Summary
Description of the AU Biorepository
a) Scope
The initial step in establishing the BRAG-Onc repository is to establish a tissue bank at AU, and the application submitted for IRB review at this time is for the GRU Tumor Bank only.
The GRU repository will be expanded to a statewide network for tissue collection (BRAG-Onc), with GRU as the primary repository, to be reviewed at a future date. Every effort will be made to use the GRU Tumor Bank as a model and establish uniform processes for acquisition, data management and consenting, throughout the network.
b) The rationale is based on the needs of the research community for a
biorepository at AU. Current approaches to medical research and development of molecular diagnostics require access to large numbers of high-quality tissue samples and this trend is expected to continue in the future. In order to meet the needs of the research community, the specimens must be collected and preserved in an appropriate manner to conserve the integrity of macromolecules, have to be well annotated with comprehensive clinical and demographic information without access to personal identifiers, and have to be properly consented for broad research use. Archived specimens obtained in the past rarely meet all of these requirements and it is therefore necessary to establish a modern biorepository at AU that will meet current and future needs.
c) Incorporation of Current Best Practices in the GRU Biorespository:
Plans for the GRU Biorepository incorporate the recommendations for best practices, obtained by reviewing existing tumor banks and tissue repositories The GRU Tumor Bank will incorporate the following state of the art features:
• Standardized protocol for tissue procurement, handling and storage with quality assurance provided by pathologists (described in Section II)
• Appropriate consent for research use (Attachment A)
• Compliance with HIPAA, federal and institutional guidelines for the protection of human subjects.
Specifically, the following safeguards will be incorporated:
a) safeguards to ensure that diagnosis is never compromised
b) maintaining confidentiality and anonymity of specimen donors, for example:
- no direct access to medical records by researchers
- honest broker system: limited access by researchers to filtered information (de-indentified/anonimized)
- sophisticated informatics for specimen tracking and data management