepository Informed Consent Template","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_CBR-biorepository-consent-template-revised-November-18-2020-clean.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Non-CBR Biorepository Informed Consent Template","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/Biorepository-Informed-Consent-Template-with-instructions-\u2014-Required-Reading.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"There are two consent instruments that must both be used to obtain consent to participation in any biorepository project:\r\n<ul class=\"rteindent1\">\r\n \t<li>a text-only informed consent document<\/li>\r\n \t<li>an illustrated informational sheet<\/li>\r\n<\/ul>\r\nUse the blue buttons below to download both types of consent instruments to use in your informed consent process.\r\n\r\nIf you are intending to utilize the University of Michigan Medical School <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/central-biorepository\/biobanking\">Central Biorepository (CBR)<\/a> to process, store, and distribute your specimens, visit the UMMS Central Biorepository website for further information. Participating projects are required to use the CBR\u2019s master consent templates.\r\n\r\n<strong>Biorepository text-only Informed Consent Template (with instructions) \u2014 Required Reading<\/strong> This document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the University of Michigan Informed Consent Template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.\r\n\r\nBelow, select one of the two templates, depending on the type of repository you plan to submit to:\r\n<ul class=\"rteindent1\">\r\n \t<li>the UM Medical School's Central Biorepostitory<\/li>\r\n \t<li>a non-CBR repository you plan to maintain yourself<\/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":"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":"Central Biorepository Informed Consent Template","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_CBR-biorepository-consent-template-revised-November-18-2020-clean.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Non-CBR Biorepository Informed Consent Template","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/Biorepository-Informed-Consent-Template-with-instructions-\u2014-Required-Reading.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"text_area","legacy_heading":"One-Time Blood or Tissue Sample (Minimal Risk) Informed Consent Template","legacy_subheading":"","legacy_section_text":"<strong>Biorepository Illustrated Informational Sheet (editable PDF)<\/strong> Edit and save the PDF to reflect the details of your biorepository project before submitting it to IRBMED for review.\r\n\r\nBelow, select one of the two templates, depending on the type of repository you plan to submit to:\r\n<ul class=\"rteindent1\">\r\n \t<li>the UM Medical School's Central Biorepostitory<\/li>\r\n \t<li>a non-CBR repository you plan to maintain yourself<\/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":"link_button","legacy_heading":"","legacy_subheading":"","legacy_section_text":"You\u00a0<strong>may not<\/strong>\u00a0use this template if\r\n<ul>\r\n \t<li>you plan to conduct genetic analysis on subjects\u2019 samples<\/li>\r\n \t<li>you plan to submit subjects\u2019 samples or data to a biorepository or data repository<\/li>\r\n<\/ul>\r\nThis template may be used\u00a0<strong>only<\/strong>\u00a0for studies that\r\n<ul>\r\n \t<li>involve a single blood or tissue sample<\/li>\r\n \t<li>pose <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal risk<\/a> to subjects<\/li>\r\n<\/ul>\r\n<strong>Template\u00a0(two versions):<\/strong>\r\n<ul>\r\n \t<li>The <strong>Working Version<\/strong> of this\u00a0document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.<\/li>\r\n \t<li>The <strong>Outline Version<\/strong> of this document is to be used to complete the document that is to be submitted to the IRBMED for review.<\/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":[{"legacy_button":{"title":"Central Biorepository\u00a0Informational Sheet (editable PDF)","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_biorepositories_pamphlet_template_20201116_corrected_links_20211020.pdf","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Non-CBR Biorepository Informed Consent Informational Sheet (editable PDF)","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_biorepositories-pamphlet-template-20190123.pdf","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"One-Time Blood or Tissue Sample (Minimal Risk) 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":[{"legacy_button":{"title":"Sample (Minimal Risk) -- Working Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_icd-blood-draw-template-4-17-2018-working_0_0.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Sample (Minimal Risk) -- Outline Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_icd-blood-draw-template-4-17-2018-outline_0.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"text_area","legacy_heading":"Survey Research Informed Consent Template","legacy_subheading":"","legacy_section_text":"You\u00a0<strong>may not<\/strong>\u00a0use this template if\r\n<ul>\r\n \t<li>you plan to conduct genetic analysis on subjects\u2019 samples<\/li>\r\n \t<li>you plan to submit subjects\u2019 samples or data to a biorepository or data repository<\/li>\r\n<\/ul>\r\nThis template may be used\u00a0<strong>only<\/strong>\u00a0for studies that\r\n<ul>\r\n \t<li>involve a single blood or tissue sample<\/li>\r\n \t<li>pose <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal risk<\/a> to subjects<\/li>\r\n<\/ul>\r\n<strong>Template\u00a0(two versions):<\/strong>\r\n<ul>\r\n \t<li>The <strong>Working Version<\/strong> of this\u00a0document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.