International Society For Biological And Environmental Repositories Research Articles

Updating International Society for Biological and Environmental Repositories Best Practices, Fifth Edition: A New Process for Relevance in an Evolving Landscape.

The recently published fifth edition of the International Society for Biological and Environmental Repositories (ISBER) Best Practices signifies a pivotal milestone in navigating the complexities of repository management. Repositories operate within a constantly evolving landscape influenced by the changing fields of biospecimen science, technology, legal requirements, and ethical considerations. This dynamic is further amplified by unprecedented local and global challenges, such as pandemics, conflicts, and supply chain disruptions. Creating this new edition required a comprehensive approach capable of delivering a focused and coherent resource reflecting the broad horizon of its diverse users. The innovative approach used the existing phased development process and integrated the canvassing of opinions, formal evaluation, and real-time collaboration platforms. Merging these techniques enabled efficient collection and effective distillation of the latest in biobanking practices, enhancing the value of the fifth edition for repositories of specimens and associated data. The expanded document is a testament to the collective efforts of many dedicated individuals who have built upon the foundations of prior editions.

The International Society for Biological and Environmental Repositories Presents Abstracts from Its Annual Meeting

Biopreservation and BiobankingAhead of Print AbstractsFree AccessThe International Society for Biological and Environmental Repositories Presents Abstracts from Its Annual Meeting“Come As You Are: Building Biobanking Bridges” In‐Person: May 3–6, 2023 Seattle, Washington Virtual: June 6–7, 2023Published Online:14 Apr 2023https://doi.org/10.1089/bio.2023.29118.abstractsAboutSectionsPDF/EPUB Permissions & CitationsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail The abstracts that follow demonstrate the broad range of timely issues addressed in the contributed Oral and Poster presentations at ISBER's 2023 Annual Meeting & Exhibits.Oral AbstractO‐01 Accelerating Translational Research by Enabling Access to Specimens and DatasetsS. Joshi1, E. Matzke2, D. Galipeau31Fred Hutchinson Cancer Research Center, Seattle, Washington, United States, 2Provincial Health Services Authority, Vancouver, British Columbia, Canada, 3Oregon Health & Science University, Portland, Oregon, United StatesStatement of the Problem: Finding appropriate clinical specimens and associated data often causes bottlenecks in the translational research pipeline. Often investigators procure specimens through only one or a small number of sources which often have limited volume of participants and demographics of the patient population. Seemingly paradoxical, groups with large numbers of banked specimens often struggle to increase awareness and use of their collected specimens, which can lead to limited return on investment for high infrastructure costs.Proposed Solution: To address the above‐mentioned challenges the Specimen & Data Acquisition Network (SAN) was formed in 2019 to increase opportunities for resource exchange in the Pacific Northwest region (Oregon, Washington, and British Columbia). The concept of SAN, a hub and spoke network to speed sharing of resources and ideas, originated in response to sparse specimen resources within our translational research program which was a key bottleneck to research endeavors. Building on existing local connections and those from our research network in other academic institutions, we began collaborations with 7 additional institutions that were aligned with our objectives and goals. SAN serves as a liaison for investigators to leverage collective resources and works to support researchers in their biobanking activities. SAN is a conduit for collaborative science across the regional translational research community.Conclusions: Currently, the SAN consists of 10 member organizations, each with representation on the governance committee. SAN began serving investigators in 2020 and, to date, has received 80 requests and connected more than 40 investigators to critical project resources spanning 12 institutions. SAN works with researchers to provide support across 6 service areas: 1) Access to specimens, 2) Access to datasets, 3) Data Management Support, 4) Research Connections, 5) Regulatory Guidance, and 6) Resource Lifecycle Management. These supportive services are catered to give researchers more time to focus on their next big discovery. Five SAN member institutions are signatory to an umbrella material/data transfer agreement that has expedited resource sharing. We envision that this will be a valuable resource for the translational research community.O‐02 Power of Consortium Shared Resources When External Threats OccurS. Hume4, 1, S. Higgins1, 2, A. J. Mountain1, 3, C. Gilfillan4, W. Ng1, 21Victorian Cancer Biobank Consortium, Melbourne, Victoria, Australia, 2Cancer Council Victoria, Melbourne, Victoria, Australia, 3Austin Health Tissue Bank, Austin Health, Heidelberg, Victoria, Australia, 4Eastern Health Tissue Bank, Eastern Health, Box Hill, Victoria, AustraliaStatement of Problem: The Eastern Health Tissue Bank (EHTB) is a hospital‐integrated cancer biobank and a member of Victorian Cancer Biobank (VCB) Consortium. In 2021, the biobank responded to several external threats that affected daily operations. These included a cyber‐threat incident at the hosting institution and multiple COVID‐19‐related disruptions as the city experienced one of the longest pandemic lockdowns globally.Unplanned events can severely and suddenly restrict biobanking activities, and small biobanks require support to ensure sustainability and business continuity.Proposed Solution: As part of the VCB Consortium, the EHTB has a strong resilience and ability to respond to external threats or incidents. As a hub‐and‐spoke Consortium (comprising a central lead agency with five cancer tissue banks), the VCB utilises shared resources to strengthen business continuity.This presentation depicts two scenarios (cyber threat and pandemic) which demonstrate the combined use of tools across a networked biobank to reduce risks and impacts from large‐scale organisational disruptions.Three Consortium‐wide tools were utilised:1) A robust Business Continuity Plan, incorporating key stakeholders' responsibilities in risk management.2) A Consortium Business Plan with local (institution) and networked (consortium) goals.3) Implementation of harmonised Standardised Operating Procedures (SOPs).Scenario Outcomes Included:1) Central Operations “Hub” provided immediate contingency support as part of a framework for rapid response/recovery, including facilitating communications with stakeholders.2) A partner “Spoke” Site allowed EHTB staff access to Biobank shared databases, group business communication platforms, and shared biospecimen storage.3) Harmonised Consortium SOPs allowed large‐scale multisite dispatches to still be completed.Conclusions: In responding to external threat incidents, a robust business continuity plan and immediate access to shared resources enabled the EHTB to retain some functionality. If the EHTB had been a standalone biobank, capacity to operate would have been diminished, resulting in the loss or suspension of activity.The resources described cannot be underestimated in their effectiveness when an external threat occurs.O‐03 The Qualification in Biorepository Science (QBRS) Examination: Progress Report on its Global ReachB. Schacter1, 2, D. Simeon‐Dubach31Medical Oncology and Hematology, CancerCare Manitoba, Winnipeg, Manitoba, Canada, 2Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada, 3medservice Daniel Simeon Dubach, Walchwil, ZG, SwitzerlandBackground: The importance of quality parameters in biobanking of biological materials like human tissues has been emphasized in the past: Biobanking standards by ISO (ISO 20387), CAP accreditation, Best Practices (ISBER Best Practices 4th ed.), OECD standards, and Standard Operating Practices and Policies by CTRNet were developed to address these challenges.While these procedures are proving invaluable to biobanks to ensure that their processes for accessing, processing, and distributing biobanked materials result in reproducibility and quality performance, they do not address the question of quality performance in the biobanking professionals themselves.Methods: The International Society for Biological and Environmental Repositories (ISBER) and ASCP BOC (American Society for Clinical Pathology Board of Certification) as two leading organisations in their fields joined forces to develop the QBRS (Qualification in Biorepository Science) examination, in order to further enhance reproducible and sustainable quality biobanking in biobanking professionals. The exam is administered online and is unique in its field.Well trained and skilled staff are essential to ensure high quality biospecimens for reproducible results in precision medicine, biomarker development, and biomedical research as a whole, while aiming for sustainable biobanking activities.Results: To date, over 58 individuals in Australia, Hong Kong, Singapore, Ireland, Wales, Nigeria, Saudi Arabia, UAE, Costa Rica, and the USA have taken and passed the exam to qualify for the QBRS, demonstrating its global appeal.Conclusions: The QBRS has become the standard which defines the required level of knowledge and skill in biobanking professionals that will assure sustained quality and reproducibility in biobanking laboratories worldwide. Successful applicants have acknowledged that achieving the QBRS makes them more desirable in hiring competitions and enhances their career trajectory. Conversely, biobanks that hire a QBRS qualified biobanker have acknowledged that they are striving for quality in their biobanking operation. The QBRS qualification establishes that the biobank in which the qualified biobanker works is one that promotes and establishes quality within its biobanking staff. Biobank directors have indicated that the QBRS exam provides further impetus for professional training for their staff.O‐04 A New Tool to Match Organ, Tissue, and Eye Post‐mortem Donors to Research Project CriteriaK. D. Kunkle, G. H. Grossman, T. Cattell, A. AbbottPrecision Ocular Biobank, Advancing Sight Network, Birmingham, Alabama, United StatesBackground: Post‐mortem repositories recover organs, tissues, and eyes for research from authorized donors. However, due to the rapid nature of the donation process conflicting with the laborious task of matching donors to research project criteria, organizations miss opportunities to identify donors for prospective recovery. The ReSync app was developed by the Precision Ocular Biobank to assist in the real‐time identification of research donors at the initial point of the referral call.Methods: ReSync is an app built in Claris FileMaker 19, a low‐code relational database engine. Although ReSync is a closed system, open‐source functionality of Claris FileMaker allows it to universally connect to external donation referral databases. Research project criteria are entered into a table in ReSync prior to activation. Exclusion and inclusion criteria in categories such as donor demographics, medical history, and referral status act as triggers to match with donor information. Once active, referral coordinators enter donor information into the host database during the initial call from the hospital with a recent or impending death. Filtering occurs through connecting pairs of fields in tables in ReSync and the host database to validate or invalidate a donor candidate against each project. When a match between a project and donor occurs, a flag alerts the coordinator in real‐time. Matching projects appear in a pop‐up window, and referral coordinators can then consult with research specialists or directly assign the case to one of the projects and initiate recovery dispatch.Results: Since its employment, ReSync has allowed the Precision Ocular Biobank to expand its open research requests from 3 to 18 at any given point, representing a six‐fold increase in concomitant projects. This also led to a dramatically decrease in the time a donor was matched to a project, from twenty minutes to five (400% decrease). Even with more projects open simultaneously, request fulfillment time decreased by 25%.Conclusions: Low‐code, automated donor matching solutions allow post‐mortem repositories with limited software developing capability to better fulfil prospective research requests. While simultaneously reducing missed opportunities and eligibility times, programs like ReSync allow for the expansion of enrolled projects.O‐05 Determining Pre‐analytical Variables and Molecular Determinants to Ensure High Quality of Luxor BiobankN. Kordy, S. Ezzat, S. Mahmoud, R. Mohamed, A. Hagag, A. M. Gamal, M. M. Saady, A. SalehResearch Department, Shefa Al Orman Hospital, Luxor, EgyptBackground: Biobank sample preparation methods must ensure long‐term functionality of the products obtained. Preanalytical variables affect the integrity of the biospecimens, and results of analyses. The quality of nucleic acids has a major importance for molecular biology techniques used in genetic analysis. Quality indicators are the tool to measure these parameters; purity and integrity are the determinants for DNA quality. This study aims to determine the quality of SOH Biobank (SOHB) by independently evaluating the preanalytical variables in terms of measurement of processing time, aliquots position audit, and the quality of DNA samples.Methodology: SOHB biospecimen collection is performed after SOH‐IRB approval. Standard operating procedures (SOPs) were written with strict adherence by the team. Blood samples are collected after participant recruitment in the biobank program and obtaining informed consent. After blood collection, the blood is processed within one‐hour and stored in ‐80 degree Celsius freezers. Quality control was determined first, through recording sample withdrawal, receiving, and processing time. Second, aliquots position audits were performed manually on recruited patients for the last 6 months of 2021 to ensure 100% accurate aliquots position, Finally, DNA extracted from buffy coat samples was stored in the duration of 01‐2017 to 02‐2022 using QIAamp DNA kit (Qiagen). Concentration and purity are measured by spectrophotometer (Multisky scan, Thermofisher). Pure DNA ratio should be between 1.8 to 2.0; a higher ratio reveals DNA degradation, while a lower ratio indicates protein contamination.Results: Mean value of processing time for 6600 samples is calculated to ensure that samples are processed and stored in ‐80 degree Celsius freezers within 1 hour of sample withdrawal. Results showed the mean value is 23 ± 0.08 minutes. Manual aliquots position audit was performed for samples stored from July to December 2021; 1087 cases showed 96% accuracy, while 4% aliquot misassigned position inside box. Purity detection for 980 samples out of 6600 samples were analyzed and showed a mean of A260/A280ratio of 1.8 ± 0.025.Conclusion: SOHB quality control results are satisfactory ensuring that SOHB can provide high‐quality samples for genomic studies. Quality control should be performed in a regular manner to ensure the appropriate management of the samples, avoiding low confidence in results, high costs, and sample wasting.O‐06 MIRRI‐ERIC: A Pan‐European Research Infrastructure for Making