{"id":747,"date":"2018-05-04T11:42:19","date_gmt":"2018-05-04T11:42:19","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/elements-and-uses-repository\/"},"modified":"2026-02-23T11:36:58","modified_gmt":"2026-02-23T16:36:58","slug":"elements-and-uses-repository","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/elements-and-uses-repository\/","title":{"rendered":"Elements and Uses of a Repository"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[43,66,27],"update-type":[],"class_list":["post-747","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-eresearch-regulatory-management-errm","topic-investigator-study-team-responsibilities","topic-repository"],"acf":{"use_legacy_editor":true,"updated_date":"2021-02-26 08:45:00","update_notice":false,"author":"IRBMED","summary":"A research <a class=\"gtip\" href=\"\/medschool\/glossary\/repository\">repository<\/a> is defined as a collection of data\/biospecimens that have been collected and stored with the intention of using the materials for future <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a>, either by the <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigator<\/a> who collected them or by sharing the materials with other investigators.\r\n\r\nResearchers interact with a repository in 3 different ways:\r\n<ol>\r\n \t<li>Primary collection\/aggregation of data\/biospecimens<\/li>\r\n \t<li>Intake, storage, maintenance and distribution of repository data\/biospecimens<\/li>\r\n \t<li>Secondary use\/analysis of data\/biospecimens obtained from a repository<\/li>\r\n<\/ol>","button_links":null,"related_content":[739,757,772,733],"legacy_path":"elements-and-uses-repository","legacy_node_id":288,"legacy_related_nids":"277, 299, 314, 266, 1470","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"1. Primary collection\/aggregation of information\/biospecimens","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":"Collecting identifiable private information and\/or identifiable biospecimens through <a class=\"gtip\" href=\"\/medschool\/glossary\/interaction\">interaction<\/a> or <a class=\"gtip\" href=\"\/medschool\/glossary\/intervention\">intervention<\/a> with living individuals is \"<a class=\"gtip\" href=\"\/medschool\/glossary\/human-subject-0\">human subjects<\/a> research\" per federal regulations\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46#46.102\">45 CFR 46.102<\/a>.\r\n\r\nIt is sometimes useful to aggregate into a research repository information\/biospecimens that are\r\n<ul>\r\n \t<li>generated for non-research purposes and<\/li>\r\n \t<li>initially collected in databases such as medical records, pathology departments, census records, or other private or public sources.<\/li>\r\n<\/ul>\r\nThis aggregation usually does not involve interaction or intervention with individuals. When researchers obtain identifiable private information and\/or identifiable biospecimens about living individuals, this is, however, also \"human subjects research\" per OHRP regulations\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46#46.102\">45 CFR 46.102<\/a>. A human subjects <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a> activity may collect information\/biospecimens for future research use as a sub-study, or as its primary purpose.\r\n\r\n\"Human subjects research\" must be conducted in accordance with federal regulations and\u00a0<a href=\"https:\/\/hrpp.umich.edu\/\">U-M Human Research Protection Program<\/a>\u00a0policies. U-M IRBs exercise oversight through the HUM project type in\u00a0<a href=\"https:\/\/its.umich.edu\/academics-research\/research\/eresearch\/regulatory-management\">eResearch Regulatory Management<\/a>\u00a0(eRRM).","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":"Studies depositing data\/biospecimens into a repository","legacy_section_text":"A human subjects research activity (approved through HUM) may collect data\/biospecimens for future research use as a sub-study, or as its primary purpose. Studies depositing into an REP for long-term storage and\/or other purposes should include \"pointers\" to the REP. Initially, these should include:\r\n<ul>\r\n \t<li>HUM page 01, question 1.1.2 for \"related projects\": enter REP# and the Repository Title.<\/li>\r\n \t<li>HUM page 11, question 11.6: check \"Retain for future research use\" (and others as applicable)<\/li>\r\n \t<li>HUM page 11-4, question 11-4.2: check \"<em>Only at the University of\r\nMichigan<\/em>\"\u00a0<strong>OR<\/strong>\u00a0\"<em>UM and Other Institutions<\/em>\" (as applicable)<\/li>\r\n \t<li>HUM page 11-4, question 11-4.3: Refer to the REP. The REP application\r\ncomprehensively addresses these questions.