{"id":731,"date":"2018-05-02T10:52:11","date_gmt":"2018-05-02T10:52:11","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/exempt-human-subjects-research\/"},"modified":"2026-02-24T13:17:08","modified_gmt":"2026-02-24T18:17:08","slug":"exempt-human-subjects-research","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/exempt-human-subjects-research\/","title":{"rendered":"Exempt Human Subjects Research"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[42,43,75,67],"update-type":[],"class_list":["post-731","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-application-types","topic-eresearch-regulatory-management-errm","topic-regulations-policies-federal-state-local","topic-subject-populations"],"acf":{"use_legacy_editor":true,"updated_date":"2025-03-31 10:30:00","update_notice":false,"author":"IRBMED","summary":"This page contains information regarding\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/human-subject-0\">human subjects<\/a> research that falls within the\u00a0<strong>federal exemption categories<\/strong> or <strong>U-M exemption categories<\/strong>. Exempt human subjects research <strong>does <\/strong>require an application and determination in the eResearch system <strong>before <\/strong>any research activity or analysis takes place.","button_links":null,"related_content":[736,768],"legacy_path":"exempt-human-subjects-research","legacy_node_id":260,"legacy_related_nids":"265, 1557, 419, 422, 310, 405","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Requesting an Exempt Determination","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_with_subheading","legacy_heading":"","legacy_subheading":"eResearch application","legacy_section_text":"Open a new project application in eResearch Regulatory Management (eResearch or eRRM) system.\r\n<ul>\r\n \t<li>IRBMED\u00a0<a href=\"\/medschool\/informational\/eresearch-regulatory-management-errm\">Guidance on eResearch<\/a><\/li>\r\n \t<li>IRBMED\u00a0<a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-education#courses\">Course Offerings<\/a>\u00a0include in-person instruction on eResearch applications.<\/li>\r\n \t<li>eRRM\u00a0<a href=\"https:\/\/its.umich.edu\/academics-research\/research\/eresearch\/regulatory-management\/training\">Training and Reference Materials<\/a>\r\n<ul>\r\n \t<li>Refer particularly to step-by-step guides available through\u00a0<strong>Procedure Documents and Tips\u00a0\u2192\u00a0PI and Study Team<\/strong>\u00a0heading<\/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},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"Specific pointers on filling out an Exempt study application:","legacy_section_text":"After you fill out the study team, project summary, &amp;c on page 01, click \u201cContinue.\u201d On page 01-1, based on your research design, choose either \".. Interaction\/Intervention\" or \"Secondary Research Uses.\" Fill out all system-required sections, use the \u201cContinue\u201d button and let the eResearch \u2018system logic\u2019 lead you through the system-required pages. After filling out all required sections, please \u201c<a href=\"https:\/\/documentation.its.umich.edu\/node\/1499\">Submit<\/a>\u201d (listed PI only) the application. Some exemptions (1, 2, 3) may permit \"<a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-frequently-asked-questions-faq#system-determined\">system-generated determination<\/a>\" as an alternative to \"Submit to IRB\"; this option is not presented for studies involving <a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/protected-health-information-phi\">PHI<\/a>\u00a0access.\r\n\r\nThe opportunity to select exemptions 1, 2, 3, 5, and 6, appear on page 01-1 after selecting \"Research Involving Subject Interaction\/Intervention\" if certain conditions are met. If none of the exemption categories seem to apply, you can indicate that on 01-1 and eResearch will route you for comprehensive IRB review and approval. Qualification for Exemption 4 is determined as part of the Secondary research application type.\r\n\r\nExempt study applications submitted to the IRB are most often processed in less than two weeks. IRB staff will contact you through the eResearch system with any questions or required clarifications. You\u2019ll receive an \u201cExempt\u201d determination through the eResearch system when all required reviews are complete.