Microbial Science and Innovation HappenR. Aznar1, M. Bosschaerts2, N. Lima3, L. Soares41Departamento de Microbiología y Ecología and Colección Española de Cultivos Tipo (CECT), Universitat de València, Valencia, Spain, 2BCCM Coordination Cell, Belgian Science Policy, Brussels, Belgium, 3CEB‐Universidade do Minho, Micoteca da Universidade do Minho, Braga, Portugal, 4MIRRI‐ERIC Central Coordinating Unit, MIRRI‐ERIC, Braga, PortugalStatement of the Problem: Several hurdles hamper microbial research and cause inefficient, ineffective, and costly science and innovation: difficulty to access strains cited in papers and databases; sharing of unverified strains; gaps in the current offer; fragmentation of resources, data, services, and expertise; and deficient support to individual culture collections (CCs).Proposed Solution: The Microbial Resource Research Infrastructure ‐ European Research Infrastructure Consortium (MIRRI‐ERIC) has been created as a pan‐European distributed research infrastructure, with the goal of solving/mitigating these bottlenecks, promoting complementarity, reducing redundancy, and continuously improving the capacity of its Partner Microbial domain Biological Resource Centres (mBRCs). MIRRI brings together ∼50 mBRCs, CCs, and research institutes from ten European countries working for the preservation, systematic investigation, provision, and valorisation of microbial resources and biodiversity, with a special focus on the domains of Health & Food, Agro‐Food, and Environment & Energy.MIRRI serves the bioscience and the bioindustry communities by facilitating the access, through a single point, to a catalogue of 400,000+ high‐quality microbial resources, such as bacteria, cyanobacteria, archaea, yeasts, filamentous fungi, micro‐algae, bacteriophages, viruses, and other microbiological material, such as microbiomes, plasmids, and genomic DNA. The MIRRI Information System will also provide users with resources' associated data, as available – e.g., taxonomy, ecology, pathogenicity, morphology, physiology, chemical characterization, DNA barcoding, or genomics.Based on its partner organisations' state‐of‐the‐art facilities/equipment and top‐level expertise, MIRRI also offers its users a diverse catalogue of high‐quality services, including pipelines of integrated, product‐oriented services made available as tailor‐made, turnkey solutions.Conclusions: The resources, services, and expertise provided by MIRRI and its partners can help researchers and bioindustries deliver the maximum value and impacts from their projects, technologies, and products.MIRRI is continuously engaged in enlarging its coverage in Europe and beyond. EU Member States, associated countries, third countries other than associated countries, and intergovernmental organisations may become a Member or an Observer of MIRRI‐ERIC. Individual organisations may become Partners of MIRRI‐ERIC.O‐07 Developing Genomic and Biomaterials Resources for Establishing Nonhuman Primate Models of Human DiseaseE. J. Vallender1, 2, S. M. Peterson3, A. Lewis3, A. J. Ericsen4, 5, K. G. Ray3, B. N. Bimber3, B. Ferguson31The University of Mississippi Medical Center, Jackson, Mississippi, United States, 2Tulane National Primate Research Center, Covington, Louisiana, United States, 3Oregon Health & Science University Oregon National Primate Research Center, Beaverton, Oregon, United States, 4Emory University, Atlanta, Georgia, United States, 5Emory National Primate Research Center, Atlanta, Georgia, United StatesBackground: Animal models of human disease play a vital role in biomedical research and therapeutic development. Nonhuman primates, in particular rhesus macaques, share behavioral, anatomical, physiological, and genetic similarities with humans that make them excellent translational models. The wealth of information developed on these animals through diverse research efforts can be leveraged through interconnected repositories of phenotypic data, biomaterials, and genomic information. Through the development of a centralized framework it is possible to accelerate the generation of nonhuman primate models of human disease and effect vital synergies that go beyond individual laboratories or research programs.Methods: The macaque Genotype and Phenotype (mGAP) resource serves as a repository for genomic data derived from rhesus macaques, largely those found at NIH‐funded Primate Research Centers. A standardized bioinformatic pipeline is used to call single nucleotide variation (SNV) and to cross reference human data on regulatory elements, disease‐associated variation, and evolutionary conservation. SNVs are also annotated using variant effect prediction tools. Data are made openly available to the research community both in aggregate as well as at the individual animal level. This information can then be tied back to specific animal health records, phenotypic information, and biomaterials through the contributing centers.Results: mGAP currently houses genomic information from 2,985 rhesus macaques including nearly 52 million variants. Of these, 11.5 thousand overlap with human ClinVar annotations and 33.2 thousand overlap with GWAS associations housed in GRASP. Many more, 125 thousand, are predicted deleterious by Polyphen2 or high impact by SnpEff. Coupled with phenotypic information derived from animal health records and pathology reports, spontaneously occurring genetic models of multiple rare human diseases have been identified and are being used for novel therapeutic development and biomarker discovery.Conclusions: Through the integration of genomic and phenotypic information, rhesus macaques are being developed and harnessed for translationally important nonhuman primate animal models. These efforts can occur at scale only through resources that bring together diverse data and research expertise while still allowing for the connection to individual animals and samples.O‐08 AI in Medicine Based on Biobank Data ‐ New Opportunities and (Not) Known RisksK. SargsyanInternational Biobanking and Education, Medical University of Graz, Graz, STMK, AustriaThe possibilities for improving effectiveness and interoperability clearly show the directions in which BBs will develop soon. Today, virtual links between different DAs allow an exchange of data and samples, which previously could only occur with great effort and long waiting times or even rejections of queries, have decreased. Furthermore, the notion of a biological “sample” is extended to imaging samples, which multiplies the amount and dimensionality of the data obtained and thus provides biobanks with a more complete picture of individual patients and entire disease patterns. With the integration of digitalization into biobanks, a steady flow of data is ensured that, in the best case, does not cease for the duration of a patient's lifetime. This steady flow of data updates and exchange enables better tracking of the health status of individual patients and populations and can provide far‐reaching and as yet unknown information for the epidemiology of certain diseases in terms of course, treatment response, and prognosis. Particularly concerning genotype‐phenotype predictions, there is the potential to use genetic traits to develop new personalized therapies or targeted therapies and to identify subgroups that, for example, have an increased risk of developing certain diseases based on their genetic features or to facilitate the early detection of the respective diseases and, among other things, to single out non‐responders and to focus more specifically on their specific needs. The consent forms that patients and donors have to fill out and accept with their signature and consent when providing samples to clinical institutes or biobanks, or similar repositories will also evolve into more flexible, dynamic, digitally accessible forms that enable patients/donors to track their own samples and their informative value or usefulness in research whenever and wherever they are. They can withdraw their consent at any time and thus exercise complete control over their genetic material processing. Thus, they will be better treated, jet better informed, and educated.O‐09 Biobanking during War: Experience of Audubon BioscienceM. Yanovytska, B. Shkurupii, H. Chytaieva, E. Serdyukova, A. Shekhovtsov, I. Voievoda, A. Yudchenko, N. Sobetska‐Koloda, T. Nguyen, A. Giardina, A. Popova, R. SemikovAudubon Bioscience, Kyiv, UkraineOn February 24, 2022, the large‐scale Russian army invasion severely interrupted the operations of our biobank in Ukraine. Our team globally and especially in Ukraine faced and is still facing many challenges. Before the events occurred (when risks of the war escalation increased), we prepared our contingency and business continuity plans. They were partially executed. We have since been able to resume operations in Ukraine.On the first day of the large‐scale war, the Operations team, together with Revenue and HR teams, organized the evacuation of the staff with all documentation and laptops, as well as laboratory equipment and ambient storage specimens to the Western region of Ukraine. We were able to eventually move the ambient specimens to the US. Once in our US operations facility, we reorganized and cataloged every specimen and reestablished our biobank there. For frozen specimens, since we can't relocate them due to the lack of proper transportation at that time, we decided to seal all freezers with specimens and installed surveillance cameras to keep them safe. Together with our temperature monitoring system, we were able to keep track of our freezers' temperature and ensured that the specimens were properly stored during the 2‐month period when only a few members of our team remained at the biobank.Ongoing Ukrainian projects were immediately transferred to other countries of operations such as Turkey, USA, Armenia, etc. In three months (May 2022) we achieved financial break‐even (monthly) confirming the fact that global organization was stabilized. After two months, when active warfare was stopped in the Kyiv region, new logistic chains were organized and we started to rebuild our workflow. By August 2022, the Ukrainian operations reached the level of pre‐war collection rates. However, we continue to distribute projects among all of our affiliates in other countries to minimize risks for our partners.In conclusion, the operations of Ukrainian biobanking have been faced with severe difficulties due to the Russian‐Ukrainian war. Although we were not able to execute our contingency and business continuity plans in full, right planning together with good execution and improvisation helped minimize the negative effect. Solutions that we put in place to ensure proper specimen storage were implemented and proved to be effective. Our ability to redistribute projects globally enabled us to continue supporting precision medicine researchers.O‐10 Survey of Adolescents Regarding Their Opinion of Research and Vaccination During the COVID‐19 PandemicQ. Aujla1, I. Kayda1, A. Ellis1, D. Goldfarb1, 2, J. Bettinger2, 3, L. Mâsse2, 3, J. Bush1, 2, S. Vercauteren1, 21Pathology and Lab Medicine, BC Children's Hospital, Vancouver, British Columbia, Canada, 2Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada, 3BC Children's Hospital Research Institute, Vancouver, British Columbia, CanadaBackground: The COVID‐19 pandemic has emphasized the importance of research into disease biology, prevention, and treatment of emerging diseases and pathogens. Currently, there is limited understanding on adolescent perceptions towards biobanking, research participation, vaccinations, and how the pandemic has altered these perceptions. The BC Children's Hospital BioBank (BCCHB) surveyed Grade 8‐12 students in British Columbia (BC) to determine perceptions before and after the pandemic about topics such as research, pediatric biobanking, vaccinations, and public health policies.Methods: A voluntary, anonymous, 15‐question online survey was distributed through student emails, online school portals, and parent newsletters. Phase 1 of the survey was conducted from May to June 2021 and Phase 2 was conducted from Sept 2021 to June 2022. Questions were edited between Phases 1 and 2 to reflect vaccine availability for adolescents, and the emergence of new variants of COVID‐19.Results: We received a total of 1,022 completed survey responses, from participants aged 12‐19 years in 13 BC school districts and compared the findings to a previous completed school survey [1]. The majority of participants (94%) agreed that COVID‐19 is a serious disease and 95% stated that the pandemic has shown them how important medical research is. While many (95%) agreed on the importance of research before the COVID‐19 pandemic, this increased to 97% after pandemic onset. This desire to contribute to research was reflected by the 80% of participants willing to donate an extra blood sample for biobanking purposes during the COVID‐19 pandemic, compared to 64% from a 2016 school survey conducted among the same age group [1]. Participants (97%) also agreed that research participation would allow them to help others. Of the adolescents surveyed, the majority (85%) were comfortable with making the decision on their own to donate a sample specifically to research. Considering the current public health climate, 92% of participants stated that they will be vaccinated, for reasons such as knowing vaccines are safe, allowing them to engage in social activities, and protecting them from COVID‐19.Conclusion: Adolescents across BC were found to be more willing to participate in research after living through the COVID‐19 pandemic. They also were found to be more willing to donate leftover samples towards biobanking after knowing the importance of research in disease diagnosis and treatment.Reference: [1] Kong CC, Tarling TE, Strahlendorf C, Dittrick M, Vercauteren SM. Opinions of Adolescents and Parents About Pediatric Biobanking. J Adolesc Health, 2016; 58(4):474‐480. doi: 10.1016/j.jadohealth.2015.12.015. PMID: 27013273.O‐11 Tissue Microarrays: Turning Hidden Resources in Research GemsA. Yuksel1, M. Krivanek2, D. R. Catchpoole11Children's Cancer Research Unit, Kids Research, The Children's Hospital at Westmead, SCHN, Westmead, New South Wales, Australia, 2Anatomical Pathology, The Children's Hospital at Westmead, Westmead, New South Wales, AustraliaIt is expected that biobanks provide critical tissue resources to researchers to conduct fundamental investigation into disease states and to ensure the best research use of all tissue biospecimens by linking them to key questions being asked in research. Recognizing the rarity of childhood cancers, small tumour specimen volumes, and the burgeoning need for tissue‐directed research, we describe here the impact of a research‐focussed biospecimen resource. The Tumour Bank at The Children's Hospital at Westmead (TB‐CHW) has initiated alongside the main source of all such tissue, our histopathology department. In 2012 we leveraged the hospital's formalin‐fixed paraffin‐embedded (FFPE) tissue block archive to commence a tissue microarray (TMA) construction program. Our purpose was to provide rationalised access to FFPE tissue whilst not impacting on the availability of blocks for future diagnostic or medico‐legal review. Construction of the TMAs that represented a single childhood cancer subtypes required a deep dive into the block archives with blocks selected covering sample collected over a couple of decade‐long periods or more. This resulted in a tissue resource where enough rare paediatric tumours representing all patients seen at a single centre are dr