<\/li>\r\n \t<li>The <strong>Outline Version<\/strong> of this document is to be used to complete the document that is to be submitted to the IRBMED for review.<\/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":"link_button","legacy_heading":"","legacy_subheading":"","legacy_section_text":"This template may be used\u00a0<strong>only<\/strong>\u00a0for studies that\r\n<ul>\r\n \t<li>involve a survey and no other procedures<\/li>\r\n \t<li>pose <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal risk<\/a> to subjects<\/li>\r\n<\/ul>\r\n<strong>Template (two versions):<\/strong>\r\n<ul>\r\n \t<li>The <strong>Working Version<\/strong> of this document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.<\/li>\r\n \t<li>The <strong>Outline Version<\/strong> of this document is to be used to complete the document that is to be submitted to the IRBMED for review.<\/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":[{"legacy_button":{"title":"Sample (Minimal Risk) -- Working Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_icd-blood-draw-template-4-17-2018-working_0_0.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Sample (Minimal Risk) -- Outline Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_icd-blood-draw-template-4-17-2018-outline_0.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"Survey Research 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":[{"legacy_button":{"title":"Survey -- Working Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_specialty-survey-working-4-17-2018_0.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Survey -- Outline Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_specialty-survey-outline-4-17-2018_0.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"text_area","legacy_heading":"Eligibility Screening Informed Consent Template","legacy_subheading":"","legacy_section_text":"This template may be used\u00a0<strong>only<\/strong>\u00a0for studies that\r\n<ul>\r\n \t<li>involve a survey and no other procedures<\/li>\r\n \t<li>pose <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal risk<\/a> to subjects<\/li>\r\n<\/ul>\r\n\u2192 \u00a0Download the template below or join the pilot project for the <a href=\"https:\/\/hrpp.umich.edu\/informed-consent-builder-pilot\/\">Informed Consent Builder<\/a> tool for access to an expanded version of this template suitable for studies that involve a <strong>survey, interview or focus group and no interventions<\/strong>.\r\n\r\n<strong>Template (two versions):<\/strong>\r\n<ul>\r\n \t<li>The <strong>Working Version<\/strong> of this document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.<\/li>\r\n \t<li>The <strong>Outline Version<\/strong> of this document is to be used to complete the document that is to be submitted to the IRBMED for review.<\/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":"link_button","legacy_heading":"","legacy_subheading":"","legacy_section_text":"This template may be used<strong>\u00a0only<\/strong>\u00a0for eligibility screening and\u00a0only\u00a0if screening procedures pose no more than minimal risk to subjects.\r\n\r\nYou\u00a0<strong>may not\u00a0<\/strong>use this template if\r\n<ul>\r\n \t<li>you plan to conduct genetic analysis of subjects\u2019 blood or tissue samples<\/li>\r\n \t<li>you plan to submit subjects\u2019 material or data to a biorepository or data <a class=\"gtip\" href=\"\/medschool\/glossary\/repository\">repository<\/a><\/li>\r\n<\/ul>\r\n<strong>Template (two versions):<\/strong>\r\n<ul>\r\n \t<li>The <strong>Working Version<\/strong> of this document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.<\/li>\r\n \t<li>The <strong>Outline Version<\/strong> of this document is to be used to complete the document that is to be submitted to the IRBMED for review.<\/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":[{"legacy_button":{"title":"Survey -- Working Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_specialty-survey-working-4-17-2018_0.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Survey -- Outline Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_specialty-survey-outline-4-17-2018_0.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"Eligibility Screening 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":[{"legacy_button":{"title":"Eligibility Screening -- Working Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_icd-eligibility-10-23-2015-instructions_0.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Eligibility Screening -- Outline Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_icd-eligibility-10-23-2015-clean_0.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"text_area","legacy_heading":"Humanitarian Use Device (HUD) Informed Consent Template","legacy_subheading":"","legacy_section_text":"This template may be used<strong>\u00a0only<\/strong>\u00a0for eligibility screening and\u00a0only\u00a0if screening procedures pose no more than minimal risk to subjects.