Field Of Biobanking Research Articles

Inclusion of transgender and gender diverse health data in cancer biorepositories

Biobanks have the potential to be a robust resource for understanding potential cancer risks associated with gender-affirming interventions. In this narrative review, we synthesized the current published literature regarding the inclusion of TGD health data in cancer biorepositories and cancer research conducted on biospecimens. Of the 6986 initial results, 153 (2.2%) assessed the biological effects of gender-affirming interventions on TGD tissues. Within that category, only one paper examined transgender tissues in relation to cancer biobanks. Strategies are offered to address the inequities in TGD tissue-based research and diversify the field of biobanking as a whole.

A Pilot Cancer-Phenome Biobanking System in a Low-Resource Southeast Asian Setting: The Philippine General Hospital Biobank Experience.

Biobanking has become an indispensable tool for translational research and health innovations. While the field of biobanking has progressed and evolved globally, biobanking in developing Association of Southeast Asian Nations (ASEAN) countries such as the Philippines remains underrepresented because of several challenges often encountered in these low- and middle-income countries. Recently, the Philippine government has undertaken enormous efforts to advancing research and development in the country, and one of the current research pursuits is the establishment of biobanks, with the hope of attaining more discoveries and innovations in the future. Given that cancer remains a leading cause of death in the Philippines, the Philippine government supported the establishment of a cancer biobank at the Philippine General Hospital (PGH). In this study, we present a specific use case of biobanking activity at the PGH Biobank, to build a cohort of biospecimens from Filipino patients with breast, endometrial, and ovarian cancer. This initiative is part of a biomonitoring study (1) to assess environmental exposures and possible risk factors in the Philippine population and (2) to develop a system of culturing human cells from Filipino patients for subsequent in vitro studies. We discuss issues faced and the solutions developed during the implementation of the biobank. Strong research collaboration, a funding source, basic infrastructure, and appropriate technology helped initiate this pilot biobank in the Philippines. Overall, the experiences of establishing the PGH Biobank may help other institutions in low-resource countries to set up cancer biobanks.

Biobanking and biomolecular resource research infrastructure: The Italian node

BBMRI-ERIC is a European research infrastructure for biobanking, bringing together all the main players from the biobanking field – researchers, biobankers, industry, and patients – to boost biomedical research. To that end, it offers quality management services, support with ethical, legal and societal issues, and a number of online tools and software solutions. Ultimately, the goal of BBMRI-ERIC and its National Nodes is to make new treatments possible.

Pisa Biobank and Tuscany Regional Biorepository

Departmental Section of Biobanks (SOD Biobanche) of the Azienda Ospedaliera Universitaria Pisana, consists of a Tissue and Cell institute, the Heart Valve Bank, and a biorepository, the Regional Biologic Archive. A clean room consisting of three laboratories (1 class C and 2 class B) represents a core facility for some of the processes and projects of the biobank. The Regional Biological Archive is a biobank which currently carries out as an institutional task the storage of serum, plasma and non-viable cells of multiorgan, multi-tissue donors and donors of corneas, as well as solid organ transplant recipients of the Tuscany Region, providing the possibility of reviewing and re-evaluating even at a distance of years the donor/recipient pairs. The mission of SOD Biobanche is to act as a transversal service platform in the field of biobanking of biological material. In this broader perspective the structure is open to new projects concerning biobanking, some of which are already in the activation phase, such as a bank for urogenital tissues, a biobank of tumors of the musculoskeletal system and an advanced therapy protocol for the use of partially osteoinduced expanded mesenchymal stem cells.

Relevant criteria for the selection of cryotubes. Experiences from the German National Cohort

Abstract Background The storage of different biomaterials over long time periods is one of the main requirements of biobanking ensuring that modifications in the composition or any other change of the biomaterials have to be avoided. In the German National Cohort samples from around 200,000 participants are processed and stored long term. Methods A tender for cryotubes and racks was performed in 2013 setting up several characteristics that were judged against each other. Tubes and racks were evaluated regarding the performance and handling in connection with the main biorepository. With a 5-year experience using the selected tubes we are able to reflect some of the criteria of the tender. Results At the end of the decision, the former company FluidX, in the meantime taken over from Brooks (Brooks Life Sciences, Manchester, UK), received the order. The experience with the external testing of the tube was useful. Conclusions Overall, the experience with the cryotubes is good and their mechanical handling at the different sites is routine in the meantime. There are some aspects that we recommend for future tenders. Further research is necessary to learn more about the cryotubes and the labware in general in the field of biobanking to store our samples as safely as possible.

