Ethical Management Experience and Enlightenment of Finnish Red Cross Blood Center Biobank / 中国医学伦理学

To strengthen the ethical management of blood samples for scientific research in blood collection and supply institutions, promote the effective use of blood sample resources, and protect the rights and interests of blood donors. Drawing on the experience of the Finnish Red Cross Blood Center biobank which has rich experience in management and recruitment, this paper summarized from the aspects of extensive informed consent, management of sample data, application of biological samples and data, and ethical management of research projects, and put forward the enlightenment to improve the ethical management of blood samples in blood collection and supply institutions, including further improving the construction of ethical laws and regulations, strengthening the ethical review norms of the ethics committee, standardizing the use of informed consent, and enhancing the privacy protection of blood donors.

Standardized establishment and informationized management of liver cancer biobank / 临床肝胆病杂志

Objective To establish a small liver cancer biobank with a standard operating procedure and the function of informationized management. Methods According to the inclusion and exclusion criteria, blood, tissue, and stool samples were collected from the patients with liver cancer who attended Liver Surgery Center, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, from August 2012 to December 2020 and signed the informed consent. In-and-out-of-storage management was performed based on the standard procedure for whole blood, serum, frozen tissue, paraffin-embedded tissue, and stool samples, and related clinical and follow-up data were collected. The frozen samples of liver cancer tissue and adjacent tissue in different years were randomly selected, and the concentration and completeness of total RNA were examined to ensure the quality of frozen samples stored in the biobank. Results The samples were collected from 4190 liver cancer patients who underwent surgery within a period of 101 natural months, and there were 41718 frozen tissue samples, 18950 paraffin-embedded tissue samples, 24389 whole blood samples, 20060 serum samples, and 5392 stool samples. The liver cancer patients had an age range of 13-88 years, and male patients accounted for 85.1%. The patients with hepatitis B accounted for 83.3%, and those with liver cirrhosis accounted for 73.5%. A standard operating procedure and an electronic data capture system were developed according to the collection, processing, storage, application, and informationized management of samples. Among the 18 frozen tissue samples randomly selected from the biobank, 16 samples had high RNA quality, which could meet the requirements of subsequent experiments. Conclusion A standardized and informationized biobank has been established for liver cancer, which provides high-quality samples for the basic research on liver cancer and helps to explore the research value of samples.

The standardization construction and quality management of colorectal neoplasm tissue sample database in the era of precision medic / 中华医学科研管理杂志

Objective:To establish a standard colorectal neoplasm tissue biobank with complete clinical information to provide high quality samples for fundamental and clinical research of colorectal neoplasm.Methods:Based on Affiliated Jinhua Hospital, Zhejiang University School of Medicine, to conduct structural design of colorectal neoplasm tissues, normal tissues and related information. Establish standard operating procedures from the collection and storage of tissue samples, standardize the entry of basic information, medical history, pathology and other relevant clinical information of the patients, and conduct random quality inspections on the pathological morphology and molecular level on a regular basis.Results:A tissue biobank of colorectal neoplasm was successfully constructed. During the establishment and improvement of this tissue biobank, standardized quality control was implemented during the whole-process including sample collection, warehousing, storage and delivery. According to the random sampling quality inspection, the RNA preservation effect was good, the rates of neoplasms in cancer tissue was >80%, and the clinical data of samples were complete.Conclusions:The preliminary construction of colorectal neoplasm tissue biobank not only improves the utilization value of tissue samples, but also provides a guarantee for realizing the bidirectional transformation of fundamental research and clinical application.