The Stability of the Anti-Müllerian Hormone in Serum and Plasma Samples under Various Preanalytical Conditions.

The anti-Müllerian hormone (AMH) is a glycoprotein that plays an important role in prenatal sex differentiation. It is used as a biomarker in polycystic ovary syndrome (PCOS) diagnostics, as well as for estimating an individual's ovarian reserve and the ovarian response to hormonal stimulation during in vitro fertilization (IVF). The aim of this study was to test the stability of AMH during various preanalytical conditions that are in accordance with the ISBER (International Society for Biological and Environmental Repositories) protocol. Plasma and serum samples were taken from each of the 26 participants. The samples were then processed according to the ISBER protocol. AMH levels were measured in all the samples simultaneously using the chemiluminescent kit ACCESS AMH in a UniCel® DxI 800 Immunoassay System (Beckman Coulter, Brea, CA, USA). The study proved that AMH retains a relatively high degree of stability during repeated freezing and thawing in serum. AMH was shown to be less stable in plasma samples. Room temperature proved to be the least suitable condition for the storage of samples before performing the biomarker analysis. During the testing of storage stability at 5-7 °C, the values decreased over time for all the plasma samples but remained stable in the serum samples. We proved that AMH is highly stable under various stress conditions. The anti-Müllerian hormone retained the greatest stability in the serum samples.

Readiness for Artificial Intelligence in Biobanking

Biopreservation and BiobankingVol. 21, No. 2 EditorialFree AccessReadiness for Artificial Intelligence in BiobankingGregory H. Grossman and Marianne K. HendersonGregory H. GrossmanAdvancing Sight Network, Birmingham, Alabama, USA.Search for more papers by this author and Marianne K. HendersonAddress correspondence to: Marianne K. Henderson, MS, CPC, National Cancer Institute, NIH, 9609 Medical Center Drive, 7E442, Rockville, MD 20850, USA E-mail Address: hendersm@mail.nih.govNational Cancer Institute, NIH, Bethesda, Maryland, USA.Search for more papers by this authorPublished Online:17 Apr 2023https://doi.org/10.1089/bio.2023.29121.editorialAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail The recent launch of the language and text processing artificial intelligence (AI) platform ChatGPT from OpenAI has markedly raised interest in AI and signaled a new era of machine and deep learning. AI can be defined as an automated software system that can ingest, compile, and analyze data and domain knowledge to present informed, context-specific outputs.As contributors to the information management (data, systems, and networks) section of the International Society for Biological and Environmental Repositories (ISBER) Best Practices 5th edition, we have been following the advances and implementation of AI in health care, research, and biobanking with great anticipation. We also see the same excitement from the ISBER membership, as illustrated by the active discussions on the ISBER Open Forum.There are many different types and categories of deep and machine learning AI platforms based on their engineering and function. Although AI was described in computer science as early as the 1950s and the earliest NIH AI in Medicine conference was held in 1975,1 it is only recently that some of the technological limitations of its use have been overcome, including data availability, to allow it to be more widely applied. We routinely encounter AI-driven programs in our daily lives, although we may not be fully aware of their presence over the past few years.Examples range from chatbots to voice assistants such as Amazon's Alexa or Apple's Siri, to screening-based algorithms, such as those used in mammography, that detect patterns that may signal abnormalities to be more closely examined. Imaging algorithms benefit from learning through continued use, to refine performance. Recently, AI has become integrated more widely into medical and scientific practices. An AI program to screen for diabetic retinopathy by interpreting clinical images was successfully modeled in India and the United States,2 with screening implemented in a country-wide health system in Thailand.3Furthermore and importantly, some approved AI screening programs have matured enough that they are autonomous, meaning that human oversight of clinical diagnosis is not required.4 These examples highlight AI's unique ability to decipher hidden patterns in data, build predictive models, and deliver actionable recommendations.Much of our field anticipates that the inevitable implementation of AI in biobanking will have profound and positive impacts, with the overall outcome of increasing specimen/data utilization, greater repository sustainability, and increased speed of scientific discovery. AI has the potential to impact all areas of biobanking, from recruiting donors, improving biobank operations, developing educational and training materials for new biobankers, increasing sample use, improving data annotation, and faster deposition of ethically-protected data. Industries across the globe are looking toward AI to help optimize operations, and biobanking will be no different.As examples, we can imagine using natural language processors to help our biobanks and their resources to market more broadly to the scientific community; or interpreting and converting free text comments or voice notes into standard categorical data fields that can facilitate data interoperability. AI in biobanking could create the draft text for consenting, standard operating procedures or operational documentation, write analytical code for samples and data, and write scripts for data deposition. We can also see its impact on accelerating the availability and analysis of large data sets, such as in the case of whole genome sequencing.Although the beneficial aspects and opportunities hold much promise, integrating AI within the biobanking continuum poses challenges and risks. What looks to be the most salient risk of implementing AI in biobanking is not the malicious actions of a self-aware superintelligence portrayed in dystopian science fiction, but something more closely aligned to an inherent human trait—bias. Data bias in AI parallels the traditional computer science concept of “garbage in, garbage out,” in which inaccurate, erroneous, or absent input leads to false or “garbage” output data (including actionable reports or decisions). It is here that we can make the most impact at this time so that biobanking is “ready” for AI applications.The continued push for incorporating and utilizing principles such as Open Science, FAIR (Findability, Accessibility, Interoperability, and Reuse), or DwC (Darwin Core), data standards such as SPREC (Standard PREanalytical Code), and guidelines such as ISO 8000 (data quality), will help to ensure robust, high-quality, and ethical data.5–8 There is also a greater need for repositories to plan for the interoperability of their data and systems to be able to integrate with AI applications in the cloud, across networks, or on virtual platforms. Another form of bias that presents a challenge is algorithmic bias.AI algorithmic bias tends to highly reflect human bias, whereby the system delivers erroneous conclusions or predictions, without showing ambiguity or confidence limits in its delivery, which can be ethically problematic and ultimately damaging to groups of people or sensitive species. This threat underscores the need for AI programmers to develop and incorporate robust ethical guidelines/guardrails to protect from harm to environments, species, and populations. The unintended harm to populations and society was called out by an Open Letter to AI developers to take a pause in their training and release of more powerful AI systems than GPT-4.9Our biobanking subject matter expert role will be needed to influence the development of these guardrails as AI methods and algorithms evolve. Two additional pillars that must be forefront in AI development include the reliability that outputs provided can be trusted and that security measures from hacking and breaches of personal or sensitive data are implemented.This most exciting and challenging era of biobanking awaits our community. We need to educate ourselves on the possible uses and impacts of deep learning, machine learning, and natural language processing applications through engagements with AI experts. Through these engagements and the formation of biobanking workgroups, we will contribute to ethically-sound AI tools and practices for biobanking and data sharing. Perhaps the most exciting aspect of AI in biobanking is that this nascent technology will have emergent and exponential benefits, accelerating our impact on the discovery and implementation of new knowledge to protect the health of our populations and the environment.To kick off further discussions, we are developing a webinar global cast on AI's impact on biobanking as part of ISBER's Webinar Planning Task Force. We look forward to continuing this dialogue, through the active engagement of members of the biobanking community and the implementation of AI in biobanking in the very near future.

ISBER Best Practices for Repositories, Moving Toward the Fifth Edition.

