{"id":740,"date":"2018-05-04T07:21:45","date_gmt":"2018-05-04T07:21:45","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/assent-children-research\/"},"modified":"2026-02-23T11:19:51","modified_gmt":"2026-02-23T16:19:51","slug":"assent-children-research","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/assent-children-research\/","title":{"rendered":"Assent of Children in Research"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[26,66,75,67],"update-type":[],"class_list":["post-740","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-informed-consent-assent","topic-investigator-study-team-responsibilities","topic-regulations-policies-federal-state-local","topic-subject-populations"],"acf":{"use_legacy_editor":true,"updated_date":"2025-05-09 14:45:00","update_notice":true,"author":"IRBMED","summary":"The <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-medical-school-irbmed\">IRBMED<\/a> has developed an assent template for researchers to use in developing an assent document appropriate for <a class=\"gtip\" href=\"\/medschool\/glossary\/children\">children<\/a> ages 10 to 14. It is available\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/document\/assent-template\/\">here<\/a>.\u00a0Below are frequently asked questions about <a class=\"gtip\" href=\"\/medschool\/glossary\/assent\">assent.<\/a> Links to additional information are at the\u00a0<a href=\"\/medschool\/guidance\/children-research\/\" target=\"_blank\" rel=\"noopener\">Children in Research<\/a> webpage.","button_links":null,"related_content":"","legacy_path":"assent-children-research","legacy_node_id":278,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Why must IRBs and researchers consider assent?","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":"Federal regulations require, \u201cThe <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-irb\">IRB<\/a> shall determine that adequate provisions are made for soliciting the <a class=\"gtip\" href=\"\/medschool\/glossary\/assent\">assent<\/a> of the <a class=\"gtip\" href=\"\/medschool\/glossary\/children\">children,<\/a> when in the judgment of the IRB the children are capable of providing assent.\u201d The IRB must make the determination\u00a0for each protocol\u00a0that includes <a class=\"gtip\" href=\"\/medschool\/glossary\/children\">children<\/a>. The IRB must require child assent unless it can be appropriately waived. <a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\/subpart-D\/section-46.408\">45 CFR 46.408<\/a> &amp; <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-50\/subpart-D\/section-50.55\">21 CFR\u00a050.55<\/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":"heading","legacy_heading":"What is assent?","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":"\u201c<a class=\"gtip\" href=\"\/medschool\/glossary\/assent\">Assent<\/a>\u201d means a child\u2019s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. This means the child must actively show his or her willingness to participate in the research, rather than just complying with directions to participate and not resisting in any way. A child has authority to say \u201cNo\u201d to participating in research. <a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\/subpart-D\/section-46.402\">45 CFR 46.402<\/a>(b), <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-50\/subpart-A\/section-50.3\">21 CFR 50.3<\/a>(n)","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":"What is an assent process?","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":"It is a reasonable effort to enable the child to understand, to the degree they are capable, what their participation in research would involve. It does not constitute a consent process and may involve different procedural elements. Parents retain responsibility to protect the child from risks. The assent should focus on elements relevant to the child (e.g. pain, time). Foremost, when assent is required by the IRB, parents and researchers must adhere to the child\u2019s decision.","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":"What if the parent and child disagree?","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":"\u201cIf a child is capable of assent and the IRB requires that assent be sought, it must be obtained before the child can participate in the research activity. Thus, if the child dissents from participating in research or does not provide a sufficiently affirmative agreement, <strong>even if his or her parents or guardian have granted permission, the child\u2019s decision prevails<\/strong>,\u201d\u00a0HHS <a class=\"gtip\" href=\"http:\/\/hhs.gov\/ohrp\/\">Office of Human Research Protections\u00a0(OHRP)<\/a>: <a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/faq\/children-research\/index.html\">Frequently Asked Questions: Children in Research<\/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":"heading","legacy_heading":"How does the IRB determine when children are capable to assent?","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":"Regulations direct IRBs to consider:\r\n<ul>\r\n \t<li>Age and maturity of the children<\/li>\r\n \t<li>Psychological state of the children<\/li>\r\n \t<li>Nature of the proposed research activity<\/li>\r\n<\/ul>\r\nRegulations give IRBs flexibility in deciding which children an investigator must assent. A judgment may be made for all children to be involved in research under a particular protocol, or for each child. The IRB\u2019s outcome should be suited\/delineated for the study at hand.