Ethical Principles for Research Governance of Biobanks

2006 ◽  
Vol 3 (6) ◽  
Author(s):  
Don Chalmers
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Large Scale ◽  
Genetic Research ◽  
Pharmaceutical Research ◽  
Epidemiological Studies ◽  
Pharmaceutical Companies ◽  
Tissue Samples ◽  
Causes Of Disease ◽  
Ethics Council

AbstractBiobanks of collected human tissue samples are rapidly expanding and becoming „essential tools in translating biomedical research into real improvements in health care”. Biobanks are rich sources for genetic research. The German National Ethics Council has noted, for example, the potential of biobanks for the identification of causes of disease and for breakthroughs in medical and pharmaceutical research. Unsurprisingly, many pharmaceutical companies operate biobank collections for research purposes and to enrol suitable clinical trial recruits so as to minimise side effects and achieve better results. Biobanks are also essential tools for conducting large-scale epidemiological studies, involving whole populations (with the neologism „epigenetic”). One commentator has noted that biobanks are invariably ”staggeringly expensive”

scholarly journals Transcriptomic resources for prairie grass (Bromus catharticus): expressed transcripts, tissue-specific genes, and identification and validation of EST-SSR markers

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ming Sun ◽  
Zhixiao Dong ◽  
Jian Yang ◽  
Wendan Wu ◽  
Chenglin Zhang ◽  
...  
Keyword(s):  
Genetic Diversity ◽  
Ssr Markers ◽  
Large Scale ◽  
Genetic Research ◽  
High Yield ◽  
Yield Strain ◽  
Tissue Samples ◽  
Prairie Grass ◽  
The Future ◽  
Genomic Resource

Abstract Background Prairie grass (Bromus catharticus) is a typical cool-season forage crop with high biomass production and fast growth rate during winter and spring. However, its genetic research and breeding has remained stagnant due to limited available genomic resources. The aim of this study was to generate large-scale genomic data using high-throughput transcriptome sequencing, and perform a preliminary validation of EST-SSR markers of B. catharticus. Results Eleven tissue samples including seeds, leaves, and stems were collected from a new high-yield strain of prairie grass BCS1103. A total of 257,773 unigenes were obtained, of which 193,082 (74.90%) were annotated. Comparison analysis between tissues identified 1803, 3030, and 1570 genes specifically and highly expressed in seed, leaf, and stem, respectively. A total of 37,288 EST-SSRs were identified from unigene sequences, and more than 80,000 primer pairs were designed. We synthesized 420 primer pairs and selected 52 ones with high polymorphisms to estimate genetic diversity and population structure in 24 B. catharticus accessions worldwide. Despite low diversity indicated by an average genetic distance of 0.364, the accessions from South America and Asia and wild accessions showed higher genetic diversity. Moreover, South American accessions showed a pure ancestry, while Asian accessions demonstrated mixed internal relationships, which indicated a different probability of gene flow. Phylogenetic analysis clustered the studied accessions into four clades, being consistent with phenotypic clustering results. Finally, Mantel analysis suggested the total phenotypic variation was mostly contributed by genetic component. Stem diameter, plant height, leaf width, and biomass yield were significantly correlated with genetic data (r > 0.6, P < 0.001), and might be used in the future selection and breeding. Conclusion A genomic resource was generated that could benefit genetic and taxonomic studies, as well as molecular breeding for B. catharticus and its relatives in the future.

THE ROAD AHEAD TO CURE AND PREVENT ALZHEIMER’S DISEASE: IMPLEMENTING PREVENTION INTO PRIMARY CARE

2015 ◽  
pp. 1-11
Author(s):  
B. Fougère ◽  
B. Vellas ◽  
J. Delrieu ◽  
A.J. Sinclair ◽  
A. Wimo ◽  
...  
Keyword(s):  
Primary Care ◽  
Health Care ◽  
Cognitive Impairment ◽  
Primary Care Physicians ◽  
Large Scale ◽  
Objective Assessment ◽  
Epidemiological Studies ◽  
Cognitive Status ◽  
Cognitive Screening ◽  
Cognitive Complaint