Biopreservation and BiobankingVol. 20, No. 1 ISBER CornerFree AccessISBER Best Practices for Repositories, Moving Toward the Fifth EditionEmma Snapes and Daniel Simeon-DubachEmma SnapesAddress correspondence to: Emma Snapes, MSc, Editor-in-Chief, ISBER Best Practices, Fifth Edition, BioConsulting, Templemartin, Bandon, County Cork P72 C935, Ireland E-mail Address: bestpractices@isber.orgBioConsulting, Cork, Ireland.Search for more papers by this author and Daniel Simeon-Dubachmedservice, Biobanking Consulting & Services, Walchwil, Switzerland.Search for more papers by this authorPublished Online:15 Feb 2022https://doi.org/10.1089/bio.2022.29102.ejsAboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail Since its first publication in 2005, the International Society for Biological and Environmental Repositories (ISBER) ISBER's Best Practices for Repositories has become a salient guidance and reference source for the global biobanking community. The document is a compendium of the optimal ways of working or principles that have been collated by the community to guide repository establishment, management, and operation. Acknowledging that practices frequently evolve with time and circumstances, the document is regularly revised to incorporate advances in biospecimen science research and biobanking technologies. The project to undertake the development of the next edition is underway and will continue throughout 2022.Each new ISBER Best Practices edition builds on the foundation of previous editions and revitalizes the document through value submitted by the community. The development of the fifth edition of the ISBER Best Practices is led by the Editor-in-Chief Emma Snapes and her team of associated editors who form the ISBER Best Practices Editorial Board. The work of the editorial board will be supervised by the Best Practices Steering Group, which reports to the ISBER Board of Directors.In advance of the next edition development, the ISBER Standards Committee convened a task force to perform a gap analysis of the fourth edition of the ISBER Best Practices. Collecting feedback from the document's global users can help determine where opportunity might exist for improvement of the document. A variety of channels have been used to facilitate feedback from the community, including a global survey, roundtable discussions at an ISBER regional meeting, and focus group discussions.The results of the gap analysis task force efforts will be compiled as a community feedback report. This report will inform the editorial board to help map the scope of work for the next edition. The editorial board is responsible for a developing and editing of the document, along with the assistance of content contributors. Each phase of writing and editing will be subject to review, including external review.Identification of Best Practice CriteriaA primary aspect to the development of the next edition is an evaluation to determine what constitutes best practices. Inclusion of a new or altered practice will more easily be justified by assessing the ability of the practice to fulfil criteria. Such criteria might include establishing an evidence foundation and rating the strength of recommendations. It will be advisable at minimum to have some measurement or evidence to support a practice is effective, and that it is at least as effective as other practices.This approach may be affected by the context of the measurement. Practices to be included need to have broad applicability relative to differing types of repository domains and geographical regions of operation. Candidates for best practice can be classified by their stage of maturation. Therefore, newly proposed practices that are considered insufficiently mature to be included in the next edition of the document may be considered for future versions.Best practices at their best simply reflect the best ways of doing things. Application of community developed best practices can help a multitude of users avoid continually reinventing the wheel and instead effectively address improvement. Best practice use may prompt new practices that can be then shared with the community at large, promoting innovation within the community. The ISBER Best Practices already act as a framework for many activities, such as effectiveness of reposition management and operation, education and onboarding, support for biobanking standards implementation, and separately for accreditation. It is hoped that the introduction of the process of engaging the voice of the user will refresh this new iteration of edition development for the ISBER Best Practices for Repositories.Readers are welcome to contact the Editor-in-Chief at bestpractices@isber.org with any feedback that will benefit this undertaking.FiguresReferencesRelatedDetails Volume 20Issue 1Feb 2022 InformationCopyright 2022, Mary Ann Liebert, Inc., publishersTo cite this article:Emma Snapes and Daniel Simeon-Dubach.ISBER Best Practices for Repositories, Moving Toward the Fifth Edition.Biopreservation and Biobanking.Feb 2022.107-108.http://doi.org/10.1089/bio.2022.29102.ejsPublished in Volume: 20 Issue 1: February 15, 2022PDF download

Workshop Proceedings: Informed Consent in Biobanking–from the Key Barriers, Challenges, and Perceptions to Digital Innovations