<\/li>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/informed-consent-document-icd-or-informed-consent-form-icf\">Informed Consent Documents (ICDs)<\/a> uploaded in HUM page 10-1, question 10-1.1: Consent document should address explicitly plans for data\/biospecimen use for future undefined research. U-M studies intending to collect biospecimens for unspecified future research use should consider using the\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/templates\/specialty-informed-consent-templates\/\">Specialty Biorepository Informed Consent Template<\/a>\u00a0+ informational sheet (in addition to or instead of another study-specific consent form, depending on the nature of the study). <strong><em>Note:<\/em><\/strong> <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/central-biorepository\">UMMS Central Biorepository\u00a0(CBR)<\/a> <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/central-biorepository\/regulatory-governance\">requires\u00a0studies depositing with them<\/a> to use the biorepository template + informational sheet; however, no relationship with CBR is implied by the use of these documents in and of themselves.<\/li>\r\n<\/ul>\r\nIRB staff create two-way hyperlinks between an REP and associated HUM(s). The links display in an REP space under \u201cRelated Projects\u201d tab, and in an HUM space under \u201cDocument\/Related Records\u201d tab. Links are \u201clive\u201d (can be used to navigate from HUM to or from REP) for study team members listed on both applications, as well as for IRB staff and reviewers.\u00a0(See also\u00a0HUM-REP connections\u00a0question at\u00a0FAQ: <a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/faq-repository-application-rep\/\">Repository application<\/a>.)\r\n\r\nHUM study teams and REP repository teams are responsible for presenting consistently their intended plans for working together in applications to the IRB.","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":"2. Intake, storage, maintenance and distribution of repository information\/biospecimens","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 repository is a collection of information and\/or biospecimens whose organizers\r\n<ul>\r\n \t<li>May receive information\/biospecimens from multiple sources<\/li>\r\n \t<li>Maintain the information\/biospecimens over time<\/li>\r\n \t<li>Control access to and use of information\/biospecimens by multiple individuals and\/or for multiple purposes, which may evolve over time.<\/li>\r\n<\/ul>\r\nA repository may receive information\/biospecimens from research and\/or non-research \"primary collections.\" Multiple IRB-approved HUM studies may deposit information\/biospecimens into a single repository registered via the REP. Among other responsibilities, the repository should have adequate procedures for recording and verifying any restrictions on future use, including but not limited to informed consent.\r\n\r\nA repository maintains the information\/biospecimens over time. Among other responsibilities, the repository should have adequate procedures for:\r\n<ul>\r\n \t<li>Data security<\/li>\r\n \t<li>Physical storage<\/li>\r\n \t<li>Sustaining the repository over time, including managing financial and physical resources<\/li>\r\n<\/ul>\r\nMany existing repositories at U-M already have approval through a HUM application. New repositories should be registered through the REP application in <a class=\"gtip\" href=\"\/medschool\/glossary\/errm\">eRRM<\/a>. (See also: \"Previously approved repository\" and \"New repository\" questions at <a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/faq-repository-application-rep\/\">FAQ: Repository application<\/a>).\u00a0Repositories maintaining identifiable <a class=\"gtip\" href=\"\/medschool\/glossary\/private-information\">private information<\/a> and\/or identifiable biospecimens require IRB approval. Repositories maintaining strictly de-identified or anonymous data\/specimens may receive a \"Not Regulated\" determination upon registration. Depending on the amount and complexity of data\/biospecimens stored, a governance or oversight committee may be appropriate for the repository, for example to review applications for use of materials, make decisions about the allocation of rare resources (primarily biospecimens), and\/or resolve disputes.\r\n\r\n\u201c<a href=\"https:\/\/michmed-medicalschool.policystat.com\/policy\/5508111\/latest\/\">Medical School Governing UMMS Research Biorepositories Policy<\/a>\u201d (available through <a href=\"https:\/\/michmed-medicalschool.policystat.com\/\">PolicyStat<\/a>, <em>level-2 login required<\/em>) Section II, D requires an oversight committee for every biorepository \"established with the express intent of sharing biospecimens or samples outside the department or beyond collaboration with its creator\/s.