{"id":757,"date":"2018-05-07T08:50:12","date_gmt":"2018-05-07T08:50:12","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/faq-repository-application-rep\/"},"modified":"2026-03-06T13:03:10","modified_gmt":"2026-03-06T18:03:10","slug":"faq-repository-application-rep","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/faq-repository-application-rep\/","title":{"rendered":"FAQ: Repository application (REP)"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[66,27],"update-type":[],"class_list":["post-757","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-investigator-study-team-responsibilities","topic-repository"],"acf":{"use_legacy_editor":true,"updated_date":"2026-03-06 13:00:00","update_notice":false,"author":"IRBMED","summary":"","button_links":null,"related_content":[739,747,772,768,733],"legacy_path":"faq-repository-application-rep","legacy_node_id":299,"legacy_related_nids":"277, 288, 314, 310, 266, 1470","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"\u201cRepository\u201d (REP) applications","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":"What is the purpose of an REP application?","legacy_section_text":"\u201cRepository\u201d (REP)<\/a> applications are a project type in eResearch Regulatory Management (eRRM)<\/a> (see also the\u00a0Repository Web Guidance\u00a0pages).\r\n\r\nREPs are designed to facilitate compliance with University policies and regulatory guidance surrounding the collection and future use of human specimens and data.\r\n\r\nREP applications were introduced through a \u201cphased roll-out\u201d in 2014\u20132015. See also\u00a0U-MIC<\/a> \"IRB Board Tip:\u00a0IRB Oversight for Data and\/or Biospecimen Repositories\"","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":"\u201cRepository\u201d (REP) applications","legacy_subheading":"What information does an REP application collect?","legacy_section_text":"Similar to other eResearch applications, REPs gather information through smartform logic and uploaded document(s). The application is then routed for review and approval by the IRB and other applicable review committees.\r\n\r\nThe REP application focuses on repository procedures for storage, maintenance, and distribution of data\/biospecimens.\r\n\r\nCollection activities for data\/biospecimens<\/strong> to be deposited into a repository will still be approved<\/a> through an HUM application.\u00a0\u201cSecondary uses\u201d of information\/biospecimens<\/strong> distributed to researchers from repositories must still be submitted for IRB assessment through an HUM application if they qualify as human subjects 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":"How do I submit my new project as a repository?","legacy_section_text":"\u201cRepository\u201d (REP) applications are created in\u00a0eResearch Regulatory Management.<\/a> The eResearch\u00a0training page\u00a0<\/a>has step-by-step guides (Procedure Documents & Tips \u2192 Repository Application heading) on filling out a REP application or related submission. Like other eResearch applications, the REPs involve completing a \u201csmartform\u201d pathway and uploading applicable supporting documents. In particular, a REP application must include an\u00a0Application Supplement Form<\/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":"What about repositories previously approved through HUM applications?","legacy_section_text":"Until release of the REP application, IRBs processed repository reviews and approvals in the eResearch system only through the \u201chuman subject study\u201d (HUM) application. As such, many existing repositories have HUM approvals.\r\n\r\nHUM applications continue to provide valid approval for all activities described in the approved application. This includes HUM applications for repository activities, or for research studies with repository components. HUM approval satisfies the registration requirement for repositories subject to the\u00a0\u201cMedical School Governing UMMS Research Biorepositories Policy<\/a>\u201d (available through PolicyStat<\/a>).\r\n\r\nOver time, many ongoing repositories should expect to submit an REP application, for instance, at the time of Continuing Review<\/a> for the HUM. Consult with\u00a0your IRB staff<\/a>\u00a0as to when\/whether this is appropriate for your\r\nrepository.\r\n\r\nIn some cases, an REP may entirely supplant an HUM and the HUM can then be terminated<\/a>. This is particularly likely if ongoing and future repository activities are limited to storage, maintenance, and distribution for \u201csecondary uses\u201d of\r\ndata\/biospecimens.