ABSTRACT
The manuscript is devoted to development of information support system for a bioresource collection - biological information system «NeuroOnc¼. Architecture and main functions of system are presented. This system was formed in the project «Development of bioresource collection of tumors of the human nervous system with molecular genetic certification for personalized treatment of patients with neuro-oncological diseases¼. The purpose of this project was not only formation of bioresource collection, but also development of various molecular genetic methods for analysis of biospecimens in context of clinical researches. Biological information systems created to support the work of bioresource collections in hospitals should become a natural part of information infrastructure. Information support of bioresource collections cannot imply only «warehouse¼ functions. This system should have tools to support various scientific and clinical researches. Biological information systems can sometimes expand medical information systems but remain sufficiently autonomous. It is advisable to develop biological information systems in large specialized companies that can support their products for many years.
Subject(s)
Nervous System Neoplasms , Humans , Nervous System Neoplasms/therapy , Nervous System Neoplasms/genetics , Biological Specimen Banks/standardsSubject(s)
Metadata , Metadata/standards , Animals , Humans , Specimen Handling/standards , Biological Specimen Banks/standardsABSTRACT
Alzheimer's disease (AD), the most common form of dementia, remains challenging to understand and treat despite decades of research and clinical investigation. This might be partly due to a lack of widely available and cost-effective modalities for diagnosis and prognosis. Recently, the blood-based AD biomarker field has seen significant progress driven by technological advances, mainly improved analytical sensitivity and precision of the assays and measurement platforms. Several blood-based biomarkers have shown high potential for accurately detecting AD pathophysiology. As a result, there has been considerable interest in applying these biomarkers for diagnosis and prognosis, as surrogate metrics to investigate the impact of various covariates on AD pathophysiology and to accelerate AD therapeutic trials and monitor treatment effects. However, the lack of standardization of how blood samples and collected, processed, stored analyzed and reported can affect the reproducibility of these biomarker measurements, potentially hindering progress toward their widespread use in clinical and research settings. To help address these issues, we provide fundamental guidelines developed according to recent research findings on the impact of sample handling on blood biomarker measurements. These guidelines cover important considerations including study design, blood collection, blood processing, biobanking, biomarker measurement, and result reporting. Furthermore, the proposed guidelines include best practices for appropriate blood handling procedures for genetic and ribonucleic acid analyses. While we focus on the key blood-based AD biomarkers for the AT(N) criteria (e.g., amyloid-beta [Aß]40, Aß42, Aß42/40 ratio, total-tau, phosphorylated-tau, neurofilament light chain, brain-derived tau and glial fibrillary acidic protein), we anticipate that these guidelines will generally be applicable to other types of blood biomarkers. We also anticipate that these guidelines will assist investigators in planning and executing biomarker research, enabling harmonization of sample handling to improve comparability across studies.
Subject(s)
Alzheimer Disease , Biological Specimen Banks , Biomarkers , Humans , Alzheimer Disease/blood , Alzheimer Disease/diagnosis , Biomarkers/blood , Biological Specimen Banks/standards , Research Design/standards , Amyloid beta-Peptides/blood , Specimen Handling/standards , Specimen Handling/methods , tau Proteins/bloodABSTRACT
Biobanks are valuable tools for developing and applying scientific research and international cooperation through the collection of biological materials and their associated data. Systematic research following the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines was conducted in late 2022 in PubMed and Scopus, and generated 17 articles to be reviewed in depth and critically assessed using the Critical Appraisal Skills Programme Checklist due to the limited available data; 12 relevant health organizations and government websites outside of peer-reviewed journals were also included. Our research identified 44 biobanks in Latin America. In general, there is a lack of regulation and legislation guaranteeing the stored materials' quality and institutional collaboration. We believe a consensus needs to be reached regarding the terminology and definitions used for biobanks. The design for informed consent should also be agreed upon to ensure the privacy of the data shared among institutions. In conclusion, in Latin America, there is a clear need for government support in creating specific procedures for biobanks and providing further support for existing biobanks.
