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Biomedical testing ethics

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https://www.readbyqxmd.com/read/28399664/ethical-considerations-surrounding-germline-next-generation-sequencing-of-children-with-cancer
#1
Liza-Marie Johnson, Kayla V Hamilton, Jessica M Valdez, Esther Knapp, Justin N Baker, Kim E Nichols
The advent of next-generation sequencing (NGS) has introduced an exciting new era in biomedical research. NGS forms the foundation of current genetic testing approaches, including targeted gene panel testing, as well as more comprehensive whole-exome and whole-genome sequencing. Together, these approaches promise to provide critical insights into the understanding of health and disease. However, with NGS testing come many ethical questions and concerns, particularly when testing involves children. These concerns are especially relevant for children with cancer, where the testing of tumor and germline tissues is increasingly being incorporated into clinical care...
May 2017: Expert Review of Molecular Diagnostics
https://www.readbyqxmd.com/read/28330491/orchestrating-differential-data-access-for-translational-research-a-pilot-implementation
#2
Marco Brandizi, Olga Melnichuk, Raffael Bild, Florian Kohlmayer, Benedicto Rodriguez-Castro, Helmut Spengler, Klaus A Kuhn, Wolfgang Kuchinke, Christian Ohmann, Timo Mustonen, Mikael Linden, Tommi Nyrönen, Ilkka Lappalainen, Alvis Brazma, Ugis Sarkans
BACKGROUND: Translational researchers need robust IT solutions to access a range of data types, varying from public data sets to pseudonymised patient information with restricted access, provided on a case by case basis. The reason for this complication is that managing access policies to sensitive human data must consider issues of data confidentiality, identifiability, extent of consent, and data usage agreements. All these ethical, social and legal aspects must be incorporated into a differential management of restricted access to sensitive data...
March 23, 2017: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/28275345/moral-enhancement-using-non-invasive-brain-stimulation
#3
REVIEW
R Ryan Darby, Alvaro Pascual-Leone
Biomedical enhancement refers to the use of biomedical interventions to improve capacities beyond normal, rather than to treat deficiencies due to diseases. Enhancement can target physical or cognitive capacities, but also complex human behaviors such as morality. However, the complexity of normal moral behavior makes it unlikely that morality is a single capacity that can be deficient or enhanced. Instead, our central hypothesis will be that moral behavior results from multiple, interacting cognitive-affective networks in the brain...
2017: Frontiers in Human Neuroscience
https://www.readbyqxmd.com/read/28104841/human-tissues-in-a-dish-the-research-and-ethical-implications-of-organoid-technology
#4
REVIEW
Annelien L Bredenoord, Hans Clevers, Juergen A Knoblich
The ability to generate human tissues in vitro from stem cells has raised enormous expectations among the biomedical research community, patients, and the general public. These organoids enable studies of normal development and disease and allow the testing of compounds directly on human tissue. Organoids hold the promise to influence the entire innovation cycle in biomedical research. They affect fields that have been subjects of intense ethical debate, ranging from animal experiments and the use of embryonic or fetal human tissues to precision medicine, organoid transplantation, and gene therapy...
January 20, 2017: Science
https://www.readbyqxmd.com/read/28071731/in-silico-experiments-of-zebrafish-behaviour-modeling-swimming-in-three-dimensions
#5
Violet Mwaffo, Sachit Butail, Maurizio Porfiri
Zebrafish is fast becoming a species of choice in biomedical research for the investigation of functional and dysfunctional processes coupled with their genetic and pharmacological modulation. As with mammals, experimentation with zebrafish constitutes a complicated ethical issue that calls for the exploration of alternative testing methods to reduce the number of subjects, refine experimental designs, and replace live animals. Inspired by the demonstrated advantages of computational studies in other life science domains, we establish an authentic data-driven modelling framework to simulate zebrafish swimming in three dimensions...