Discussion on the sharing mechanism of cerebration of constructing the sharing platform for respiratory disease biobank / 中华医学科研管理杂志

Objective:Standardized sample resources and high-quality clinical big data are important resources for medical research, only through resource sharing can maximize its utilization.Which can be utilized to the max only through resource sharing.Methods:This paper attempts to explore the sharing mechanism of the resource sharing platform and proposes some aspects such as the platform construction background, management regulations, legal ethical system, data sharing principles, benefit distribution, etc.This article attempts to explore the sharing mechanism based on the resource sharing platform of the respiratory disease biobank, proposes the contents that should be included in the sharing mode.Detailed information including the platform construction background, management procedures, legal and ethical system, data sharing principles and benefit distribution should take into consideration in the operating mechanism of the platform.Results:Establishing a resource sharing platform matches the development of clinical research in China.The tailored sharing model which is suitable for the field of respiratory diseases will also guide the rapid development of clinical research.Conclusions:The construction of a respiratory disease biobank sharing platform is conducive to promoting the opening and sharing of biological samples and information resources in the context of big data.

A review on the application of UK Biobank in neuroimaging / 生物医学工程学杂志

UK Biobank (UKB) is a forward-looking epidemiological project with over 500, 000 people aged 40 to 69, whose image extension project plans to re-invite 100, 000 participants from UKB to perform multimodal brain magnetic resonance imaging. Large-scale multimodal neuroimaging combined with large amounts of phenotypic and genetic data provides great resources to conduct brain health-related research. This article provides an in-depth overview of UKB in the field of neuroimaging. Firstly, neuroimage collection and imaging-derived phenotypes are summarized. Secondly, typical studies of UKB in neuroimaging areas are introduced, which include cardiovascular risk factors, regulatory factors, brain age prediction, normality, successful and morbid brain aging, environmental and genetic factors, cognitive ability and gender. Lastly, the open challenges and future directions of UKB are discussed. This article has the potential to open up a new research field for the prevention and treatment of neurological diseases.

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BACKGROUND@#Particulate matter (PM) < 2.5 μm (PM@*METHODS@#We obtained DNA methylation and exercise data of 496 participants (aged between 30 and 70 years) from the Taiwan Biobank (TWB) database. We also extracted PM@*RESULTS@#DLEC1 methylation and PM@*CONCLUSIONS@#We found significant positive associations between PM

Bibliometric analysis of Biobank based on Web of ScienceTM / 中华医学科研管理杂志

Objective To provide evidence for the long-term development of biobank in China,we retrieved literature on biobank for analyzing the development status and trend of Biobank in the world and China.Methods Using the topic of "Biobank" to search articles from 2008 to 2017 in the core collection of Web of ScienceTM,we conducted statistical analysis covering the annual published quantity,the corresponding national/regional distribution,h-index,and the authors of these articles.Results A total number of 2012 articles on Biobank published from 2008 to 2017 were retrieved from the core collection of Web of ScienceTM,in which the annual published quantity on Biobank in the world and China was basically similar,and was on the upward trend;among them,the top three countries/regions with the published quantity were United States,England and China;the top three countries/regions with the h-index were United States,England and the Netherlands,and China ranked fifth;the cooperation degree and co-authorship rate of the authors in China were higher than that in the world.Conclusions The annual growth trend of published quantity on Biobank in China is basically consistent with that in the world.Chinese Biobank plays an important role in the world,and the Chinese researchers on biobank attach more importance to cooperation.However,the scientific research achievements with significant academic influence need to be further improved.Therefore,in order to build a standardized and high-quality biobank,Chinese biobank still needs innovation and exploration continuously.

Use of the ACP® and BTS extenders for cooling at 15°C white-lipped peccary (Tayassu pecari) semen / Uso dos diluidores ACP® e BTS para refrigeração a 15°C de sêmen de queixada (Tayassu pecari)