\r\n\r\nIn other cases, when data\/biospecimen collection continues, or when the repository is an additional aim in a specific research study, the HUM application will continue to remain active<\/a>, but should be Amended to minimize duplication of information with the REP. Amendment also provides an opportunity to begin using the Biorepository Specialty Informed Consent Template<\/a>\u00a0+ informational sheet<\/a>, if appropriate.","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 do HUM and REP applications work together?","legacy_section_text":"The REP application is designed to address specific types of information associated with repositories that are not optimally captured in the HUM application. It also facilitates connections between repositories and studies that\r\ncontribute or withdraw materials from them, in order to clarify application processes for those projects.\r\n\r\nIRB staff create two-way hyperlinks between an REP and associated HUM(s). Study teams must notify IRB staff of the relationship so the links can be created (see\u00a0Studies depositing data\/biospecimens into a repository<\/strong>\u00a0and\u00a0Studies obtaining data\/biospecimens from a repository<\/strong>\u00a0headings at\u00a0Elements and Uses of a Repository<\/a> guidance webpage). The links display in an REP and HUM spaces under \u201cRelated Projects\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.","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":"Repositories not covered by UMMS policy","legacy_subheading":"What about repositories previously approved through HUM applications?","legacy_section_text":"Until release of the REP application, IRBs processed repository reviews and approvals in the eResearch system only through the \u201chuman subject study\u201d (HUM) application. As such, many existing repositories have HUM approvals.\r\n\r\nHUM applications continue to provide valid approval for all activities described in the approved application. This includes HUM applications for repository activities, or for research studies with repository components. HUM approval satisfies the registration requirement for repositories subject to the\u00a0\u201cMedical School Governing UMMS Research Biorepositories Policy<\/a>\u201d (available through PolicyStat<\/a>).\r\n\r\nOver time, many ongoing repositories should expect to submit an REP application, for instance, at the time of Continuing Review<\/a> for the HUM. Consult with\u00a0your IRB staff<\/a>\u00a0as to when\/whether this is appropriate for your\r\nrepository.\r\n\r\nIn some cases, an REP may entirely supplant an HUM and the HUM can then be terminated<\/a>. This is particularly likely if ongoing and future repository activities are limited to storage, maintenance, and distribution for \u201csecondary uses\u201d of\r\ndata\/biospecimens.\r\n\r\nIn other cases, when data\/biospecimen collection continues, or when the repository is an additional aim in a specific research study, the HUM application will continue to remain active<\/a>, but should be Amended to minimize duplication of information with the REP. Amendment also provides an opportunity to begin using the\u00a0Specialty Biorepository\r\nInformed Consent Template<\/a>\u00a0+ informational sheet<\/a>, if appropriate.","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":"How do HUM and REP applications work together?","legacy_section_text":"The following are\u00a0not\u00a0<\/strong>subject to the\u00a0\u201cMedical School Governing UMMS Research Biorepositories Policy<\/a>\u201d (available through PolicyStat<\/a>):\r\n\r\n \t- Data repositories that do not store biospecimens<\/li>\r\n \t
- Repositories that collect and store biospecimens solely as part of routine clinical care or hospital procedures, such as those stored in blood banks<\/a> or pathology specimens used in clinical care<\/li>\r\n \t
- Research biorepositories that are neither maintained by Michigan Medicine faculty or staff, nor at Michigan Medicine facilities.<\/li>\r\n<\/ul>\r\nSee also\u00a0UMMS Biorepository decision tree<\/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":"heading","legacy_heading":"UMMS policy on biorepositories and tissue ownership","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":"Ref. \u201cMedical School Governing UMMS Research Biorepositories Policy<\/a>\u201d (available through PolicyStat<\/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":"UMMS policy on biorepositories and tissue ownership","legacy_subheading":"Why has UMMS adopted this policy?","legacy_section_text":"This policy promotes the effective use of UMMS<\/a> resources to gather, store, and disseminate human biological<\/a> specimens intended for research use in accordance with federal and state laws and regulations and sound scientific\r\nand ethical principles. It specifies the governance of biospecimen collection, usage, and disposition within all UMMS research biorepositories. Its intent is to facilitate establishment and expansion of biorepositories to support research and to promote sharing of biospecimen resources to the greatest extent practicable while remaining in compliance with\r\ngovernmental and University requirements.","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":"Do I need to register my project as a biorepository?","legacy_section_text":"Ref. Policy<\/a> II.A and III.A\r\n\r\nRefer to Repositories not covered by UMMS policy (above) and to\u00a0UMMS Biorepository Decision Tree<\/a>.