January 10, 2017: Scientific Reports
https://www.readbyqxmd.com/read/27968834/methylation-loci-associated-with-body-mass-index-waist-circumference-and-waist-to-hip-ratio-in-chinese-adults-an-epigenome-wide-analysis
#6
Biqi Wang, Wenjing Gao, Jun Li, Canqing Yu, Weihua Cao, Jun Lv, Zengchang Pang, Liming Cong, Hua Wang, Xianping Wu, Liming Liang, Tangchun Wu, Liming Li
BACKGROUND: DNA methylation has been implicated in the pathology of obesity, but little is known about such epigenetic variants in Chinese people. We conducted an epigenome-wide analysis of methylation at CpG sites in relation to body mass index (BMI), waist circumference (WC) and waist-to-hip ratio (WHR) among Chinese adult populations. METHODS: 469 twins from the Chinese National Twin Registry were the discovery cohort. After quality control, methylation levels in whole blood leukocyte DNA were tested for association with BMI, WC, and WHR using mixed linear regressions, adjusting for demographics, lifestyle, and family structure...
October 2016: Lancet
https://www.readbyqxmd.com/read/27858217/alternative-animal-and-non-animal-models-for-drug-discovery-and-development-bonus-or-burden
#7
Irlan Almeida Freires, Janaina de Cássia Orlandi Sardi, Ricardo Dias de Castro, Pedro Luiz Rosalen
Mammalian models have served as a basis for R&D over the past decades. Nevertheless, these models are expensive, laborious, may yield results that cannot always be translated into the human in vivo situation and, more recently, have reverberated great social and ethical dilemmas. Hence, the prospect of changes in the global scientific scenario and the Three Rs principle (Reduction, Replacement and Refinement) have encouraged the development of alternative methods to the use of mammals. Despite the efforts, suitable alternative tests are not available in all areas of biomedical research, as regulatory acceptance requires time, prior validation and robust financial and scientific investment...
November 17, 2016: Pharmaceutical Research
https://www.readbyqxmd.com/read/27681358/genome-privacy-challenges-technical-approaches-to-mitigate-risk-and-ethical-considerations-in-the-united-states
#8
Shuang Wang, Xiaoqian Jiang, Siddharth Singh, Rebecca Marmor, Luca Bonomi, Dov Fox, Michelle Dow, Lucila Ohno-Machado
Accessing and integrating human genomic data with phenotypes are important for biomedical research. Making genomic data accessible for research purposes, however, must be handled carefully to avoid leakage of sensitive individual information to unauthorized parties and improper use of data. In this article, we focus on data sharing within the scope of data accessibility for research. Current common practices to gain biomedical data access are strictly rule based, without a clear and quantitative measurement of the risk of privacy breaches...
January 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/27646927/surveillance-for-hemodialysis-access-stenosis-usefulness-of-ultrasound-vector-volume-flow
#9
Andreas H Brandt, Jonas Jensen, Kristoffer L Hansen, Peter Hansen, Theis Lange, Marianne Rix, Jørgen A Jensen, Lars Lönn, Michael B Nielsen
PURPOSE: To investigate if ultrasound vector-flow imaging (VFI) is equal to the reference method ultrasound dilution technique (UDT) in estimating volume flow and changes over time in arteriovenous fistulas (AVFs) for hemodialysis. MATERIALS AND METHODS: From January 2014 to January 2015, patients with end-stage renal disease and matured functional AVFs were consecutively solicited to participate in this prospective study. All patients were included after written informed consent and approval by the National Committee on Biomedical Research Ethics and the local Ethics Committee (journal no...
November 2, 2016: Journal of Vascular Access
https://www.readbyqxmd.com/read/27491669/study-design-for-a-randomised-controlled-trial-to-explore-the-modality-and-mechanism-of-tai-chi-in-the-pulmonary-rehabilitation-of-chronic-obstructive-pulmonary-disease
#10
Juan-Juan Fu, Jie Min, Peng-Ming Yu, Vanessa M McDonald, Bing Mao
INTRODUCTION: Although pulmonary rehabilitation (PR) is associated with significant clinical benefits in chronic obstructive pulmonary disease (COPD) and has been recommended by guidelines, PR with conventional exercise training has not been widely applied in the clinic because of its inherent limitations. Alternative exercise such as Tai Chi has been investigated and the results are promising. However, the strengths and weaknesses of the exercise modality of Tai Chi, conventional PR and a combination of Tai Chi and conventional PR and the possible mechanisms underlying Tai Chi exercise remain unclear...