\r\n\r\n<a href=\"http:\/\/research-compliance.umich.edu\/irb-health-sciences-and-behavioral-sciences-hsbs\">IRB-HSBS<\/a>\u00a0(UM Central Campus IRB) processes some Exempt human research study applications submitted by <a class=\"gtip\" href=\"\/medschool\/glossary\/umhs\">UMHS<\/a> or Medical School faculty (requests for Exemption 1, 2, or 3 that do\u00a0not\u00a0involve\u00a0<a href=\"\/medschool\/guidance\/protected-health-information-phi\">PHI<\/a>\u00a0access and do not require<a class=\"gtip\" href=\"\/medschool\/glossary\/limited-irb-review\/\"> <em>limited IRB review<\/em><\/a> process under the 2018 Revised Common Rule).\u00a0<strong>IMPORTANTLY<\/strong>,\u00a0<a href=\"http:\/\/research-compliance.umich.edu\/operations-manual-irb-jurisdiction-and-cooperative-research#whichirb\">default IRB jurisdiction<\/a>\u00a0for UMHS faculty is unchanged: if you normally submit to IRBMED (by choosing \"IRBMED\" in question\u00a0<strong>1.9\u00a0<\/strong>of an HUM application), please continue to do so.","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_with_subheading","legacy_heading":"","legacy_subheading":"Questions?","legacy_section_text":"Contact your IRB with questions or concerns. Email:\r\n<ul>\r\n \t<li><a href=\"mailto:irbhsbs@umich.edu\">IRB-Health Sciences and Behavioral Sciences<\/a><\/li>\r\n \t<li><a href=\"mailto:irbmed@umich.edu\">IRBMED<\/a><\/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":"What is an Exemption?","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":"\u201cExempt human subjects research\u201d is a specific sub-set of \u201cresearch involving human subjects\u201d that does\u00a0<strong>not<\/strong>\u00a0require ongoing IRB oversight, because the\u00a0<strong>only<\/strong>\u00a0involvement of human subjects falls into one or more specifically defined \u201cExempt categories.\u201d\r\n<ul>\r\n \t<li>Federal regulations governing <a class=\"gtip\" href=\"\/medschool\/glossary\/human-subject-0\">human subjects<\/a> protection specify categories of \u201chuman subjects research\u201d that are \u201cexempt from this policy.\u201d [<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\">45 CFR 46<\/a>.104(d)] These are described further in the \"Federal Exemptions\" below.<\/li>\r\n \t<li>U-M recognizes additional exemptions as a \u201c<a href=\"\/medschool\/policies\/statement-practice-flexibility-initiatives\/\">flexibility initiative<\/a>\u201d. These are available\u00a0only\u00a0for research that is not federally funded, nor subject to other additional regulations. These are described further in the \"U-M Flexibility Initiative Exemption Categories\" below.<\/li>\r\n<\/ul>\r\nExempt human subjects research generally poses \u201cno more than minimal\u201d risk, involves simple, well-understood study designs, and does not involve subjects likely to be vulnerable to <a class=\"gtip\" href=\"\/medschool\/glossary\/coercion\">coercion<\/a> or <a class=\"gtip\" href=\"\/medschool\/glossary\/undue-influence\">undue influence<\/a>. Research that involves both exempt and non-exempt activities is\u00a0not\u00a0exempt.\r\n\r\nExempt status does\u00a0<strong>not<\/strong>\u00a0lessen researchers\u2019 ethical obligations to subjects as articulated in the\u00a0<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/belmont-report\/index.html\">Belmont Report<\/a>, in disciplinary codes of professional conduct, and in U-M policies such as Human Research Protection Program (HRPP) <a class=\"gtip\" href=\"https:\/\/hrpp.umich.edu\/resource\/operations-manual\/\">Operations Manual (OM)<\/a>\u00a0Part 1, section IV\u00a0and SPG\u00a0<a href=\"http:\/\/spg.umich.edu\/policy\/303.05\">Policy for Research with Human Participants)<\/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":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"How is Exemption different from Not Regulated determination?","legacy_section_text":"\u201cExempt human subjects research\u201d meets the regulatory definitions for \u201c<a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a>\u201d [<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\">45 CFR 46<\/a>.102(d)] and for \u201cinvolving human subjects\u201d [45 CFR 46.102(f)], and also meets criteria for exemption [45 CFR 46.104(d) or a \u201cU-M Exemption Category\u201d per <a href=\"https:\/\/hrpp.umich.edu\/resource\/operations-manual\/\">HRPP Operations Manual<\/a> (OM) Part 4.VI.B.2]. By U-M policy, exempt research must be submitted before the research begins; if an Exemption determination is finalized, no further IRB oversight is necessary so long as the research activity remains within the scope of the exemption category.\r\n\r\n\u201cActivities not regulated as human subjects research\u201d <strong>do\u00a0not<\/strong>\u00a0meet the regulatory definition of \u201cresearch,\u201d\u00a0<strong>and\/or do not<\/strong>\u00a0meet the regulatory definition of \u201cinvolving human subjects.