{"id":849,"date":"2018-05-22T09:59:22","date_gmt":"2018-05-22T09:59:22","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/statement-practice-interpretation-expedited-category-5\/"},"modified":"2026-04-13T15:42:25","modified_gmt":"2026-04-13T19:42:25","slug":"statement-practice-interpretation-expedited-category-5","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/policies\/statement-practice-interpretation-expedited-category-5\/","title":{"rendered":"Statement of Practice: Interpretation of Expedited Category (5)"},"template":"","categories":[24],"tags":[],"content-type":[72],"topic":[42,75,46,67],"update-type":[],"class_list":["post-849","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-policies","topic-application-types","topic-regulations-policies-federal-state-local","topic-statements-of-practice","topic-subject-populations"],"acf":{"use_legacy_editor":true,"updated_date":"2018-08-28 12:30:00","update_notice":false,"author":"IRBMED","summary":"Expedited Category (5) pertains to research\u00a0involving data\/materials that have been collected previously for research or non-research purposes\u00a0and\/or\u00a0will be collected solely for non-research purposes, provided that certain criteria are met.\r\n\r\n<a href=\"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_SP-ExpeditedReview5-2014-03-05-Website.pdf\">Click here for PDF version.<\/a>","button_links":null,"related_content":"","legacy_path":"statement-practice-interpretation-expedited-category-5","legacy_node_id":409,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"I. Statement of Practice","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":"IRBMED may apply Expedited Category (5) to research projects (or elements thereof) involving data\/materials that either have been collected previously for research or non-research purposes\u00a0<em>and\/or<\/em> will be collected solely for non-research purpose; when the general Applicability criteria in the <a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/categories-of-research-expedited-review-procedure-1998\/index.html\">published list of 1998<\/a>\u00a0are met, including:\r\n<ul>\r\n \t<li>Research activities present no more than <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal risk<\/a> to <a class=\"gtip\" href=\"\/medschool\/glossary\/human-subject-0\">human subjects<\/a><\/li>\r\n \t<li>Research is not classified<\/li>\r\n \t<li>Identification of the subjects and\/or their responses would\u00a0<strong>not<\/strong>\u00a0reasonably place them at risk of criminal<strong> or<\/strong> civil liability or be damaging to the subjects;\u00a0or\u00a0reasonable and appropriate protections will be implemented so that risks related to invasion of <a class=\"gtip\" href=\"\/medschool\/glossary\/privacy\">privacy<\/a> and breach of <a class=\"gtip\" href=\"\/medschool\/glossary\/confidentiality\">confidentiality<\/a> are no greater than minimal<\/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":"II. Background","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":"Following regulations issued by <a class=\"gtip\" href=\"\/medschool\/glossary\/office-human-research-protection-ohrp\">OHRP<\/a>\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/section-46.110\">45CFR46.110<\/a>\u00a0and <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a>\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-56.110\">21CFR56.110<\/a>, <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-medical-school-irbmed\">IRBMED<\/a> commonly uses <a class=\"gtip\" href=\"\/medschool\/glossary\/expedited-review\">'expedited review' <\/a>procedures for initial and <a class=\"gtip\" href=\"\/medschool\/glossary\/continuing-review-cr\">continuing review<\/a>, and review of proposed changes, for research described by one or more categories on the\u00a0<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/categories-of-research-expedited-review-procedure-1998\/index.html\">1998 list of Expedited Categories<\/a>\u00a0published at\u00a0<a href=\"https:\/\/www.federalregister.gov\/documents\/1998\/11\/09\/98-29749\/protection-of-human-subjects-categories-of-research-that-may-be-reviewed-by-the-institutional-review\">63 FR 60364.<\/a>\r\n\r\n<strong>Category (5)<\/strong>\u00a0<em>applies to\u00a0Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).<\/em>\r\n\r\nThis can be read to suggest that the category covers only materials generated for non-research purposes, whether retrospective or prospective.\r\n\r\nHowever, OHRP issued in 2007 a\u00a0<strong>clarification of the scope of Expedited Category<\/strong> (5)\u00a0at\u00a0<a href=\"https:\/\/www.federalregister.gov\/documents\/2007\/10\/26\/E7-21126\/protection-of-human-subjects-categories-of-research-that-may-be-reviewed-by-the-institutional-review\">72 FR 60849<\/a>:\u00a0<em>OHRP has concluded that expedited review category 5 was intended to, and should, include ... research involving existing information or specimens that were previously collected for research purposes---provided they were not collected for the currently proposed research.<\/em>","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":"III. Resources","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":"<ol>\r\n \t<li>45 CFR 46.110: <a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/section-46.110\">https:\/\/www.ecfr.gov\/current\/title-45\/section-46.110<\/a><\/li>\r\n \t<li>21 CFR 56.110: <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-56.110\">https:\/\/www.ecfr.gov\/current\/title-21\/section-56.110<\/a><\/li>\r\n \t<li>OHRP, Categories of Research That May Be Reviewed ...through an <a class=\"gtip\" href=\"\/medschool\/glossary\/expedited-review\">Expedited Review<\/a> Procedure:\u00a0<a href=\"http:\/\/www.hhs.gov\/ohrp\/policy\/expedited98.html\">http:\/\/www.hhs.gov\/ohrp\/policy\/expedited98.html<\/a><\/li>\r\n \t<li>Federal Register, 72 FR 60849,\u00a0<a href=\"https:\/\/federalregister.gov\/a\/E7-21126\">https:\/\/federalregister.gov\/a\/E7-21126<\/a><\/li>\r\n \t<li><a href=\"https:\/\/hrpp.umich.edu\/u-mic\/\">UMIC<\/a> Expedited Review, Category 5<\/li>\r\n<\/ol>","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":"","update_notice_end":"","update_notice_text_blocks":null,"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"Contact us at <a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/a> or 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: April 13, 2026 3:40PM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/849","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\/849\/revisions"}],"predecessor-version":[{"id":1966,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/849\/revisions\/1966"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=849"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=849"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=849"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=849"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=849"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=849"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}