{"id":725,"date":"2018-05-01T09:14:05","date_gmt":"2018-05-01T09:14:05","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/use-and-distribution-biospecimens-and-data-policy\/"},"modified":"2026-08-19T16:38:10","modified_gmt":"2026-08-19T20:38:10","slug":"use-and-distribution-biospecimens-and-data-policy","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/policies\/use-and-distribution-biospecimens-and-data-policy\/","title":{"rendered":"Use and Distribution of Biospecimens and Data Policy"},"template":"","categories":[23],"tags":[60,59],"content-type":[72],"topic":[26,75,27],"update-type":[],"class_list":["post-725","document","type-document","status-publish","hentry","category-central-biorepository","tag-biorepository-use","tag-data-use","content-type-policies","topic-informed-consent-assent","topic-regulations-policies-federal-state-local","topic-repository"],"acf":{"use_legacy_editor":true,"updated_date":"2026-07-13 12:00:00","update_notice":false,"author":"Central Biorepository","summary":"The University of Michigan Medical School (\u201cUMMS\u201d) Central Biorepository (\u201cCBR\u201d) serves as central storage, access, and administrative hub for human biospecimens and data associated with or derived from them. This policy operates subject to the Policy of Governance of UMMS Research Biorepositories (\u201cResearch Biorepositories Policy\u201d) and applies to all CBR resources.\r\n\r\nThis policy establishes a framework for appropriate utilization of CBR resources.\r\nIt:\r\n<ul>\r\n \t<li>Fosters collaboration among U-M <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigators<\/a>;<\/li>\r\n \t<li>Provides a process for <a class=\"gtip\" href=\"\/medschool\/glossary\/equitable\">equitable<\/a> access to CBR resources;<\/li>\r\n \t<li>Ensures that use and distribution of CBR resources meet all regulatory, legal, and ethical standards;<\/li>\r\n \t<li>Promotes use of CBR resources for scientifically sound and valuable research; and<\/li>\r\n \t<li>Facilitates efficient and proper distribution of CBR resources.<\/li>\r\n<\/ul>","button_links":null,"related_content":"","legacy_path":"use-and-distribution-biospecimens-and-data-policy","legacy_node_id":248,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Definitions","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":"<strong>CBR program<\/strong>: A U-M <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a> effort that participates in the CBR by collecting biospecimens and storing all or some of those biospecimens in the CBR.\r\n\r\n<strong>CBR resources<\/strong>: Materials or biospecimens collected under a CBR program and data associated with or derived from those biospecimens for research.\r\n\r\n<strong>Collection<\/strong>: All the CBR resources comprised by a single CBR program.\r\n\r\n<strong>Primary Use<\/strong>: A specific research use (i.e., testing of a specific hypothesis or set of hypotheses, creation of a biorepository) for which a resource was initially acquired in <a class=\"gtip\" href=\"\/medschool\/glossary\/compliance\">compliance<\/a> with all applicable legal requirements.\r\n\r\n<strong>Secondary Use<\/strong>: Any other research use, whether proposed by the investigator who acquired and\/or deposited the resource into the CBR or by any other investigator.\r\n\r\n<strong>Use Proposal<\/strong>: An application to the CBR\u00a0or CBR program\u00a0seeking approval for a\u00a0Secondary Use of CBR resources.\r\n\r\n<strong>Oversight Committee<\/strong>: A committee for review of Use Proposals concerning a particular Collection. Oversight Committees for Collections sponsored by Michigan Medicine faculty are subject to standards established in the Research Biorepositories Policy. Synonyms for \u201cOversight Committee\u201d may be \u201cSteering Committee\u201d, \u201cGovernance Committee\u201d, or another title, provided that the Committee is chartered with the same responsibilities as those outlined for an Oversight Committee in the Research Biorepositories Policy.","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":"Principles","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":"<strong>A.<\/strong> CBR resources comprise human biological material and data provided by patients and research participants to the University, stored at the CBR for future additional research purposes, with the University retaining ownership of these biospecimens and any derivatives, unless stipulated otherwise by research agreements for which biospecimens are collected.