Regulatory & Governance

Establishment

The UMMS Central Biorepository Steering Committee is established to provide strategic direction and operational guidance to the University of Michigan Medical School Central Biorepository (CBR). The goal of the committee is to provide guidance in optimizing operations in alignment with stakeholder needs, advance policy development, and ensure active and diverse faculty engagement in the acceptance and integration of CBR programs as the biorepository’s scale and institutional impact expand. The CBR Steering Committee may make recommendations to the UMMS Executive Vice Dean for Research.
 

Mission

The CBR Steering Committee’s mission is threefold:

• Strategic and Policy Advocacy
  To advise on and help set CBR policies, demonstrate and promote the institutional value of the biorepository, guide strategic utilization, and facilitate broad awareness and engagement of CBR resources across UMMS.
• Operational Guidance
  To review and advise on biospecimen and repository operations, including CBR service offerings, key performance indicators (KPI), space management, pediatric and special collections, distribution mechanisms, and best practices in biospecimen stewardship.
• Oversight Committee
  To fulfill an oversight and adjudicatory function for biospecimen access and distribution in accordance with established CBR policies and Policy for Governance of University of Michigan Medical School Research Biorepositories, when secondary use requests cover multiple biorepository programs or conflicts concerning the use and allocation of CBR-managed biospecimen resources arise.
   

Scope

The CBR Steering Committee is structured to foster broad stakeholder engagement in biospecimen management and to provide actionable guidance to the UMMS CBR Director and staff, ensuring the highest standards in biospecimen and data stewardship. The committee provides oversight for operational excellence and responsiveness to the needs of researchers and institutional leadership, offers strategic vision and expert advice to advance the value of the CBR as a resource for research discovery, innovation, and improved healthcare outcomes across UMMS, and provides expertise to ensure compliance with all applicable local, state, and federal regulations.

When the Committee behaves as an Oversight Committee, it may review and approve requests for secondary use of biospecimens that span across several CBR biorepository projects and adjudicate conflicts that may arise from the requested use of these materials. In these cases, each principal investigator responsible for the requested biospecimen(s) will be included as an ad hoc voting member of the Committee. 

The Oversight Committee will consider at least the following during decision-making:  

• 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

Out of scope: 

• Operational activities are the responsibility of the CBR Director and staff
• Day-to-day management of the CBR or individual research projects
• Authorization of direct financial expenditures (recommendations only)
• Oversight of research infrastructure projects unless they are related to biorepository policy/governance
• Personnel management
   

Functions

Strategic & Policy    

• Provide strategic direction and expertise for compliance, biospecimen discovery, innovation, and faculty engagement.
• Recommend biorepository policy, IRB/regulatory alignment, and the Committee’s mission, function, and charter.
• Advise on faculty engagement and outreach to encourage responsible use of CBR resources.

Operational    

• Review and recommend improvements in biospecimen management and space utilization.
• Advise on integration of special projects, pediatric samples stewardship and management, and sunset of collections.
• Review operational performance through KPIs, benchmarking, and quality/risk management.
• Provide institutional accountability and service.

Oversight    

• Establish and review sample prioritization, conflict resolution, and transparent distribution procedures.
   

Responsibilities

• Guide the Central Biorepository to ensure compliance with University of Michigan policies and federal regulations for human subjects’ research.
• Review outcomes of the College of American Pathologists Biorepository Accreditation Program.
• 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 on strategy, problem-solving, and issues related to specific projects or the overall business.
• When operating as an Oversight Committee, ratify CBR policies for reviewing and approving of secondary uses of biospecimens as appropriate.
   

Assumptions

• Members are empowered to represent their constituents and make recommendations.
• The CBR Director and the UMMS leadership will support implementation of committee recommendations when feasible and appropriate.
• Committee members will have access to relevant operational and policy information.

Leads

• Chair: CBR Director, Victoria Blanc, PhD – ongoing leadership for the committee. The Chair is responsible for convening meetings, setting agendas (in collaboration with administrative staff and committee members), facilitating discussions, and ensuring effective communication between the committee and UMMS leadership.
• Administrative Support: Leslie McCormick.
   

Committee Structure 

• The CBR Steering Committee includes members from Michigan Medicine and relevant U-M schools (e.g., the School of Public Health), prioritizing research-active members and those engaged in major CBR collaborations or service.
• Member composition represents a broad cross-section of Michigan Medicine, with expertise in biospecimen science, basic, translational, and clinical research, regulatory affairs, and UMMS leadership.
• Senior administrative leaders may delegate committee participation to empowered and knowledgeable faculty/staff.
• All members will actively participate in operational and strategic/policy/scientific discussions.
• At least two members of the Committee, including the Chair, will participate as part of the Oversight Committee function.
• The CBR Steering Committee will avoid undue concentration of administrative (Associate Dean-level) roles to foster direct engagement by research-active faculty.
• The CBR Steering Committee may form standing or ad hoc subcommittees as needed (e.g., for operations or specific projects), with overlapping membership for continuity.
   

Quorum, Decision-Making, and Communications

• A quorum is a simple majority of voting members. If quorum is not met, meetings may be rescheduled at the Chair’s discretion.
• Meetings will be held periodically, with sessions convened as needed.
• Decisions regarding policy recommendations and major operational changes shall, when appropriate, be subject to committee vote.
• Minutes and action items shall be recorded and shared with CBR leadership and, as appropriate, UMMS governance bodies.
• Reports will be provided to UMMS Leadership, and information will be disseminated to stakeholders as appropriate.
   

Expectations

• Committee members are expected to serve in the best interests of Michigan Medicine and the university, prioritizing institutional interests over those of their own departments or personal agendas.
• Demonstrate respect for diverse perspectives and professional conduct.
• Prepare for meetings and complete assignments on time.
• Participate actively in discussions and decision-making.
• Maintain meeting etiquette (e.g., keep camera on and mute as appropriate for virtual meetings).
• Uphold confidentiality and act as stewards of institutional trust.
   

Key Stakeholders

• UMMS Leadership
• CBR Director and staff
• Regulatory Compliance Office
• IRBMED
• MM research faculty and community
• UM research faculty actively utilizing CBR resources
     

Committee Membership

Voting Members:
CBR Director (Chair)
Faculty representatives 
UMMS leadership or designees

Ex Officio:
Associate Dean for Research

Non-voting Members:
Regulatory affairs consultant
Informatics and infrastructure consultant
Other subject-matter experts as needed
Administrative staff
CBR staff
 

Committee Charter Revision

The charter will be reviewed and updated at least every 3 years, with revisions proposed by the committee and approved by the CBR Director and UMMS leadership.

Approved 1/12/2026 by:

Steven L. Kunkel, Ph.D.
Executive Vice Dean for Research, U-M Medical School
Peter A. Ward Distinguished University Professor
Endowed Professor of Pathology Research

Karl Jepsen, Ph.D.
Associate Dean for Research – Basic & Translational
Professor of Orthopaedic Surgery
Professor of Biomedical Engineering

Cassandra Wong
Senior Director for Research 
Office of Research, Michigan Medicine

Victoria Blanc, Ph.D.
Director, Central Biorepository
Michigan Medicine