Most old adults receive their health care from their primary care practitioner; as a consequence, as the population ages, the manifestations and complications of cognitive impairment and dementia impose a growing burden on providers of primary care. Current guidelines do not recommend routine cognitive screening for older persons by primary care physicians, although the vast majority recommend a cognitive status assessment and neurological examination for subjects with a cognitive complaint. Also, no clinical practice guidelines recommend interventions in older adults with cognitive impairment in primary care settings. However, primary care physicians need to conduct a review of risks and protective factors associated with cognitive decline and organize interventions to improve or maintain cognitive function. Recent epidemiological studies have indicated numerous associations between lifestyle-related risk factors and incidental cognitive impairment. The development of biomarkers could also help in diagnosis, prognosis, selection for clinical trials, and objective assessment of therapeutic responses. Interventions aimed at cognitive impairment prevention should be pragmatic and easy to implement on a large scale in different health care systems, without generating high additional costs or burden on participants, medical and social care teams.

Transcriptomic resources for prairie grass (Bromus catharticus): expressed transcripts, tissue-specific genes, and identification and validation of EST-SSR markers

2021 ◽  
Author(s):  
Ming Sun ◽  
Zhixiao Dong ◽  
Jian Yang ◽  
Wendan Wu ◽  
Chenglin Zhang ◽  
...  
Keyword(s):  
Genetic Diversity ◽  
Ssr Markers ◽  
Large Scale ◽  
Genetic Research ◽  
High Yield ◽  
Yield Strain ◽  
Tissue Samples ◽  
Prairie Grass ◽  
The Future ◽  
Genomic Resource

Abstract Background: Prairie grass (Bromus catharticus) is a typical cool-season forage crop with high biomass production and fast growth rate during winter and spring. However, its genetic research and breeding has remained stagnant due to limited available genomic resources. The aim of this study was to generate large-scale genomic data using high-throughput transcriptome sequencing, and perform a preliminary validation of EST-SSR markers of B. catharticus.Results: Eleven tissue samples including seeds, leaves, and stems were collected from a new high-yield strain of prairie grass BCS1103. A total of 257,773 unigenes were obtained, of which 193,082 (74.90%) were annotated. Comparison analysis between tissues identified 1803, 3030, and 1570 genes specifically expressed in the seed, leaf, and stem, respectively. A total of 37,288 EST-SSRs were identified from unigene sequences, and more than 80,000 primer pairs were designed. We synthesized 420 primer pairs and selected 52 ones with high polymorphisms to estimate genetic diversity and population structure in 24 B. catharticus accessions worldwide. Despite low diversity indicated by an average genetic distance of 0.358, the accessions from South America and Asia and wild accessions showed higher genetic diversity. Moreover, South American accessions showed a pure ancestry, but Asian accessions demonstrated mixed relationships, which indicated a different probability of gene flow among the two regions. Phylogenetic analysis clustered the studied accessions into four clades. Finally, phenotypic clustering and Mantel analysis suggested the total phenotypic variation was mostly contributed by the genetic component. Stem diameter, plant height, leaf width, and biomass yield significantly correlated with genetic data (r > 0.6, P < 0.001), and might be genetically stable in the future selection and breeding.Conclusion: A genomic resource was generated that could benefit genetic and taxonomic studies, as well as molecular breeding for B. catharticus and it relatives in the future.

scholarly journals Systematiske oversikter og epidemiologisk forskning

2013 ◽  
Vol 23 (2) ◽  
Author(s):  
Inger Natvig Norderhaug
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Systematic Reviews ◽  
Epidemiological Studies ◽  
English Summary ◽  
International Consensus ◽  
Health Care Interventions ◽  
Study Protocols ◽  
Causes Of Disease ◽  
Meta Analyses