Biological material of human and nonhuman origin has been collected for decades, creating repositories through the years that serve as source for research and education, with the ultimate goal to establish a high-quality healthcare system on international levels and to introduce novel therapeutic approaches based on personalization.[1]Biobanking is a general term used for the collection, storage, and procurement of biological materials, and its standard discipline. Biobanking has evolved from small university-based repositories for specific research to infrastructures that accommodate biosamples for large-scale national and international purposes, annotated with related clinical data and information, essential for fundamental science.[2,3] Collection and utilization of human biospecimen in all kinds of research activities have become a priority to health-related organizations; biospecimens have increased rapidly both in size and in number, leading to new trends and needs in biobanking that must incorporate big data and modern technologies requirements.[4]As the biobank market grows globally, international collaborations for sample collection and dissemination have expanded. The demand for evolution in biobanking best practices seems to be unavoidable, so as to prevent not only technical issues in biospecimen collection, processing, and storage but also ethical, legal, and social issues arising from the extended use of biospecimens and their primary and secondary data in new research areas.[5,6] For these purposes, standardization of procedures for both biosample and associated metadata management and tracking are essential for current biobank operational systems and biospecimen quality assurance.[7]Biobanks' organization and operation are based on models of working processes as well as national and international regulatory standards for compliance. These processes ensure, on one hand, the proper biosample handling and link of data, and on the other, donors' autonomous rights and data protection.[8] International best practices and guidelines for biospecimen handling and facilities requirements that can assure certification or accreditation are already implemented in biobanking networks.[9] In addition, inventory database systems for tracking are specifically designed to meet federal requirements related to data privacy and security.[10] Nevertheless, sets of compliance requirements for data protection, seem to be more complicated on international levels, considering the main regulations applied in the European Union and United States.[11,12] Despite their differences, both sets of standards set the same following goals: to protect individuals' privacy by securing and regulating current and downstream data collection, transmission, analysis, and disclosure; and provide them with rights over their biospecimens and sensitive data.[13,14] But, these diverse regulatory schemes and approaches of biobanking governance among countries might lead to significant barriers in biosample export and authorization for worldwide utilization in research activities.[15]As part of the regulatory schemes that have been set, one of the most important principles in current biobanking and research is the consent procedure by which donors' give their permission for future biosample and data processing.[16] Informed consent is a mandatory part of the donors' welfare system; it is required for any type of research-related activities that use human beings as subjects, combining ethical, legal, and practical implications.[17,18] The main scope of this procedure is to provide information to participants for data disclosure. This information empowers their decision-making and their autonomous choices by providing an adequate understanding beforehand of the research program they're going to be involved in, as well as their current and future rights.[19] Regulations and government standards implied in biobanking compared with other research activities, such as clinical trials, have significant points that should be taken under consideration as biobanks store and manage large amount of biosamples annotated with primary and secondary data for a long period of time.[20] Consequently, samples will be required in new research activities over the years that cannot be predicted or are not planned yet, making the implementation of consent procedure a challenge that should be carefully designed to be complete and valid, protect all parties, and comply with standard requirements.[21,22]Overviewing biobanking evolution and operational systems, consent modifications over the years have created six different models of consent types that are currently applicable to biobanks.[23] Each of the following consent types described below set and retrieve specific rights to donors and biobanks, respectively, upon biosample and related data, and actually predetermine the future utilization of both[24–28]:Within the framework of donors' rights for autonomous choice, they can choose their consent status, which represents their preference for future authorization of biospecimens and linked data given to all subsequent entities involved.[29] More specifically, they choose the appropriate identifiers and/or alphanumeric code that should be linked to their personal data to assure their preferable level of anonymization, data protection, and further contact.[30] In many cases original identifiers are irreversible, having been stripped from identifying data and making it impossible for anyone to link the biospecimens to their sources. Other identifiers are coded, allowing the possibility of eventually finding the original source. The coding actually raises significant questions and issues; for example, what should biobanks do with sufficient data that cannot be used, and/or what should be done in circumstances of possible hidden medical conditions that are accidentally identified during random research?[31]Addressing such issues and other limitations, barriers, current, and future challenges in research-related activities in biobanking sector, along with the right consent application for the best interest of all parties, was the main scope of the virtual workshop that took place on May 16, 2021, as part of International Society for Biological and Environmental Repositories (ISBER) annual meeting and exhibit event. The 3-hour workshop aimed to introduce all ethical, legal, and practical applications of informed consent according international regulations, following its evolutionary course through the years, and representing future perspectives and applications based on novel technologies in the era of digitalization. Twenty-three representatives from the biobanking and scientific sector gave their opinions and insights on the current operational strategies and consent options applied in biobanks and discussed the perspective of implementation of novel procedures that could cover technological evolution and set universally accepted principles. Based on potential real-time scenarios and survey questions, the final part of the workshop aimed to create an indicative point of view on how biobanks apprehend the present system, and what are the levels of readiness and/or willingness to change, by implementing novel technologies and giving donors total control over their biospecimens and related data.Occasioned by the ISBER virtual annual meeting and exhibits, an educational workshop with the title “Informed Consent in Biobanking; from the Key Barriers, Challenges and Perceptions to the Digital Innovations” was conducted by Metabio's executives, following the mission of ISBER as a global biobanking organization that represents global interest on ethical biobanking and the universal interest on informed consent. The workshop took part virtually via Zoom and was divided into four separate sections.A poll survey consisted of 21 questions. Before all presentations 20 participants were asked to complete the poll survey, by answering consent-specific questions, addressing both current systems and future perspectives. The main scope of the survey was to investigate what present procedures are followed by the industry in research-related activities; how satisfactory are they; if they provide standard principles on international level; if they are easily implemented in scientific procedures and provide effectiveness in patient or donor follow-up; the willingness and/or the need for innovative technologies in future biobanking considering the rapid evolution in technology and research; and how familiar participants are with different consent-related options and/or donors' rights before the main detailed presentations.Section 2 explored the evolution of informed consent and a complete description of current and future needs, covering topics such as informed consent requirements, historic background, different regulations, challenges and barriers, consent types, and statuses available. The main scope of this first presentation was to introduce all consent applications and options as part of innovation and progress accessible, and to attract attention to a largely undisclosed problem within the community, by presenting main issues and limits in international networking.A detailed description of novel digital applications for donors' and/or patients' engagement by introducing the Real-time Dynamic Tiered e-consent tool and addressing modifications and system biobanking requirements for its integration were discussed in Section 3. The main scope of this second presentation was to provide all information for innovative technologies in consent sectors and answer the following important questions: Do biobankers really want it? Can it really be applied? What are the advantages and disadvantages of digitalized consent forms, and how ready is the current system to incorporate these novel technologies globally?During the final part of the workshop activity, three different use cases (Fig. 1) of potential real-life scenarios were presented. Having all scenarios in mind, different options and types of informed consent were discussed, scenario-related questions were also discussed, and the group came to a consensus for the best consent type for patients or donors, as well as decide which is for the best interest of biobanks and which could combine both interests. Participants were separated into subgroups, by joining randomly created breakout rooms and in the end one representative from each group cited the main discussion points. The primary scope of these use cases was to present difficult research-related circumstances, raise concerns to informed consent implementations, search for balance between regulations, patients' or donors' rights, and ethical issues, and conclude if there is one consent type that could protect all parties and comply with all standard requirements, covering needs of both biobanks and individuals. One primary question arising from these scenarios was whether or not the patients' or donors' decisions via their informed consent can be set aside for the common good, or the possibility to prevent future disease outcome through random research findings. What should entities do if they do not have the legal right to communicate further with an individual, but they have strong evidence-based findings that they and/or a family member not included in the consent procedure would eventually develop a specific disease? Is there a consent type that could prevent such circumstances? Who informs individuals of research-related results?In addition, subgroups brainstormed the topic of consent management and dynamic e-consent requirements in current systems, addressing the possible implications and potential applications when the usage chain of biosample and associated data is managed 100% by the donor.The poll survey results are represented below, divided into the following three separate question packs: (1) Questions 1 through 10 in Figures 2, 3, and 4; (2) Questions 11 through 19 in Figures 5, 6, and 7; and (3) Questions 20 and 21 in Figure 8.Sixteen participants completed the question pack from questions 1 through 10. Participants were asked about their susceptibility to implement novel digital consent types in their current system, as well as questions about potential issues associated with both donor's participation and biosample utilization and/or dissemination. According to responses, it seems that the most common type of consent status they come across in their organization is coded (56%), followed by anonymized, identifiable, and identified with mean value of 16%. The majority of participants (> 40%) believe that multimedia and novel technologies might help toward patients' or donors' participation increase in research-related activities; however, they seem to be susceptible to adopting e-consent processes in their current system (94%), due to legal, ethical, and standard principals (44%), followed by the lack of human involvement and the need for familiarization and training with equality of 19%. Some also considered the big change in requirements in current processes (13%) and the increased cost (6%). Of participants, 31% had experienced inability of biosample sourcing and/or procurement due to data transmission issues related to consent-related legislation inconsistencies, and 13% had participated in research-related activities that actually failed due to consent procedures. Considering patient or donor participation and their right to withdraw as participants for selected personal reasons was the leading cause of withdrawal (44%); 19% selected inability to follow-up; and 31% did not know the actual reasons. For questions related to the main procedures used in organizations to evaluate patients' or donors' voluntariness, competence, and comprehension of the “Use of statement of agreement included already in the informed consent” was selected by 44% of participants; it was followed by “Other” or “Face-to-face interaction” chosen by 25% in both instances. Random research findings associated with patients' or donors' well-being were not reported to individuals according to one-fourth of participants; on the other hand, 75% of participants agreed that they actually communicate with patients in such circumstances in person, via telephone, or with other procedures, not involved in the present survey as an option. When asked about the primary reason they believe re-consent should be required, half of participants selected the answer “If data and biosamples will be used in unrelated research fields” and the other half the answer “Implementation of novel technologies and research activities” and “Do not know” together.Sixteen participants completed the question pack from questions 11 through 19. The second pack of questions were set to investigate the current consent type implemented in organizations and if it covered needs both on local or international levels. Barriers for the establishment of international standard principles were also brought up, along with the main reasons participants believed patients; or donors' influence their decision to be enrolled in research-related activities. The majority of participants represented the biobanking sector. According to their opinions and personal experiences, there was more than one reason that prevented individuals from donating and/or participating in research, including their cultural background, friends, and family and lack of trust in related procedures. Currently, most of the organizations, based on participants' answers, seemed to use blanket and/or broad consent models (69%) followed by study-specific models (19%). Dynamic and tiered consent were used by a minority of the participants (6%). More than half of participants were satisfied with the current consent type implemented within their organizations (69%). On the other hand, no consensus was observed if the current consent types used addressed the need for cooperative partnership within an international network research system; 31% of participants believed it did, 31% believed it did not, and 38% selected the “Partially” or the “Do not know” answer. Even so, it seems that if they had to choose the fit for purpose consent type to be used in the future, no big changes would be made, having blanket and/or broad consent as the major preference. According to participants' opinions, the main barrier for global consent consensus were both the lack of international standard principles and language. In addition, participants were asked how easy it was to obtain consent and to define the average time of the total procedure; answers were controversial, with 44% claiming that there were difficulties and 51% claiming it was an easy procedure. The average time was also different in ranging from days (44%) to months (38%).Twenty participants completed the question pack with questions 20 and 21. Participants were asked about the kind of donation control patients or donors should have as well as their willingness to provide patients total control over their biosample donation and associated data. Most of the participants selected the option “All of the above,” regarding the first issued raised from question 20, including control over both biosamples and associate data, communication, research findings, and research field in general. Of participants, 15% selected the option “None of the above.” Controversy was observed among participants for question 21, related to patients' or donors' total control over their donations. Of the participants, 40% were not amenable to giving total control over biospecimens and related data to patients or donors. Nearly 50% of participants responded positively to the prospect of providing individuals with total or partial control.Workshop participants presented their leading discussion points over informed consent types and real-life scenarios, considering all parties. There was consensus that research findings might be essential for patients' or donors' well-being; however, there was controversy if those research results should be returned to individuals if that option was not mentioned in their consent status. Representatives from US–based biobanks reported that in such circumstances, educated staff with high expertise undertook the procedure to inform patients or donors in potential health-related results. Most of the participants agreed that by using broad consent, their organization was legally covered to use data and metadata without the need to consider re-consenting for follow-ups. According to group members' feedback, there was not such a consent type in most organizations that included patients' or donors' personal agreement for further contact; usually, following broad-consent methodology, associated hospitals or research centers decided further communication contextually and continued taking patients' or donors' associated metadata.The same controversy was apparent regarding third parties, such as family members. On the one hand, participants believed that family members were already involved in research-related activities and were covered by the given informed consent signed from an individual because they provided their family history to all entities. On the other hand, susceptibility was observed about the right to use and share data associated with family members, as well as the spectrum of research-relative activities in which these data can be used in the future.The informed consent doctrine, first introduced in the late 20th century, has gone through many stages of development and evolution over the past decades, not only historically based but also technologically, addressing the needs of each era in regulation, science, research, and healthcare in general.[32–35] Although these changes are incorporated in informed consent procedures and principles, so as to assure individuals' rights over their donation and data and provide them with autonomy, many issues and challenges still remain and might became more complicated as the evolution of current research and innovation processes increase rapidly.[36] Informed consent requires many modifications in the era of “omics” and “big data” on national and international levels, by setting regulations and standard principles for harmonization among countries, to cover main areas of concern and pitfall points in the global biobanking network.[37,38] The lack of harmonization, standardization, and common language were the main barriers according to the workshop's poll participants for global consent consensus.Language is not only a barrier for biobanks and other health-related entities that share data and information, but also leads to inadequate understandings from patients or donors.[39] Alongside religious influence, cultural background, false patient perceptions about research procedures, and potential family influence, many individuals refuse to participate in clinical trials and/or donate biospecimens and related data.[40–42] According to poll participants and their personal experiences, cultural background, friends, family, and lack of trust in related procedures were all significant factors contributing to patients' or donors' final decision-making for donation and participation in research activities, emphasizing more on friends and family influence and/or the lack of trust in such procedures, regardless of the cultural background.The lack of harmonization and standard consent type in the biobanking industry and other health-related sectors, create a large gap in informed consent requirements because some of the consent types used do not adhere to its main principles, such as broad consent.[43] Donations using broad consent, from a sample cohort that can be used in any research type, although the current broad consent type cannot be described as adequately informed from a patient perspective, which means that one of four major criteria that is considered for the process of informed consent to be complete and valid is not.[44,45] Despite that, broad consent was not only majorly used in the present biobanking industry but also was preferable for future needs according to the poll survey answers, followed by that of study specific consent, mostly as part of a clinical trial. Of note, more than half of the participants feel that the current consent type addresses the needs of their organizations but does not completely address the needs for future cooperative partnerships within an international network research system. Taking into account the workshop's results from The National Institutes of Health Clinical Center Department of Bioethics in 2013,[46] it seems that broad consent is preferable by both researchers and patients. From the scientists' perspectives the lack of extra burden to seek individuals' permission each time new research is conducted is a priority and from the patients' perspective the need to sign up only once and not be further contacted is preferable. Patients also agreed that an optimal and ethical permissible broad consent should consist of the following three main components: initial broad consent, procedure of approval of future research related-activities, and an ongoing process for donors follow-up and communication.The follow-up procedure was not always feasible (19%), according to the poll survey, and wass actually one of the causes for patients' or donors' withdrawal. On the other hand, considering the option of anonymity for increased protection of individuals' identity (from the ethical point of view) makes further communication with individuals extremely difficult or not possible at all.[47] Anonymized samples arise a major barrier in longitudinal data collection and partially limits research activities in biobanks as the big data collections cannot be sufficiently used and distributed among other research-related entities.[48] In many instances of substantial changes in initial consent, further communication between investigators and individuals is essential for future research activities, leading to the need for re-consent procedures.[49] The poll participants selected the following two main reasons that re-consent is needed: if data and biosamples will be used in unrelated research fields, and in the case of implementation of novel technologies and research activities.A mandatory challenge arises in the implementation of informed consent; the evaluation of individuals' comprehension, voluntariness, and autonomous decision-making, which are not standardized among entities and countries.[50] Asking poll participants how they assess these procedures, variability was observed including face-to-face interactions, structured questionnaires, and statement of agreement included in informed consent procedures. Thus, lack of clarity in potential future utilization of their biospecimens and concerns about the security, privacy, and disclosure of their sensitive data, increase the lack of public trust and may lead to failure of healthcare-related programs, emphasizing patients' or donors' desire for greater transparency and engagement in research.[51] Of the survey participants, 13% have experienced research failure due to consent procedures.Introduction of dynamic consent options as a solution for patients' or donors' engagement through interactive interfaces seems to respond more effectively to these challenges, as it has the potential to accommodate different consent approaches in biobanking and healthcare in general, protect donor's interests over time and contains all the range of characteristics to enable individuals' incorporation as “equal” partners in research-related activities and enrollment in the usage chain of data use.[52,53] Dynamic e-consent is a promising innovative tool for both patients and biobanks and/or other health-associated sectors, based on its potentials, including the ability for major longitudinal studies on targeted population cohorts; establishment of novel clinical research international networking; supporting of large-scale cross-border data sharing and ongoing communication between all stakeholders; and the ability of an effective and easy future way for follow-up. Thus, solving most if not all the issues raised by survey participants.[54–56] Despite that, dynamic consent models were not the first choice for future use by the poll participants, but the susceptibility for adopting an electronic digital consent was observed by an impressive majority of 94%. Although most of the executives and scientists within the workshop agreed that a novel technical solution for consent processes might help in patients' or donors' recruitment for research, their biggest concern was associated with legal, ethical, and standard principles for compliance. Some of the participants considered also the technical competence of the staff members, including the need for familiarization and training, alongside the lack of human involvement. A few more issues were raised in the subject, such as the possible increased cost of the implementation of these novel technologies and the big changes in current systems although preferable. These concerns come to consensus with previous reviews addressing the challenges, limits, and future needs for electronic consent implementation in current systems, supporting the requirements for both technical infrastructures set up and standard polices and guidance establishment within national and international frameworks.[57–59]A key role in healthcare quality and personalized medicine affects patients' partnership in research-related activities; thus, patient-centric approaches and strategies are developed to support enrollment and giving patients more information and control over donation.[60] Building trust and relationships between biobanks and patients is mandatory for future research development.[61] According to the survey results, half of the participants would give patients/donors control over their donation and associated data either totally or partially. On the other hand, 40% of the participants are not willing to give them total control over their biosample and data usage. Asking them what kind of donation control would they be willing to provide to patients, the following three main areas were selected: control over biosample and related data utilization; control over future communication for re-consent and research findings; and control over research field, related to their donation. It is critical to note that 15% of participants were not willing to give any of the above types of control to participants.Sheehan et al[62] previously published some of the main points of criticism related to the implementation of dynamic consent and the right it gives to patients, emphasizing the concerns for patients potentiality to interfere with the research processes and their ability to express their preferences in related activities, which subsequently might affect the final research conduction. Criticisms for the implementation of dynamic consent, being an extra burden to current and future processes in biobanking activities has been reported by Steinsbekk et al[63] as well. Despite that, the majority of the biobanking representatives in the poll survey were willing to incorporate patients in research and give them authority to more research-related outcome disclosure.These workshop results and conclusion remarks have certain limitations considering the very small number of participants and the lack of diversity background among them. In addition, large-scale focus groups, including participants from different fields, such as biobanking, research institutes, healthcare providers and pharma, alongside a group of patients or donors, might give more representative insight of current and future needs and considerations in the field of informed consent and best practices requirements for both patients and other stakeholders' rights. Some very mandatory pitfalls in biobanking and informed consent were discussed, giving a boost for brainstorming and food for thought to achieve a global informed consent type consensus in healthcare and biobanking industry.As the nature of healthcare changes in the era of large-scale studies and big data analytics, biobanking evolution and incorporation of computing and networking technologies might be unavoidable so as to create harmonized and standardized procedures for patients' engagement and consent consensus on international levels. From past to present, via the ISBER virtual annual meeting and exhibits, an educational workshop was conducted to inform participants about consent evolution, challenges, issues, barriers, regulations, and novel technological options. Possible implications and potential applications are raised when the usage chain of biosample and associated data is managed totally by the donor, as well as considerations of novel technologies incorporation in the current system. The main consent-related issues deal with organizations' present and future perspectives. According to survey results, biobank representatives seem to realize the gap in current operational systems and come to consensus with previous reviews about the main issues and barrier in obtaining consent from participants and the need for harmonized standard polices for international networking, along with practical ways for patients' enrollment in research. Although willingness levels from close to the half of participants to give patients total control over their biospecimens and related data were observed, some considerations for the implementation on these novel technologies and big changes in current systems still remains. Further exploration is needed by focusing on more a diverse, large-scale group of participants to have more information on current issues and the initial steps needed to achieve the best quality in future global healthcare.