CURRENT BEST PRACTICES AND BIOBANKING RECOMMENDATIONS

The biobank is a structure established with the goal of long-term responsible storage of biological samples and the associated data for their further use in scientific and clinical research. The objectives of biobanking are the creation of unified recommendations on: the planning of premises and the selection of equipment for storage; development of management methods and staff training; standardization of methods for the collection, shipping, processing and storage of biomaterial of various origins, as well as methods for quality control and validation of the applied methods; creation and use of databases of information accompanying biospecimens. The lack of common standards for conducting the preanalytical phase has been the cause of low accuracy and poor reproducibility of research results. To date, a large number of guidelines and best practices have been published that provide an answer to a wide range of problems in organizing the biobanking process. The article provides an overview of the most famous biobanking guidelines that can be used to solve various research problems. Biobanking in Russia is actively developing. Since 1996 there is a work on the legislative regulation of biobanking activities, as a result of which a number of regulatory documents have been issued. An important stage in the development of biobanking in Russia was the establishment of the “National Association of Biobanks and Biobanking Specialists” (NASBio) in 2018, which included representatives of medical and research institutions, commercial firms, and qualified specialists in the field of biobanking. One of the key tasks of NASBio is the adaptation and implementation of the best biobanking practices in Russian research institutes and centers. The use of modern guidelines and best practices on biobanking will lead to an increase in the quality of research and publications.

Quality management in biobank. World tendencies and experience of biobank of FSI «NMRC for preventive medicine» of the Ministry of healthcare of Russia.

This paper provides several definitions of the term "biobank"; a list of standards developed by the International Organization for Standardization (ISO) applicable to the activities of biobanks; analyzes the legal and ethical requirements; the Russian legal framework in the field of biobanking, the best international practices and recommendations; describes the experience of the development and implementation of quality management systems according to ISO 9001 in Biobanks established in different countries, and the experience of the Bank of Biological Material of the National Medical Research Center for Preventive Medicine of the Ministry of Healthcare of Russia. The ISO 20387 Biobanking Standard, released in August 2018, combined the knowledge and experience of specialists from around the world and defined the general requirements that must be fulfilled by biobanks and repositories wishing to guarantee their customers the high quality of the preanalytical stage of scientific research, biological samples and associated data. In 2019, the Russian version of this standard is expected. Documents of the quality management system provide the reproducibility of activities on the main storage processes and facilitates the process of incorporating a new employee; conducting internal and external audits; Biobank knowledge management - continuous staff education. The introduction of an effective quality management system into biobank activity warrants the high quality of biological samples, the standardized pre-analytical stage, reliable, regulated long-term storage of biomaterial and related information for use in research purposes today and in future.

The complex ethical landscape of biobanking

The complex ethical landscape of biobanking

Can dynamic consent facilitate the protection of biomedical big data in biobanking in Malaysia?

As with many other countries, Malaysia is also developing and promoting biomedical research to increase the understanding of human diseases and possible interventions. To facilitate this development, there is a significant growth of biobanks in the country to ensure continuous collection of biological samples for future research, which contain extremely important personal information and health data of the participants involved. Given the vast amount of samples and data accumulated by biobanks, they can be considered as reservoirs of precious biomedical big data. It is therefore imperative for biobanks to have in place regulatory measures to ensure ethical use of the biomedical big data. Malaysia has yet to introduce specific legislation for the field of biobanking. However, it can be argued that its existing Personal Data Protection Act 2010 (PDPA) has laid down legal principles that can be enforced to protect biomedical big data generated by the biobanks. Consent is a mechanism to enable data subjects to exercise their autonomy by determining how their data can be used and ensure compliance with legal principles. However, there are two main concerns surrounding the current practice of consent in biomedical big data in Malaysia. First, it is uncertain that the current practice would be able to respect the underlying notion of autonomy, and second, it is not in accordance with the legal principles of the PDPA. Scholars have deliberated on different strategies of informed consent, and a more interactive approach has recently been introduced: dynamic consent. It is argued that a dynamic consent approach would be able to address these concerns.