\u201d Not Regulated projects do\u00a0<strong>not<\/strong> require IRB oversight at\u00a0<strong>any<\/strong> point, although an eResearch application is still indicated if review for <a href=\"\/medschool\/guidance\/hipaa\/\">HIPAA<\/a> considerations is required.\r\n\r\nSee also UM <a href=\"https:\/\/hrpp.umich.edu\/resource\/operations-manual\/\">HRPP OM<\/a> Part 4:\r\n<ul>\r\n \t<li>Section I\u00a0Determining What is Research and What is Not<\/li>\r\n \t<li>Section II\u00a0Determining Whether Research Involves Human Subjects<\/li>\r\n \t<li>Section V on\u00a0Not Regulated projects<\/li>\r\n \t<li>Section VI on\u00a0Exempt studies<\/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_with_subheading","legacy_heading":"","legacy_subheading":"How are Exempt studies regulated?","legacy_section_text":"<strong>U-M\u00a0Policy on Exempt Research <a href=\"https:\/\/hrpp.umich.edu\/resource\/operations-manual\/\">(OM<\/a> Part 4.VI) requires application for and determination of \u201cexempt\u201d eligibility before starting the research. <\/strong>\u00a0No <a class=\"gtip\" href=\"\/medschool\/glossary\/continuing-review-cr\">continuing review<\/a> or amendments are required as long as the research stays within the boundaries of the exemption category. Changes <strong>not<\/strong>\u00a0requiring Amendment to an Exempt study include, but are not limited to, new study team members, formatting changes to surveys, or change between two web-based survey platforms.\r\n\r\nThe IRB also does not review the any <a href=\"\/medschool\/glossary\/informed-consent\">informed consent<\/a> process or document(s) (if any)and\/or recruitment materials,\u00a0 except when \u201c<a class=\"gtip\" href=\"\/medschool\/glossary\/limited-irb-review\">Limited IRB review<\/a>\u201d is required for Exemption 2(iii) or Exemption 3(i)(C). However, expectation for all human subject research involving subject interaction\u2014whether exempt or not\u2014is for researchers to inform the subjects regarding the research and seek\/secure the consent of subjects. Study teams are strongly encouraged to utilize a consent process that provides sufficient information to participants in order to inform their decision regarding participation. Please use the Exempt consent template available through the <a href=\"\/medschool\/templates\/specialty-informed-consent-templates\">IRBMED Specialty Informed Consent Templates<\/a> webpage and through the <a href=\"https:\/\/hrpp.umich.edu\/informed-consent-builder-pilot\/\">Informed Consent Builder<\/a> tool; the <a href=\"\/medschool\/templates\/standard-informed-consent-template\">Standard<\/a> consent template is <strong>not<\/strong> appropriate.\r\n\r\nExempt studies may also be subject to\u00a0<a href=\"\/medschool\/guidance\/hipaa\">HIPAA<\/a> Privacy Rule regulation. For instance, a study involving medical record review to identify potential subjects, or medical record review to gather a dataset that would be eligible for Exemption 4, involves access to\u00a0<a href=\"\/medschool\/guidance\/protected-health-information-phi\">Protected Health Information\u00a0(PHI)<\/a> and probably should request a\u00a0<a href=\"\/medschool\/guidance\/waiver-or-alteration-hipaa-authorization\">waiver of HIPAA authorization<\/a>.\r\n\r\nFor some Exemption applications, the Principal Investigator is permitted to issue a \"<a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-frequently-asked-questions-faq#system-determined\">system-generated determination<\/a>,\" letter based on responses to key questions within qualifying human subjects exemption categories. The IRB does not review projects with system-generated determinations. \"System-generated determination\" is not available to projects involving access to <a href=\"\/medschool\/guidance\/protected-health-information-phi\">Protected Health Information\u00a0(PHI)<\/a>, so is uncommon for IRBMED studies.","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_with_subheading","legacy_heading":"","legacy_subheading":"Consent in Exempt Research","legacy_section_text":"The expectation for all human subject research\u2014whether exempt or not\u2014is for researchers to inform the subjects regarding the research and seek\/secure the consent of subjects. The regulations offer some regulatory flexibility with <a href=\"\/medschool\/glossary\/informed-consent\">informed consent<\/a> for exempt research. Please see below for the specific process for exempt research (categories 1, 2, and 3).