{"id":872,"date":"2018-06-01T12:02:36","date_gmt":"2018-06-01T12:02:36","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/emergency-research-planned-and-approved-exception-informed-consent\/"},"modified":"2026-02-23T11:38:06","modified_gmt":"2026-02-23T16:38:06","slug":"emergency-research-planned-and-approved-exception-informed-consent","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/emergency-research-planned-and-approved-exception-informed-consent\/","title":{"rendered":"Emergency Research (Planned and Approved) with Exception from Informed Consent"},"template":"","categories":[24],"tags":[77],"content-type":[41],"topic":[44,26,66,75],"update-type":[97],"class_list":["post-872","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","tag-regulatory","content-type-guidance","topic-fda-drugs-devices-biologics","topic-informed-consent-assent","topic-investigator-study-team-responsibilities","topic-regulations-policies-federal-state-local","update-type-information-only"],"acf":{"use_legacy_editor":true,"updated_date":"2022-08-31 22:30:00","update_notice":true,"author":"IRBMED","summary":"<h3>Overview<\/h3>\r\nThe Food and Drug Administration (FDA)\u00a0regulation at <a class=\"gtip\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-50\/subpart-B\/section-50.24\" target=\"_blank\" rel=\"noopener\">21 CFR 50.24<\/a>,\u00a0and Office for Human Research Protections (OHRP)\u00a0<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/emergency-research-informed-consent-requirements\/index.html\" target=\"_blank\" rel=\"noopener\">Secretary's Waiver<\/a>, allows a narrow exception to the requirement to prospectively obtain and document <a class=\"gtip\" href=\"\/medschool\/glossary\/informed-consent\">informed consent<\/a> from research participants. According to the regulation, IRBs may approve certain <strong>emergency research protocols<\/strong> in which participants are unable to give informed consent at the time of enrollment due to their medical condition.\r\n\r\nThese studies require additional steps to ensure that potential participants in the communities where the study takes place have adequate opportunity to learn about the study at any time:\r\n<ul>\r\n \t<li>\u201cCommunity Consultation\u201d prior to IRB submission of the full study protocol<\/li>\r\n \t<li>\u201cPublic Disclosure\u201d (such as advertisements)\r\n<ul>\r\n \t<li>before study initiation, of plans for the investigation and its risks and expected benefits<\/li>\r\n \t<li>after study completion, of study results and the demographics of the study population.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\nThe IRB also approves and oversees these additional steps.\r\n<h3>Guidance Documents<\/h3>\r\n<ul>\r\n \t<li>IRBMED <a href=\"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed-EFIC-Process-Flow-Chart.pdf\">flowchart on extended process for\u00a0approval and oversight of EFIC studies<\/a><\/li>\r\n \t<li><a href=\"https:\/\/hrpp.umich.edu\/u-mic\/\">U-MIC<\/a>\u00a0presentation:\u00a0Exception from Informed Consent Requirements for Emergency Research<\/li>\r\n \t<li><a href=\"https:\/\/www.fda.gov\/media\/80554\/download\">FDA Guidance:\u00a0Exception from Informed Consent for Studies Conducted in Emergency Settings<\/a><\/li>\r\n \t<li><a href=\"http:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/emergency-research-informed-consent-requirements\/\">OHRP Guidance:\u00a0Emergency Research Consent Waiver<\/a><\/li>\r\n \t<li><a href=\"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_EFIC_0.pdf\">IRBMED Position Statement 2007\u00a0on Allowing Exception From Informed Consent For Emergency Care Research<\/a><\/li>\r\n<\/ul>","button_links":null,"related_content":[730],"legacy_path":"emergency-research-planned-and-approved-exception-informed-consent","legacy_node_id":1005,"legacy_related_nids":"259","legacy_content_section":null,"update_notice_type":[97],"update_notice_start":"2022-08-31 12:00:00","update_notice_end":"2022-10-31 14:00:00","update_notice_text_blocks":[{"update_notice_text":"<p>This page received minor updates, including updated links to external guidance. The EFIC flowchart demonstrating the approval &amp; oversight process is newly 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\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\nA <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.\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: February 23, 2026 11:35AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/872","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":3,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/872\/revisions"}],"predecessor-version":[{"id":1892,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/872\/revisions\/1892"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/97"}],"acf:post":[{"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=872"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=872"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=872"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=872"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=872"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=872"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}