{"id":726,"date":"2018-05-01T09:35:31","date_gmt":"2018-05-01T09:35:31","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/establishment-biospecimen-collections-within-central-biorepository\/"},"modified":"2026-08-20T12:43:06","modified_gmt":"2026-08-20T16:43:06","slug":"establishment-biospecimen-collections-within-central-biorepository","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/policies\/establishment-biospecimen-collections-within-central-biorepository\/","title":{"rendered":"Establishment of Biospecimen Collections Within the Central Biorepository"},"template":"","categories":[23],"tags":[60,59],"content-type":[72],"topic":[66],"update-type":[],"class_list":["post-726","document","type-document","status-publish","hentry","category-central-biorepository","tag-biorepository-use","tag-data-use","content-type-policies","topic-investigator-study-team-responsibilities"],"acf":{"use_legacy_editor":true,"updated_date":"2026-07-20 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 for Governance of UMMS Research Biorepositories (\u201cResearch Biorepositories Policy\u201d) and applies to all CBR resources. This policy establishes requirements ensuring that all CBR resources are acquired and managed responsibly and in accord with all applicable regulations, policies, and sound ethical principles.","button_links":null,"related_content":"","legacy_path":"establishment-biospecimen-collections-within-central-biorepository","legacy_node_id":249,"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":"CBR program: A U-M research effort that participates in the CBR by collecting biospecimens and storing all or some of those in the CBR.\r\n\r\nCBR resources: Materials or biospecimens collected under a CBR program and data associated with or derived from those biospecimens for research.\r\n\r\nCollection: The CBR resources comprised by a single CBR program.\r\n\r\nPrimary Use: 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 compliance with all applicable legal requirements.\r\n\r\nSecondary Use: 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\nUse Proposal: An application to the CBR seeking approval for a Secondary Use of CBR resources.","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":"A.<\/strong> The CBR is institutional infrastructure intended to advance the UMMS<\/a> research<\/a> mission by increasing the quality and efficiency of human biospecimen studies and by facilitating collaboration among U-M investigators<\/a>.\r\n\r\nB.<\/strong> Long-term storage of biospecimens allows development of collections sizable enough to enable high-quality scientific investigations of them. At the same time, for the CBR to be a valuable institutional resource and financially sustainable, use of CBR biospecimens for active<\/a> research must keep adequate pace with deposit of new CBR biospecimens. Therefore, the CBR will accept deposits of biospecimens that can reasonably be expected to be used in a timely manner for quality research purposes.\r\n\r\nC. <\/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 the ownership of these biospecimens and any derivatives, unless stipulated otherwise by research agreements for which biospecimens are collected.","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":"A.<\/strong> The CBR may accept any human biospecimens that are prospectively collected according to processes developed jointly by the contributing investigator\u2019s team and CBR personnel.\r\n\r\nB.<\/strong> The CBR Director, in consultation with the CBR Steering Committee, may approve transfer of a preexisting collection to the CBR by taking into account the retrospective collection\u2019s quality, purpose, scientific value, associated data, safety, and expected duration of storage.\r\n\r\nC.<\/strong> The CBR operates at Biosafety Level (BSL) 2 and will not accept biospecimens categorized as BSL 3 or 4.\r\n\r\nD.<\/strong> Biospecimens may be deposited into the CBR for storage for specific periods of time, until a specific target number of specimens is met, or indefinitely.\r\n\r\nE.<\/strong> Investigators seeking to establish or transfer a biospecimen collection to the CBR must gain approval from the CBR Director. Approval for use of CBR infrastructure will not be unreasonably withheld from project teams that request CBR services,\u00a0undergo an audit of any retrospective biospecimens for which storage is requested, and meet the requirements of Subsection F below.\r\n\r\nF.<\/strong> Requirements for use of CBR for establishment of a collection<\/em>. Establishment of a CBR biospecimen collection requires that contributing investigators:\r\n
    \r\n \t
  1. State a clear initial or potential research<\/a> purpose for establishment of the biospecimen collection within the CBR. Establishment of a biospecimen collection solely for future unspecified research meets this requirement when it can reasonably be expected that the collection will be adequately in demand among the research community.<\/li>\r\n \t
  2. Describe the funding intended to support the proposed biospecimen collection.<\/li>\r\n \t
  3. Allow the CBR to make available limited information about deposited biospecimens to other investigators and be willing to review proposals for secondary use of deposited biospecimens,\u00a0according to the CBR policy\u00a0GOV003 Use and Distribution of CBR Biospecimens and Data.<\/em><\/strong><\/li>\r\n \t
  4. Seek consent from biospecimen donors according to the CBR policy\u00a0GOV005 Consent and HIPAA<\/a> Privacy Rule Authorization<\/strong><\/em>.<\/li>\r\n \t
  5. Submit with each biospecimen the following associated data as appropriate:<\/li>\r\n<\/ol>\r\n

    a. Donor information: sex; race\/ethnicity; age at time of collection;<\/p>\r\n

    b. Diagnosis under investigation, if any;<\/p>\r\n

    c. Type and appropriate details of collection procedure;<\/p>\r\n

    d. Date of collection;<\/p>\r\n

    e. Records or verification of informed donor consent and appropriate authorizations;<\/p>\r\n

    f.\u00a0Any additional data (e.g., clinical, survey, laboratory results, etc.) fundamental to the biospecimen\u2019s research value that can be accommodated by the CBR laboratory information management system (LIMS).<\/p>\r\nResearch investigators may seek and obtain exceptions to (3) and\/or (4) of this subsection. Terms of any nonstandard arrangements approved by the CBR director will be documented. The CBR director may seek guidance from the CBR Steering Committee in making any such exceptions.\r\n\r\nG.<\/strong>Prior to acceptance of biospecimens into the CBR, the following materials must be finalized and\/or documented by CBR personnel and\/or contributing study teams:\r\n

      \r\n \t
    1. LIMS Integration: Documentation of the technical details required to enable accounting of the biospecimen collection by the CBR LIMS and to establish joint work processes;<\/li>\r\n \t
    2. Standard Operating Procedures\/Process Workflows: All applicable, logistics, workflow, kit preparation, and other operations documents;<\/li>\r\n \t
    3. Governance: An Oversight Committee (OC) charter for the Collection, as described in the UMMS<\/a> Tissue Ownership Policy;\r\n