\r\n\r\n<u>For Exempt 2 or 3 where <a class=\"gtip\" href=\"\/medschool\/glossary\/limited-irb-review\">Limited IRB review<\/a> applies: <\/u>\r\n<ul>\r\n \t<li>Utilize the Exempt consent template available through the <a href=\"\/medschool\/templates\/specialty-informed-consent-templates\">IRBMED Specialty Informed Consent Templates<\/a> webpage and through the <a href=\"https:\/\/hrpp.umich.edu\/informed-consent-builder-pilot\/\">Informed Consent Builder<\/a> tool.<\/li>\r\n \t<li>Upload the completed consent document and recruitment documents (as applicable) in the IRB application.<\/li>\r\n \t<li>IRBMED will review and approve these documents but will <strong>not<\/strong> finalize them with IRBMED approval stamp in the header.<\/li>\r\n<\/ul>\r\n<u>For Exempt 1 or 2 or 3 where Limited IRB review is not applicable: <\/u>\r\n<ul>\r\n \t<li>Usually, IRBMED does not review the informed consent process or document (if any) unless Limited IRB review is needed by the regulations.<\/li>\r\n \t<li>The study teams are strongly encouraged to utilize a consent process that provides sufficient information to participants to inform their decision regarding participation. You may use the Exempt consent template available through the <a href=\"\/medschool\/templates\/specialty-informed-consent-templates\">IRBMED Specialty Informed Consent Templates<\/a> webpage and through the <a href=\"https:\/\/hrpp.umich.edu\/informed-consent-builder-pilot\/\">Informed Consent Builder<\/a> tool.<\/li>\r\n<\/ul>\r\nUse of a formal informed consent document (such as the <a href=\"\/medschool\/templates\/standard-informed-consent-template\">IRBMED Standard consent template<\/a>) containing all of the elements of consent is <strong>not<\/strong> indicated for an Exempt study.\r\n\r\n<em>Note:<\/em> as with other exempt studies, it is <em>not<\/em> necessary to submit an Amendment in the eResearch system for changes to the consent document (except if this accompanies change to the scope of the research).","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_with_subheading","legacy_heading":"","legacy_subheading":"Restrictions on Exemptions","legacy_section_text":"U-M policy applies Exemption only to \u201cno more than <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal risk<\/a>\u201d research.\r\n\r\nExemptions<strong>\u00a0do not apply<\/strong>\u00a0to research with\u00a0<strong><a class=\"gtip\" href=\"\/medschool\/glossary\/prisoner\">prisoners<\/a><\/strong>, except for research aimed at involving a broader subject population that only incidentally includes prisoners. [<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\">45 CFR 46<\/a>.104(b)(2)].\r\n\r\nExemption 2(iii) and Exemption 3 <strong>do not apply<\/strong> to research with <a class=\"gtip\" href=\"\/medschool\/glossary\/children\">children<\/a>.\r\n\r\nExemptions\u00a0<strong>other than\u00a0<\/strong><a href=\"http:\/\/research-compliance.umich.edu\/operations-manual-part-4#exempt\">Federal Exemption Category 6<\/a>\u00a0<strong>do not apply\u00a0<\/strong>to <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a>-regulated research.\r\n\r\n&nbsp;","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":"Federal Exemptions","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_with_subheading","legacy_heading":"","legacy_subheading":"Federal Exemption Categories","legacy_section_text":"<a href=\"\/medschool\/guidance\/federal-exemption-categories\">Click here<\/a> for details on each Exemption category.\r\n<ol>\r\n \t<li>Research, <strong>conducted in established or commonly accepted educational settings<\/strong>, that specifically involves <strong>normal educational practices<\/strong> that are <strong>not likely to adversely impact students' opportunity<\/strong> to learn required educational content<strong> or the assessment of educators<\/strong> who provide instruction.<\/li>\r\n \t<li><strong>Research that only includes interactions <\/strong>involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) <strong>if at least one of the following criteria is met<\/strong>:\r\n<ul>\r\n \t<li>(i) The information obtained is recorded by the investigator in such a manner that the<strong> identity of the human subjects cannot readily be ascertained<\/strong>, directly or through identifiers linked to the subjects;<\/li>\r\n \t<li>(ii) Any <strong>disclosure of the human subjects' responses <\/strong>outside the research <strong>would not reasonably place the subjects at risk<\/strong> of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or<\/li>\r\n \t<li>(iii) The information obtained is recorded by the investigator in such a manner that the identity of <strong>the human subjects can readily be ascertained<\/strong>, directly or through identifiers linked to the subjects, <strong>and an IRB conducts a <a class=\"gtip\" href=\"\/medschool\/glossary\/limited-irb-review\"><em>limited IRB review<\/em><\/a><\/strong> to make the determination required by \u00a7<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\">46<\/a>.111(a)(7).