\r\n\r\nYou\u00a0<strong>may not\u00a0<\/strong>use this template if\r\n<ul>\r\n \t<li>you plan to conduct genetic analysis of subjects\u2019 blood or tissue samples<\/li>\r\n \t<li>you plan to submit subjects\u2019 material or data to a biorepository or data <a class=\"gtip\" href=\"\/medschool\/glossary\/repository\">repository<\/a><\/li>\r\n<\/ul>\r\n<strong>Template (two versions):<\/strong>\r\n<ul>\r\n \t<li>The <strong>Working Version<\/strong> of this document provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the template prior to submitting it to the IRBMED for review. Investigators are responsible for understanding and following all instructions.<\/li>\r\n \t<li>The <strong>Outline Version<\/strong> of this document is to be used to complete the document that is to be submitted to the IRBMED for review.<\/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":"link_button","legacy_heading":"","legacy_subheading":"","legacy_section_text":"See Humanitarian Use Device (<a class=\"gtip\" href=\"\/medschool\/glossary\/humanitarian-use-device-hud\">HUD<\/a>) guidance\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/humanitarian-use-device-requirements-u-m-physicians-investigators\">here.<\/a>\r\n\r\n<strong>Template (two versions):<\/strong>\r\n<ul>\r\n \t<li>The<strong> Working Version<\/strong>\u00a0provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the template prior to submitting it to IRBMED for review. Investigators are responsible for understanding and following all instructions.<\/li>\r\n \t<li>The <strong>Outline Version<\/strong>\u00a0is to be used to complete the document to be submitted to IRBMED for review.<\/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":[{"legacy_button":{"title":"Eligibility Screening -- Working Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_icd-eligibility-10-23-2015-instructions_0.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Eligibility Screening -- Outline Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_icd-eligibility-10-23-2015-clean_0.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"Humanitarian Use Device (HUD) 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":[{"legacy_button":{"title":"HUD - Working Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_HUD-consent-instructions-5-11-2020.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"HUD - Outline Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_HUD-consent-clean-5-11-2020.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"text_area","legacy_heading":"FDA Expanded Access Informed Consent Template","legacy_subheading":"","legacy_section_text":"See Humanitarian Use Device (<a class=\"gtip\" href=\"\/medschool\/glossary\/humanitarian-use-device-hud\">HUD<\/a>) guidance\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/humanitarian-use-device-requirements-u-m-physicians-investigators\">here.<\/a>\r\n\r\n<strong>Template (two versions):<\/strong>\r\n<ul>\r\n \t<li>The<strong> Working Version<\/strong>\u00a0provides detailed instructions for completing the template, including required language, alternate text, and information about sections that may be altered. These instructions are to guide and assist you in completing the template prior to submitting it to IRBMED for review. Investigators are responsible for understanding and following all instructions.<\/li>\r\n \t<li>The <strong>Outline Version<\/strong>\u00a0is to be used to complete the document to be submitted to IRBMED for review.<\/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":"link_button","legacy_heading":"","legacy_subheading":"","legacy_section_text":"See Emergency Use guidance\u00a0<a href=\"\/medschool\/guidance\/emergency-use-test-article-life-threatening-circumstances\">here<\/a>.\r\nSee <a class=\"gtip\" href=\"\/medschool\/glossary\/expanded-access\">Expanded Access<\/a> guidance\u00a0<a href=\"\/medschool\/guidance\/fda-expanded-access-program-university-michigan\">here<\/a>.\r\n\r\n<strong><span style=\"margin: 0px;padding: 0px\"><a href=\"https:\/\/az.research.umich.edu\/medschool\/templates\/fda-expanded-access-informed-consent-template\" target=\"_blank\" rel=\"noopener\">FDA Expanded Access Conset Template<\/a> <\/span><\/strong>is designed for use in both <a class=\"gtip\" href=\"\/medschool\/glossary\/compassionate-use\">Compassionate Use<\/a> and <a class=\"gtip\" href=\"\/medschool\/glossary\/emergency-use\">Emergency Use<\/a>\u00a0cases.\r\n\r\nFor assistance with obtaining <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a> and IRBMED approval to use an Expanded Access investigational medical product, contact\u00a0<a href=\"https:\/\/www.michr.umich.edu\/rdc\/2015\/9\/4\/regulatory-support-for-fda-regulated-clinical-research\">MICHR IND \/ IDE Investigator Assistance Program (MIAP)<\/a>\u00a0by emailing\u00a0<a href=\"mailto:UM-Expanded-Access-Request@med.umich.edu\">UM-Expanded-Access-Request@med.umich.edu<\/a>","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":"HUD - Working Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_HUD-consent-instructions-5-11-2020.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"HUD - Outline Version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_HUD-consent-clean-5-11-2020.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"FDA Expanded Access 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":[{"legacy_button":{"title":"FDA Expanded Access Consent Template","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_expanded-access-consent-20200411.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"text_area","legacy_heading":"Exempt Research Template","legacy_subheading":"","legacy_section_text":"See Emergency Use guidance\u00a0<a href=\"\/medschool\/guidance\/emergency-use-test-article-life-threatening-circumstances\">here<\/a>.