Knowledge about reproduction of white-lipped peccary is of great importance to assist with the conservation of this species and enable its rational use in captivity. This study aimed to evaluate the effect of ACP-103®, ACP-116® and BTS semen extenders on sperm viability during cooling of Tayassu pecari semen. Five ejaculates from four adult males were chilled. The animals were submitted to the protocols of sedation and anesthesia for semen collection by the electroejaculation method. After collection, the semen was macro- and microscopically assessed and diluted to reach 35x106 spermatozoa/mL in each of the three different extenders tested. The fresh-extended semen was packed in a BotuFLEX® thermal box to keep samples at 15°C for 24 hours. After cooling, the following semen parameters were analyzed: sperm motility, functional and structural integrity of sperm membranes, mitochondrial activity, chromatin condensation, and the thermoresistance test was performed. The parameters sperm motility, structural and functional integrity of sperm membranes, mitochondrial activity, and chromatin condensation were preserved after use of the extenders tested, and were similar to those of in natura semen (p>0.05). Curvilinear velocity (VCL) (p<0.05) was the only parameter with reduced values after cooling regardless of the extender used. The percentage of sperm with normal morphology was greater in samples cooled using the BTS extender (p<0.05). The ACP-103®, ACP-116® and BTS extenders can be used for the cooling and preservation of white-lipped peccary semen at 15°C for 24 hours.(AU)

Para auxiliar na conservação da espécie e permitir o uso racional do queixada em cativeiro é de grande importância o conhecimento sobre a reprodução da espécie. Objetivou-se avaliar o efeito dos diluidores de sêmen ACP-103®, ACP-116® e BTS na viabilidade espermática durante a refrigeração do sêmen do Tayassu pecari. Foram refrigerados cinco ejaculados provenientes de quatro machos adultos. Os animais foram contidos com auxílio de puçá e submetidos ao protocolo de sedação e anestesia para realização da coleta de sêmen pelo método da eletroejaculação. Depois da coleta, o sêmen foi avaliado macro e microscopicamente e diluído para atingir 35x106 espermatozoides/mL em cada um dos três diferentes diluidores testados. O sêmen diluído foi acondicionado em caixa térmica BotuFLEX® para manter as amostras a 15°C por um período de 24 horas. Depois da refrigeração, os espermatozoides foram avaliados quanto aos parâmetros de movimento espermático, integridade funcional e estrutural das membranas espermáticas, atividade mitocondrial, condensação da cromatina e teste de termorresistência. Os diluidores testados preservaram as características cinéticas, a integridade estrutural e funcional das membranas espermáticas, a atividade mitocondrial e a condensação da cromatina semelhante ao sêmen in natura (P>0,05). O único parâmetro que reduziu com o processo de refrigeração independente do diluidor utilizado foi a Velocidade Curvilinear (VCL) (P<0,05). Foi observado aumento do percentual de espermatozoides morfologicamente normais nas amostras refrigeradas em BTS (P<0,05). Os diluidores ACP-103®, ACP-116® e BTS podem refrigerar e conservar o sêmen de queixada a 15°C por 24 horas.(AU)

Analysis of the application mechanism of clinical biobank / 中华医学科研管理杂志

Objective Analyze the application status and existed problems of clinical biobank in China,propose possible application mechanisms for clinical biobank.Methods Through questionnaire survey and case analysis combined with relevant literature reports from home and abroad,conduct qualitative analysis to understand the application status and problems of clinical biobank.Results With the rapid development of biobank,its application rate was far from expected.The construction of clinical database lags behind in China will affect the application of samples.The lag of application mechanism will affect the opening and application of the biobank.Conclusions At the beginning of construction,the clinical biobank should take full account of what and how resources can be used,and establish tailored application mechanism.More attention should be paid to the possible benefit of biobank construction.

Bibliometric analysis of biobank based on Web of ScienceTM / 中华医学科研管理杂志

Objective To provide evidence for the long-term development of biobank in China,we retrieved literature on biobank for analyzing the development status and trend of biobank in the world and China.Methods Using the topic of "Biobank" to search articles from 2008 to 2017 in the core collection of Web of ScienceTM,we conducted statistical analysis covering the annual published quantity,the corresponding national/regional distribution,h-index,and the authors of these articles.Results A total number of 2012 articles on biobank published from 2008 to 2017 were retrieved from the core collection of Web of ScienceTM,in which the annual published quantity on biobank in the world and China was basically similar,and was on the upward trend;among them,the top three countries/regions with the published quantity were United States,England and China;the top three countries/regions with the h-index were United States,England and the Netherlands,and China ranked fifth;the cooperation degree and co-authorship rate of the authors in China were higher than that in the world.Conclusions The annual growth trend of published quantity on biobank in China is basically consistent with that in the world.Chinese biobank plays an important role in the world,and the Chinese researchers on biobank attach more importance to cooperation.However,the scientific research achievements with significant academic influence need to be further improved.Therefore,in order to build a standardized and high-quality biobank,Chinese biobank still needs innovation and exploration continuously.