\" This requirement applies whenever the repository is funded by a <a class=\"gtip\" href=\"\/medschool\/glossary\/umms\">UMMS<\/a> Department, it operates in UMMS space, or the creator of the repository holds even a partial appointment in the Medical School Faculty. (See also: \"UMMS policy\" questions at <a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/faq-repository-application-rep\">FAQ: Repository application<\/a>).\r\n\r\nA repository distributes information\/biospecimens for multiple research uses over time. Some repositories are intended only for use by a select few <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigators<\/a>. Some repositories intend limited purposes for their information\/biospecimens. Others are available for general use to any qualified investigators and for a wide variety of scientific investigations. Among other responsibilities, the repository should have adequate policies\/procedures for\r\n<ul>\r\n \t<li>verifying that a proposed use is consistent with restrictions imposed at collection of information\/biospecimens.<\/li>\r\n \t<li>ensuring security and <a class=\"gtip\" href=\"\/medschool\/glossary\/confidentiality\">confidentiality<\/a> of data\/biospecimens during transfer\/release<\/li>\r\n \t<li>identifying and managing proposed research uses that present especially high <a class=\"gtip\" href=\"\/medschool\/glossary\/risk\">risk<\/a> to subjects or groups of which they are members<\/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":"3. Secondary use\/analysis of information\/biospecimens obtained from a repository","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":"Primary uses are defined as those specific research uses for which information\/biospecimens were initially acquired. A secondary use\u00a0investigates a new research question, whether conducted by the <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigator<\/a> who initially acquired the information\/biospecimens or by any other investigator.\r\n\r\nSome repositories, such as the\u00a0<a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/central-biorepository\/\">UMMS Central Biorepository<\/a><u>,<\/u>\u00a0will distribute information\/biospecimens for primary uses, if the repository provides biospecimen processing and\/or storage services as a component of a particular study. More commonly, repositories store information\/biospecimens long-term which are intended for secondary use.\r\n\r\nA repository likely will have an application process for requesting secondary use of data\/biospecimens, which may be more or less restrictive depending on the scope and resources of the repository, in addition to any requirements for IRB approval. <a href=\"\/medschool\/guidance\/secondary-use-research\/\">Secondary uses<\/a> that meet the definition of \"<a class=\"gtip\" href=\"\/medschool\/glossary\/human-subject-0\">human subjects<\/a> research\" must be conducted in accordance with federal regulations and\u00a0<a href=\"http:\/\/hrpp.umich.edu\">U-M Human Research Protection Program\u00a0policies<\/a>. U-M IRBs exercise oversight through the HUM project type in\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/eresearch-regulatory-management-errm\/\">eResearch Regulatory Management<\/a>\u00a0(eRRM).","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":"Studies obtaining data\/biospecimens from a repository","legacy_section_text":"Secondary use analysis of data and\/or biospecimens (including distributions from data repositories and biorepositories) require IRB oversight if the analysis meets the regulatory definition for \"<strong>human subjects research<\/strong>.\" See <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-frequently-asked-questions-faq\">IRBMED FAQ<\/a> questions <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-frequently-asked-questions-faq#research-types\">\"What kind of research and other activities require IRB review?\"<\/a> and <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-frequently-asked-questions-faq#submit-application\">\"Do I need to submit an IRB application?\"<\/a> Secondary use analysis \"involves human subjects\" when the investigator conducting the research \"obtains identifiable private data.\"\r\n\r\neResearch HUM application type <strong>\"<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/secondary-use-research\/\">Secondary research uses<\/a> of private information and\/or biospecimens\"<\/strong> is designed to route any secondary use studies where U-M study team performs data analysis through the correct IRB review and determination path (i.e., not regulated, exempt, or comprehensive IRB approval).\r\n\r\nNot Regulated may apply if the researchers doing the analysis <strong>do not<\/strong> at any point have access to \"re-identify\" the data.