CBR Frequently Asked Questions (FAQ)

The CBR is available to University of Michigan researchers and their collaborators. We provide a shared resource for the storage, management, and distribution of human biospecimens intended for a broad range of research programs, including future or unspecified studies.

We house hundreds of thousands of human biospecimens, including DNA, tissue, plasma, serum, and more. Navigate to the Access Biospecimens page on the CBR website to see a live overview of current holdings.

Yes. Biospecimens collected from patients of the Academic Medical Center within Michigan Medicine are linked to the Electronic Health Records (EHR).

• Identifiable EHR data and biospecimens require Institutional Review Board-Medical (IRBMED) approval.
• Approved Michigan Medicine faculty and staff may search for biospecimens from patients meeting certain clinical criteria through DataDirect.  
• Some study teams may collect other phenotypic data.  Visit the study-of-interest webpage or contact the study PI for specifics.
   

All participants in the Michigan Genomics Initiative have genotype data and DNA available through the University of Michigan AI & Digital Health Innovation program. 

Other biorepository programs may have genetic data available. Visit the study-of-interest webpage or contact the study PI for specifics.

We operate as a recharge unit within the Medical School Office of Research. Services are offered at cost-recovery rates for U-M investigators. You can find our current Service Rates on our CBR Webpage.

No. The University of Michigan does not sell biospecimens. We share materials with academic collaborators for documented research. Industry or non-academic partners may access resources only through formal research partnerships with U-M faculty, governed by institutional data and biospecimen transfer procedures.

No. The Central Biorepository (CBR) does not accept, store, manage, process, or distribute microbial or animal biospecimens. The CBR is limited to the storage and management of human research biospecimens only, in accordance with institutional policies and regulatory requirements.

If you’re not sure whether your materials are eligible for storage in the CBR, please contact the CBR team prior to collection or submission.

UMMS defines a Biorepository (such as the CBR) as a resource comprising “biospecimens of human biological material, stored with the intent that the resource be used for future additional research purposes. A biorepository may also include research, medical, and/or biospecimen-derived information associated with the biospecimens for research.” The CBR is a professional facility and service provider that houses and manages those biospecimens. 

While the terms biorepository and biobank are often used interchangeably, we make a general distinction:

• A Biorepository refers to the overall facility and infrastructure for storing and managing biospecimens and their associated data.
• A Biobank is the specific collection of biological biospecimens and associated data curated for your research goals.

When you start a biobank with us, you maintain the scientific vision and design of your collection while leveraging our standardized infrastructure, regulatory oversight, and advanced tracking system to ensure biospecimen integrity.

1. Review the CBR Policy for Establishment of Biospecimen Collections within the Central Biorepository, the Biorepository Route Map, and Pre-Onboarding Considerations.
2. Contact us at [email protected].
3. We will help you onboard and configure your project within our LabVantage LIMS system.

Prospective collections from Michigan Medicine patients must use the Biorepository Informed Consent Template and Information Pamphlet Template. 

If a study has two arms (e.g., a specific research protocol and a biorepository opt-in), then use two consent templates:

• Standard Informed Consent Template
• Biorepository Informed Consent Template and Information Pamphlet

More information can be found at Guidance for Writing HUM Applications for Creating a Biorepository at the CBR.

Yes. You will need:

1. HUM Application: For collection activities (recruitment, informed consent, interaction/interventions with specimen donors).
2. REP Application: For collection and future use of human specimens and data (e.g., physical storage, data security, administrative infrastructure)
   • Note: Most researchers can reference the CBR’s REP (REP00000002) in their HUM application (Question 1.1.2) instead of creating their own.

If you are depositing biospecimens into the CBR, you usually do not need your own REP application. You can reference the CBR’s REP (REP00000002) within your HUM application through Question 1.1.2.

It may make sense to complete your own REP if:

• You will be storing collected biospecimens in your own lab space, rather than sending them all to the CBR for storage.
• Your collection will include its own special administrative and/or regulatory elements.

IRBMED staff can assist you in making this decision during the review of the HUM application; please refer to the guidance provided in the Elements and Uses of a Repository – Medical School Office of Research.

Yes. The CBR holds a CoC from the National Institutes of Health (NIH) that covers biospecimens and data derived from biospecimens collected and obtained through the CBR - Biorepository Informed Consent Template and Information Pamphlet Template.

The CBR has provided step-by-step guidance for “Writing HUM Applications for creating a biospecimen collection at the CBR”, which you can refer to as you assemble your HUM. Please note that this is not an exhaustive set of instructions for completing your HUM application. This information provides guidance on policies and practices for CBR activities. You may need to include more information in each section depending on the specifics of your study. 

Contact us early! We can provide cost estimates, a Letter of Support, and standard infrastructure language to strengthen your proposal. Please view Facility & Resource Profile Templates for more information. 

Requesting these biospecimens from the Central Biorepository (CBR) involves several administrative, regulatory, and data coordination steps. Because every project is unique, this is a general workflow—steps may happen concurrently or in a different order depending on whether you already have access to biospecimen information. The CBR team is available to assist and guide you through inquiries at any point in the process.