Procurement, Storage, and Use of Blood in Biobanks.

Blood is a widely used biospecimen in the field of biobanking, secondary to the ease with which it is collected along with the wide variety of analytes obtained from it for analysis. It carries the potential to further the search for biomarkers in countless diseases; therefore, the standardization and optimization of blood collection procedures is of importance in assuring reproducibility of results. Here, we briefly review procedures for the procurement, storage, and use of blood and its fractions for biobanking purposes. Select commonly used methods for collecting blood withvarious vacutainer blood collection tubes are described, along with optimal storage conditions of various samples in short- and long-term situations.

A Stepwise Procedure to Define a Data Collection Framework for a Clinical Biobank.

Current guidelines for clinical biobanking have a strong focus on obtaining, handling, and storage of biospecimens. However, to allow for research tying biomarker analysis to clinical decision making, there should be more focus on collection of data on donor characteristics. Therefore, our aim was to develop a stepwise procedure to define a framework as a tool to help start the data collection process in clinical biobanking. The Radboud Biobank (RB) is a central clinical biobanking facility designed in accordance with the standards set by the Parelsnoer Institute, a Dutch national biobank originally initiated with eight different disease cohorts. To organize the information of these cohorts, we used our experience and knowledge in the field of biobanking and translational research to identify research domains and information categories to classify data. We extended this classification system to a stepwise procedure for defining a data collection framework and examined its utility for existing RB biobanks. Our approach resulted in the definition of a three-step procedure: (1) Identification of research domains and relevant questions within the field that may benefit from biobank samples. (2) Identification of information categories and accompanying subcategories that are relevant for answering questions in identified research domains. (3) Reduction to an efficient framework based on essentiality and quality criteria. We showed the utility of the procedure for three existing RB biobanks. We developed guidelines for the definition of a framework that supports the standardization of the biobank data collection process. Connecting the biobank database to pertinent information collected from the electronic health record will improve data quality and efficiency for both care and research. This is crucial when using the corresponding biospecimens for scientific research. Further, it also facilitates the combination of different clinical biobanks for a specific disease.

Implantation and extravillous trophoblast invasion: From rare archival specimens to modern biobanking

Extravillous trophoblast invasion serves to attach the placenta to the uterus and to enable access to nutrients for the embryo throughout pregnancy – secretions of the uterine glands in the first trimester, maternal blood in the second and third trimester. For assessing extravillous trophoblast invasion, histology (in combination with immunohistochemistry) still plays a major role in placental research. This is especially true for the re-assessment of rare archival specimens from early human implantation sites or placenta in utero with the background of recent knowledge which may help to strengthen current hypotheses. This review summarizes the recently expanded picture of extravillous trophoblast invasion, gives an overview about fundamental archival specimens in placental research, presents new images of archival specimens, gives insights into the latest developments in the field of biobanking and provides insight into the current situation on sample usage in the absence of biobanks. Modern techniques allow expanding our hitherto believed concept of extravillous trophoblast invasion, which is not restricted to spiral arteries: Extravillous trophoblasts also invade into uterine glands and uterine veins and thereby connect all these luminal structures with the intervillous space. All biomedical research dramatically depends on the quality of the assessed biological samples. Hence, researchers should be aware that the time between collection of a sample from a body and the beginning of analysis (pre-analytical phase) may have more impact on the outcome of a study than previously assumed.

