Biobank

The term "biobank" first appeared in the late 1990s and is a broad term that has evolved in recent years. One definition is "an organized collection of human biological material and associated information stored for one or more research purposes." Collections of plant, animal, microbe, and other nonhuman materials may also be described as biobanks but in some discussions the term is reserved for human specimens. They may range in size from individual refrigerators to warehouses, and are maintained by institutions such as hospitals, universities, nonprofit organizations, and pharmaceutical companies. Population-based biobanks need no particular hospital affiliation because they take samples from large numbers of all kinds of people, perhaps to look for biomarkers for disease susceptibility in a general population. • Virtual biobanks integrate epidemiological cohorts into a common pool. Virtual biobanks allow for sample collection to meet national regulations. • Tissue banks harvest and store human tissues for transplantation and research. As biobanks become more established, it is expected that tissue banks will merge with biobanks. These numbers represent a fundamental worldwide change in the nature of research between the time when such numbers of samples could not be used and the time when researchers began demanding them. Some of the challenges raised by the advent of biobanks are ethical, legal, and social issues pertaining to their existence, including the fairness of collecting donations from vulnerable populations, providing informed consent to donors, the logistics of data disclosure to participants, the right to ownership of intellectual property, and the privacy and security of donors who participate. ==Types and applications==

Human genetics research By the late 1990s, scientists realized that although many diseases are caused at least in part by a genetic component, few diseases originate from a single defective gene; most genetic diseases are caused by multiple genetic factors on multiple genes. Because the strategy of looking only at single genes was ineffective for finding the genetic components of many diseases, and because new technology made the cost of examining a single gene versus doing a genome-wide scan about the same, scientists began collecting much larger amounts of genetic information when any was to be collected at all. Diversification of biobank samples is needed and researchers should consider the factors effecting the underrepresented populations. Conservation, ecosystem restoration and geoengineering In November 2020 scientists began collecting living fragments, tissue and DNA samples of the endangered corals from the Great Barrier Reef for a precautionary biobank for potential future restoration and rehabilitation activities. A few months earlier another Australian team of researchers reported that they evolved such corals to be more heat-resistant. ==Biological specimens==

The specimens stored by a biobank and made available to researchers are taken by sampling. Specimen types include blood, urine, skin cells, organ tissue, and other materials. Increasingly, methods for sampling tissue specimens are becoming more targeted, sometimes involving the use of MRI to determine which specific areas of tissue should be sampled. The biobank keeps these specimens in good condition until a researcher needs them to conduct a test, do an experiment, or perform an analysis. Storage Biobanks, like other DNA databases, must carefully store and document access to samples and donor information. The samples must be maintained reliably with minimal deterioration over time, and they must be protected from physical damage, both accidental and intentional. The registration of each sample entering and exiting the system is centrally stored, usually on a computer-based system that can be backed up frequently. Icelandic law holds that the Icelandic government has custodial rights of the physical samples themselves while the donors retain ownership rights. In contrast, Tonga and Estonia give ownership of biobank samples to the government, but their laws include strong protections of donor rights. ==Ethics==

The key event which arises in biobanking is when a researcher wants to collect a human specimen for research. When this happens, some issues which arise include the following: right to privacy for research participants, ownership of the specimen and its derived data, the extent to which the donor can share in the return of the research results, and the extent to which a donor is able to consent to be in a research study. With respect to consent, the main issue is that biobanks usually collect samples and data for multiple future research purposes and it is not feasible to obtain specific consent for all possible future research. It has been discussed that one-off consent or a broad consent for various research purposes may not suffice ethical and legal requirements. Dynamic consent is an approach to consent that may be better suited to biobanking, because it enables ongoing engagement and communication between the researchers and sample/data donors over time. ==Governance==

There is no internationally accepted set of governance guidelines that are designed to work with biobanks. Biobanks typically try to adapt to the broader recommendations that are internationally accepted for human subject research and change guidelines as they become updated. For many types of research and particularly medical research, oversight comes at the local level from an institutional review board. Institutional review boards typically enforce standards set by their country's government. To different extents, the law used by different countries is often modeled on biobank governance recommendations that have been internationally proposed. Key organizations Some examples of organizations that participated in creating written biobanking guidelines are the following: History In 1998, the Icelandic Parliament passed the Act on Health Sector Database. This act allowed for the creation of a national biobank in that country. In 1999, the United States National Bioethics Advisory Commission issued a report containing policy recommendations about handling human biological specimens. National biobanks are often funded by public/private partnerships, with finance provided by any combination of national research councils, medical charities, pharmaceutical company investment, and biotech venture capital. In this way, national biobanks enable an economic relationship mediated between states, national populations, and commercial entities. It has been illustrated that there is a strong commercial incentive underlying the systematic collection of tissue material. This can be seen particularly in the field of genomic research where population sized study lends itself more easily toward diagnostic technologies rather than basic etiological studies. Considering the potential for substantial profit, researchers Robert Mitchell and Catherine Waldby argue that because biobanks enroll large numbers of the national population as productive participants, who allow their bodies and prospective medical histories to create a resource with commercial potential, their contribution should be seen as a form of "clinical labor" and therefore participants should also benefit economically. Legal cases There have been cases when the ownership of stored human specimens have been disputed and taken to court. Some cases include: • Moore v. Regents of the University of California • Greenberg v. Miami Children's Hospital Research Institute == See also ==