Evolutionary concepts in biobanking - the BC BioLibrary

Abstract

Background: Medical research to improve health care faces a major problem in the relatively limited availability of adequately annotated and collected biospecimens. This limitation is creating a growing gap between the pace of scientific advances and successful exploitation of this knowledge. Biobanks are an important conduit for transfer of biospecimens (tissues, blood, body fluids) and related health data to research. They have evolved outside of the historical source of tissue biospecimens, clinical pathology archives. Research biobanks have developed advanced standards, protocols, databases, and mechanisms to interface with researchers seeking biospecimens. However, biobanks are often limited in their capacity and ability to ensure quality in the face of increasing demand. Our strategy to enhance both capacity and quality in research biobanking is to create a new framework that repatriates the activity of biospecimen accrual for biobanks to clinical pathology.

Methods: The British Columbia (BC) BioLibrary is a framework to maximize the accrual of high-quality, annotated biospecimens into biobanks. The BC BioLibrary design primarily encompasses: 1) specialized biospecimen collection units embedded within clinical pathology and linked to a biospecimen distribution system that serves biobanks; 2) a systematic process to connect potential donors with biobanks, and to connect biobanks with consented biospecimens; and 3) interdisciplinary governance and oversight informed by public opinion.

Results: The BC BioLibrary has been embraced by biobanking leaders and translational researchers throughout BC, across multiple health authorities, institutions, and disciplines. An initial pilot network of three Biospecimen Collection Units has been successfully established. In addition, two public deliberation events have been held to obtain input from the public on the BioLibrary and on issues including consent, collection of biospecimens and governance.

Conclusion: The BC BioLibrary framework addresses common issues for clinical pathology, biobanking, and translational research across multiple institutions and clinical and research domains. We anticipate that our framework will lead to enhanced biospecimen accrual capacity and quality, reduced competition between biobanks, and a transparent process for donors that enhances public trust in biobanking.

Figure 1

The BC BioLibrary and its components. The BC BioLibrary is a framework that lies upstream from biobanks in the cycle that begins and ends with people and leads to their better health. Specifically addressing the aspects of biobanking that involve collection and processing of biospecimens, the components include: 1) the Biospecimen Collection Units which are embedded in the hospital pathology departments and facilitates research orientated biospecimen processing by trained personnel using SOPs; 2) data management infrastructures which enable integration of consent information provided to biobanks with biospecimens from patient donors; and 3) public engagement processes to allow informed deliberation and input from the public into the governance of biobanking.

Figure 2

The possible status of biospecimens collected by the BC BioLibrary BCU, as determined by the consent linked to the biospecimen in relation to the time of surgery. The consent status of biospecimens collected and held by the BCU is influenced by two possible mechanisms for consent: #1) Pre-Operative Consent: If consent is secured pre-operatively by a biobank then the biospecimen (green circle) is collected by the BCU and distributed to the biobank as a coded but identifiable biospecimen that can be linked to the patient donor clinical data by the biobank. #2) Post-Operative Consent: If consent is to be sought post-operatively then the biospecimen is collected by the BCU and held as an identifiable biospecimen (orange circle) for a period of up to 90 days (orange lines). During this time the consent status of the biospecimen may change and allow distribution to a biobank as follows: Accomplished - biospecimen (green circle) is distributed as per the procedure following a Pre-Operative Consent process. Not accomplished - the biospecimen (grey circle) and all related collection data is anonymized and distributed to a biobank (if approved to receive such biospecimens) or destroyed Withheld - biospecimen (purple circle) and all related collection data is destroyed.