Subject(s)
Biological Specimen Banks , Biomedical Research , Latin America , Humans , Biological Specimen Banks/standards , Biological Specimen Banks/legislation & jurisprudenceABSTRACT
OBJECTIVE: The World Endometriosis Research Foundation established the Endometriosis Phenome and Biobanking Harmonisation Project (EPHect) to create standardized documentation tools (with common data elements) to facilitate the comparison and combination of data across different research sites and studies. In 2014, 4 data research standards were published: clinician-reported surgical data, patient-reported clinical data, and fluid and tissue biospecimen collection. Our current objective is to create an EPHect standard for the clinician-reported physical examination (EPHect-PE) for research studies. DESIGN: An international consortium involving 26 clinical and academic experts and patient partners from 11 countries representing 25 institutions and organizations. Two virtual workshops, followed by the development of the physical examination standards underwent multiple rounds of iterations and revisions. SUBJECTS: N/A MAIN OUTCOME MEASURE(S): N/A RESULT(S): The EPHect-PE tool provides standardized assessment of physical examination characteristics and pain phenotyping. Data elements involve examination of back and pelvic girdle; abdomen including allodynia and trigger points; vulva including provoked vestibulodynia; pelvic floor muscle tone and tenderness; tenderness on unidigital pelvic examination; presence of pelvic nodularity; uterine size and mobility; presence of adnexal masses; presence of incisional masses; speculum examination; tenderness and allodynia at an extra-pelvic site (e.g., forearm); and recording of anthropometrics. CONCLUSION(S): The EPHect-PE standards will facilitate the standardized documentation of the physical examination, including the assessment and documentation of examination phenotyping of endometriosis-associated pelvic pain.
Subject(s)
Biological Specimen Banks , Biomedical Research , Endometriosis , Phenotype , Physical Examination , Humans , Female , Endometriosis/pathology , Endometriosis/diagnosis , Physical Examination/standards , Biomedical Research/standards , Biological Specimen Banks/standards , Pelvic Pain/diagnosis , Pelvic Pain/etiology , Pelvic Pain/pathologyABSTRACT
O que são Biobancos? Para que servem? Como são formados? E principalmente: como garantir os direitos dos participantes de pesquisa que têm seus materiais biológicos guardados nesses lugares? Descubra aqui, ouvindo este episódio.
Subject(s)
Biological Specimen Banks/standards , Human Experimentation/ethics , Bioethics , Specimen Handling/standardsABSTRACT
The UK Biobank (UKB) is a highly promising dataset for brain biomarker research into population mental health due to its unprecedented sample size and extensive phenotypic, imaging, and biological measurements. In this study, we aimed to provide a shared foundation for UKB neuroimaging research into mental health with a focus on anxiety and depression. We compared UKB self-report measures and revealed important timing effects between scan acquisition and separate online acquisition of some mental health measures. To overcome these timing effects, we introduced and validated the Recent Depressive Symptoms (RDS-4) score which we recommend for state-dependent and longitudinal research in the UKB. We furthermore tested univariate and multivariate associations between brain imaging-derived phenotypes (IDPs) and mental health. Our results showed a significant multivariate relationship between IDPs and mental health, which was replicable. Conversely, effect sizes for individual IDPs were small. Test-retest reliability of IDPs was stronger for measures of brain structure than for measures of brain function. Taken together, these results provide benchmarks and guidelines for future UKB research into brain biomarkers of mental health.
Subject(s)
Biological Specimen Banks , Brain/diagnostic imaging , Databases, Factual , Depression/diagnosis , Mental Disorders/diagnosis , Neuroimaging/standards , Self Report , Aged , Biological Specimen Banks/standards , Databases, Factual/standards , Depression/diagnostic imaging , Female , Humans , Male , Mental Disorders/diagnostic imaging , Middle Aged , Neuroimaging/methods , Reproducibility of Results , Self Report/standards , United KingdomABSTRACT
Disease-relevant human induced pluripotent stem cells (iPSCs) are generated worldwide for research purposes; however, without robust and practical ethical, legal, and quality standards, there is a high risk that their true potential will not be realized. Best practices for tissue procurement, iPSC reprogramming, day-to-day cultivation, quality control, and data management aligned with an ethical and legal framework must be included into daily operations to ensure their promise is maximized. Here we discuss key learning experiences from 7 years of operating the European Bank for induced Pluripotent Stem Cells (EBiSC) and recommend how to incorporate solutions into a daily management framework.
