Cores, Shared Resources & Support Offices

Advancing medical knowledge and discovery through biospecimen storage

The Johns Hopkins All Children’s (JHAC) Pediatric Biorepository Facility supports research worldwide and offers advanced processing, cryopreservation, and analysis for archival and hypothesis-driven research. Our biobank generates a wealth of medical knowledge, promotes sample networks, and enhances research collaborations in child health.

The Biorepository stores biological specimens collected from participants, who provide their permission for this activity prior to the removal of all identifying information. These specimens may be used immediately for specific research aims generated by researchers and physician-scientists or banked for future unspecified research.

Commitment to Quality

Established in 2013, the Biorepository is one of only a few pediatric biorepositories in the world accredited by the College of American Pathologists (CAP). As a requirement for CAP accreditation, a full quality management plan is in place, which includes quality monitors for operational aspects and quality improvement, with the design to remedy biospecimen issues as soon as possible. The Biorepository is an active member of ISBER (International Society for Biological and Environmental Repositories) and is committed to helping foster collaboration, education, and training opportunities. Together, these activities promote best practices and improve sustainability.

Commitment to the Research Participant & Biospecimen Access 

The Johns Hopkins All Children’s Pediatric Biorepository safeguards access to specimens through diligent and scientific custodianship, while also minimizing risk to patient privacy and confidentiality. 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. Access to biobanked specimens (defined as specimens available for future research by participant consent that are not committed to a specific study aim) is overseen by the Biospecimen Access Committee (BAC). The BAC provides this crucial governance function, and its authority is supported by the inclusion of a diverse, volunteer membership consisting of physicians, scientists, Biorepository leadership, Institutional Review Board representative, ethics experts, and patient/family representatives.

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

•  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.

•  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.

ACCESSING BIOSPECIMENS

1. Review available biospecimens using the following link: Biospecimen Availability Portal (a JHED ID is required for access).

2. Complete a BAC Biospecimen Access Request Form (link under construction currently – in the interim please request the form via email to the JHACH Biorepository. To complete the access request form, you will need the following items:

a. IRB protocol number (IRB decision may not be finalized at this step, however the protocol must be approved prior to biospecimen release from the Biorepository).

   i. Note: If specimens will be sent to an organization outside of Johns Hopkins Medicine, unless otherwise exempt from the JHM Transferring Human Biospecimens to Outside Organizations Policy, you must complete a JHM Human Biospecimen Transfer Information Sheet (Transferring Human Biospecimens to Outside Organizations). This link describes the policy and any relevant exceptions. You will submit this form within the eIRB portal         when submitting your IRB protocol. In addition, this circumstance will also require a material transfer agreement (MTA) and an IRB approval letter from the requesting investigator’s home institution prior to release of any biospecimens from the Biorepository.

b. Funding support.

c. Requestor NIH biosketch or curriculum vitae (CV) summarizing key funding and publications.

d. Recommendation from the applicable Institute-Based Research Council, Institute Director, or the Department Chair associated with the biobank.

e. Biospecimen information (sample types, number of biospecimens, volume requirements, quality limits e.g., no hemolysis, and requested inventory IDs obtained from the Biospecimen Availability Portal).

f. Research Protocol (sharing background, hypothesis, specific aim(s), and methods).

BIOREPOSITORY ACKNOWLEDGEMENT

Should the use of the Tissue-Based Diagnosis and Research Core or Biorepository and any associated biospecimens result in a scientific publication, please acknowledge accordingly. A simple example may be “we would like to acknowledge the Johns Hopkins All Children’s Pediatric Biorepository for sample support.” Publications are an important measure of our impact and help communicate biospecimen utilization to the public and our patient donors.

OTHER INVESTIGATOR RESOURCES

1. Supported Biobanks (WEBSITE IN PROGRESS)

2. Pediatric Biospecimen Innovation Center (PBIC) at Johns Hopkins All Children's (hopkinsmedicine.org)