<\/li>\r\n<\/ul>\r\nApplication of Exemption 2(i) and 2(ii) is limited for research involving <a class=\"gtip\" href=\"\/medschool\/glossary\/children\">children<\/a>. Exemption 2(iii) may not be applied to research involving children.<\/li>\r\n \t<li><strong>Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses<\/strong> (including data entry) or audiovisual recording <strong>if the subject prospectively agrees <\/strong>to the intervention and information collection <strong>and at least one of the following criteria is met<\/strong>:\r\n<ul>\r\n \t<li>(A)The information obtained is recorded by the investigator in such a manner that <strong>the identity of the human subjects cannot readily be ascertained<\/strong>, directly or through identifiers linked to the subjects;<\/li>\r\n \t<li>(B) Any <strong>disclosure of the human subjects' responses <\/strong>outside the research <strong>would not reasonably place the subjects at risk <\/strong>of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation;<\/li>\r\n \t<li>(C) The information obtained is recorded by the investigator in such a manner that <strong>the identity of the human subjects can readily be ascertained<\/strong>, directly or through identifiers linked to the subjects, <strong>and an IRB conducts a <a class=\"gtip\" href=\"\/medschool\/glossary\/limited-irb-review\"><em>limited IRB review<\/em><\/a> <\/strong>to make the determination required by \u00a7<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\">46<\/a>.111(a)(7).<\/li>\r\n<\/ul>\r\nExemption 3 may not be applied to research involving <a href=\"\/medschool\/glossary\/children\">children<\/a>.<\/li>\r\n \t<li><strong>Secondary research for which consent is not required:<\/strong> Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:\r\n<ul>\r\n \t<li>(i) The identifiable private information or identifiable biospecimens are <strong>publicly available<\/strong>;<\/li>\r\n \t<li>(ii) Information, which may include information about biospecimens, is <strong>recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained<\/strong> directly or through identifiers linked to the subjects, the <strong>investigator does not contact the subjects, and the investigator will not re-identify subjects<\/strong>;<\/li>\r\n \t<li>(iii) The research involves <strong>only information collection and analysis <\/strong>involving the investigator's<strong> use of identifiable health information <\/strong>when that use is <strong>regulated under 45 CFR parts 160 and 164, subparts A and E<\/strong> <strong>[HIPAA]<\/strong>; or<\/li>\r\n \t<li>(iv) The research is <strong>conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities<\/strong>,...<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Research and demonstration projects that are<strong> conducted or supported by a Federal department or agency<\/strong>, ... and that\u00a0 are designed to study, evaluate, or otherwise examine:\r\n<ul>\r\n \t<li>Public benefit or service programs;\u00a0<strong>or<\/strong><\/li>\r\n \t<li>procedures for obtaining benefits or services under those programs;\u00a0<strong>or<\/strong><\/li>\r\n \t<li>possible changes in or alternatives to those programs or procedures;\u00a0<strong>or<\/strong><\/li>\r\n \t<li>possible changes in methods or levels of payment for benefits or services under those programs. ...<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Taste and food quality evaluation and consumer acceptance studies,\r\n<ul>\r\n \t<li>(i) if wholesome foods without additives are consumed, or<\/li>\r\n \t<li>(ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ol>\r\n<p class=\"rteindent1\">U-M does not implement federal exemptions 7 and 8.