Construction of Biobank based on the real world study / 中华医学科研管理杂志

Objective To explore the strategies of constructing clinical biobank based on the real world study.Methods Biospecimens have been collected since November 2014,as well as continuingly construction of the biobank resources to match the implenmentation of real world study.Related measurements adopted including standardized ethical management,quality control,automated data management,and follow-up management.Results Biospecimens and clinical data information were collected with high quality according to standard SOPs.Sophisticated equipment and data automation management mode were used to make sure the protection of patient privacy and data security.At the same time,biospecimens and data information management system were improved gradually to fulfill the integration and sharing of biospecimen data resources.Conclusions Biorepositories are the key to translational medical research,biospecimens collected in our biobank will link with clinical data information simultaneously,which increase the resource pool that can be applied in real world study.

Discussion on Ethical Supervision and Informed Consent of Biobank / 中国医学伦理学

With the constant deepening of medical research and the need of translational medicine,it is neces-sary to normalize the construction of biobank with high - standard. However,there are no issued ethical guideline and standard for biobank in China at present. Based on this,this paper expounded the related ethical guidelines for biological samples and the review and supervision of ethics committee,and deeply expounded the issues of informed consent related to biobank,that is,the informed information of informed consent,the need to get explicit consent from the donor when collect,preserve and use the biological samples and the mode of informed consent,in order to lay the foundation for the future development of standards and norms.

Quality control of biobank / 医学研究生学报

The main duty of biobank is collecting,storing and managing biospecimen. The use of high-quality biospecimen is a key factor in the further development of translational medicine. To ensure utilizing limited and precious biospecimen more efficiently, and the accuracy,comparability and repeatability of research consequences,it is important to put a high premium on the quality control of biobank. Some countries have already paid attention to the establishment of the quality control system of biobank,however,the inter-national organizations have not reached an acknowledged consensus so far. This paper briefly reviews the quality control of operating procedure,biospecimen,clinical data and quality control report of the biobank.

International experience research on biobank sharing / 中华医学科研管理杂志

Objective Successful experience of biobank sharing in several developed countries or areas are analyzed to provide some reference for China.Methods This article reviews the sharing measures of biobanks in some developed countries or areas,such as United States,European Union countries,and summaries their successful experience on organization structure,operating mechanism and corresponding service.Results Based on their own characteristics,suitable sharing organizational structunes,unified standards and pubilc information platforms have been established in these developed countries.They kept improving the sharing rules and processes,as well as corresponding service.Conclusions As to the problems of biobank sharing in China,we suggest that we should establish the system of resources sharing,make standards of biobank building,promote the standardization of the existing biobanks,construct the national information platform and formulate favorable polices for biobank sharing.

Analysis on clinical Bio-Bank quality construction mechanism / 中华医学科研管理杂志

Objective Based on Total Quality Management (TQM) theory,our study aims to analyze the clinical Bio-Bank overall quality management implications,basic characteristics,principles,and management mechanisms,and provide theoretical basis for the clinical Bio-Bank quality construction.Methods Using theoretical and literature research methods,Bio-Bank overall quality management qualitative analysis was conducted,putting forward a framework of Bio-Bank comprehensive quality management.Results Biological sample overall quality management was defined theoretically including its connotation,concepts and basic characteristics.We also put forward an application principle and basic operation method at the application level.Conclusions Total Quality Management (TQM) is applied to the clinical Bio-Bank construction,from where,the scientific and unique management content can effectively optimize the Bio-Bank management regulation and standardization of the sample operation process in the PDCA cycle,which is critical to improve the quality of clinical Bio-Bank.