\r\nSee <a class=\"gtip\" href=\"\/medschool\/glossary\/expanded-access\">Expanded Access<\/a> guidance\u00a0<a href=\"\/medschool\/guidance\/fda-expanded-access-program-university-michigan\">here<\/a>.\r\n\r\n<strong><span style=\"margin: 0px;padding: 0px\"><a href=\"https:\/\/az.research.umich.edu\/medschool\/templates\/fda-expanded-access-informed-consent-template\" target=\"_blank\" rel=\"noopener\">FDA Expanded Access Conset Template<\/a> <\/span><\/strong>is designed for use in both <a class=\"gtip\" href=\"\/medschool\/glossary\/compassionate-use\">Compassionate Use<\/a> and <a class=\"gtip\" href=\"\/medschool\/glossary\/emergency-use\">Emergency Use<\/a>\u00a0cases.\r\n\r\nFor assistance with obtaining <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a> and IRBMED approval to use an Expanded Access investigational medical product, contact\u00a0<a href=\"https:\/\/www.michr.umich.edu\/rdc\/2015\/9\/4\/regulatory-support-for-fda-regulated-clinical-research\">MICHR IND \/ IDE Investigator Assistance Program (MIAP)<\/a>\u00a0by emailing\u00a0<a href=\"mailto:UM-Expanded-Access-Request@med.umich.edu\">UM-Expanded-Access-Request@med.umich.edu<\/a>","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":"The expectation for all human subject research\u2014whether exempt or not\u2014is for researchers to inform the subjects regarding the research and seek\/secure the consent of subjects.\r\n\r\nUse the <strong>Exempt\u00a0Consent Template<\/strong> for Exempt studies requiring\u00a0<a class=\"gtip\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/limited-irb-review\/\">Limited IRB review<\/a>\u00a0(categories 2(iii) and 3(i)(C). You may use it for other\u00a0Exempt human subjects research\u00a0that involves interaction\/intervention (categories 1, 2, and 3).\r\n\r\nDo\u00a0<strong>not\u00a0<\/strong>use this template for studies requiring comprehensive (regularly regulated) IRB review and approval.","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":"FDA Expanded Access Consent Template","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_expanded-access-consent-20200411.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"Exempt Research 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":[{"legacy_button":{"title":"Exempt Consent Template","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_Exempt-Consent-Template.doc","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"text_area","legacy_heading":"Foreign Language Short Forms","legacy_subheading":"","legacy_section_text":"The expectation for all human subject research\u2014whether exempt or not\u2014is for researchers to inform the subjects regarding the research and seek\/secure the consent of subjects.\r\n\r\nUse the <strong>Exempt\u00a0Consent Template<\/strong> for Exempt studies requiring\u00a0<a class=\"gtip\" href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/limited-irb-review\/\">Limited IRB review<\/a>\u00a0(categories 2(iii) and 3(i)(C). You may use it for other\u00a0Exempt human subjects research\u00a0that involves interaction\/intervention (categories 1, 2, and 3).\r\n\r\nDo\u00a0<strong>not\u00a0<\/strong>use this template for studies requiring comprehensive (regularly regulated) IRB review and approval.\r\n\r\nDownload the template below or join the pilot project for the <a href=\"https:\/\/hrpp.umich.edu\/informed-consent-builder-pilot\/\">Informed Consent Builder<\/a> tool.","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":"<ol>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">Investigators<\/a> are responsible for understanding and following the\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/consent-accommodations-lep-illiterate-deaf-blind\/\">Research Participants with Limited English Proficiency <em>etc.<\/em><\/a>\u00a0before using the forms below. Please note, the instructions on this page are for filling out the form, NOT the guidance for using a <a class=\"gtip\" href=\"\/medschool\/glossary\/short-form\">short form<\/a> with a subject.\u00a0Be sure to read the\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/consent-accommodations-lep-illiterate-deaf-blind\/\">Guidance<\/a>.<\/li>\r\n \t<li>Do not alter or add to the text of these forms.<\/li>\r\n \t<li>Do not alter the header or footer.<\/li>\r\n \t<li>The interpreter on hand during the consent conversation\u00a0should fill in the needed blanks where information is to be provided and have the appropriate parties sign and date the form where indicated.<\/li>\r\n \t<li>If a language or translation error on a foreign language short form is discovered, notify the IRBMED immediately so we can correct the problem.<\/li>\r\n<\/ol>\r\nThe short form documents below were created in June 2018; all translations are certified by Babel Linguistics. For certification documentation, contact the IRBMED office.\r\n\r\nI<strong>F YOU NEED A SHORT FORM IN A LANGUAGE THAT IS NOT LISTED,<\/strong> OR IF YOU NEED INSTRUCTIONS FOR USING THE FORMS, EMAIL\u00a0<a href=\"mailto:irbmed@umich.edu?subject=Foreign%20language%20short%20form%20question\">IRBMED@UMICH.EDU<\/a>.","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":"Exempt Consent Template","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/10\/res_irbmed_Exempt-Consent-Template.doc","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"Foreign Language Short Forms","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":"Arabic","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-ARABIC.