<\/p>","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":"U-M Flexibility Initiative Exemption Categories","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":"\"<a href=\"\/policies\/statement-practice-flexibility-initiatives\/\">Flexibility Initiatives<\/a>\" (sometimes also known as \"demonstration projects\") permit U-M to depart from process standards incorporated in federal regulations (and associated guidance by federal regulatory agencies) for those categories of research to which those regulations need not apply. Federal regulations do not apply to research that is not federally-supported, does not fall under FDA jurisdiction, and is not held to federal regulation by contract. While continuing to apply the highest ethical standards for the protection of human subjects, flexibility initiatives decrease the administrative burden on investigators and IRB 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":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"Restrictions on \u201cU-M Exemption Categories\u201d","legacy_section_text":"Studies are not eligible for \u201cU-M Exemption Categories\u201d per <a href=\"https:\/\/hrpp.umich.edu\/resource\/operations-manual\/\">HRPP OM<\/a> Part VI.B if they involve <strong>any<\/strong>\u00a0of the following:\r\n<ul>\r\n \t<li>Study activity posing greater than <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal risk<\/a><\/li>\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=\"\/medschool\/guidance\/international-council-harmonisation-good-clinical-practice-ich-gcp\">ICH-GCP E6<\/a> compliance)<\/li>\r\n \t<li>\u201cClinical trial\u201d under the <a href=\"https:\/\/grants.nih.gov\/policy-and-compliance\/policy-topics\/clinical-trials\/definition\">NIH Definition<\/a><\/li>\r\n \t<li><a href=\"https:\/\/hrpp.umich.edu\/resource\/research-involving-prisoners\/\">Prisoners<\/a> as subjects<\/li>\r\n \t<li>Receipt of a <a href=\"https:\/\/hrpp.umich.edu\/certificates-confidentiality\">Certificate of Confidentiality<\/a>\u00a0to protect identifiable research data<\/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_with_subheading","legacy_heading":"","legacy_subheading":"U-M Exemption Categories","legacy_section_text":"<strong>U-M Exemption 5: Research and demonstration projects sponsored by the State of Michigan<\/strong>\r\n\r\nState of Michigan-supported research and demonstration projects conducted by or subject to the approval of\u00a0<strong>state department or agency heads<\/strong>, and that otherwise meet the following requirements:\r\n<ul>\r\n \t<li>The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutritional services under the Older Americans Act);<\/li>\r\n \t<li>It must be conducted pursuant to specific statutory authority;<\/li>\r\n \t<li>There must be no statutory requirements that the project be reviewed by an IRB;<\/li>\r\n \t<li>The project must not involve significant physical invasions or intrusions upon the privacy of participants.<\/li>\r\n<\/ul>\r\nThis exemption is an extension of\u00a0<a href=\"\/medschool\/guidance\/federal-exemption-categories\">Federal Exemption<\/a>\u00a05.","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":"References","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>U-M <a href=\"https:\/\/hrpp.umich.edu\/resource\/operations-manual\/\">HRPP\u00a0Operations Manual<\/a> Part 4.VI<\/li>\r\n \t<li>IRBMED\u00a0<a href=\"\/medschool\/policies\/statement-practice-flexibility-initiatives\/\">Statements of Practice: Flexibility Initiatives<\/a><\/li>\r\n \t<li><a href=\"https:\/\/hrpp.umich.edu\/u-mic\/\">U-MIC<\/a> educational presentation: \"Exemptions 1 and 2\"<\/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":"2014-12-16 05:00:00","update_notice_end":"2025-02-01 17:00:00","update_notice_text_blocks":[{"update_notice_text":"<a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-frequently-asked-questions-faq#system-determined\">System-generated determination<\/a>\u00a0capability\u00a0<a href=\"https:\/\/its.umich.edu\/academics-research\/research\/eresearch\/regulatory-management\/release-notes\/951782\">will be restored on December 16, 2024<\/a>."}],"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\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 24, 2026 1:15PM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/731","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\/731\/revisions"}],"predecessor-version":[{"id":1897,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/731\/revisions\/1897"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/768"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/736"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=731"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=731"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=731"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=731"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=731"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=731"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}