\r\n\r\nYour project does not have to be registered as a biorepository if you are immediately using and disposing of the biospecimens you collect, or if you are storing biospecimens for a single specified research use.\r\n\r\nIf you are cataloging and storing biospecimens for possible future additional uses, your project must be registered by completing an REP application. While your project might not currently include biospecimens for distribution, you are encouraged to think ahead to the possibility that this may one day be the case and consider registering your project as a repository, through the REP application, as soon as you can foresee it becoming one. \u201cDistribution of biospecimens\u201d is meant to include using biospecimens yourself for new research purposes \u2013 repurposing existing specimens is considered \u201cdistribution to oneself.\u201d\r\n\r\nIt is expected that hundreds of U-M projects will need to register as biorepositories.\r\n\r\nSee also\u00a0Elements and Uses of a Repository<\/a>\u00a0guidance page.","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":"What is the purpose of the oversight committee required by the UMMS policy?","legacy_section_text":"Ref. Policy<\/a> II.D and III.C\r\n\r\nThe purpose of the oversight committees required by the UMMS policy is to facilitate the appropriate use and distribution of bio-resources. These committees will minimize the need for higher level administration to become involved in dispute resolution about the use of biospecimens.\r\n\r\nAn oversight committee is required if you plan to share biospecimens outside your department or beyond your original collaborators. Oversight committees are important procedural mechanisms for managing repository resources and requests to use those resources, especially if the repository contains rare or difficult-to-obtain materials.\r\n\r\nOversight committees consist of at least three individuals, at least two of whom are scientists, to fulfill the functions described in Sections II.D and III.C of the policy. The composition and function of the oversight committee are described as part of the process in registering the repository via the REP.","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":"Will the oversight committee be an ancillary committee that needs to approve a proposed biospecimen use before an application for secondary use goes to the IRB?","legacy_section_text":"Oversight committees are not formal ancillary committees in the eResearch review process. Each oversight committee is formed once the REP is approved, and operates within the construct of the individual repository. One function of the oversight committee is to decide upon proposed secondary uses of biospecimens within the review parameters delineated in the approved REP application.","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":"Consent\/HIPAA Authorization","legacy_subheading":"What is the purpose of the oversight committee required by the UMMS policy?","legacy_section_text":"Ref. Policy<\/a> II.D and III.C\r\n\r\nThe purpose of the oversight committees required by the UMMS policy is to facilitate the appropriate use and distribution of bio-resources. These committees will minimize the need for higher level administration to become involved in dispute resolution about the use of biospecimens.\r\n\r\nAn oversight committee is required if you plan to share biospecimens outside your department or beyond your original collaborators. Oversight committees are important procedural mechanisms for managing repository resources and requests to use those resources, especially if the repository contains rare or difficult-to-obtain materials.\r\n\r\nOversight committees consist of at least three individuals, at least two of whom are scientists, to fulfill the functions described in Sections II.D and III.C of the policy. The composition and function of the oversight committee are described as part of the process in registering the repository via the REP.","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 can repositories manage informed consent?","legacy_section_text":"Research studies involving interaction<\/a>\/intervention<\/a> with subjects usually include an informed consent process, and often employ a comprehensive written\u00a0informed consent document. (These may include HIPAA<\/a> authorization \u2013\r\nsee\u00a0below.) When\u00a0data\/biospecimens from these studies are deposited in a repository,<\/a> the repository takes on responsibility for awareness of and compliance with the terms of the consent.