Construction and application of malaria biobank / 中国血吸虫病防治杂志

To establish a systemized malaria biobank with well-rounded epidemiologic data and a computer-aid management system, thus to provide qualified sources for malaria elimination and human malaria research.The malaria biobank was based on the platform of Jiangsu Institute of Parasitic Diseases. The blood smear samples, dried blood samples, whole blood samples and parasite strains isolated from patients (from both local and imported cases) were collected since 2011 according to a standardized operational procedure. The biobank management software was applied to input of the epidemiological data and samples, and the quality of samples was monitored regularly.A standard malaria biobank was established. The Information Management System was applied to input, storage and output of samples. Totally 99.42% (2 223/2 236) of the blood smear samples, 92.58% (2 070/2 236) of the dried blood samples, 94.50% (2 113/2 236) of whole blood, and 2.06% (46/2 236) of the isolated stains in 2 236 reported cases were included in the malaria biobank in Jiangsu Province from 2011 to 2017. Based on the malaria biobank, 99.42% (2 223/2 236) of the blood smears and 82.74% (1 850/2 236) of DNA (from dried blood and whole blood samples) from malaria patients in Jiangsu Province were re-checked. Moreover, the samples in the malaria biobank were used in the studies of the mechanism of parasite drug resistance, malaria molecular epidemiology, and diagnosis technology development and evaluation.The establishment of malaria biobank provides a guarantee for malaria elimination in Jiangsu Province and also provides a qualified resource for malaria research.

Joinville stroke biobank: study protocol and first year's results / Biobanco de acidente cerebrovascular de Joinville: protocolo de estudos e resultados dos primeiros anos

ABSTRACT Aiming to contribute to studies that use detailed clinical and genomic information of biobanks, we present the initial results of the first Latin American Stroke Biobank. Methods: Blood samples were collected from patients included in the Joinville Stroke Registry and four Brazilian cities. Demographic socio-economic data, cardiovascular risk factors, Causative Classification System for Ischemic Stroke, Trial of Org 10172 in Acute Stroke Treatment and National Institutes of Health scores, functional stroke status (modified Rankin) and brain images were recorded. Additionally, controls from both geographic regions were recruited. High-molecular-weight genomic DNA was obtained from all participants. Results: A total of 2,688 patients and 3,282 controls were included. Among the patients, 76% had ischemic stroke, 12% transient ischemic attacks, 9% hemorrhagic stroke and 3% subarachnoid hemorrhage. Patients with undetermined ischemic stroke were most common according the Trial of Org 10172 in Acute Stroke Treatment (40%) and Causative Classification System for Ischemic Stroke (47%) criteria. A quarter of the patients were under 55 years of age at the first-ever episode. Conclusions: We established the Joinville Stroke Biobank and discuss its potential for contributing to the understanding of the risk factors leading to stroke.

RESUMO Com o objetivo de contribuir para estudos que utilizam informações clínicas e genômicas de biobancos, apresentamos os resultados iniciais do primeiro Biobanco Latinoamericano em Acidente Vascular Cerebral (AVC). Métodos: Foram coletadas amostras de sangue de pacientes recrutados pelo Registro de AVC de Joinville e posteriormente de quatro cidades brasileiras. Foram registrados dados socioeconômicos demográficos, fatores de risco cardiovasculares, Causative Classification System (CCS), Trial of Org 10172 in Acute Stroke Treatment, National Institutes of Health, estado funcional (Rankin modificado) e imagens cerebrais. Adicionalmente, foram recrutados controles das regiões geográficas correspondentes. Obteve-se DNA genômico de todos participantes. Resultados: Foram incluídos 2688 pacientes e 3282 controles. Entre os pacientes, 76% tiveram AVC isquêmico, 12% ataques isquêmicos transitórios, 9% AVC hemorrágico e 3% hemorragia subaracnóidea. Os casos indeterminados foram os mais frequentes e classificados de acordo com TOAST (40%) e CCS (47%). Um quarto dos pacientes tinham menos de 55 anos no primeiro evento. Conclusões: Estabelecemos o Joinville Stroke Biobank, e discutimos aqui seu potencial na compreensão dos fatores de risco do AVC.

