A biorepository can be defined as a center that collects, processes, stores, and distributes biospecimens to help support clinical research and scientific investigations. A biorepository can contain biospecimens from various living organisms including animals, humans, arthropods, plants, and more. The general purpose of a biorepository is to maintain biospecimens and its associated information for possible use in the future. The biorepository is in charge of the quality and manages the distribution of the samples available in their collection. It is a physical structure where biospecimens are stored along with all the relevant policies and processes.
As previously mentioned, the four main operations in a biorepository are:
Collection – This phase is where samples are collected and recorded in the laboratory information management system. All samples are given a unique barcode or identification number and the data associated with the sample is also recorded in the system.
Processing – Processing of samples include a standardized quality testing process to minimize variation such as sample handling. This phase also prepares the samples for storage.
Storage – In this phase, the samples are held in the inventory before distributed as requested. The inventory system contains various storage requirements due to the different types of biospecimens available.
Distribution – This stage includes retrieving samples that are requested from the biorepository inventory system
All the above operations ensure that the biospecimen is of the highest quality as it is collected, processed, stored, and distributed per regulations and standard operating procedures (SOPs). SOPs have a crucial role as it helps to reduce the incidences of issues, provide standardized guidelines for biospecimen storage, ensure biospecimens are high-quality and provide a framework of how to conduct seamless and reliable operations in a biorepository.
Addressing Biorepository Status and Gaps
Biorepositories are crucial to the research field as it represents a credible microbial forensics infrastructure that spans testing, research, evaluation, development, verification, independent validation, analysis, and investigation. Currently, various existing biorepositories are highly heterogenous and populated with private collections, government collections, individual laboratory collections, user-group collections, organism-specific collections, geographical collections, commercial collections, and large-scale public collections. However, many of these biorepositories are not accessible to the public as companies and organizations can limit access to their collections. The processes and procedures for quality control, culture expansion, maintenance, preservation, quality assurance, biosecurity, staff training, and bioinformatics data can be variable and problematic. The access of meta-data such as the geographic location of isolation, taxonomic identification methods, phenotypic properties, and bibliographic references may be unavailable or incomplete. These data gaps and procedural variations can compromise the utility of samples in various programs. For these reasons, it would be best to adhere to standards and protocols that are uniform and implemented by the biorepository community.
Issues that a Biorepository Faces
Since biorepositories play a vital role in the advancement of research, they are also subjected to scrutiny and face some issues. For example:
Expectations – A donor who donates a specimen such as tissue, blood, or urine expects the specimen to be valued, handled appropriately, and distributed accordingly to contribute to scientific knowledge. Furthermore, they also expect their privacy to be respected and used only in ways for which consent has been granted.
Custodianship – Since specimens are irreplaceable because an individual is never the same as the point of time the specimen is obtained, the more a specimen is used, the more valuable it has more potential to examine the different causal pathways without having to test and collect parameters that are already determined. A thoughtfully collected collection that contains the sociodemographic information can lead to data and inventions that have commercial value. This means that investigators can become reluctant to share their specimens. In responsible custodianship, proper handling and storage is a necessity. This entails following the SOPs, having trained personnel, ensuring quality control, etcetera.
Informed Consent – Since various biorepositories are specifically established for designated studies and subsequently maintained, the informed consent that was obtained then may differ and pose ethical issues when the samples are used again after that. If the tissues are linked to personal information, it is subjected to privacy regulations which have additional requirements. The Health Insurance Portability and Accountability Act (HIPAA) required that permission is obtained for each use. Although investigators can ask donors for permission to recontact them for permission to use the samples in future studies, there are also issues where some participants are lost to follow-up or dislike being contacted while data made anonymous destroys the linkage of the identifying information.
Privacy – While specimens become more valuable with associated information such as medical history, clinical history, and sociodemographic information of the donor, this makes it more difficult to protect the privacy of the individual and may lead to future issues such as jeopardizing the ability of the individual to obtain health insurance. Clear policies should be in place to protect the privacy and confidentiality of both donors and data.
While many may view a biorepository as simply a physical structure that holds various biospecimens, there are many responsibilities and issues involved in operating a biorepository. Biorepository staff has to be adequately trained to ensure seamless operations and handle various ethical issues such as privacy and confidentiality. Ultimately, a biorepository plays a crucial role in guaranteeing the future of clinical research.
Biorepository. Wikipedia. Accessed 8/14/2019. https://en.wikipedia.org/wiki/Biorepository
Foxman B. Human and animal subject protection, biorepositories, biosafety considerations, and professional ethics. Molecular Tools and Infectious Disease Epidemiology. 2012.
Leighton T, Murch R. Biorepositories and their foundations – Microbial forensic considerations. Microbial Forensics (Second Edition). 2011.