Subject(s)
Biological Specimen Banks/statistics & numerical data , Cellular Reprogramming/genetics , Cryopreservation/methods , Induced Pluripotent Stem Cells/cytology , Induced Pluripotent Stem Cells/metabolism , Biological Specimen Banks/ethics , Biological Specimen Banks/standards , Cell Culture Techniques/methods , Cell Culture Techniques/standards , Cell Differentiation/genetics , Cell Line , Europe , Humans , Quality ControlABSTRACT
Aim: We investigated the effect of pre-analytical sample handling variations on coronavirus disease 2019-relevant circulating cytokine levels IFN-γ, IL-10, IL-12p70, IL-17A, IL-6 and TNF-α. Materials & methods: We collected blood in different collection tubes (ethylenediaminetetraacetic acid, sodium citrate, lithium heparin, serum), and subjected ethylenediaminetetraacetic acid plasma to among others increasing delays in centrifugation or -80°C storage. Six subjects were included in each experimental condition. Cytokine levels were measured in these samples using the Simoa Cytokine 6-plex kit. Results: Different tube types resulted in different blood cytokine levels. IL-17A and IL-6 levels declined with 3 h centrifugation delay. IFN-γ levels declined with 24 h postcentrifugation storage delay. IL-17A levels declined with 2-week storage delay. Conclusion: It is recommended to centrifuge tubes quickly following collection, for accurate cytokine measurement.
Subject(s)
Biological Specimen Banks/standards , COVID-19/blood , Cytokines/blood , Quality Control , SARS-CoV-2/metabolism , Specimen Handling/standards , Adult , Female , Humans , Male , Middle AgedABSTRACT
The term "biobanking" is often misapplied to any collection of human biological materials (biospecimens) regardless of requirements related to ethical and legal issues or the standardization of different processes involved in tissue collection. A proper definition of biobanks is large collections of biospecimens linked to relevant personal and health information (health records, family history, lifestyle, genetic information) that are held predominantly for use in health and medical research. In addition, the International Organization for Standardization, in illustrating the requirements for biobanking (ISO 20387:2018), stresses the concept of biobanks being legal entities driving the process of acquisition and storage together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as well as related information and data. In this review article, we aim to discuss the basic principles of biobanking, spanning from definitions to classification systems, standardization processes and documents, sustainability and ethical and legal requirements. We also deal with emerging specimens that are currently being generated and shaping the so-called next-generation biobanking, and we provide pragmatic examples of cancer-associated biobanking by discussing the process behind the construction of a biobank and the infrastructures supporting the implementation of biobanking in scientific research.
Subject(s)
Biological Specimen Banks , Biomedical Research , Precision Medicine , Specimen Handling , Accreditation , Biological Specimen Banks/classification , Biological Specimen Banks/ethics , Biological Specimen Banks/legislation & jurisprudence , Biological Specimen Banks/standards , Biomedical Research/classification , Biomedical Research/ethics , Biomedical Research/legislation & jurisprudence , Biomedical Research/standards , Guidelines as Topic , Humans , Policy Making , Precision Medicine/classification , Precision Medicine/ethics , Precision Medicine/standards , Specimen Handling/classification , Specimen Handling/ethics , Specimen Handling/standards , Stakeholder Participation , Terminology as TopicABSTRACT
Samples used in biomedical research are often collected over years, in some cases from subjects that may have died and thus cannot be retrieved in any way. The value of these samples is priceless. Sample misidentification or mix-up are unfortunately common problems in biomedical research and can eventually result in the publication of incorrect data. Here we have compared the Fluidigm SNPtrace and the Agena iPLEX Sample ID panels for the authentication of human genomic DNA samples. We have tested 14 pure samples and simulated their cross-contamination at different percentages (2%, 5%, 10%, 25% and 50%). For both panels, we report call rate, allele intensity/probability score, performance in distinguishing pure samples and contaminated samples at different percentages, and sex typing. We show that both panels are reliable and efficient methods for sample authentication and we highlight their advantages and disadvantages. We believe that the data provided here is useful for sample authentication especially in biorepositories and core facility settings.
