{"id":845,"date":"2018-05-22T07:14:13","date_gmt":"2018-05-22T07:14:13","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/statement-practice-flexibility-initiatives\/"},"modified":"2026-04-08T11:03:27","modified_gmt":"2026-04-08T15:03:27","slug":"statement-practice-flexibility-initiatives","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/policies\/statement-practice-flexibility-initiatives\/","title":{"rendered":"Statement of Practice: Flexibility Initiatives"},"template":"","categories":[24],"tags":[],"content-type":[72],"topic":[42,75,46,67],"update-type":[],"class_list":["post-845","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":"2020-02-03 14:45:00","update_notice":false,"author":"IRBMED","summary":"The University of Michigan's federalwide assurance\u00a0with the Department of Health and Human Services (HHS)\u00a0allows the IRB\u00a0flexibility\u00a0in its application of federal regulations to studies not federally funded or\u00a0FDA-regulated.\r\n\r\n<a href=\"\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_SP.FlexibilityInitiatives.2015.03.21.pdf\">Click here for PDF version.<\/a>","button_links":null,"related_content":[861,731,736,863,739],"legacy_path":"statement-practice-flexibility-initiatives","legacy_node_id":405,"legacy_related_nids":"422, 260, 265, 522, 277","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"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":"The University of Michigan maintains a\u00a0federalwide assurance\u00a0(<a class=\"gtip\" href=\"\/medschool\/glossary\/fwa\">FWA<\/a>00004969) with the Department of Health and Human Services (<a href=\"https:\/\/www.hhs.gov\">HHS<\/a>) in which it pledges to comply with federal regulations for all federally supported <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a> and also to follow the ethical principles of the\u00a0<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/belmont-report\/index.html\">Belmont Report<\/a>\u00a0(National Commission for the Protection of<a class=\"gtip\" href=\"\/medschool\/glossary\/human-subject-0\"> Human Subjects<\/a> of Biomedical and <a class=\"gtip\" href=\"\/medschool\/glossary\/behavioral-research\">Behavioral Research<\/a>). This commitment allows the IRB <a href=\"http:\/\/research-compliance.umich.edu\/human-subjects\/hrpp-flexibility-initiatives\">flexibility<\/a>\u00a0in its application of federal regulations to studies that are not federally funded or <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a> regulated. While continuing to apply the highest ethical standards for the protection of human subjects, this initiative will decrease the administrative burden on investigators and IRBMED Staff.","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":"Flexibility Initiative Criteria","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":"To qualify for any flexibility initiative, a study must pose\u00a0no more than <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal risk<\/a>\u00a0to subjects<strong> and may\u00a0not<\/strong>\u00a0include <strong>any<\/strong> of the following:\r\n<ul>\r\n \t<li>Federal funding or federal training grants (direct or prime sponsorship)<\/li>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a> regulated components<\/li>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/sponsor\">Sponsor<\/a> or other contractual restrictions (including <a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/international-council-harmonisation-good-clinical-practice-ich-gcp\">ICH-GCP E6<\/a> compliance)<\/li>\r\n \t<li>\"Clinical trial\" under the <a href=\"https:\/\/grants.nih.gov\/policy\/clinical-trials\/definition.htm\">NIH Definition<\/a><\/li>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/prisoner\">Prisoners<\/a>\u00a0as subjects<\/li>\r\n \t<li>Receipt of a <a href=\"https:\/\/hrpp.umich.edu\/certificates-of-confidentiality\/\">Certificate of Confidentiality<\/a>\u00a0to protect identifiable research data<\/li>\r\n<\/ul>\r\nStudies intended to support proposals or future awards for federal funding usually should not use \u201cflexibility initiatives,\u201d out of an \u2018abundance of caution.\u2019 However, former federal funding is not a barrier to flexibility initiatives for an ongoing study.\r\n\r\nIf a study also involves external site(s), the study team should check with outside contacts before agreeing to a U-M flexibility initiative.","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":"List of Flexibility Initiatives","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>Flexibility initiatives at <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-medical-school-irbmed\">IRBMED<\/a> include, but are not necessarily limited to:<\/h4>\r\n<ul>\r\n \t<li><strong>U-M Exemption 5<\/strong>: Research and demonstration projects sponsored by the State of Michigan<\/li>\r\n \t<li><strong>\u201cNo continuing review required\u201d for ongoing studies <\/strong>(without triggering additional \u201c2018 Requirements\u201d under the Common Rule) that do not include genetic analysis<\/li>\r\n \t<li><strong>24-month approval for Repository (REP) Applications<\/strong> that are not intended to facilitate genetic analysis<\/li>\r\n<\/ul>\r\n<h4>Prior (retired) flexibility initiatives<\/h4>\r\n<ul>\r\n \t<li>June 11, 2018 - January 20, 2019 : <strong>Pilot<\/strong> some of the 2018 Common Rule enhancements<\/li>\r\n \t<li>2015 - June 10, 2018\r\n<ul>\r\n \t<li>U-M Exemption 2A<\/li>\r\n \t<li>U-M Exemption 7<\/li>\r\n \t<li>Two-Year Approvals<\/li>\r\n<\/ul>\r\n<\/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":"","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 8, 2026 11:00AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/845","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":5,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/845\/revisions"}],"predecessor-version":[{"id":1963,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/845\/revisions\/1963"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/739"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/863"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/736"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/731"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/861"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=845"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=845"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=845"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=845"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=845"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=845"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}