<p>En god helsetjeneste forutsetter god kunnskap som grunnlag for de valg som gjøres. Systematiske oversikter som sammenfatter tilgjengelig forskningsbasert kunnskap er en viktig del av beslutningsgrunnlaget, enten det er snakk om effektene av tiltak, hvorfor sykdom oppstår, diagnostikk, prognose, eller hvordan sykdom oppleves for dem som rammes.</p><p>Systematiske oversikter er blitt en vel anerkjent kilde for kunnskap om effekt av helsetiltak, med bred internasjonal enighet om metodene som bør benyttes ved utvikling av slike oversikter. Når det gjelder systematiske oversikter for å sammenfatte resultater fra epidemiologisk forskning på årsaksspørsmål er erfaringene langt mindre.</p><p>Samtidig som systematiske oversikter over epidemiologiske studier i større grad bør inngå i beslutningsprosesser, er det et betydelig behov for metodeutvikling. Dette gjelder særlig kriterier for vurdering av kvalitet på epidemiologiske studier, metoder for sammenfatning av resultater i metaanalyser og kriterier for å gradere tillit til de endelige estimatene. Publikasjonsskjevheter er en utfordring for all forskning, og det er behov for initiativ for å sikre bedre rapportering av funn fra epidemiologiske studier, blant annet publisering av studieprotokoller.</p><p>Norderhaug IN. <strong>Systematic reviews of epidemiological research</strong>. <em>Nor J Epidemiol</em> 2013; <strong>23</strong> (2): 125-130.</p><p><strong>ENGLISH SUMMARY</strong></p><p>In health care, good knowledge is key to sound decision making. Good management of knowledge can be achieved through systematic reviews for various questions including the effects of health care interventions, causes of disease, how to best diagnose diseases, prognosis, as well as people’s experiences from living with disease.</p><p>Systematic reviews are well recognized and valued resources to inform decisions regarding health care interventions. Furthermore there is broad international consensus on methods for conducting systematic reviews on the effects of health care interventions. Although the need for systematic reviews is recognized also for epidemiological questions, such as the causes of disease, the level of experience in this area is far less than for systematic reviews on the effects of interventions.</p><p>Thus, alongside the need for better integration of systematic reviews in epidemiology into health care decision making processes, methodological developments are needed, particularly on how to assess the quality of epidemiological studies, methods for combining the results in meta-analyses, and criteria for grading our confidence in the final estimates.</p><p>Publication bias is a problem in all research, and initiatives are needed to improve planning and reporting of epidemiological studies, such as publication of study protocols.</p>

Currents in Contemporary Ethics

2003 ◽  
Vol 31 (3) ◽  
pp. 450-454 ◽  
Author(s):  
Mary R. Anderlik ◽  
Mark A. Rothstein
Keyword(s):  
Health Care ◽  
Financial Support ◽  
Large Scale ◽  
University Of California ◽  
Pharmaceutical Companies ◽  
Research Subjects ◽  
Commercial Development ◽  
New Developments ◽  
Financial Gain ◽  
The University

In financial disputes involving research, the parties are traditionally individual researchers and their institutions, biotech and pharmaceutical companies, and other entities engaged in the commercial development of biomedical research. Occasionally, research subjects claim that researchers have misled them or misappropriated their biological materials to derive financial gain. The best known example is the case of Moore v. Regents of the University of California, decided in 1990.With new developments in genomics, large-scale repositories of tissue and other biological specimens are increasingly important. Biobanks have been established by various researchers, commercial entities, health-care institutions, and even entire countries. Individuals who contribute specimens almost always retain no commercial interest in any resulting research and language to that effect is now customarily included in informed consent documents signed at the time the specimen is given. Suppose, however, that the research subjects actually collect the specimens themselves, recruit the researcher, and provide financial support for the research.

scholarly journals Relationship between Bacillus Calmette Guerin Vaccination Policy and Coronavirus Disease-2019 (COVID-19) Incidence

2021 ◽  
Author(s):  
Soheila Alyasin ◽  
Zahra Kanannejad ◽  
Hossein Esmaeilzadeh ◽  
Hesamedin Nabavizadeh ◽  
Mohammad Amin Ghatee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Large Scale ◽  
Mortality Rates ◽  
Epidemiological Studies ◽  
Bcg Vaccine ◽  
Confounding Factors ◽  
Protective Effects ◽  
Bacillus Calmette Guerin ◽  
Vaccination Policy ◽  
Bcg Vaccination