Subject(s)
Biological Specimen Banks/standards , Biomedical Research/standards , Biometric Identification , Biomedical Research/methods , Biometric Identification/methods , DNA Contamination , Female , Humans , Male , Microsatellite Repeats , Polymorphism, Single NucleotideABSTRACT
The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic reveals a major gap in global biosecurity infrastructure: a lack of publicly available biological samples representative across space, time, and taxonomic diversity. The shortfall, in this case for vertebrates, prevents accurate and rapid identification and monitoring of emerging pathogens and their reservoir host(s) and precludes extended investigation of ecological, evolutionary, and environmental associations that lead to human infection or spillover. Natural history museum biorepositories form the backbone of a critically needed, decentralized, global network for zoonotic pathogen surveillance, yet this infrastructure remains marginally developed, underutilized, underfunded, and disconnected from public health initiatives. Proactive detection and mitigation for emerging infectious diseases (EIDs) requires expanded biodiversity infrastructure and training (particularly in biodiverse and lower income countries) and new communication pipelines that connect biorepositories and biomedical communities. To this end, we highlight a novel adaptation of Project ECHO's virtual community of practice model: Museums and Emerging Pathogens in the Americas (MEPA). MEPA is a virtual network aimed at fostering communication, coordination, and collaborative problem-solving among pathogen researchers, public health officials, and biorepositories in the Americas. MEPA now acts as a model of effective international, interdisciplinary collaboration that can and should be replicated in other biodiversity hotspots. We encourage deposition of wildlife specimens and associated data with public biorepositories, regardless of original collection purpose, and urge biorepositories to embrace new specimen sources, types, and uses to maximize strategic growth and utility for EID research. Taxonomically, geographically, and temporally deep biorepository archives serve as the foundation of a proactive and increasingly predictive approach to zoonotic spillover, risk assessment, and threat mitigation.
Subject(s)
Biological Specimen Banks/organization & administration , Communicable Disease Control , Communicable Diseases, Emerging/prevention & control , Community Networks/organization & administration , Public Health Surveillance/methods , Animals , Animals, Wild , Biodiversity , Biological Specimen Banks/standards , Biological Specimen Banks/supply & distribution , Biological Specimen Banks/trends , COVID-19/epidemiology , Communicable Disease Control/methods , Communicable Disease Control/organization & administration , Communicable Disease Control/standards , Communicable Diseases, Emerging/epidemiology , Communicable Diseases, Emerging/microbiology , Communicable Diseases, Emerging/virology , Community Networks/standards , Community Networks/supply & distribution , Community Networks/trends , Disaster Planning/methods , Disaster Planning/organization & administration , Disaster Planning/standards , Geography , Global Health/standards , Global Health/trends , Humans , Medical Countermeasures , Pandemics/prevention & control , Public Health , Risk Assessment , SARS-CoV-2/physiology , Zoonoses/epidemiology , Zoonoses/prevention & controlABSTRACT
We report a shipping container that enables a disruptive logistics for cytogenetic biodosimetry for radiation countermeasures through pre-processing cell culture during transportation. The container showed precise temperature control (< 0.01 °C) with uniform sample temperature (< 0.1 °C) to meet the biodosimetry assay requirements. Using an existing insulated shipping box and long shelf life alkaline batteries makes it ideal for national stockpile. Dose curve of cytogenetic biodosimetry assay using the shipping container showed clear dose response and high linear correlation with the control dose curve using a laboratory incubator (Pearson's correlation coefficient: 0.992). The container's ability of pre-processing biological samples during transportation could have a significant impact on radiation countermeasure, as well as potential impacts in other applications such as biobanking, novel molecular or cell-based assays or therapies.
Subject(s)
Biological Specimen Banks/standards , Radioactive Hazard Release , Specimen Handling/standards , Transportation/standards , Biological Assay/standards , Cytogenetic Analysis/standards , Cytogenetics/standards , Humans , Ships/standardsABSTRACT
Aim: Organoid technology has enormous potential for precision medicine, such as has recently been demonstrated in the field of cystic fibrosis. However, storage and use of organoids has been associated with ethical challenges and there is currently a lack of harmony in regulation and guidelines to govern the rapid emergence of 'organoid medicine'. Developing sound governance demands incorporation of the perspectives of patients as key stakeholders. Materials & methods: We conducted 17 semi-structured interviews with people with cystic fibrosis to explore their perspectives on the ethics and governance of organoid biobanking. Results: We identified three themes: prioritization of research and trust, ambivalent views on commercial involvement and transparency and control. Conclusion: Our study offers important insights for ethically robust governance of 'organoid medicine'.
Lay abstract Organoids are living tissues that can be grown in a lab out of stem cells, which can replicate some features of actual organs in the body. They can be used to study diseases or develop drugs, but also to test the effectiveness of therapy for a specific patient (which is called precision medicine). Organoid technology is promising for the treatment of cystic fibrosis. At the same, storing and using organoids raises ethical and practical challenges. In order to ensure that the interests of those who provide the cells are respected, we interviewed people with cystic fibrosis. Their motivation to participate in organoid research was high, but at the same time they wanted to know how their organoids are used. In addition, while they did not feel the need to be directly involved in decisions about how their tissue is used, they valued ongoing communication from biobanks about its activities.