Translating Basic Research to Astronaut Health in Space: NASA Ames Rodent Specimen Biobanking for the Human Research Program

Abstract As an extension of NASA Ames’ long history and sustaining international collaboration for sharing tissues acquired from one-off spaceflight experiments, we have recently established a new mobile operation for acquiring small animal biospecimens from ongoing ground-based studies supported by the NASA Human Research Program (HRP) organized at Johnson Space Center (JSC). Goals of Ames’ Biospecimen Sharing Programs (BSPs) are to: (1) advance understanding of physiological responses and adaptations to the space environment utilizing animal models in support of fundamental space and gravitational biology research, and to promote human health in space and on Earth, (2) provide a repository of high-quality, well-preserved, and carefully archived and maintained biospecimens by applying modern approaches and established best practices in the biobanking field, and (3) establish a database for gathering broad and comprehensive scientific information corresponding to these samples, including cutting edge techniques for tracking and archiving of structural, descriptive, and administrative metadata. This program, modeled after contemporary human and animal biobanking initiatives, is yielding a rich archive of quality specimens that can be used to address a broad range of current and future scientific questions relevant to NASA Life Sciences, Exploration Medicine, and beyond.

Trends in Biobanking: A Bibliometric Overview.

Biobanks have become indispensable tools for a wide array of life and environmental sciences, and biotechnology. To evaluate trends in biobanking, 20,000 bibliographic records were retrieved and analyzed between 1939 and 2014 from the Scopus database using a series of biobank-related search terms within titles and keywords. Since the 1990s, the field of biobanking has been, and still is, experiencing above-average growth in terms of publications, journals, and thematic orientations. Almost two-thirds of all indexed biobanking documents have been published in the last decade, with now >1,000 publications in 600 distinct journals per year. Around 50,000 individual authors can be identified who have so far contributed to the field of biobanking, with an average of 1.5 publications per author. Author affiliations follow an uneven distribution: 42% of the authors are based in Europe, 33% in North America, 13% in Asia, 5% in South America, 4% in Australasia, and 2% in Africa. Analyzing the most common title words revealed (as did the journals) a strong focus on blood banking, but other biospecimen types-especially seeds, cells, and tissues-have been gaining increasing weight recently. Among medical applications, transfusion dominates, followed by transplantation. While a noticeable increase in disease and especially health occurred at the beginning of the millennium, cohort and consent seem to have become high-relevance topics only in this decade. In terms of banked organisms, human dominates, followed by viruses and plants (especially represented through seed banking). A very rough estimate based on subject categories suggests that a third of all publications in biobanking focus on organisms other than humans. However, animal, fungal, and microbial biobanking are still underrepresented, especially when considering their shares in global biodiversity.

Sustainability in Biobanking: Model of Biobank Graz.

Research infrastructures remain the key for state-of-the-art and successful research. In the last few decades, biobanks have become increasingly important in this field through standardization of biospecimen processing, sample storage, and standardized data management. Research infrastructure in cohort studies and other sample collection activities are currently experiencing a lack of long-term funding. In this article, the Biobank Graz discusses these aspects of sustainability including the definition of sustainability and necessity of a business plan, as well as cost calculation model in the field of biobanking. The economic state, critical success factors, and important operational issues are reviewed and described by the authors, using the example of the Biobank Graz. Sustainability in the field of biobanking is a globally important matter of necessity, starting from policy making and ending with security and documentation on each operational level.

Review of Developing and Organizing an Institutional Biospecimen Repository, edited by Donna E. Hansel and Scott D. Jewell

W ith increasing use of human tissue specimens in biomedical research comes the need for higher quality and more centralized biorepositories. There is significant variability in biospecimen quality and usability across institutions at this time, prompting the development of best practices, guidelines, and biorepository accreditation programs in recent years. Some institutions have an existing centralized biorepository, some have scattered ‘‘satellite’’ biorepositories housed in research laboratories, while others do not have organized biospecimen repository at all. Current standards for biorepositories require attention to patientinformed consent processes, timely and standardized procedures for biospecimen collection, processing, and biobanking to ensure excellent tissue quality, and establishment of ethical policies for granting access and distribution of specimens for research. With these considerations in mind, the authors of Developing and Organizing Institutional Biospecimen Repository have put together a key reference guide for anyone responsible for establishing and maintaining biorepositories. Written by authors who have established expertise in the field of biobanking, this collaborative publication provides readers with a comprehensive framework with which to implement biobanking strategies. The book is divided into ten chapters, beginning with defining the role of the biorepository at an institution (Chapter 1) and the key role of the pathology department (Chapter 2). The authors then address management and key personnel (Chapter 3), infrastructure and scope of services that could be provided by the repository (Chapter 4), standardization of specimen collection, processing, and storage flow (Chapter 5), quality control of specimens (Chapter 6), informatics (Chapter 7), the very detailed informed consent process (Chapter 8), cost assessment (Chapter 9), and relationships with outside institutions and industry (Chapter 10). In those ten chapters, the authors address a myriad of practical concerns and issues, including how to obtain institutional and funding support, deciding on location and space, what types of biospecimen kits and freezers are recommended, software designs to manage biospecimen data, when to obtain informed consent, budgeting, and how to assess/approve requests for specimens. They also address contentious issues such as how access to biospecimens will be granted, which parties will have priority access to specimens/data, and how to manage intellectual rights resulting from research using human tissues. This detailed guide to biorepository establishment and management will prove a handy reference for those in charge of all or part of a biorepository. With up-to-date information on the latest equipment, links to guidelines established by biorepository societies, important details on standard collecting and processing procedures and more, this book is both comprehensive and user-friendly. It is a must-have for pathologists or professionals involved in any aspect of biorepository planning, maintenance, or development as well as research, legal and financial realms.