\r\n\r\n<strong>B.<\/strong>\u00a0Meritorious Secondary Uses of CBR resources are valuable opportunities for collaboration among <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigators<\/a>, strengthen the research portfolio of the University of Michigan Medical School, and speed the pace of research.\r\n\r\n<strong>C.<\/strong> The investigators who deposit any particular biospecimens into the CBR are typically in the best position to assess the merit of Use Proposals pertaining to those biospecimens.\r\n\r\n<strong>D.<\/strong> The CBR Steering Committee may act as an Oversight Committee under the Research Biorepositories Policy, and as defined the in the Steering Committee Charter.","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":"Policy","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":"<strong>A. <\/strong>Distribution Requests will be fulfilled only for:\r\n<ol>\r\n \t<li>Primary Uses; and<\/li>\r\n \t<li>Secondary Uses that have been <a class=\"gtip\" href=\"\/medschool\/glossary\/approved-decision\">approved<\/a> by either:<\/li>\r\n<\/ol>\r\na. the CBR Steering Committee, acting as an Oversight Committee;\r\n\r\nor\r\n\r\nb.\u00a0the otherwise designated Oversight Committee(s) for the Collection(s) from which the requested resources originate.\r\n\r\n<strong>B. <\/strong>Any Use Proposal seeking CBR resources from multiple collections must be reviewed only by the CBR Steering Committee if there are conflicting approvals from the multiple designated Oversight Committees.\r\n\r\nThe CBR director has administrative discretion to steer a given Use <a class=\"gtip\" href=\"\/medschool\/glossary\/proposal\">Proposal<\/a>\u00a0towards one CBR Program over another if the number of CBR resources sought can be adequately managed via that one Program, and it makes sense to do so.\r\n\r\nWhen\u00a0other agreements require a\u00a0particular Oversight Committee\u00a0(e.g.,\u00a0one defined by the National Institutes of Health)\u00a0also review such a Use Proposal, the contributing investigator will notify the CBR of this requirement.\r\n\r\n<strong>C.\u00a0<\/strong>When the CBR Steering Committee acts as an Oversight Committee, each principal <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigator<\/a> who deposited any of the\u00a0CBR resources subject to the Use Proposal under review will be included as a voting member of the Committee.\r\n\r\n<strong>D.<\/strong> Any change in the scope of a use approved under Section IV(a)(2), above, must be approved by the Oversight Committee(s) that granted the initial approval.\r\n\r\n<strong>E. <\/strong>Decisions made on Use Proposals under Section IV(a)(2)(b), above, may be <a class=\"gtip\" href=\"\/medschool\/glossary\/appeal-decision\">appealed<\/a> to the CBR Steering Committee by any involved party.\r\n\r\nDecisions made by the CBR Steering Committee (acting as an Oversight Committee) on Use Proposals may be resubmitted with changes or, thereafter, appealed to the <a class=\"gtip\" href=\"\/medschool\/glossary\/dean\">Dean<\/a> of the Medical School or the Dean\u2019s designee. Appeals must be submitted in writing and must present the appellant\u2019s specific disagreements with the judgment of the committee.\r\n\r\n<strong>F.\u00a0<\/strong>The CBR Steering Committee may suspend or terminate approval of access to CBR resources if an investigator fails to comply with applicable policies or procedures or to exercise his\/her access within a reasonable period of time. If the research has IRB oversight, compliance issues will be reported 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":"Procedures","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":"<strong>A.<\/strong><em> Designation of Oversight Committees<\/em>. Any investigator depositing materials into the CBR must designate an Oversight Committee to meet the standards established in the Research Biorepositories Policy.\r\n<p style=\"padding-left: 40px\">1. Stewardship and Continuity of Oversight. Oversight Committees retain responsibility for long-term stewardship of biospecimens held at the CBR, regardless of study status (i.e. termination) or Principal Investigator departure from U-M. An Oversight Committee must always be available for decision-making regarding CBR resources.