Bacillus Calmette Guerin (BCG) was designed for protecting children against tuberculosis. Also, it can protect against other infectious diseases through the induction of trained immunity. Due to its heterologous protective effects, the BCG vaccine has been proposed as a treatment option for coronavirus disease-2019 (COVID-19). Epidemiological studies have found that countries without BCG vaccination policy have experienced higher mortality rates related to COVID-19 infection than those with BCG vaccination policy. However, there are some confounding factors such as age, population intensity, immigration, the pandemic phase, and data accuracy that may affect these results. Therefore, this hypothesis should be evaluated by clinical trial studies. Large-scale clinical trials are in progress to investigate if the BCG vaccine could be used as a useful tool for protection against COVID-19 infection.

scholarly journals Lack of an association between gallstone disease and bilirubin levels with risk of colorectal cancer: a Mendelian randomisation analysis

2021 ◽  
Author(s):  
Richard Culliford ◽  
Alex J. Cornish ◽  
Philip J. Law ◽  
Susan M. Farrington ◽  
Kimmo Palin ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Large Scale ◽  
Causal Effect ◽  
Gallstone Disease ◽  
Epidemiological Studies ◽  
Mendelian Randomisation ◽  
Linear Relationships ◽  
Potential Risk Factors ◽  
The Relationship ◽  
Circulating Levels

Abstract Background Epidemiological studies of the relationship between gallstone disease and circulating levels of bilirubin with risk of developing colorectal cancer (CRC) have been inconsistent. To address possible confounding and reverse causation, we examine the relationship between these potential risk factors and CRC using Mendelian randomisation (MR). Methods We used two-sample MR to examine the relationship between genetic liability to gallstone disease and circulating levels of bilirubin with CRC in 26,397 patients and 41,481 controls. We calculated the odds ratio per genetically predicted SD unit increase in log bilirubin levels (ORSD) for CRC and tested for a non-zero causal effect of gallstones on CRC. Sensitivity analysis was applied to identify violations of estimator assumptions. Results No association between either gallstone disease (P value = 0.60) or circulating levels of bilirubin (ORSD = 1.00, 95% confidence interval (CI) = 0.96–1.03, P value = 0.90) with CRC was shown. Conclusions Despite the large scale of this study, we found no evidence for a causal relationship between either circulating levels of bilirubin or gallstone disease with risk of developing CRC. While the magnitude of effect suggested by some observational studies can confidently be excluded, we cannot exclude the possibility of smaller effect sizes and non-linear relationships.

scholarly journals Multimorbidity clusters in patients with chronic obstructive airway diseases in the EpiChron Cohort

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jonás Carmona-Pírez ◽  
Beatriz Poblador-Plou ◽  
Ignatios Ioakeim-Skoufa ◽  
Francisca González-Rubio ◽  
Luis Andrés Gimeno-Feliú ◽  
...  
Keyword(s):  
Substance Use ◽  
Chronic Conditions ◽  
Large Scale ◽  
Mental Health Problems ◽  
Epidemiological Studies ◽  
Chronic Obstructive ◽  
High Morbidity ◽  
Airway Diseases ◽  
Obstructive Sleep ◽  
Obstructive Airway Diseases

AbstractChronic obstructive airway diseases such as chronic obstructive pulmonary disease (COPD), asthma, rhinitis, and obstructive sleep apnea (OSA) are amongst the most common treatable and preventable chronic conditions with high morbidity burden and mortality risk. We aimed to explore the existence of multimorbidity clusters in patients with such diseases and to estimate their prevalence and impact on mortality. We conducted an observational retrospective study in the EpiChron Cohort (Aragon, Spain), selecting all patients with a diagnosis of allergic rhinitis, asthma, COPD, and/or OSA. The study population was stratified by age (i.e., 15–44, 45–64, and ≥ 65 years) and gender. We performed cluster analysis, including all chronic conditions recorded in primary care electronic health records and hospital discharge reports. More than 75% of the patients had multimorbidity (co-existence of two or more chronic conditions). We identified associations of dermatologic diseases with musculoskeletal disorders and anxiety, cardiometabolic diseases with mental health problems, and substance use disorders with neurologic diseases and neoplasms, amongst others. The number and complexity of the multimorbidity clusters increased with age in both genders. The cluster with the highest likelihood of mortality was identified in men aged 45 to 64 years and included associations between substance use disorder, neurologic conditions, and cancer. Large-scale epidemiological studies like ours could be useful when planning healthcare interventions targeting patients with chronic obstructive airway diseases and multimorbidity.