The 2015 ISBER Annual Meeting & Exhibits in Phoenix, Arizona, USA: bridging the canyon-connecting biobank communities through innovations in global health, research and environmental preservation.

The 2015 International Society for Biological and Environmental Repositories (ISBER; http://www.isber .org) Annual Meeting & Exhibits will be held May 5–9, 2015 in Phoenix, Arizona, USA, at the Sheraton Phoenix Downtown. The Grand Canyon, one of the geological wonders of the world, will be an inspirational backdrop, while the conference will focus on the creation of highimpact innovations, partnerships, and networks across the biobanking landscape. The meeting theme is ‘‘Bridging the Canyon—Connecting Biobank Communities through Innovations in Global Health, Research, and Environmental Preservation.’’ This theme sets the focus firmly on the intrinsic, central nature of biobanking in enabling significant research and clinical care, through the preservation and availability of highquality tissue and environmental samples. The wide array of speakers from the medical, pharmaceutical, and environmental fields at the symposia is a testament to the ever-widening need and fulfilment of the pivotal role of biobanking. With the varied and growing maturation of the biobanking field across the world, however, there are newer challenges, viewed as gaps or canyons in our collective knowledge. These may be underlying factors (e.g., specimen preparation), operating factors (e.g., consent and/or financial operating models), or technological factors (e.g., the curation of big data) presenting demanding challenges at times to the development of the field. The increasing rate at which these obstacles are identified, discussed, and eventually overcome demonstrates the power of biobanking networks. The meeting will focus on the ability to expand our biobanking reach through technological developments, high-throughput pharmaceutical research, and the better understanding, management, and preservation of archival material. Biobanking is a dynamic field developing in both well-established institutions and emerging centers in farreaching geographical areas with newer biobanks, such as in China, India and Africa. The conference will focus on developments across geography and fields, to provide a current snapshot of the industry and its future direction. The ISBER Annual Meeting & Exhibits will feature six symposia with invited speakers, many educational and corporate workshops, a rare disease session, interactive discussions, contributed paper sessions, ISBER Working Group meetings, poster displays, a large exhibit hall, networking opportunities, social events and much more. The following symposia have been developed to emphasize the variety of biobank communities and how they connect with many and diverse fields (including biomedical, biotechnology, pharmaceutical, animal and environmental) to foster and disseminate innovative solutions.

Innovative ways for information transfer in biobanking

Purpose – Biobanks are collections of biological samples (e.g. tissue samples and body fluids) and their associated data intended for various approaches in medical research. The field of biobanking evolves rapidly as an interdisciplinary branch of research and requires educational efforts to provide skilled experts in Europe and beyond. New ways in research and research education play a pivotal role in the future of biobanking. Design/methodology/approach – The increasing of requests and potential uses of biospecimens from biobanks necessitates an international and national intensified transfer of forward looking knowledge and know-how. In Austria, this could be realized by special trainings as well as a postgraduate education. Furthermore, the forward looking research and further development of infrastructure will play a pivotal role in biobanks in the future. Findings – Few opportunities are available for specific education on biobanking in Europe. This could be remedied by the creation networks of ISO-certified biobanks and co-operation with interested parties. Research limitations/implications – The current research focuses on the situation of information transfer in the field of biobanking in Europe. A wider investigation in better harmonization and standardization of methods in other parts of the world would be beneficial. Originality/value – The value of biomolecular resources such as biobanks has previously been discussed in detail, e.g. by the Time magazine. The paper focuses on demonstrating the importance for education in the future of biobanking in general.