<\/p>\r\n<strong>B. <\/strong><em>Use Proposals<\/em>. Investigators interested in Secondary Uses of CBR Resources must prepare and submit a Use Proposal, which will be shared with the designated Oversight Committee. Researchers may contact the CBR at any time for assistance, such as a request for study contact information, or what information each Oversight Committee requires for its review.\r\n\r\nInvestigators and Oversight Committees are encouraged to keep CBR staff as informed as possible as Use Proposals develop so that issues can be anticipated and managed, necessary documentation can be prepared timely, and CBR staff can assemble any additional materials to assist in Oversight Committee review.\r\n\r\n<strong>C.<\/strong><em>\u00a0Approval and Distributions.<\/em> Secondary Uses will be considered fully approved and actionable when the following have been provided to CBR staff:\r\n<ol>\r\n \t<li>Documented approval of the Use Proposal by the designated Oversight Committee(s) for the CBR resources sought, including a clear statement of the approved aims and hypotheses to be tested;<\/li>\r\n \t<li>A description of the CBR resources approved for distribution under the use, including but not limited to their type, number, and quantity;<\/li>\r\n \t<li>Documented approval by a federally registered Institutional Review Board or other appropriate ethics committee;or\r\nSufficient detail (including all data elements that will be combined and associated with the biospecimens sought) for the CBR to determine (with IRB consultation as needed) that the proposed project is not subject to human protections regulations.\u00a0 As a best practice, U-M investigators should complete a brief not-regulated application in eResearch in order to obtain a not-regulated IRB determination.<\/li>\r\n \t<li>Signed copies of required Memoranda of Understanding.<\/li>\r\n<\/ol>\r\n<p style=\"padding-left: 40px\">The CBR may provide letters of conditional approval, such as for grant applications, when one or more of the above elements has not yet been completed. However, such conditional approval will not permit distribution of CBR resources.<\/p>\r\n<strong>D<\/strong>.\u00a0<em>Recording approved uses<\/em>. The CBR maintains records of the uses for which CBR resources may be distributed. CBR staff will provide investigators with copies of any such records relevant to their approved uses. In addition, the CBR requires and maintains records of:\r\n<ul>\r\n \t<li>The HUM number for the approved use<\/li>\r\n \t<li>The name of the Oversight Committee and member's names<\/li>\r\n \t<li>A current copy of the Oversight Committee Charter<\/li>\r\n \t<li>Relevant Memoranda of Understanding<\/li>\r\n<\/ul>\r\n<strong>E.\u00a0<\/strong><em>Distribution of biospecimens. <\/em>CBR staff will distribute requested biospecimens and will track these distributions after receiving the following information from the requestor:\r\n<ul>\r\n \t<li>The approved uses for the\u00a0resources<\/li>\r\n \t<li>The HUM number for the approved use<\/li>\r\n \t<li>The specific resources being requested, with reference to\u00a0Sample IDs, including alternates if necessary<\/li>\r\n \t<li>Any sample processing requirements<\/li>\r\n \t<li>Shipping address<\/li>\r\n<\/ul>\r\n<strong>F.\u00a0<\/strong><em>Distribution of biospecimen-associated and biospecimen-derived data.<\/em> Requested data accommodated by the CBR laboratory information management system (LIMS) will be transferred to approved users. CBR staff will provide approved users with available information about how CBR-resource data accommodated by systems other than the CBR LIMS can be accessed.\r\n\r\n<strong>G. <\/strong><em>Amendments. <\/em>Investigators must contact CBR staff or CBR Programs to seek approval for changes to the scope of a previously approved project (e.g., any change to hypothesis being tested, or to type, number, or quantity of biospecimens sought), via a new Use Proposal, which references the first. CBR staff will route the amendment to the appropriate Oversight Committee(s) for review and approval, as necessary. No distributions will be made beyond the terms of the documented approval. IRBMED amendments may also be necessary. IRB approval of amendments can be sought contemporaneously with CBR and\/or CBR Program approvals. CBR staff and requesting Study Team staff may work together to develop the IRB amendment as necessary. Distributions will take place when all necessary approvals are obtained.