\r\n<ul>\r\n \t<li>U\u2013M faculty, staff and\/or students\/trainees receive\u00a0data\/specimens without identifiable data through an 'honest broker', either internal (<em>e.g.,<\/em> <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/data-office-clinical-translational-research\/self-serve-data-tools\">DataDirect<\/a>, <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/central-biorepository\/access-biospecimen\">Central Biorepository<\/a>, <a href=\"https:\/\/www.pathology.med.umich.edu\/cutting\">Tissue Procurement Service<\/a>) or external (<em>e.g.,<\/em> <a href=\"http:\/\/www.ncbi.nlm.nih.gov\/gap\">dbGaP<\/a>, <a href=\"https:\/\/biolincc.nhlbi.nih.gov\/home\/\">BioLINCC<\/a> or <a href=\"http:\/\/www.resdac.org\/cms-data\/request\/cms-data-request-center\">CMS-ResDAC<\/a>). In this case, choose either \"<strong>Secondary research uses...<\/strong>\" or \"<strong>Activities not regulated...<\/strong>\" in application type 01-1.<\/li>\r\n \t<li>U-M faculty, staffa and\/or students\/trainees PREPARE \"coded\" or \"de-identified\" dataset\/specimens for analysis by EXTERNAL investigators (U-M role is limited to data PROVIDER). In this case, choose \"<strong>Activities not regulated...<\/strong>\" in application type 01-1.<\/li>\r\n<\/ul>\r\n<a href=\"\/medschool\/guidance\/exempt-human-subjects-research\">Exemption<\/a> 4 is available for retrospective and\/or prospective data\/biospecimens and applies to most IRBMED secondary use research without biospecimens\r\n<ul>\r\n \t<li>public data sources such as phone book;<\/li>\r\n \t<li>non-public data\/biospecimens sources if study team\u00a0may\u00a0view but will\u00a0not\u00a0record\u00a0any\u00a0direct or indirect identifiers.<\/li>\r\n \t<li>\"HIPAA exemption\" - no biospecimens and all data are covered by HIPAA\r\n<ul>\r\n \t<li>data sources are regulated as PHI;<\/li>\r\n \t<li>ALL study team members are members of a HIPAA \"covered entity (CE)\";<\/li>\r\n \t<li>ALL institutions involved with the study are \"covered entities\";<\/li>\r\n \t<li>The data either NEVER leaves a CE, or is covered by HIPAA-specific data use agreements throughout any and every transfer.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\nComprehensive (non-exempt) IRB review and approval is required when \"not regulated\" and \"exempt\" are not available. For instance,\r\n<ul>\r\n \t<li>Research dataset for analysis comprises\/includes identifiable private information <strong>not <\/strong>covered under HIPAA<\/li>\r\n \t<li>Biospecimen analysis where associated identifiable data are kept<\/li>\r\n \t<li>Requirement from data\/biospecimen provider for full or expedited IRB review (<em>e.g.,<\/em> some <a href=\"http:\/\/www.ncbi.nlm.nih.gov\/gap\">dbGaP<\/a> datasets, based on Data Use Certification)<\/li>\r\n \t<li>Data are intended for <a class=\"gtip\" href=\"\/medschool\/glossary\/investigational-device-exemption-ide\">IDE (Investigational Device Exemption)<\/a> or In Vitro Diagnostic (IVD) device application to <a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a><\/li>\r\n \t<li>Secondary use is paired with interaction\/intervention. In this case, choose \"<strong>Human Subjects research involving interaction or intervention<\/strong>...\" in application type 01-1.<\/li>\r\n<\/ul>\r\n<strong>NOTE: <\/strong>Exemption 4 eligibility is expanded under Revised Common Rule, active as of January 2019. U-M applied the expanded Exemption 4 as a <a href=\"\/medschool\/policies\/statement-practice-flexibility-initiatives\">Flexibility Initiative<\/a> June 2018 - January 2019. Pre-2018 Exemption 4 covered <strong>only<\/strong> analyses where <strong>both <\/strong>(1) all data already existed at time of IRB application <strong>and<\/strong> (2) one of the following applied:\r\n<ul>\r\n \t<li>public data\/biospecimen sources such as phone book;<\/li>\r\n \t<li>non-public data\/biospecimens sources such as medical records only if study team may view but will not record any direct or indirect identifiers.<\/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":"Informed Consent &amp; HIPAA authorization for secondary use","legacy_section_text":"An application for \"secondary use\" research may ask about consent and\/or <a class=\"gtip\" href=\"\/medschool\/glossary\/hipaa\">HIPAA<\/a> authorization for the data\/biospecimens received. Consent process or waiver and HIPAA authorization process or waiver <strong>MUST<\/strong> be compatible with each other.\r\n<h4>Informed Consent<\/h4>\r\nThe IRB regulations regarding informed consent apply only to secondary use research requiring comprehensive (non-exempt) IRB review and approval. It is common for these to operate under a waiver of consent and waiver of HIPAA authorization. Waivers are\u00a0<strong>not<\/strong> necessary for \"secondary use\" research if the initial consent collecting data\/biospecimens already addresses permission for unspecified future use: this constitutes \"pre-existing consent.