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Chinese","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-CHINESE.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Finnish","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_finnish-short-form-20180521.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"French","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-FRENCH.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Russian","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-RUSSIAN.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Spanish","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-SPANISH.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"English language version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-English.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<ol>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">Investigators<\/a> are responsible for understanding and following the\u00a0<a href=\"\/medschool\/guidance\/consent-accommodations-lep-illiterate-deaf-blind\/\">Research Participants with Limited English Proficiency <em>etc.<\/em><\/a>\u00a0before using the forms below. Please note, the instructions on this page are for filling out the form, NOT the guidance for using a <a class=\"gtip\" href=\"\/medschool\/glossary\/short-form\">short form<\/a> with a subject.\u00a0Be sure to read the\u00a0<a href=\"\/medschool\/guidance\/consent-accommodations-lep-illiterate-deaf-blind\/\">Guidance<\/a>.<\/li>\r\n \t<li>Do not alter or add to the text of these forms.<\/li>\r\n \t<li>Do not alter the header or footer.<\/li>\r\n \t<li>The interpreter on hand during the consent conversation\u00a0should fill in the needed blanks where information is to be provided and have the appropriate parties sign and date the form where indicated.<\/li>\r\n \t<li>If a language or translation error on a foreign language short form is discovered, notify the IRBMED immediately so we can correct the problem.<\/li>\r\n<\/ol>\r\nThe short form documents below were created in June 2018; all translations are certified by Babel Linguistics. For certification documentation, contact the IRBMED office.\r\n\r\nI<strong>F YOU NEED A SHORT FORM IN A LANGUAGE THAT IS NOT LISTED,<\/strong> OR IF YOU NEED INSTRUCTIONS FOR USING THE FORMS, EMAIL\u00a0<a href=\"mailto:irbmed@umich.edu?subject=Foreign%20language%20short%20form%20question\">IRBMED@UMICH.EDU<\/a>.","legacy_media_position":false,"legacy_media_file":null,"legacy_media_url":"","legacy_glossary_term":null,"legacy_glossary_nids":"","legacy_resource":null,"legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"link_button","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":false,"legacy_media_file":null,"legacy_media_url":"","legacy_glossary_term":null,"legacy_glossary_nids":"","legacy_resource":null,"legacy_resource_nids":"","legacy_buttons":[{"legacy_button":{"title":"Arabic","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-ARABIC.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Chinese","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-CHINESE.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Finnish","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_finnish-short-form-20180521.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"French","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-FRENCH.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Russian","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-RUSSIAN.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Spanish","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-SPANISH.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"English language version","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_20180720-ShortForm-English.docx","target":"_blank"},"legacy_import_link":true}]}],"update_notice_type":[98],"update_notice_start":"2026-04-08 13:00:00","update_notice_end":"2026-05-07 17:00:00","update_notice_text_blocks":[{"update_notice_text":"The <a href=\"https:\/\/hrpp.umich.edu\/informed-consent-builder-pilot\/\">Informed Consent Builder<\/a> tool, offered by the HRPP as a pilot in 2026, now offers a template suitable for studies that involve a <strong>survey, interview or focus group and no interventions<\/strong>, in addition to an <strong>Exempt consent<\/strong> and a <strong>written assent for child participants.<\/strong> You can also submit questions or suggestions for expanding the pilot."}],"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-emergencieson-call#irbmed-staff\">IRBMED staff<\/a> is available through <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\">our website<\/a>.\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: April 8, 10:45AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/733","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":6,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/733\/revisions"}],"predecessor-version":[{"id":1964,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/733\/revisions\/1964"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/98"}],"acf:post":[{"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\/730"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=733"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=733"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=733"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=733"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=733"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=733"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}