\r\n\r\n<strong>H.\u00a0<\/strong><em><a class=\"gtip\" href=\"\/medschool\/glossary\/suspension\">Suspension<\/a> or <a class=\"gtip\" href=\"\/medschool\/glossary\/termination\">termination<\/a> of committee approval.<\/em> The CBR Director may, after exhausting reasonable efforts to resolve perceived investigator <a class=\"gtip\" href=\"\/medschool\/glossary\/compliance\">compliance<\/a> issues, suspend distribution of CBR resources to the investigator. Any such case will be brought to the CBR Steering Committee for resolution no sooner than seven days and no later than forty-two days from the date of suspension. In resolving any such issues, the Steering Committee will follow institutional policies and procedures and report cases to other institutional entities, including IRBMED as 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":"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":"<a class=\"gtip\" href=\"\/medschool\/glossary\/45-cfr-46\">45 CFR Part 46<\/a>\r\n\r\nPolicy for Governance of University of Michigan Medical School Research Biorepositories.","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":"History of Policy","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. Original <a class=\"gtip\" href=\"\/medschool\/glossary\/approval-date\">Approval Date<\/a>: 03\/10\/2015\r\n\r\nB. Revisions\r\n<ol>\r\n \t<li>05\/19\/2015: Reformatted with no substantive changes.<\/li>\r\n \t<li>06\/15\/2017: Scope of this policy harmonized with that of the CBR <a class=\"gtip\" href=\"\/medschool\/glossary\/certificate-confidentiality-coc\">Certificate of Confidentiality<\/a>; removed references in procedures section to specific actions in the LIMS that are no longer being used.<\/li>\r\n \t<li>03\/19\/2018: Minor clarifications made in \u00a7\u00a7IV(B), V(B)(4) and V(E).<\/li>\r\n \t<li>6\/18\/2020: Updated title Medical School Governing UMMS Research Biorepositories Policy (\u201cResearch Biorepositories Policy\u201d) throughout; Added permission for CBR Director to route certain multi-collection Use Proposals towards one Program vs. another (\u00a7IVB); Divided \u00a7B into two sections, creating a new \u00a7C Approvals and Distributions; added clarifying language throughout; added clarifying statements in the definition of Oversight Committee.<\/li>\r\n \t<li>08\/29\/2023: Updated references, formatting, header, and footer. Removed reference to CBR Governance Committee, replaced by the CBR Advisory Committee.<\/li>\r\n \t<li>07\/13\/2026: Removed reference to CBR Advisory Committee, replaced by the CBR Steering Committee. Added requirements of Oversight Committee documentation and maintenance. Minor editorial changes for clarity.<\/li>\r\n<\/ol>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Approval","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":"<p>Signed by:&nbsp;<strong>Victoria Blanc<\/strong>, Director of University of Michigan Medical School Central Biorepository on 29&nbsp;August&nbsp;2023<br \/>\r\n(original signed document on file at CBR)<\/p>","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\u00a0<a href=\"mailto:CBR-Requests@med.umich.edu\">CBR-Requests@med.umich.edu<\/a>\u00a0or 734-647-8809\r\n\r\n2800 Plymouth Road, NCRC Building 60, Room 1661, Ann Arbor, MI 48109-2800\r\n\r\nEdited By: <a href=\"mailto:dagi@umich.edu\">dagi@umich.edu<\/a>\r\nLast Updated: August 19, 2026 at 4:04 PM","global_contact_block_select":null},"permalink_manager":null,"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/725","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\/725\/revisions"}],"predecessor-version":[{"id":2058,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/725\/revisions\/2058"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=725"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=725"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=725"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=725"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=725"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=725"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}