The Johns Hopkins All Children’s Pediatric Biorepository was established in 2013 to assist pediatric researchers and doctors world-wide in:
- Processing, cryopreserving and storing blood, tissue and other biospecimens used for archival and hypothesis-driven clinical research.
- Promoting sample networks and enhancing research collaborations in child health.
- Providing education and training in biorepository science with a special emphasis in pediatrics.
The biorepository is located in the Outpatient Care Center and is directly accessible from Johns Hopkins All Children’s Hospital. The biorepository includes a receiving center, bioprocessing lab and secure cryostorage room.
An expansion to the biorepository is expected to be completed by 2018. The facility environment and all cryoequipment are surveyed 24/7 by a remote monitoring and alarm system.
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 EC is comprised of Directors, Deans, Department Chairs, Legal Council, and outside biorepository experts. It is in direct support of the Director of Research and the Vice Dean. The EC makes recommendations to the Research Council and Vice Dean. The SAC functions as a designee of the Executive Committee. Its mandate is to oversee the submission and access to “true biobank” specimens and associated data. This committee, comprised of Biorepository leaders, medical division representatives, biorepository and other core leaders, bioethicist, IT and other representatives, monitors requests, assures that all compliance requirements have been met, and makes recommendations to the EC.
Quality control, assurance and improvement are a continuing commitment to biorepository clients through leadership, planning and accreditation. The Biorepository was fully accredited by the College of American Pathologists in February, 2015. 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/competency of management and staff.
The College of American Pathologists (CAP), the leading organization of board-certified pathologists and pathology laboratories, serves patients, pathologists and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.
The CAP offers high-value, integrated solutions and experiences that empower CAP members and customers to achieve excellence in the practice of pathology and laboratory medicine.
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, 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.
The overall vial storage capacity is 300,000 with expansion plans for 1.5 million. The biorepository is equipped to process and store whole blood, buffy coats, sera, plasma, CSF, 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.
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, wherein the merits 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 Biorepository Storage and Access Committee (SAC) provides this crucial governance function, and its purview is supported by the inclusion of a diverse, volunteer membership consisting of physicians, scientists, Biorepository management, Institutional Review Board (IRB) representative, ethics experts, and patient/family representatives.
The history of the Johns Hopkins All Children’s Pediatric Biorepository can be traced to the convergence of a broad futuristic vision of George Dover, M.D., pediatrician-in-chief at the Hopkins Children's Center, the concepts and expertise of Margaret B. Penno, Ph. D., director of the biorepositories and the will and resources of Dr. Jonathan Ellen, president and vice dean.
Johns Hopkins All Children's Hospital presented the ideal place to house the biorepository in a pediatric setting, well-aligned with the vision for academic transformation at Johns Hopkins All Children's following the integration with Johns Hopkins Medicine. The biorepository began to take shape with the blessings of Dr. Dover and Johns Hopkins All Children's president and vice dean Jonathan Ellen, M.D., and the involvement of Dr. Penno, Neil Goldenberg, M.D., Ph.D., director of research at Johns Hopkins All Children's and associate professor of pediatrics at Johns Hopkins, and a multidisciplinary committee, consisting of people from facilities to clinical lab to IT to research.