Subject(s)
Biological Specimen Banks/ethics , Biological Specimen Banks/standards , Cystic Fibrosis/psychology , Organoids , Adolescent , Adult , Biological Specimen Banks/legislation & jurisprudence , Biomedical Research , Commerce , Female , Humans , Interviews as Topic , Male , Middle Aged , Ownership , Qualitative Research , Trust , Young AdultABSTRACT
Presence of metastasis translates unequivocally into worse prognosis for our patients. Translational medicine has been our response to offer patients better therapeutic options. This chapter aims to provide an overview for clinicians to send the necessary metastatic tissue on the right path toward the laboratory bench, overcoming biases and possible data misinterpretations derived from poor sample quality.
Subject(s)
Neoplasms/pathology , Tissue Preservation/methods , Biological Specimen Banks/standards , Cytodiagnosis/methods , Cytodiagnosis/standards , Humans , Neoplasm Metastasis , Neoplasms/surgery , Tissue Preservation/standardsABSTRACT
Patients consented to biobanking studies typically do not specify research conducted on their samples and data. Our objective was to gauge cancer biobanking participant preferences on research topics. Patient-participants of a biobanking study at a comprehensive cancer center who had an appointment within the last 5 years, had a valid email address, and with a last known vital status of alive, were emailed a newsletter containing a link to a survey about preferences and priorities for research. The survey assessed demographics and research interest in three domains: cancer site, cancer-related topics, and issues faced by cancer patients. 37,384 participants were contacted through email to participate in the survey. 16,158 participants (43.2%) opened the email, 1,626 (4.3% overall, 10% of those who opened the email) completed the survey, and 1,291 (79.4% of those who completed the survey) selected at least one research priority. Among those who selected at least one research priorities for cancer-relevant topics, the most commonly selected were cancer treatment (66%), clinical trials (54%), and cancer prevention (53%). Similarly, the most selected priorities for cancer-related issues faced by patients were physical side effects of cancer (57%), talking to the oncologist (53%), and emotional challenges due to cancer (47%). Differences by gender were observed, with females reporting more interest in research generally. Cancer patients participating in a biobanking protocol prioritized research on treatments, prevention and side effects, which varied by gender.
Subject(s)
Biological Specimen Banks/organization & administration , Neoplasms/therapy , Patient Preference/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Biological Specimen Banks/standards , Education , Electronic Mail/statistics & numerical data , Female , Humans , Male , Middle Aged , Neoplasms/diagnosis , Registries , Research , Surveys and Questionnaires , Young AdultSubject(s)
Biological Specimen Banks/ethics , Genetic Testing/ethics , Social Discrimination/prevention & control , Biological Specimen Banks/legislation & jurisprudence , Biological Specimen Banks/standards , China , Europe , Genetic Testing/legislation & jurisprudence , Genetic Testing/standards , Human Genetics/organization & administration , Human Rights , Humans , Social Discrimination/trends , Societies, Scientific/standardsABSTRACT
Primary progenitor cell types adequately isolated from fetal tissue samples present considerable therapeutic potential for a wide range of applications within allogeneic musculoskeletal regenerative medicine. Progenitor cells are inherently differentiated and extremely stable in standard bioprocessing conditions and can be culture-expanded to establish extensive and robust cryopreserved cell banks. Stringent processing conditions and exhaustive traceability are prerequisites for establishing a cell source admissible for further cGMP biobanking and clinical-grade production lot manufacture. Transplantation programs are ideal platforms for the establishment of primary progenitor cell sources to be used for manufacture of cell therapies or cell-based products. Well-defined and regulated procurement and processing of fetal biopsies after voluntary pregnancy interruptions ensure traceability and safety of progeny materials and therapeutic products derived therefrom. We describe herein the workflows and specifications devised under the Swiss Fetal Progenitor Cell Transplantation Program in order to traceably isolate primary progenitor cell types in vitro and to constitute Parental Cell Banks fit for subsequent industrial-scale cGMP processing. When properly devised, derived, and maintained, such cell sources established after a single organ donation can furnish sufficient progeny materials for years of development in translational musculoskeletal regenerative medicine.