\r\n\r\nClick\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_Child-Assent-Guidelines_0.pdf\">here<\/a> for a table showing common IRB determinations whether to require assent based on the age of the participant and whether the study offers the prospect of direct benefit.\r\n\r\nFor guidance on assent age ranges, please visit the Human Research Protection Program (HRPP) page.","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":"When can the IRB waive assent?","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":"View Assent Age Ranges Guidance","url":"https:\/\/hrpp.umich.edu\/resource\/assent-age-ranges\/","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"When can the IRB waive assent?","legacy_subheading":"","legacy_section_text":"There are 3 waiver options:\r\n\r\n1. Capabilities of some or all children is so limited they\u00a0cannot\u00a0be consulted.\r\n\r\n2. Study offers important benefit unavailable outside of the research.\r\n<ul>\r\n \t<li>When the study offers a treatment that is thought to be a better option than those currently available, or it offers the only alternative.<\/li>\r\n \t<li>Criterion of \u2018potential direct benefit\u2019 is not sufficient to grant this waiver.<\/li>\r\n<\/ul>\r\n3. Assent can also be waived under the same criteria as a consent waiver:\r\n<ul>\r\n \t<li>the study is <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal risk<\/a><\/li>\r\n \t<li>subjects\u2019 rights and welfare aren\u2019t adversely affected<\/li>\r\n \t<li>assent is not practicable (for reasons other than\u00a0children\u2019s capabilities)<\/li>\r\n \t<li>if the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable form<\/li>\r\n \t<li>when appropriate, the subjects will be provided pertinent information<\/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":"How do researchers communicate assent plans to the IRB?","legacy_subheading":"","legacy_section_text":"There are 3 waiver options:\r\n\r\n1. Capabilities of some or all children is so limited they\u00a0cannot\u00a0be consulted.\r\n\r\n2. Study offers important benefit unavailable outside of the research.\r\n<ul>\r\n \t<li>When the study offers a treatment that is thought to be a better option than those currently available, or it offers the only alternative.<\/li>\r\n \t<li>Criterion of \u2018potential direct benefit\u2019 is not sufficient to grant this waiver.<\/li>\r\n<\/ul>\r\n3. Assent can also be waived under the same criteria as a consent waiver:\r\n<ul>\r\n \t<li>the study is <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal risk<\/a><\/li>\r\n \t<li>subjects\u2019 rights and welfare aren\u2019t adversely affected<\/li>\r\n \t<li>assent is not practicable (for reasons other than\u00a0children\u2019s capabilities)<\/li>\r\n \t<li>if the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable form<\/li>\r\n \t<li>when appropriate, the subjects will be provided pertinent information<\/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":"How do researchers communicate assent plans to the IRB?","legacy_subheading":"","legacy_section_text":"In section 10.2, <a href=\"\/medschool\/guidance\/eresearch-regulatory-management-errm\">eResearch<\/a> prompts researchers to describe the process to seek and obtain informed assent for children and parental consent\/permission (e.g., setting, timing, personnel involved, arrangements for\r\nanswering subject questions before and after the consent is signed).","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":"In section 10.2, <a href=\"\/medschool\/guidance\/eresearch-regulatory-management-errm\">eResearch<\/a> prompts researchers to describe the process to seek and obtain informed assent for children and parental consent\/permission (e.g., setting, timing, personnel involved, arrangements for answering subject questions before and after the consent is signed).","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}],"update_notice_type":[98],"update_notice_start":"2025-05-12 00:00:00","update_notice_end":"2025-07-12 00:00:00","update_notice_text_blocks":[{"update_notice_text":"The new HRPP guidance on developing <a href=\"https:\/\/hrpp.umich.edu\/resource\/assent-age-ranges\/\">Assent Age Ranges<\/a> supplements this page's heading \"How does the IRB determine when children are capable to assent?\""}],"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\n<p>A <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">list of IRBMED staff<\/a> is available at our website.<\/p>\r\n\r\nEdited by: larkspur@umich.edu\r\nLast updated: February 23, 2026 11:15AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/740","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\/740\/revisions"}],"predecessor-version":[{"id":1882,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/740\/revisions\/1882"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/98"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=740"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=740"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=740"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=740"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=740"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=740"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}