Highlights from 2022: Innovations in Digital Health, Diagnostics, and Biomarkers

The second volume of Innovations in Digital Health, Diagnostics and Biomarkers (IDDB) has successfully come to a close. The Journal was launched during a historic pandemic, and as the fields of biomedical research and healthcare are now moving into a transition period (from the pandemic emergency towards a new normal), it is evident that the pandemic has been a universal catalyst for innovative thinking. During such transition, drivers for change have ranged from introducing new technologies to developing new operating frameworks for existing capacities, anchored in a context-dependent manner. Thus, the emerging innovations vary and often reflect a regionally defined and fragmented set of requirements.Notwithstanding the latter, manuscripts published in IDDB demonstrate wide interest in digital health, diagnostics, and biomarkers research, which defines the publishing niche that we are developing through a consistent multidisciplinary approach .[1] For example, original research by Liang et al.[2] reported the phototoxicity sensitivity for cells grown in vitro, and Pardes et al.[3] introduced the use of a mobile health platform for remote assessment of suicidal ideation, depression, and anxiety. The team of Qu et al.[4] provided a detailed review of innovative technologies for healthcare application, pointing out existing gaps, challenges, and opportunities, as well as identifying key areas where immersive technologies can impact healthcare provision. Additional articles by Medina et al.,[5] and Kozlakidis et al.[6] showcase focused areas of scientific activity, namely construction and application of biobank infrastructure for infectious diseases and a state-of-the-art review of betel nut use, respectively.Innovations are often fuelled by individual perspectives, as they emerge over a specific field of scientific activity, such as in this case. The editorial by Cheong and Wang[7] describes the Chinese experience with digital health applications in public health interventions. The commentary by Xu[8] focuses on aspects of biopsy specimen acquisition during longitudinal sampling. The inclusion of such diverse subjects and expertise is one of the unique advantages of publishing with IDDB, reducing institutional blocks that stifle further connections and limits creativity. The transdisciplinary nature of innovation is aptly demonstrated in the three related manuscripts by Arnholdt-Schmitt et al.[9–11], where original observations regarding balancing of reactive oxygen and nitrogen species (ROS and RNS, respectively) in plants, which contributes to shaping a foundational mechanism of health resilience. This group conducted pilot testing of early metabolic responses in cultured primary target cells infected with influenza H3N2 and SARS-CoV-2.The achievements made by scientists are also reported in international conference proceedings. One example is the 2021 International Society for Biological and Environmental Repositories (ISBER) virtual workshop proceedings by Ivanova and Katsaounis.[12] This report summarizes key barriers, challenges, and perceptions to digital innovations with respect to informed consent in biobanking (and wider implications for longitudinal sampling and organ donation). Additionally, IDDB has been privileged to publish the abstracts presented at the 2022 Advancing Healthcare Innovation Summit (AHIS)[13] in Cincinnati, OH, USA. As with the manuscripts mentioned above, abstracts from AHIS represent a wide geographical and subject coverage, having healthcare innovation and a strong belief in the potential impact of such innovation as their common denominator.I would personally like to thank the Journal staff for their tireless support during this second year (including social media support for @EditorsIDDB). I thank my Associate Editor, Dr Daniel Catchpoole, and the entire editorial board for continuous encouragement and scientific direction of the Journal as it continues to develop. We are excited to have two young professionals (Drs Beheshta Paiman and Gowhar Rashid) who recently joined IDDB as part of a year-long editorial fellowship. A special mention should be made for the Innovative Healthcare Institute (IHCI) that shoulders the cost of operations and publication under the leadership of Dr. Abdulrahman Jazieh. Finally, I gratefully acknowledge the many reviewers[14] who actively supported the peer-review process, which was applied to all manuscripts alike and has resulted in stronger contributions to the body of literature on healthcare innovations.

Collection and storage of DNA-containing biomaterial and isolated DNA

The advances of biomedicine include the new technologies, diagnosis and treatment techniques, as well as the practical use of new types of biological targets, in particular, nucleic acids. Genomic deoxyribonucleic acid (DNA), extracellular DNA (exDNA) and microbiome DNA obtained from different types of samples (tissues, blood and its derivatives, feces, etc.) are used as objects of genetic research. The use of new technologies for DNA analysis required the development of standardized methods for processing biological samples in order to obtain high-quality DNA samples. The research uses various methods for collecting, preparing samples and storing various DNA-containing biomaterials and isolated DNA, as well as methods for assessing the quality of samples and biobank standards. It is obvious that the use of uniform standards will allow large-scale genetic research on the basis of biobanks and research laboratories. Specialists from professional organizations such as International Society for Biological and Environmental Repositories (ISBER), Biobanking and BioMolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC), European, Middle Eastern & African Society for Biopreservationa and Biobanking (ESBB) and the Russian National Association of Biobanks and Biobanking Professionals.

Biobanking in the COVID-19 Era and Beyond: Part 2. A Set of Tool Implementation Case Studies.

The COVID-19 era has brought about a number of novel challenges for the global biobanking community. An array of diverse tools (e.g., standards, best practices, and plans) exists to support quality and fitness-for-purpose in biobank operations. The International Society for Biological and Environmental Repositories (ISBER) COVID-19 Response Task Force has set out to identify needs and gaps in these tools and make recommendations for the next generation of available tools, having closely examined the COVID-19-related challenges. While conducting this work to examine the relationships between tools and biobank adaptability, a subgroup of the task force conducted a parallel effort to develop and describe individual COVID-19 era case studies based on a number of operating biobanks. Each case study presents a different combination of implemented tools. Observations and lessons learned from these case studies are provided, and experiences with tool implementation are discussed. This information is supplemented by data relating to tool usefulness that was obtained through an ISBER survey discussed in a companion article. The knowledge gained from this study will be combined with other task force efforts to make recommendations to better position the biobanking community in their response to future emergencies.

Biobanking in the COVID-19 Era and Beyond: Part 1. How Early Experiences Can Translate into Actionable Wisdom.

The era of COVID-19 has brought about a number of novel challenges for the global biobanking community. To better position the biobanking community to cope with current and future challenges, the International Society for Biological and Environmental Repositories (ISBER) COVID-19 Response Task Force was convened to identify needs and gaps in biobanking tools (existing resources that support good practice), for example, standards, best practices, business, etc. and to make recommendations to benefit the community. Toward these goals, the Task Force assembled a set of questions to explore individual biobanks' experiences, with emphasis on identification of key challenges and approaches, including tools employed. A survey was designed with the use of these questions and administered by ISBER. This article presents a summary of the aggregated data obtained from the survey responses, illustrating some of the major issues encountered and identifying which tools the survey respondents found most useful. In particular, this article focuses on the challenges identified during the early months of the COVID-19 era. Recommendations are provided to support biobank emergency preparedness for the future, address lessons learned, and propose solutions to bridge identified gaps. The analysis and the complete survey dataset will also inform the larger Task Force goal to develop specific tool recommendations.

Diverse Responses of the Biobanks in Indo-Pacific Rim Region During the COVID-19 Pandemic: Case Scenarios from Two Low- and Middle-Income Countries and Two High-Income Countries in the Indo-Pacific Rim Region.

Background: Biobankers have been unexpectedly involved in the pandemic of COVID-19 since early 2020. Although specific guidance was not available, the International Society for Biological and Environmental Repositories (ISBER) Best Practices and the ISO 20387 document have been utilized to deal with the pandemic disaster. The ISO experts and best practice experts in ISBER teamed up to share the available information and learn the experiences of biobanks concerning COVID-19 through organizing webinars, surveys, and town hall meetings. Four ISBER regional ambassadors (RAs) from the Indo-Pacific Rim (IPR) region were also actively involved at one of the town hall meetings. These RAs, who are from Australia, India, Indonesia, and Japan, and the Director-at-Large of the region, have summarized their experiences in this article. Materials and Methods: The ISBER Standards Committee COVID-19 Task Force has kindly provided the survey results. The extracted glossary from the results was categorized into 10 factors: (1) crisis management; (2) sample-related issues; (3) logistics-related issues; (4) equipment-related issues; (5) ethical, legal, and social implication-related issues; (6) operation-related issues; (7) personnel-related issues; (8) management-related issues; (9) infection-related issues; and (10) research-related issues. Each IPR RA has provided a case considering these 10 factors. Results and Discussion: Two key points have emerged from the scenarios, which are as follows: (1) impacts of the biobanks in low- and middle-income countries (LMICs) are similar to those in high-income countries (HICs) and (2) tolerance of the biobanks in LMICs is not so robust as those in HICs. Furthermore, communication strategies with internal and external stakeholders are critical for a biobank to manage this crisis. This article summarizes the impacts, indicates the opportunities that COVID-19 has brought to the biobank community, and highlights the usefulness of the network beyond biobank services. Lastly, the biobanks need to turn the challenges into opportunities to overcome the crisis.

