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Biomedical testing ethics

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https://www.readbyqxmd.com/read/27858217/alternative-animal-and-non-animal-models-for-drug-discovery-and-development-bonus-or-burden
#1
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
#2
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...
September 28, 2016: 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
#3
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...
September 1, 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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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...
May 30, 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
#11
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
#12
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
#13
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
#14
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
https://www.readbyqxmd.com/read/26684777/brain-magnetic-resonance-imaging-co2-stress-testing-in-adolescent-postconcussion-syndrome
#15
W Alan C Mutch, Michael J Ellis, Lawrence N Ryner, M Ruth Graham, Brenden Dufault, Brian Gregson, Thomas Hall, Martin Bunge, Marco Essig, Joseph A Fisher, James Duffin, David J Mikulis
OBJECT A neuroimaging assessment tool to visualize global and regional impairments in cerebral blood flow (CBF) and cerebrovascular responsiveness in individual patients with concussion remains elusive. Here the authors summarize the safety, feasibility, and results of brain CO2 stress testing in adolescents with postconcussion syndrome (PCS) and healthy controls. METHODS This study was approved by the Biomedical Research Ethics Board at the University of Manitoba. Fifteen adolescents with PCS and 17 healthy control subjects underwent anatomical MRI, pseudo-continuous arterial spin labeling MRI, and brain stress testing using controlled CO2 challenge and blood oxygen level-dependent (BOLD) MRI...
September 2016: Journal of Neurosurgery
https://www.readbyqxmd.com/read/26675187/coaching-to-augment-mentoring-to-achieve-faculty-diversity-a-randomized-controlled-trial
#16
Simon N Williams, Bhoomi K Thakore, Richard McGee
PURPOSE: The Academy for Future Science Faculty (the Academy) is a novel coaching intervention for biomedical PhD students designed to address limitations in previous efforts to promote faculty diversity. Unlike traditional research mentoring, the Academy includes both group and individual coaching, coaches have no research or evaluation roles with the students, and it is based on social science theories. The authors present a qualitative case study of one of the coaching groups and provide statistical analyses indicating whether one year in the Academy effects students' perceptions of the achievability and desirability of an academic career...
August 2016: Academic Medicine: Journal of the Association of American Medical Colleges
https://www.readbyqxmd.com/read/26565143/reducing-sample-size-in-experiments-with-animals-historical-controls-and-related-strategies
#17
Matthew Kramer, Enrique Font
Reducing the number of animal subjects used in biomedical experiments is desirable for ethical and practical reasons. Previous reviews of the benefits of reducing sample sizes have focused on improving experimental designs and methods of statistical analysis, but reducing the size of control groups has been considered rarely. We discuss how the number of current control animals can be reduced, without loss of statistical power, by incorporating information from historical controls, i.e. subjects used as controls in similar previous experiments...
November 13, 2015: Biological Reviews of the Cambridge Philosophical Society
https://www.readbyqxmd.com/read/26346877/the-horsens-aarhus-femoro-acetabular-impingement-hafai-cohort-outcome-of-arthroscopic-treatment-for-femoroacetabular-impingement-protocol-for-a-prospective-cohort-study
#18
Signe Kierkegaard, Bent Lund, Ulrik Dalgas, Henrik Sørensen, Kjeld Søballe, Inger Mechlenburg
INTRODUCTION: During the past decade, it has become increasingly more common to offer hip arthroscopic surgery when treating people with femoroacetabular impingement (FAI). Nevertheless, the latest reviews conclude that it still remains to be properly investigated how surgery affects the patients. Specifically, detailed information on the functional, muscular and mechanical impact of surgery in larger groups is lacking. Furthermore, the long-term outcome of the surgery is still to be investigated...
2015: BMJ Open
https://www.readbyqxmd.com/read/26338683/acupuncture-for-patients-with-chronic-urticaria-a-systematic-review-protocol
#19
REVIEW
Qin Yao, Yongming Ye, Xiaoxu Liu, Zongshi Qin, Zhishun Liu
INTRODUCTION: This systematic review protocol aims to describe a meta-analysis to assess the effectiveness and safety of acupuncture therapy for patients with chronic urticaria. METHODS AND ANALYSIS: We will electronically search the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, the Web of Science, Traditional Chinese Medicine, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Chinese Scientific Journal Database (VIP database) and Wan-Fang Database from their inception...
2015: BMJ Open
https://www.readbyqxmd.com/read/26168106/developing-educational-resources-to-advance-umbilical-cord-blood-banking-and-research-a-canadian-perspective
#20
Carla Pereira Beak, Sophie B Chargé, Rosario Isasi, Bartha M Knoppers
In 2013 Canadian Blood Services (CBS) launched the National Public Cord Blood Bank (NPCBB), a program to collect, process, test, and store cord blood units donated for use in transplantation. A key component of the creation of the NPCBB is the establishment of a program that enables cord blood not suitable for banking or transplantation to be used for biomedical research purposes. Along with the development of processes and policies to manage the NPCBB and the cord blood research program, CBS-in collaboration with researchers from the Stem Cell Network-have also developed educational tools to provide relevant information for target audiences to aid implementation and operation...
May 2015: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
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