\" In some cases, a \"secondary use\" researcher may need to recontact original subject-donors of data\/biospecimens to request a new consent.\r\n<table border=\"1\" cellspacing=\"1\" cellpadding=\"1\">\r\n<tbody>\r\n<tr>\r\n<td><strong>Situation\u00a0<\/strong><\/td>\r\n<td><strong>Expected answers<\/strong><\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Full waiver of consent\r\n<strong>or<\/strong>\r\nUse of data from prior research study for purpose not contemplated in original consent<\/td>\r\n<td><strong>10.3<\/strong>: Request for waiver of informed consent\/parental\r\npermission\/legally authorized representative consent<strong>10-3.1<\/strong>: Waiver \u2013 General - ALL of the project<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Use of data from prior research study for purpose consistent with original consent<\/td>\r\n<td><strong>10.3<\/strong>: Pre-existing consent covers this activity\r\n\r\n<strong>10.3.1<\/strong>:\u00a0Refer to REP<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Re-consent<\/td>\r\n<td><strong>10.3<\/strong>: Re-consent\/<a class=\"gtip\" href=\"\/medschool\/glossary\/assent\">assent<\/a> subjects for use of existing data\/records\/specimens for a new research purpose.\r\n\r\n<strong>10-1<\/strong>\u00a0filled out<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n<h4>HIPAA Authorization<\/h4>\r\n<table border=\"1\" cellspacing=\"1\" cellpadding=\"1\">\r\n<tbody>\r\n<tr>\r\n<td><strong>Situation<\/strong><\/td>\r\n<td><strong>Expected answers<\/strong><\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Full waiver of consent\r\n<strong>or\u00a0<\/strong>Use of data from prior research study for purpose not contemplated in original consent<\/td>\r\n<td><strong>25-1.3<\/strong>: Authorization \"... will not be obtained from any subjects\u201d\r\n\r\n<strong>25-1.3.2<\/strong>: \"Request for full or partial waiver ...\u201d\r\n\r\n<strong>25-2.1<\/strong>: \u201cEntire project\u201d<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Use of data from prior research study for purpose\u00a0<em>consistent\r\nwith original consent<\/em><\/td>\r\n<td><strong>25-1.3<\/strong>: Authorization \u201c...was\/will be obtained\r\nfrom all subjects\u201d<strong>25-1.3.1<\/strong>: \u201cintegrated with\u201d or \"separate from\" informed consent document, as applicable to original authorization<\/td>\r\n<\/tr>\r\n<tr>\r\n<td>Re-consent<\/td>\r\n<td><strong>25-1.3:<\/strong> Authorization \u201c...was\/will be obtained from all subjects\u201d\r\n\r\n<strong>25-1.3.1<\/strong>: \u201cintegrated with\u201d or \"separate from\" informed consent document\r\n\r\n<em>Is PARTIAL authorization waiver ALSO required for pre-screening? This depends on whether original authorization mentioned possible\r\nre-contact.<\/em>\u00a0If so...\r\n\r\n<strong>25-1.3<\/strong>: \"... will not be obtained from some subjects before....\"\r\n\r\n<strong>25-1.3.1<\/strong>: \u201cintegrated with\u201d or \"separate from\" informed consent document\r\n\r\n<strong>25-1.3.2<\/strong>: \"Request for full or partial waiver ...\u201d\r\n\r\n<strong>25-2.1<\/strong>: \u201cRecruitment portion only\"<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>","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":"2021-02-26 05:45:00","update_notice_end":"2021-03-15 15:45:00","update_notice_text_blocks":[{"update_notice_text":"<p>Information regarding the availability of \"HIPAA Exemption\" (in section 3 of this page) was updated to current IRBMED interpretation.<\/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\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 11:30AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/747","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\/747\/revisions"}],"predecessor-version":[{"id":1891,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/747\/revisions\/1891"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/733"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/772"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/757"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/739"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=747"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=747"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=747"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=747"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=747"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=747"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}