The workflow typically involves the following components:

• Biospecimen Discovery: Researchers most often begin with a discovery phase. You can use DataDirect to explore available cohorts and determine if there are biospecimens at the CBR that meet your criteria.
• Request & Oversight Review: You must submit a CBR Use Proposal Form. This information will be used to obtain approval from the appropriate Study Oversight Committee.
• Regulatory Documentation & Approvals: Before samples can be distributed, you will need:
  1. a completed HUM application and IRB approval (required whether you need identifiable data or not). More information about IRB requirements can be found on the IRB website and Research A-Z.
  2. approval(s) from the Oversight Committee(s) for the original collection.
  3. a signed Memorandum of Understanding (MOU), and
  4. any other applicable documentation (e.g., Material Transfer Agreement (MTA))  

Sample & Data Coordination: Once all committee and IRB approvals are fully secured, you will submit your finalized biospecimen list to the CBR for distribution and coordinate with the Data Office for corresponding data delivery.

DataDirect allows you to search Electronic Health Records (EHR) linked to biorepository biospecimens. Your DataDirect access decision criteria depend on the type of access you have, and fulfillment of applicable trainings and/or permissions:

• De-identified DataDirect (UMICH Level-1)
  • Use this for aggregate cohort discovery. Because dates are shifted for privacy, it cannot provide individual specimen IDs, only counts of available participants. IRB approval is not required.
• PHI DataDirect (Michigan Medicine Level-2)
  Use this when you need results suitable for requesting samples from the CBR.
  • Cohort mode (no IRB approval required): Suitable for initial query to filter, allows you to view participant counts that match your clinical, and biorepository criteria for future PHI needs.
  • PHI Mode (Requires IRB approval): Enables users to re-run queries, to identify specific patients, download clinical data, and request biospecimens from the CBR. 
     

• Clinical/phenotypic data: Usually linked via the Michigan Medicine EHR. Some collections also include study-specific phenotypes outside the EHR.
• Genetic data: Available for some collections (e.g., MGI and select other biorepository programs).

• Start with DataDirect to find biospecimens meeting your specific clinical criteria.
• If not available, check the collection/study webpage (or contact the PI) for phenotypes or genetics not reflected in DataDirect.

• Biospecimens only (no identifiable EHR data): for Deidentified DataDirect or PHI DataDirect Cohort mode, no IRMED approval is required.
• Biospecimens + identifiable EHR data: IRBMED approval required.
• Genetic data access: Follow the governance/process for the specific program
  • MGI genotype data: available via U‑M AI & Digital Health Innovation
  • Other collections: see the Study-of-Interest page for access requirements

Some research programs/initiatives often have their specific access procedures. Please visit the study webpages (listed below) to request more information.

• Clinical Phenotyping and Resource Biobank Core (C-PROBE)
• Immunity Associated with SARS-CoV2 (IASO)
• Kidney Precision Medicine Project (KPMP)
• Mary Tyler Moore Ocular Biorepository and Resource Center (MTM-BRC)
• Michigan Genomics Initiative (MGI)
• Nephrotic Syndrome Study Network (NEPTUNE)
   

This often requires two IRB applications: one HUM for the new collection and one for the secondary analysis of existing biospecimens. Please coordinate with the primary study PI if you plan to recontact subjects.

• For Any U-M Research Project: DNA extraction (blood, saliva, etc.) and RNA extraction (PAXgene).
• For Biobanking Projects: Aliquoting and PBMC isolation for long-term banking.

We use LabVantage LIMS to ensure full traceability. Study teams can access authorized data through searches or request custom reports from the HITS LabVantage team.

The CBR is CAP-Accredited. We use standardized SOPs, 24/7 environmental monitoring of freezers, and a full chain-of-custody audit trail within our LIMS to ensure specimen integrity.

Please use our Research Resource Identifier (RRID) in your publications:

“The authors acknowledge the University of Michigan Medical School Central Biorepository (RRID: SCR_026485) for providing biospecimen services...”

• General/Consultation Inquiries: [email protected]
• Appointments: If you would like to request a consultation, submit the Appointment Request form. 

Yes, the Central Biorepository (CBR) provides comprehensive support to ensure researchers can effectively integrate biospecimen science into their studies. 

Before you begin working with the CBR, please review our Pre-Onboarding Considerations for guidance on navigating the early steps of working with us. 

We offer one-on-one project consultations to help you design collection protocols, select appropriate kits, and determine the best processing workflows for your specific research goals. 

Periodically, the CBR offers webinars and informational sessions. 

For general CBR inquiries, contact [email protected]. If you would like to request a consultation, submit the Appointment Request form. 

The HITS team provides training and support for our LIMS, LabVantage. 

• Access: LabVantage access and use are a part of working with the CBR. The system is configured for your needs during the onboarding process.
• Training: Comprehensive training is provided as part of onboarding. If you are a new user to an existing study, you can request LV training through the LabVantage Order Guide.
• Support: For technical issues, submit a HITS ticket with "LabVantage" in the subject to facilitate ticket routing.
   

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