Cores, Shared Resources & Support Offices

Advancing medical knowledge and discovery through biospecimen storage

The Pediatric Biorepository at Johns Hopkins All Children’s Hospital assists researchers and doctors worldwide in processing, cryopreserving and storing blood, tissue and other specimens for archival and hypothesis-driven research. Our biobank holds a wealth of medical knowledge and specimens, promotes sample networks and enhances research collaborations in child health.   

Established in 2013 and expanded in 2018, the biorepository is the only pediatric biorepository in Florida accredited by the College of American Pathologists (CAP).  

As part of the CAP certification, a full quality management plan is in place, including quality monitors for biospecimens, processes, sample tracking, databases, business continuity, equipment and instrumentation, communication and training of management and staff.  

ISBER  

ISBER is a global organization which creates opportunities for sharing ideas and innovations in biobanking and harmonizes approaches to evolving challenges for biological and environmental repositories.  
 
ISBER (International Society for Biological and Environmental Repositories) fosters collaboration, creates education and training opportunities, and provides an international showcase for state-of-the-art policies, processes, and research findings, and innovative technologies, products, and services. Together, these activities promote best practices that cut across the broad range of repositories that ISBER serves. To advance the Biorepository Sciences, the Johns Hopkins All Children's Pediatric Biorepository participates regularly in meetings as contributors to presentations and committees. 

Biorepository Capacity  

The overall vial storage capacity is up to 3 million tube samples. The biorepository is equipped to process and store whole blood, buffy coats, sera, plasma, cerebrospinal fluid, DNA, RNA and frozen tissue. All biospecimens are tracked throughout their life cycle—from kit building to sample disposition—using a customized laboratory information system. The laboratory information management system integrates manual and automated workflow processes, captures biospecimen annotated data, controls permissions, assigns unique identifiers, provides reports and maintains an audit trail that is fully compliant with 21CFR Part 11 and GLP requirements.   

Governance   

The biorepository is overseen by an Executive Committee (EC) and a Biospecimen Storage and Access Committee (SAC). The EC provides oversight and guidance for the staging, growth and scope, including sample types accepted, of the biorepository. The SAC functions as a designee of the EC. Its mandate is to oversee the submission and access to “true biobank” specimens and associated data. This committee, comprising biorepository leaders, medical division representatives, biorepository and other core leaders, bioethicists, IT and other representatives, monitors requests, assures that all compliance requirements have been met, and makes recommendations to the EC.  

Commitment to the Research Participant  

The Johns Hopkins All Children’s Pediatric Biorepository safeguards and provides research and access to specimens of the highest quality and integrity through diligent and scientific custodianship, while also minimizing risk to patient privacy and confidentiality. This important function is a cornerstone to the academic integration with Johns Hopkins Medicine and the continual evolution and improvement of the research mission here at Johns Hopkins All Children's Hospital to provide better care to our patients.   

The decision to store or use biospecimens is an important one. The value of any request for advancing medical knowledge must be weighed against the irreplaceability of the specimen, as well as any ethical, legal or scientific challenges arising from the proposed research purpose. The SAC provides this crucial governance function, and its authority is supported by the inclusion of a diverse, volunteer membership consisting of physicians, scientists, Biorepository management, Institutional Review Board representative, ethics experts and patient/family representatives.