\r\n\r\nRepositories may also receive data\/biospecimens generated without prior research consent (such as data from medical records, or residual or to-be-discarded tissue from surgeries). Some repositories should request a\u00a0waiver\r\nof informed consent<\/a> as part of the REP application: for details, see\u00a0Informed Consent\/HIPAA authorization\u00a0section at\u00a0Responsibility for REP Oversight and Compliance<\/a>\u00a0webpage.","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":"Consent\/HIPAA Authorization","legacy_subheading":"How can repositories manage HIPAA authorization?","legacy_section_text":"Like other human subjects research at Michigan Medicine, many data\/biospecimen repositories involve accessing, storing, and\/or distributing\u00a0Protected Health Information\u00a0(PHI)<\/a> subject to\u00a0HIPAA Privacy Rule<\/a>\u00a0protections.\r\n\r\nMedical research studies with a comprehensive written\u00a0informed consent process<\/a> usually include signed HIPAA authorization as part of the\u00a0informed consent document. When\u00a0data\/biospecimens from these studies are deposited in a repository<\/a>, the repository takes on responsibility for awareness of and compliance with the terms of the consent\/authorization.\r\n\r\nClinically generated data\/biospecimens might be deposited in a repository without prior research HIPAA authorization (UMHS\u00a0Notice of Privacy Practices<\/a>\u00a0does\u00a0not<\/strong> qualify as a research HIPAA authorization). Some repositories should request a\u00a0waiver of HIPAA authorization<\/a> as part of the REP application: for details, see Informed Consent\/HIPAA authorization\u00a0section at\u00a0Responsibility for REP Oversight and Compliance<\/a>\u00a0webpage.\r\n\r\nThe\u00a0REP application<\/a>\u00a0section 3 and\u00a0Application Supplement Form\u00a0sections I and II include questions about a\r\nrepository\u2019s plans regarding PHI<\/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":"What kinds of studies use the specialized Biorepository consent with informational pamphlet?","legacy_section_text":"IRBMED makes available a comprehensive Biorepository Specialty\u00a0Informed Consent Template<\/a>\u00a0intended to be\r\nused\u00a0with\u00a0<\/strong>an illustrated informational sheet (trifold pamphlet format). The consent forms based on this template in most cases are 2 pages long. U-M studies intending to collect biospecimens for unspecified future research should consider whether the biorepository template + informational sheet will be effective for their consent processes (instead of or in addition to a study-specific consent form, depending on the nature of the study).\r\n\r\nThe biorepository template + informational sheet was originally developed in conjunction with\u00a0UMMS Central\r\nBiorepository<\/a>\u00a0(CBR).\u00a0CBR requires<\/a> studies depositing with them to use the biorepository template + informational sheet however, no relationship with CBR is implied by the use of these documents in and of themselves.\r\n\r\nNOTE<\/strong>:\u00a0Do not use<\/strong> the IRBMED Specialty Informed Consent Template for \u201cOne-time blood or tissue sample\u201d if the study deposits into a repository.","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\u00a0irbmed@umich.edu<\/a>\u00a0or 734-763-4768 \/ (Fax 734-763-1234)\r\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\nA list of IRBMED staff<\/a> is available at our website.\r\n\r\nEdited By: larkspur@umich.edu<\/a>\r\nLast Updated: March 6, 2026 1:00PM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/757","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\/757\/revisions"}],"predecessor-version":[{"id":1903,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/757\/revisions\/1903"}],"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\/768"},{"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\/747"},{"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=757"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=757"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=757"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=757"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=757"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=757"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}