scholarly journals Implementing an Integrated Large-Scale Clinical Information System for ISSSTE’s Hospital Network in Mexico

2021 ◽  
Vol 3 (2) ◽  
pp. 444-453
Author(s):  
Arturo Cervantes Trejo ◽  
Sophie Domenge Treuille ◽  
Isaac Castañeda Alcántara
Keyword(s):  
Health Care ◽  
Information System ◽  
Health Care Services ◽  
Large Scale ◽  
Clinical Information System ◽  
Clinical Information ◽  
Public Hospitals ◽  
Care Services ◽  
Cost Reductions

AbstractThe Institute for Security and Social Services for State Workers (ISSSTE) is a large public provider of health care services that serve around 13.2 million Mexican government workers and their families. To attain process efficiencies, cost reductions, and improvement of the quality of diagnostic and imaging services, ISSSTE was set out in 2019 to create a digital filmless medical image and report management system. A large-scale clinical information system (CIS), including radiology information system (RIS), picture archiving and communication system (PACS), and clinical data warehouse (CDW) components, was implemented at ISSSTE’s network of forty secondary- and tertiary-level public hospitals, applying global HL-7 and Digital Imaging and Communications in Medicine (DICOM) standards. In just 5 months, 40 hospitals had their endoscopy, radiology, and pathology services functionally interconnected within a national CIS and RIS/PACS on secure private local area networks (LANs) and a secure national wide area network (WAN). More than 2 million yearly studies and reports are now in digital form in a CDW, securely stored and always available. Benefits include increased productivity, reduced turnaround times, reduced need for duplicate exams, and reduced costs. Functional IT solutions allow ISSSTE hospitals to leave behind the use of radiographic film and printed medical reports with important cost reductions, as well as social and environmental impacts, leading to direct improvement in the quality of health care services rendered.

scholarly journals Multicenter Evaluation of an ELISA for the Detection of Cryptosporidium spp. Antigen in Clinical Human Stool Samples

2021 ◽  
Vol 9 (2) ◽  
pp. 209
Author(s):  
Romy Razakandrainibe ◽  
Célia Mérat ◽  
Nathalie Kapel ◽  
Marc Sautour ◽  
Karine Guyot ◽  
...  
Keyword(s):  
Large Scale ◽  
Cryptosporidium Oocyst ◽  
Clinical Importance ◽  
Epidemiological Studies ◽  
Elisa Test ◽  
Enzyme Linked Immunosorbent Assay ◽  
Cryptosporidium Spp ◽  
Stool Samples ◽  
Conventional Microscopy ◽  
Human Stool

Human cryptosporidiosis remains underdiagnosed, and rapid/accurate diagnosis is of clinical importance. Diagnosis of the Cryptosporidium oocyst in stool samples by conventional microscopy is labor-intensive, time-consuming, and requires skillful experience. Thus, we aimed to evaluate the usefulness of a coproantigen enzyme-linked immunosorbent assay (ELISA) test in detecting Cryptosporidium spp. from fecal specimens. For this aim, we evaluated the performances of a commercial ELISA (CoproELISA Cryptosporidium kit, Savyon Diagnostics, Israel) for the detection of Cryptosporidium spp. in random clinical stool samples through a multicenter study. The sensitivity and specificity for coproantigen ELISA were 98.86% and 94.32%, respectively. The coproantigen ELISA results indicate that the simple, rapid, reliable, and standardized immunoassay test is sensitive and specific for routine diagnosis, and may be useful for large-scale epidemiological studies of cryptosporidiosis.

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