Association between body weight change during early and middle adulthood and the risk of type 2 diabetes in middle aged and elderly population / 中华流行病学杂志

Objective To examine the association between weight changes during early and middle adulthood and the risk of type 2 diabetes mellitus in middle aged and elderly population.Methods Based on the Guangzhou Biobank Cohort Study (GBCS),28 736 residents aged ≥50 years were included in Guangzhou.Multivariate logistic regression was used to analyze the association between body weight changes during early or middle adulthood and age when the heaviest weight reaching the threshold on the risk of type 2 diabetes mellitus in middle age or elderly population.Adjustments on age,smoking,alcohol consumption,physical activity,education level,occupation,district of residence and body mass index etc.,were made.Results The mean age was 64.3 (standard deviation=6.7) years in men and 61.0 (standard deviation=7.0) years in women,with the prevalence rates of diabetes as 13.1％ and 13.7％ in men and women,respectively.Compared to those with stable body weight,the risk of diabetes increased with weight gain during early and middle adulthood in both men and women (both P values for trend ＜0.01).Participants who gained more than 20 kg during early and middle adulthood were associated with the highest risk of diabetes in men (OR=2.83,95％ CI:1.99-4.02) and women (OR=3.13,95％CI:2.47-3.96).Compared to those who reached the highest weight at age 20,those who reaching the highest weight at 40 to 49 years were associated with the highest risk of diabetes,with OR being 5.32 (95％CI:1.92-14.8) in men and 3.41 (95％CI:2.49-4.67) in women,respectively.Weight loss in adulthood was associated with self-reported but not newly diagnosed diabetic cases in both middle and older aged men and women.Conclusion Weight gain during early and middle adulthood may increase the risk of diabetes in middle and older aged population.The detrimental effect of obesity on diabetes might become significantly visible in the next decades.

China Hainan Centenarian Cohort Study: study design and preliminary results / 中华流行病学杂志

Objective To investigate the health status,functional ability,mental psychology,health care and other longevity-related characteristics of individuals aged ≥ 100 years as well as risk factors in Hainan province,China.Methods China Hainan Centenarian Cohort Study (CHCCS) is a community-based,prospective cohort study to establish multi-dimensional database consisting of questionnaire findings,anthropometric parameters and biological specimens as well as imaging features.With the household registration information provided by the Department of Civil Affairs of Hainan province,a baseline survey was conducted in centenarians in 18 counties in Hainan with the oldest old in 5 counties as controls between 2014 and 2017.The survey included face to face interview,physical examination and biological specimen collection.After the baseline survey,the participants of CHCCS were followed up at an interval of 2 years to collect the information about their living status,disease status or major death causes.Results According to the information provided by the Department of Civil Affairs of Hainan province in 2014,the survey found that 1 473 centenarians were still living.By December 2016,1 002 of them had agreed to be surveyed.The average age of 722 centenarians with complete information in the baseline survey was (102.7± 2.7) years,the majority of them were females (83.0％),widows (88.8％),in Han ethnic group (84.5％),lived with family members (87.8％),illiterates (89.7％) and farmers (81.0％).Conclusion CHCCS has provided longevity-related information of the large longevity population and collected the valuable and rare biological specimens with great urgency to establish an interdisciplinary platform and base for longevity,senility and healthy aging research.

Ethical Considerations on the Construction and Supervision of Biobank / 中国医学伦理学

The biobank has become an important support to the development of medicine.This article analyzed the necessity of enhancing the ethical management of biobank from the aspects of resource utilization,social cognition and participation,and ethical supervision of its construction.It pointed out strict qualification approval,criteria formulation and regular supervision in ethical intervention,analyzed five existing ethical conflicts in biobank construction,and discussed the main points to be considered in ethical supervision.