August 4, 2016: BMJ Open
https://www.readbyqxmd.com/read/27439177/biostatistical-analysis-of-quantitative-immunofluorescence-microscopy-images
#11
C Giles, M A Albrecht, V Lam, R Takechi, J C Mamo
Semiquantitative immunofluorescence microscopy has become a key methodology in biomedical research. Typical statistical workflows are considered in the context of avoiding pseudo-replication and marginalising experimental error. However, immunofluorescence microscopy naturally generates hierarchically structured data that can be leveraged to improve statistical power and enrich biological interpretation. Herein, we describe a robust distribution fitting procedure and compare several statistical tests, outlining their potential advantages/disadvantages in the context of biological interpretation...
December 2016: Journal of Microscopy
https://www.readbyqxmd.com/read/27421296/spatial-temporal-dynamics-and-structural-determinants-of-child-and-maternal-mortality-in-a-rural-high-hiv-burdened-south-african-population-2000-2014-a-study-protocol
#12
B Tlou, B Sartorius, F Tanser
INTRODUCTION: Child (infant and under-5) and maternal mortality rates are key indicators for assessing the health status of populations. South Africa's maternal and child mortality rates are high, and the country mirrors the continental trend of slow progress towards its Millennium Development Goals. Rural areas are often more affected regarding child and maternal mortalities, specifically in areas with a high HIV burden. This study aims to understand the factors affecting child and maternal mortality in the Africa Centre Demographic Surveillance Area (DSA) from 2003 to 2014 towards developing tailored interventions to reduce the deaths in resource poor settings...
2016: BMJ Open
https://www.readbyqxmd.com/read/27417865/the-ethics-of-infection-challenges-in-primates
#13
Anne Barnhill, Steven Joffe, Franklin G Miller
In the midst of the recent Ebola outbreak, scientific developments involving infection challenge experiments on nonhuman primates (NHPs) sparked hope that successful treatments and vaccines may soon become available. Yet these studies pose a stark ethical quandary. On the one hand, they represent an important step in developing novel therapies and vaccines for Ebola and the Marburg virus, with the potential to save thousands of human lives and to protect whole communities from devastation; on the other hand, they intentionally expose sophisticated animals to severe suffering and a high risk of death...
July 2016: Hastings Center Report
https://www.readbyqxmd.com/read/27406638/randomised-controlled-trial-testing-the-effect-of-cotrimoxazole-prophylaxis-on-morbidity-and-mortality-outcomes-in-breastfed-hiv-exposed-uninfected-infants-study-protocol
#14
Anna Coutsoudis, Brodie Daniels, Eshia Moodley-Govender, Noluthando Ngomane, Linda Zako, Elizabeth Spooner, Photini Kiepiela, Shabashini Reddy, Louise Kuhn, Gita Ramjee
INTRODUCTION: No randomised controlled trial (RCT) has examined the efficacy of cotrimoxazole (CTX) prophylaxis in HIV-exposed uninfected (HEU) infants during the breastfeeding period, in this new era of effective prevention of mother-to-child transmission (PMTCT) prophylaxis. The efficacy of CTX prophylaxis has presently been demonstrated only in HIV-infected children. The absence of proven benefits in HEU breastfed infants associated with infectious diseases justifies an RCT as proposed...
2016: BMJ Open
https://www.readbyqxmd.com/read/27296402/-lynch-syndrome-%C3%A2-the-pathologist-s-diagnosis
#15
M Dušek, L Hadravský, K Černá, J Stehlík, M Švajdler, B Kokošková, M Dubová, M Michal, O Daum
Lynch syndrome (formerly known as hereditary non-polyposis colorectal cancer) is the most com-mon hereditary colorectal cancer syndrome. The syndrome is caused by a germline mutation of one of the mismatch repair (MMR) genes responsible for DNA replication error repair. Impaired function of the proteins encoded by these genes leads to microsatellite instability (MSI), which is associated with increased incidence of neoplasms: mainly colorectal cancer. According to recent estimates, up to 5% of all colorectal cancers are associated with Lynch syndrome...
2016: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/27241870/knowledge-of-the-nigerian-code-of-health-research-ethics-among-biomedical-researchers-in-southern-nigeria
#16
Olubunmi A Ogunrin, Folasade Daniel, Victor Ansa
Responsibility for protection of research participants from harm and exploitation rests on Research Ethics Committees and principal investigators. The Nigerian National Code of Health Research Ethics defines responsibilities of stakeholders in research so its knowledge among researchers will likely aid ethical conduct of research. The levels of awareness and knowledge of the Code among biomedical researchers in southern Nigerian research institutions was assessed. Four institutions were selected using a stratified random sampling technique...
