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.   

Primary purpose

The BAC facilitates appropriate access by investigators and non-commercial entities to, and utilization of, human research biospecimens collected under Institutional Review Board (IRB)-approved biobanking studies.

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 (BAC). The EC provides oversight and guidance for the staging, growth and scope, including sample types accepted, of the biorepository. The BAC 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.  

BIOSPECIMEN ACCESS COMMITTEE (BAC)

The Biospecimen Access Committee (BAC) serves to advance the Johns Hopkins All Children’s Hospital (JHACH) research mission, and that of Johns Hopkins Medicine, by facilitating high-quality, ethical, innovative research designed to advance knowledge in child health and disease and improving health outcomes for children through enhanced prevention, diagnosis, and treatment of disease.

PURPOSE

• Primary purpose

           The BAC facilitates appropriate access by investigators and non-commercial                         entities to, and utilization of, human research biospecimens collected under                           Institutional Review Board (IRB)-approved biobanking studies.

• Secondary purpose

           The BAC facilitates access to human clinical tissue and fluid remnant biospecimens               maintained and archived by the Pathology Division at JHACH or in the JHAC                             Pediatric Biorepository.

 RESPONSIBILITIES/PROCESSES

BAC provides an independent review of requests for access to biospecimens stored in research biobanks and clinical remnant biospecimens and assures that the study proposal associated with each request has been approved by the corresponding Research Council of the primary JHAC Institute or Department with which the biobank is associated, the JHM IRB, and the IRB of record of the requesting investigator’s home institution (if outside of Johns Hopkins Medicine).

COMPOSITION

The two Co-Chair roles reflect representation from JHM (Baltimore) and JHACH and include individuals with relevant expertise in research with biospecimens.  The Committee is comprised of the following individuals:

1. Medical Director of the JHAC Pediatric Biorepository
2. Scientific Director of the JHAC Pediatric Biorepository
3. Department/Institute Director(s) (or other designated representatives)
4. Chair/Co-Chair of the JHM JHACH IRB
5. JHACH Bioethicist, member of JHM Berman Institute for Bioethics
6. Director/designee. JHU SOM Department of Pediatrics
7. Physician Representative from JHACH Anatomic/Clinical Pathology and Laboratory Medicine.
8. JHM Associate Dean for Research, or designee, at JHACH
9. JHM Associate Dean for Administration, or designee, at JHACH
10. At least one (1) Parent/Patient Representative(s)

MEETINGS

The BAC meets at least 2x annually with interim or more frequent meetings conducted as required.

USEFUL LINKS

1. Biorepository at Johns Hopkins All Children's (hopkinsmedicine.org)
2. Pediatric Biospecimen Innovation Center (PBIC) at Johns Hopkins All Children's (hopkinsmedicine.org)
3. Transferring Human Biospecimens to Outside Organizations (hopkinsmedicine.org)

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.