{"id":742,"date":"2018-05-04T07:50:52","date_gmt":"2018-05-04T07:50:52","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/children-research\/"},"modified":"2026-02-23T11:27:13","modified_gmt":"2026-02-23T16:27:13","slug":"children-research","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/children-research\/","title":{"rendered":"Children in Research"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[26,66,75,47],"update-type":[],"class_list":["post-742","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-payments-reimbursement"],"acf":{"use_legacy_editor":true,"updated_date":"2021-03-08 15:00:00","update_notice":true,"author":"IRBMED","summary":"The involvement of children of any age in human subjects research involves additional regulatory and ethical considerations. Resources on the main categories for consideration follow.\r\n\r\n<em>Children\u00a0<\/em>are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted (<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46#section-46.402\">45 CFR 46.402<\/a>)","button_links":null,"related_content":"","legacy_path":"children-research","legacy_node_id":280,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Neonates (less than 28 days of age)","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>Regulations: <a href=\"https:\/\/ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46#section-46.205\">Research Involving Neonates of uncertain viability, and nonviable neonates (45 CFR 46.205)<\/a><\/li>\r\n \t<li>Research on viable neonates is covered under regulations on child subjects, <a href=\"https:\/\/ecfr.federalregister.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46#subpart-D\">45 CFR 46 Subpart D<\/a> (.401 and following)<\/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":"Assent (pediatric participant's agreement to participate in research)","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":"<h4>Guidance and Resources in Research A-Z<\/h4>\r\n<ul>\r\n \t<li><a href=\"\/medschool\/guidance\/assent-children-research\">Assent of Children in Research<\/a><\/li>\r\n \t<li><a href=\"\/medschool\/templates\/assent-template\">Assent Template<\/a> \u2013 recommended for children ages 10- to 14-years-old<\/li>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_Child-Assent-Guidelines_0.pdf\">Assent Guidelines<\/a> \u2013 tool demonstrating common IRB determinations for when assent is required, based on the age of the participant and whether the study offers the prospect of direct benefit<\/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":"Office of Human Research Protections (OHRP)","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>Regulations: <a href=\"https:\/\/ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46#subpart-D\">Additional Protections for Children Involved as Subjects in Research (45 CFR 46, Subpart D)<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/faq\/children-research\/index.html\">Frequently Asked Questions: Children in Research\u00a0<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.youtube.com\/watch?v=I18bRCmVuAE\">Research with Children: What Parents Need to Know<\/a>\u00a0\u2013 7-minute video<\/li>\r\n \t<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/special-protections-for-children\/index.html\">Special Protections for Children as Research Subjects<\/a> (Overview of the 4 regulations under which child subjects are permitted)<\/li>\r\n \t<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/guidance-on-407-review-process\/index.html\">Research involving greater risk than 'minor increase over minimal' without direct benefit to participants<\/a> \u2013 Guidance for 45 CFR 46.407<\/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":"Food and Drug Administration (FDA)","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>Regulations: <a href=\"https:\/\/ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-50#subpart-D\">Additional Safeguards for Children in Clinical Investigations (21 CFR 50, Subpart D)<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/general-clinical-pharmacology-considerations-pediatric-studies-drugs-and-biological-products\">General\u00a0 Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products<\/a> (\u201cPediatric Drug Development\u201d Draft Guidance 2022)<\/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":"Other","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 style=\"list-style-type: circle\">\r\n \t<li>National Cancer Institute Guidance: <a href=\"https:\/\/www.cancer.gov\/about-cancer\/treatment\/clinical-trials\/patient-safety\/childrens-assent\">Children\u2019s Assent<\/a> Information directed at parents, and in \u2018plain language,\u2019 on the process and meaning of children\u2019s assent; illustrative for all types of research.<\/li>\r\n \t<li>NIH <a href=\"https:\/\/grants.nih.gov\/policy\/inclusion\/lifespan.htm\">Inclusion Across the Lifespan Policy<\/a> \u2013 Applications and proposals involving human subjects research must address plans for including individuals across the lifespan in the PHS Human Subjects and Clinical Trial Information Form. Any age-related exclusions must include a rationale and justification based on a scientific or ethical basis.<\/li>\r\n \t<li><a href=\"\/medschool\/document\/research-involving-children-who-are-wards-state-or-any-other-agency-institution\/\">Wards of the State as Research Subjects<\/a> \u202f\u2013 There are both state and federal laws that regulate what is allowed and what must be done when a ward participates in a\u202fresearch\u202fstudy.<\/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":[],"update_notice_start":"2021-03-08 12:00:00","update_notice_end":"2021-05-08 14:00:00","update_notice_text_blocks":[{"update_notice_text":"<p>Links in this page were updated, and minor clarifications added.<\/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\n\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:\u00a0<a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: February 23, 2026 11:25AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/742","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":1,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/742\/revisions"}],"predecessor-version":[{"id":1887,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/742\/revisions\/1887"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=742"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=742"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=742"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=742"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=742"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=742"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}