What is a biobank? Differing definitions among biobank stakeholders

While there is widespread agreement on the broad aspects of what constitutes a biobank, there is much disagreement regarding the precise definition. This research aimed to describe and analyze the definitions of the term biobank offered by various stakeholders in biobanking. Interviews were conducted with 36 biobanking stakeholders with international experience currently working in Switzerland. The results show that, in addition to the core concepts of biological samples and linked data, the planned use of samples (including sharing) is held to be a key criterion. It also emerges that some researchers avoid the term in order to circumvent certain regulatory guidelines, including informed consent requirements. Developments in the field of biobanking will be complicated if researchers are unaware, or deny that their collection is a biobank. A clear definition of the term is therefore an important step towards fostering collaboration amongst researchers, enabling them to more easily identify potential sources of samples.

ISBER annual awards.

The International Society for Biological and Environmental Repositories (ISBER) will award two competitive awards at its Annual Meeting this year in Sydney, Australia. In order to receive one of these awards, a person's name must first be submitted to the ISBER Nominating Committee. The Committee considers all nominations and forwards its recommendations to the ISBER Council. The ISBER Council then approves the recipients. The ISBER Outstanding Achievement in Biobanking Award is sponsored for the second year by Taylor-Wharton and recognizes individuals who have made outstanding contributions to the field of biobanking. Past awardees include Drs. Kurt Zatloukal, Carolyn Compton, and Robert Hewitt. ISBER is proud to announce the addition of Dr. Jim Vaught to this distinguished list. Dr. Vaught is being recognized for his exceptional vision and leadership and his extensive influence on the field of biobanking. His accomplishments in biobanking are far reaching and varied, from study design to specimen collection, processing, and storage. As a founding member of ISBER and ISBER's second President, his vision for an international forum that addresses the technical, legal, ethical, and managerial issues relevant to repositories of biological and environmental specimens has become a successful reality. His participation and leadership in committees across many agencies of the US Government in support of biospecimen collections has been invaluable. His leadership and guidance of the National Cancer Institute's Office of Biorepositories and Biospecimens Research (now BBRB) has been an important presence in providing guidance documents for cancer-focused biobanking activities. As the Editor-in-Chief of Biopreservation and Biobanking (ISBER's Official Journal) and previous Chair of the ISBER Publications Committee, Dr. Vaught has helped drive the rejuvenation/re-creation of the journal in support of the biospecimen science and biobanking fields. The second award is the ISBER Distinguished Leadership & Service Award. This award is designed to honor ISBER members who have demonstrated exceptional leadership to further the mission and goals of the Society and/or significant, long-standing contributions to the Society. Past awardees include Ms. Elaine Gunter, Mr. Phil Baird, Dr. Robert Hewitt, and Ms. Marianna Bledsoe. ISBER is proud to announce the addition of Dr. Fay Betsou to this distinguished list. Dr. Betsou is being recognized for her tireless energy and leadership of the Biospecimen Science Working Group (BSWG). The BSWG is by far the most productive ISBER working group and has produced several very significant and influential products for the scientific community, including the Standard PREanalytical Code (SPREC) for biospecimens. Dr. Betsou has also provided outstanding leadership for ISBER's innovative Biorepository Proficiency Testing (PT) Program. Her expert participation as a contributor and editor of ISBER's Best Practices for Repositories, participation on Council, and her active role in providing insightful answers on the member Listserv on biospecimen quality, have all demonstrated her exceptional leadership role in ISBER. These awards will be presented to the recipients at the ISBER Business meeting on May 8, 2013. We hope you will join us in congratulating these very deserving recipients of our two top honor awards. Below are biosketches for the 2013 ISBER Awardees, Drs. Vaught and Betsou.