Quality Matters: A Global Discussion in Qatar.

The International Biobanking Conference titled "Quality Matters: A Global Discussion in Qatar" was held on March 25-27, 2019, in the vibrant city of Doha, Qatar. The 3-day event was organized and hosted by the Qatar Biobank (QBB) and the European, Middle Eastern and African Society for Biopreservation and Biobanking (ESBB), with supporting collaboration from the International Society for Biological and Environmental Repositories (ISBER) and the Biobanking and BioMolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI-ERIC). The aim was to highlight the role of biobanking in medical research and advancing health care, as well as improving clinical outcomes. The conference convened experts from across the globe to discuss continuing efforts to harmonize biobanking-related processes to achieve high-quality standards and to support international advancements in medical research for our diverse populations. The scientific agenda drew more than 1000 scientists, researchers, industry experts, and health professionals from five continents. The conference focused on the quality aspect of biobanking through seven sessions over 3 days. Researchers, scientists, and experts from around the world were invited to present, and included special presentations from QBB demonstrating their standing as a leading clinical biobank innovator in support of population and genomic medicine. The 3-day conference concluded with a session on Best Practices and Standards, a topic much in discussion with today's context.

National Cancer Institute Biospecimen Evidence-Based Practices: Harmonizing Procedures for Nucleic Acid Extraction from Formalin-Fixed, Paraffin-Embedded Tissue.

Variable and suboptimal biospecimen handling practices have been identified as impediments to biomarker discovery,1,2 including predictive biomarkers for oncology3 indicating a clear and present need for evidence-based, standardized practices. The United States and international efforts have been launched to better understand and mitigate variability during the preanalytical phase and decrease associated effects by promoting harmonization of procedures both within and across institutions. The Biorepositories and Biospecimen Research Branch (BBRB) of the United States National Cancer Institute (NCI) publishes best practice documents aimed at improving the quality of data generated from human biospecimens (https://biospecimens.cancer.gov/bestpractices/overview.asp) and sponsors research initiatives (https://biospecimens.cancer.gov/programs/default.asp) and the Biospecimen Research Database (BRD; http://biospecimens.cancer.gov/brd) to better understand thresholds and effects of individual preanalytical factors in biospecimen handling. The BRD allows users to query both a curated literature repository and standard operating procedure (SOP) library for a specific preservative, diagnosis, analyte, or preanalytical factor. The BRD incorporates information from international efforts, including those by the International Society for Biological and Environmental Repositories (ISBER) and the European Union-sponsored SPIDIA program (standardization and improvement of generic preanalytical tools and procedures for in vitro diagnostics; www.spidia.eu), among others. To facilitate the implementation of evidence-based practices in biospecimen handling, BBRB has developed a document series termed Biospecimen Evidence-Based Practices (BEBP), which contains step-by-step procedural guidelines derived from peer-reviewed primary research articles and expert experience.4 The aim of the BEBP series is to promote a practical level of standardization and improve overall biospecimen quality and data reproducibility by specifying both optimal methods and suitable alternatives, while merging published evidence with practical knowledge of experts in the field. The intent of the BEBP is not to serve as a SOP, but to facilitate the development of evidence-based SOPs by individual laboratories. The present BEBP focuses on nucleic acid extraction from formalin-fixed, paraffin-embedded (FFPE) tissue biospecimens (see Supplementary Data; Supplementary Data are available online at www.liebertpub.com/bio). Such biospecimens are being increasingly utilized in genomic research, and it has become clear over the past decade that variable and suboptimal FFPE biospecimen collection and processing practices can alter the quantity and/or quality of extracted DNA and RNA.5 Concordance between the molecular data generated with FFPE and snap-frozen biospecimens varies widely among reports, with correlations ranging from weak to very strong for the same analytical method.6 While lack of concordance may be partially attributable to differences in biospecimen handling during FFPE processing, available evidence suggests that the extraction method can compound or mitigate effects introduced during biospecimen collection, processing, and storage, thus affecting the suitability of samples for downstream analysis.7–11 When deciding on a nucleic acid extraction procedure, it is paramount to consider artifacts that may have been introduced during formalin fixation and processing, such as nucleic acid fragmentation,12 nucleic acid–protein crosslinking,13,14 denaturation,15,16 and additions of methylol groups to nucleic acids.15,17 Importantly, many such formalin-induced modifications to DNA and RNA are reversible13,18–21; for example, the addition of a demodification step as well as optimization of multiple steps during the extraction procedure can attenuate effects introduced during fixation and processing. However, FFPE-specific optimization steps are interdependent and must be considered collectively when developing a strategy for extraction. While several commercial extraction kits are marketed as being tailored for FFPE biospecimens, experts contributing to the BEBP advised validating any kit for the intended tissue type, processing regime, and analytical platform before implementation in experimental studies. Validation includes experiments to confirm the feasibility and accuracy of the intended analytical use, the reproducible performance of the kit, and the robustness to processing regimes.

Selecting a Laboratory Information Management System for Biorepositories in Low- and Middle-Income Countries: The H3Africa Experience and Lessons Learned

Biorepositories in Africa need significant infrastructural support to meet International Society for Biological and Environmental Repositories (ISBER) Best Practices to support population-based genomics research. ISBER recommends a biorepository information management system which can manage workflows from biospecimen receipt to distribution. The H3Africa Initiative set out to develop regional African biorepositories where Uganda, Nigeria, and South Africa were successfully awarded grants to develop the state-of-the-art biorepositories. The biorepositories carried out an elaborate process to evaluate and choose a laboratory information management system (LIMS) with the aim of integrating the three geographically distinct sites. In this article, we review the processes, African experience, lessons learned, and make recommendations for choosing a biorepository LIMS in the African context.

[A cryobank as an attribute of omics technologies].

Biobanks are systematic and annotated collections of biological samples based on the system of standard operating procedures (SOP) and corresponding to the recommendations of the International Society for Biological and Environmental Repositories (ISBER). Standardization of conditions of obtaining, processing, storage of samples and providing to an end user are crucial in the activities of the biobank. The attributes of biobanks include common principles of labeling and annotation of biological samples using specialized software, an automated monitoring system of storage conditions, and registration of biosamples. Cryobanks are the biobanks maintained at the storage conditions from -196°C to -150°C that provide better cell viability and the highest preservation of biological molecules. Cryobanking is the most essential part of the infrastructure of population and personalized medicine, pharmaceuticals and biopharmacology, conservation of rare and endangered species, as well as biotechnology in general. Next Generation Biobanking, a concept especially designed for omics technologies, involves annotating biological samples on many biomarkers based on Next Generation Sequencing techniques, as well as collecting biological material from the same patient at different time points (for example, at different stages of the disease, before and after the operation, at different periods of therapy) with a detailed annotation of physiological, biochemical and clinical data. Epigenetic studies (DNA methylation, microRNA, etc.), as well as bioinformatic data analysis are of great importance in the activity of Next Generation Biobanking. Such biobanks should function based on the new ethical principles of the post-genomic era.

International Society for Biological and Environmental Repositories (ISBER) tools for the biobanking community.

Biopreservation and BiobankingVol. 12, No. 6 ISBER CornerInternational Society for Biological and Environmental Repositories (ISBER) Tools for the Biobanking CommunityDebra Leiolani Garcia, Paige M. Bracci, Denise Marie Guevarra, and Nicole SieffertDebra Leiolani GarciaInternational Society for Biological and Environmental Repositories (ISBER) Education and Training Committee.AIDS and Cancer Specimen Resource, University of San Francisco.Search for more papers by this author, Paige M. BracciAIDS and Cancer Specimen Resource, University of San Francisco.Search for more papers by this author, Denise Marie GuevarraAIDS and Cancer Specimen Resource, University of San Francisco.Search for more papers by this author, and Nicole SieffertInternational Society for Biological and Environmental Repositories (ISBER) Education and Training Committee.MD Anderson Cancer Center.Search for more papers by this authorPublished Online:15 Dec 2014https://doi.org/10.1089/bio.2014.1264AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View article"International Society for Biological and Environmental Repositories (ISBER) Tools for the Biobanking Community." Biopreservation and Biobanking, 12(6), pp. 435–436FiguresReferencesRelatedDetailsCited byThe Access Technology Program of the Indiana Clinical Translational Sciences Institute (CTSI): A model to facilitate access to cutting-edge technologies across a state19 August 2020 | Journal of Clinical and Translational Science, Vol. 5, No. 1Biobanking for necrotizing enterocolitis: Needs and standardsJournal of Pediatric Surgery, Vol. 55, No. 7Health professionals’ opinions on supporting a cancer biobank: identification of barriers to combat biobanking pitfalls2 September 2015 | European Journal of Human Genetics, Vol. 24, No. 5Quality assessment and preservation of RNA from biobank tissue specimens: a systematic review23 November 2015 | Journal of Clinical Pathology, Vol. 69, No. 3 Volume 12Issue 6Dec 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:Debra Leiolani Garcia, Paige M. Bracci, Denise Marie Guevarra, and Nicole Sieffert.International Society for Biological and Environmental Repositories (ISBER) Tools for the Biobanking Community.Biopreservation and Biobanking.Dec 2014.435-436.http://doi.org/10.1089/bio.2014.1264Published in Volume: 12 Issue 6: December 15, 2014PDF download

C-28: ISBER best practices in action at CDC’s CASPIR biorepository

The International Society for Biological and Environmental Repositories (ISBER), has developed a set of best practice guidelines for repositories, reflecting the collective experience of its members and repository professionals. The enterprise has been driven by the need for standardized, evidence based methods for collection, long-term storage, retrieval and distribution of specimens, to ensure availability of high quality biological and environmental specimens for research use. The ISBER Best Practices document represents effective strategies for the management of specimen collections and repositories, and is regularly revised to incorporate new advances. Biorepostories represent the infrastructure that includes both the physical facilities and the full range of activities associated with the repository. The Best Practices address all aspects of a repository required to ensure the quality of both specimens and associated data. A self-assessment tool is available from ISBER to assist repositories gage how well they adhere to the Best Practices. The CASPIR (CDC and ATSDR Specimen Packaging, Inventory, and Repository) at the Centers for Disease Control and Prevention (CDC), is an example of a large, long term biorepository that utilizes the ISBER Best Practices framework to ensure consistent management of specimens and associated data. The CDC accrues millions of irreplaceable specimens in the course of Public Health investigations, including a variety of human, microbial and environmental samples. CASPIR was established as a centralized facility to preserve the integrity of CDC’s unique and valuable specimens for future research in a secure facility, with continuously maintained uniform conditions and standard operating procedures and quality measures.

Overview of the International Society for Biological and Environmental Repositories (ISBER) Working Groups.

