Johns Hopkins All Children’s Pediatric Biorepository

About the Johns Hopkins All Children’s Pediatric Biorepository

Johns Hopkins All Children’s Pediatric Biorepository is located in the Outpatient Care Center and is directly accessible from Johns Hopkins All Children’s Hospital by using the pedestrian bridge. 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.

Biorepository Governance

The Biorepository is overseen by an Executive Committee (EC) and a Biospecimen Submission 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.

Capacity

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.

Laboratory Sample and Information Management System

The Johns Hopkins All Children’s Pediatric Biorepository uses STARLiMS, a comprehensive database solution, to streamline and automate the specimen lifecycle - from kit building to sample disposition. The laboratory information management system integrates the workflow processes, controls permissions, assigns unique identifiers, provides reports and maintains an audit trail. STARLIMS complies with 21CFR Part 11 and GLP requirements and is compatible with other databases such as I2B2.

Commitment to the Research Participant

The Johns Hopkins All Children’s Pediatric Biorepository provides research 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 ACH 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 Specimen Access and Use 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), ethics experts, and patient/family representatives.