Ensuring Integrity & Compliance
The CBR meets the highest ethical, regulatory, and scientific standards.
The Central Biorepository complies with federal regulations and other applicable standards and operates under approval from the UMMS Institutional Review Boards (IRBMED). Our IRB-approved program sets standards and processes to provide regulatory support and guidelines for all Central Biorepository users – those depositing new materials and those requesting existing materials.
Informed Consent
Central Biorepository donors give broad consent for future use and distribution of biospecimens and data after reviewing the Central Biorepository Information sheet and signing the consent form below:
- Biorepository Information Sheet Template (October 2021)
- Biorepository Consent/Authorization Template (October 2021)
These documents were developed in collaboration with IRBMED, UMHS Compliance, and other experts across campus, and should be included in the IRB application for the study.
Certificate of Confidentiality
The National Institutes of Health (NIH) has issued the Central Biorepository a Certificate of Confidentiality for the protection of individual-level data that would identify research participants. The certificate applies to all data associated with or derived from biospecimens collected under the Central Biorepository and is available for use by all investigators doing research with these data.
Central Biorepository policies are established by the CBR Advisory Committee. Policies encourage use of the Central Biorepository and collaboration among University of Michigan investigators while ensuring that all research using our resources meets the highest ethical, regulatory, and scientific standards.
Here is our full list of policies to review:
- Acknowledgement and Authorship Policy
- Institutional Review Board Oversight Policy
- Use and Distribution of Biospecimens and Data Policy
- Establishment of Biospecimen Collections Policy
- Consent and HIPAA Privacy Rule Authorization Policy
- Privacy and Confidentiality Protections for Individual-Level Data Policy
The CBR Advisory Committee provides guidance to the UMMS Central Biorepository Director and staff to ensure value is provided to CBR stakeholders in the UMMS Office of Research, Michigan Medicine, and the University of Michigan research enterprise. The Committee offers expertise in support of the CBR mission and in compliance with applicable rules and regulations, at the local, state, and federal level.
The Advisory Committee reviews and advises on key policies and procedures of the Central Biorepository. Operational activities and strategy development are the responsibility of the CBR Director and staff.
In certain circumstances outlined in CBR policies, this Committee may act as a Biorepository Oversight Committee, as per the Policy for Governance of Michigan Medicine Medical School Research Biorepositories. The Advisory Committee performs an oversight function when secondary investigators request biospecimens collected across multiple biorepository projects, and the request must be reviewed in toto rather than at the level of each individual biorepository program. In addition, the Committee may adjudicate conflicts that arise in the use and distribution of biospecimen resources managed by the Central Biorepository. This Committee may make recommendations to the UMMS Executive Vice Dean for Research.
The Committee provides guidance to the CBR Director and designees relative to the missions of Michigan Medicine, the University of Michigan Medical School Office of Research, and the Central Biorepository. The Committee advises on the efficient and efficacious operation of the unit in compliance with all applicable regulations and standards. The Committee members may assist in dissemination of information regarding biospecimens stored in the CBR, promote CBR resources and services, and make suggestions for service additions or eliminations.
When the Committee behaves as an Oversight Committee, it may review and approve requests for secondary uses of biospecimens that span across CBR biorepository projects and adjudicate conflicts that may arise in the requested use of these materials. In these cases, each principal investigator responsible for the requested biospecimens will be included as an ad hoc voting member of the Committee. The Committee considers at least the following during decision-making the:
- scientific value of the proposed work
- uses specified by prior agreements such as grants, protocols, and informed consent
- quantity of materials requested relative to the amount available
- rarity and/or renewability of requested materials
- research design, including statistical power and safeguards for scientific integrity
- compatibility with ongoing projects supported by the CBR
- conformance to sound ethical or other applicable standards
- Guide the Central Biorepository to ensure compliance with University of Michigan policies and federal regulations for human subjects’ research
- Review outcomes of College of American Pathologists Biorepository Accreditation Program inspection programs
- Act as an advocate for the CBR and affiliated projects across the wider organization
- Approve CBR policies and governance procedures in reference to the larger organization
- Provide feedback on risk management procedures, including the identification, monitoring, and mitigation of risk
- Review key performance indicators and operational metrics and evaluate efficacy of unit operations
- Provide advice in strategy, problem-solving, and issues related to specific projects or the overall business
- When operating as an Oversight Committee, enact CBR policies for review and approval of secondary uses of biospecimens as appropriate
- Victoria Blanc, Ph.D., Director, Central Biorepository, Chair
- Marion Hofmann Bowman, M.D., Clinical Associate Professor and Cardiovascular Health Improvement Project
- Tara Bradsher, Office of General Counsel
- Charles Burant, M.D., Ph.D., Director, Taubman Institute
- Karl Jepsen, Ph.D., Associate Dean for Research
- Jackie Jeruss, M.D., Ph.D., Associate Dean for Regulatory Affairs
- Salim Hayek, M.D., Assistant Professor of Internal Medicine, Cardiology; Precision Health
- Ray Hutchinson, M.D., Associate Dean for Regulatory Affairs Emeritus
- Heidi Iglay-Reger, Ph.D., Taubman Insitute, Operations Representative
- Evan Keller, D.V.M., Ph.D., Director, Research Cores, UMOR; Associate Director of Shared Resources, Rogel Cancer Center
- Matthias Kretzler, M.D., Professor of Internal Medicine, Nephrology; Computational Medicine and Bioinformatics
- Steven Kunkel, Ph.D., Executive Vice Dean for Research U-M Medical School, Chief Scientific Officer, Michigan Medicine
- Bill Rainey, Ph.D., Professor, Molecular and Integrative Physiology; Internal Medicine
Other Attendees
- Pam Bemmett-Baker, Ph.D., Research Supervisor, Central Biorepository
- Serena Giovinazzi, Ph.D., Quality Program Manager, Central Biorepository
- Lauren Humphrey-Stark, Clinical Research Coordinator, Cardiovascular Health Improvement Project
- Jennifer McNamara, FCVC Clinical Research Program Manager; MI-AORTA Research Admin Manager
- Savanna Sneeringer, Customer Service and Project Manager, Central Biorepository
Administrative Support
- Leslie McCormick, Administrative Assistant, Central Biorepository
View the University of Michigan Policy for the Transfer of Human Data & Biospecimens to Industry and Non-Academic and Non-Governmental Entities. (U-M level 1 Authentication Required)
When individual-level patient/participant data or biospecimens are to be transferred to an external for-profit organization, please download and complete the Data & Biospecimen Sharing Checklist and submit to [email protected]. The Data Office will then follow up to assist with your request for approval from the Medical School Human Data & Biospecimen Release Committee. The following are required for a successful request for data or biospecimen sharing with industry:
- Review and approval by the Medical School Human Data & Biospecimen Release Committee and the Dean of the Medical School prior to requesting that the appropriate central unit(s) negotiate an agreement.
- Data Sharing Agreement with the external organization.
- Unfunded Agreement in the eResearch Proposal Management System.
For detailed information, view Data & Biospecimen Sharing.
2800 Plymouth Road
Ann Arbor, MI 48109
Hours of Operation: 7:30 am - 4:30 pm, Monday - Friday
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We're Accredited – The Central Biorepository is accredited by the College of American Pathologists (CAP) Biorepository Accreditation Program.