Biopreservation and BiobankingVol. 12, No. 5 ISBER CornerOverview of the International Society for Biological and Environmental Repositories (ISBER) Working GroupsRebecca S. PughRebecca S. PughSearch for more papers by this authorPublished Online:23 Oct 2014https://doi.org/10.1089/bio.2014.1252AboutSectionsView articleView Full TextPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetailsCited ByBiobank and Expertise Networks7 June 2017Quest for Missing Proteins: Update 2015 on Chromosome-Centric Human Proteome Project23 July 2015 | Journal of Proteome Research, Vol. 14, No. 9 Volume 12Issue 5Oct 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:Rebecca S. Pugh.Overview of the International Society for Biological and Environmental Repositories (ISBER) Working Groups.Biopreservation and Biobanking.Oct 2014.358-360.http://doi.org/10.1089/bio.2014.1252Published in Volume: 12 Issue 5: October 23, 2014PDF download

Abstract 5319: The role of ISBER (The International Society for Biological and Environmental Repositories) in cancer research

Abstract High quality biospecimen collections are essential for biomarker discovery in Cancer Research. Biomarker analytical and clinical performance depends heavily upon the pre-analytical variation of biospecimens used. For this reason, standardization of procedures is of utmost importancein the collection, preparation, and storageof biospecimens, making it possible to accurately associateprocessing methods withappropriate end-use applications.  The International Society for Biological and Environmental Repositories (ISBER) is a professional society of organizations and individuals who share an interest in promoting consistent, high quality standards, ethical principles, and Best Practices in biospecimen banking. ISBER, with almost 500 individual and organizational members throughout the world, is the leading international forum for promoting innovation in the science and management of biospecimen collection, processing, storage, distribution, and use. ISBER educational resources and meetings focus on a wide variety of topics from biorepository development, maintenance, and improvement, to technical concerns regarding equipment, quality assurance and control, regulation, human subject privacy, and confidentiality. Additional tools developed by ISBER, many of which are web-based, are available to assist researchers in ensuring biospecimen quality and biorepository compliance with Best Practices. ISBER routinely provides information about existing biorepositories and their biospecimen collections as well. For more information, please visit http://www.ISBER.org. Citation Format: Debra L. Garcia, Katherine Sexton, William E. Grizzle, Fay Betsou. The role of ISBER (The International Society for Biological and Environmental Repositories) in cancer research. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 5319. doi:10.1158/1538-7445.AM2014-5319

Pediatric Immunological Disorders Biorepository (PIDBioRep) at University of São Paulo Medical School, Brazil.

Biopreservation and BiobankingVol. 11, No. 5 Biobank ProfileOpen AccessPediatric Immunological Disorders Biorepository (PIDBioRep) at University of São Paulo Medical School, BrazilPublished Online:16 Oct 2013https://doi.org/10.1089/bio.2013.1153AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail IntroductionThe Pediatric Immunological Disorders Biorepository (PIDBioRep) is a clinical-laboratory database and biorepository with an open-ended prospective patient-based cohort, located at the University of São Paulo Medical School (FMUSP- Faculdade de Medicina da Universidade de São Paulo) Children's Hospital in Brazil. Its purpose was to set up an infrastructure for research on pediatric immunological disorders, particularly early-onset autoimmune diseases and primary immunodeficiencies. Participants are being recruited from all of the hospital specialty divisions that currently comprise an estimated cohort of 1,200 infants, children, and adolescents with diagnoses of organ-specific and systemic autoimmune diseases and 300 patients with well-defined primary immunodeficiencies. The PIDBioRep complies Brazil's regulations regarding the use and storage of biological samples.1,2,5,6,7 The ethical committee of our hospital approved the informed consent form that is provided to each patient.The PIDBioRep establishment resulted in facility remodeling and equipment purchases as well as training staff to receive, prepare, and store samples. Biological samples are stored in cryotubes with barcodes and different color caps according to sample type, and standard kits are used to isolate genomic DNA and RNA from peripheral blood.The partnership with the Medical Informatics Laboratory team from A.C. Camargo Hospital allowed the Children's Hospital to customize and use the software in the hospital server, which can be accessed through the internal network. Systems installed are as follows: i) LOGIN - fits all systems, its main functions include management of people (register and permissions), rules, domains, messages and modification of user information, including passwords; ii) BIOBANK - registers and oversees tissues and blood samples; collections linked to projects; containers and freezers; procedures for RNA, DNA and protein extraction; applications made by researchers; storage, removal and disposal of samples and administration of all samples history; iii) XUSD – centralizes and manages structured models, defines which models users may access, fills in models already indexed, stores information in a structured form, searches information in models, imports data from another database and exports data to a file with a CSV extension.All patients have their medical records reviewed, and a structured protocol is completed in order to create the clinical-laboratory database. Parents or care providers respond to a questionnaire regarding a patient's personal medical history and presence of other family members with autoimmune disease and/or primary immunodeficiency. During this time, laboratory tests for autoantibodies and reports of lifestyles, events or emotional changes that parents or care providers consider possible triggers to autoimmune disease are recorded. Questionnaires are transferred to XUSD. Once informed consent is obtained and the clinical-laboratory protocol is completed, whole blood samples are sent for cryopreservation and storage of serum, plasma, DNA and, depending on the active line of research, RNA, urine, tissue samples, breast milk or mononuclear cells are also stored at the Laboratory for Medical Research (LIM-36) at Children's Hospital. To guarantee adequate processing and storage of samples, standard technical procedures have been established based on the quality management system BIOBANK. While biological sample collection is being conducted, BIOBANK software links with the clinical-laboratory database, turning the biorepository into a complete tool to make full use of these samples. The link between biological samples and patients' clinical-laboratory data are maintained so that a patient may be contacted to obtain additional samples. The researcher who gains access to specimens receives only the sample number, which provides protection for patient confidentiality throughout the entire process. All institutional researchers can send forms and request samples from the scientific committee.The clinical-laboratory database and biorepository have promoted advances in clinical research as well as facilitated both molecular investigation of common genetic bases of autoimmune diseases and a better understanding of frequencies, associations and modes of inheritance of these disorders. The facility is currently participating in a thematic project and gives support for ongoing research initiatives, especially properly storing serum and DNA for future analyses. In addition, researchers have used clinical-laboratory information and human biological samples collected by this facility, resulting in a series of works.3,4,8–15Therefore, as a pioneer initiative, this clinical-laboratory database and biorepository will supply researchers with important information and an apparatus that can illuminate the causative factors of autoimmune diseases and primary immunodeficiencies.Title of biobank: Pediatric Immunological Disorders Biorepository (PIDBioRep) at University of São Paulo Medical School, BrazilSite location: University of São Paulo Medical School, Children's Hospital, LIM-36, São Paulo, BrazilContact information:E-mail: bernadete.liphaus@hc.fm.usp.br or magdascs@usp.brInstituto da Criança, LIM-36, telephone 55-11-26618606Bernadete L Liphaus, MD, PhD orMagda Carneiro-Sampaio, MD, PhDDate of operations: December 2009Date range of cases: December 2009 to presentCategory of biobank: Basic/Translational/Epidemiological/ClinicalFocus of biobank: Clinical-laboratory data and longitudinal top-quality collection of several types of samples exclusively from pediatric cohorts of patients and age-matched healthy volunteers. Specifically, the collection includes infants, children and adolescents with early-onset diagnoses of organ-specific and systemic autoimmune diseases, including juvenile systemic lupus erythematosus, juvenile idiopathic arthritis, juvenile dermatomyositis, type 1 diabetes mellitus, thyroiditis, celiac disease, inflammatory bowel disease, immune thrombocytopenic purpura and autoimmune hepatitis. The collection also includes samples from infants and children with diagnoses of auto-inflammatory diseases and 62 different well-defined primary immunodeficiencies.Membership of biobank: Clinical and research staff from Children's Hospital, including allergy and immunology, clinical genetic, endocrinology, gastroenterology, hematology and rheumatology divisions and the Brazilian Consortium for Reference and Training in Primary Immunodeficiencies (CoBID).Major source of funding: São Paulo Research Foundation grant (FAPESP-Fundação de Amparo à Pesquisa do Estado de São Paulo, 2008-58238-4) and Children's Hospital institutional financial support.Proportional funding sources for biobank:Institution core budget: 10 %Grants: 90 %Example input statistics:Overall response to consent: In accordance with Brazil's regulations regarding the storage and use of human biological materials for research, all (100%) participants give written consent before any sample is sent to the biorepository.Total individual cases held: 256100 % cases associated with blood biospecimens: 302 sera samples, 312 plasma samples and 365 DNA samplesExample output statistics:The clinical-laboratory database and biorepository value has effectively been demonstrated by its participation—giving support for ongoing projects, especially thematic research in autoimmunity and immunodeficiencies, and a series of dissertations, theses and published articles from work performed at our facility. Approximately 70 biospecimens and 26 cases were released this year (2013). Since the clinical-laboratory database and biorepository was established it has collaborated on 44 presented abstracts, two dissertations, three theses, eight published articles and five ongoing research projects.3,4,8–15What are the most valuable/highest priority cases in your biobank?As a research infrastructure and center of competence, we believe that our pediatric population provides a unique opportunity to study genetic factors involved in reducing tolerance with minimal influence of environmental factors. Furthermore, primary immunodeficiencies may represent special human models for unraveling components of pathogenesis of autoimmune diseases, as there are immunodeficiencies that are systematically associated with autoimmunity.What are your major challenges?One major challenge is maintenance of organizational structure of the clinical-laboratory database and biorepository that is based on three points: compliance with legislation, a formal process to record and access clinical data, and standardized technical procedures for collecting and storing samples. Another major challenge is keeping the trust and collaboration among multiple institutional research teams with various types of expertise. The establishment of an institutional database and biorepository requires the ability to involve different professionals and to allocate long-term resources and labor time. Likewise, effectively designing a database necessitates a user-friendly platform that will return the largest possible amount of clinical information. One additional challenge when creating a patient-based biorepository is ensuring that participants are adequately informed about the purposes of storing samples and possible future uses of the collection. Furthermore, biobanking is not an end in itself and to prove its value, the collected samples must be used in research projects that result in gain of knowledge of diseases being studied, which eventually will lead to development of new treatments, diagnostic and prevention methods.What would you do with $1 million to improve the value of your biobank:1. Invest in training staff (laboratory technologist, research nurse and data manager) to collect standardized clinical and laboratory information as well as to receive, prepare and store samples;2. Train a professional at Children's Hospital Service of Technology and Information in Health to help with further software maintenance and customization;3. Establish an appropriate technique for preserving cell lineages from patients with well-defined primary immunodeficiencies and identify gene mutations;4. Obtain a large and high-quality DNA collection to promote epidemiological genetic studies in Brazil;5. Include samples from patients all over the country participating in the CoBID.AcknowledgmentsThe authors acknowledge Diogo F.C. Patrão, Joyce M.A. Reis, Fernanda A.M. Fonseca, Luiz P. Camargo, Fernando Camargo, and Francisco Costa-Neto for their contribution on systems installation and adaptation, data acquisition, and smple storing.References1 Ministério da Saúde do BrasilDiretrizes Nacionais para Biorrepositório e Biobanco de Material Biológico Humano com Finalidade de Pesquisa. 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