December 2016: Journal of Empirical Research on Human Research Ethics: JERHRE
https://www.readbyqxmd.com/read/27231002/efficacy-and-safety-of-acupuncture-for-chemotherapy-induced-leucopoenia-protocol-for-a-systematic-review
#17
Jiayun Nian, Xu Sun, Jiao Guo, Chen Yan, Xiaomin Wang, Guowang Yang, Lin Yang, Mingwei Yu, Ganlin Zhang
INTRODUCTION: Many cancer patients experience leucopoenia during chemotherapy. Granulocyte- colony-stimulating factor (G-CSF) is used to treat chemotherapy-induced leucopoenia (CIL) but has various limitations. Clinical trials have indicated that acupuncture may prevent bone marrow suppression and increase leucocyte counts after chemotherapy. The objective of this review is to assess the efficacy and safety of acupuncture for treating CIL. METHODS AND ANALYSIS: This systematic review will electronically search the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Library, Medline, EMBASE, the China National Knowledge Infrastructure Database (CNKI), the Chinese Biomedical Literature Database (CBM), the Chinese Scientific Journal Database (VIP Database) and the Wanfang database from their inception to 1 January 2016...
2016: BMJ Open
https://www.readbyqxmd.com/read/26935702/the-potential-use-of-piglets-as-human-pediatric-surrogate-for-preclinical-pharmacokinetic-and-pharmacodynamic-drug-testing
#18
Elke Gasthuys, Tim Vandecasteele, Pauline De Bruyne, Johan Vande Walle, Patrick De Backer, Pieter Cornillie, Mathias Devreese, Siska Croubels
Pediatric drug research is still substandard, not reaching the same quality level as adult drug research. Despite the efforts made by the Food and Drug Administration and European Medicines Agency to reduce off-label use in children, the lack of clinical studies involving the pediatric population still stands. Pharmacokinetic and pharmacodynamics studies (PK/PD) taking growth and maturation into account are necessary to rationalize dosing strategies in children. Currently, traditional animal models such as rats, mice, dogs and primates are used to conduct pharmacokinetic and pharmacodynamic studies, however age-related trials are rather uncommon...
2016: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/26814353/common-swine-models-of-cardiovascular-disease-for-research-and-training
#19
Verónica Crisóstomo, Fei Sun, Manuel Maynar, Claudia Báez-Díaz, Virginia Blanco, Monica Garcia-Lindo, Jesús Usón-Gargallo, Francisco Miguel Sánchez-Margallo
Cardiovascular diseases are a major health concern and therefore an important topic in biomedical research. Large animal models allow researchers to assess the safety and efficacy of new cardiovascular procedures in systems that resemble human anatomy; additionally, they can be used to emulate scenarios for training purposes. Among the many biomedical models that are described in published literature, it is important that researchers understand and select those that are best suited to achieve the aims of their research, that facilitate the humane care and management of their research animals and that best promote the high ethical standards required of animal research...
February 2016: Lab Animal
https://www.readbyqxmd.com/read/26743702/markers-of-achievement-for-assessing-and-monitoring-gender-equity-in-translational-research-organisations-a-rationale-and-study-protocol
#20
MULTICENTER STUDY
Pavel V Ovseiko, Laurel D Edmunds, Linda H Pololi, Trisha Greenhalgh, Vasiliki Kiparoglou, Lorna R Henderson, Catherine Williamson, Jonathan Grant, Graham M Lord, Keith M Channon, Robert I Lechler, Alastair M Buchan
INTRODUCTION: Translational research organisations (TROs) are a core component of the UK's expanding research base. Equity of career opportunity is key to ensuring a diverse and internationally competitive workforce. The UK now requires TROs to demonstrate how they are supporting gender equity. Yet, the evidence base for documenting such efforts is sparse. This study is designed to inform the acceleration of women's advancement and leadership in two of the UK's leading TROs--the National Institute for Health Research (NIHR) Biomedical Research Centres (BRCs) in Oxford and London--through the development, application and dissemination of a conceptual framework and measurement tool...
January 7, 2016: BMJ Open
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