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Biomedical testing ethics

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https://www.readbyqxmd.com/read/29404973/correctable-myths-about-research-misconduct-in-the-biomedical-sciences
#1
Barbara K Redman
A recent National Academy report on research integrity noted that policies are not evidence-based, with no formal entity responsible to attend to this deficit. Here we describe four areas of research misconduct (RM) regulations governing Public Health Service funded research that are empirically and/or ethically questionable. Policies for human subject protection, RM and conflict of interest are not harmonized, making it extremely difficult to deal with complex cases which often contain allegations in all of these areas...
February 5, 2018: Science and Engineering Ethics
https://www.readbyqxmd.com/read/29239234/adoption-of-in-vitro-systems-and-zebrafish-embryos-as-alternative-models-for-reducing-rodent-use-in-assessments-of-immunological-and-oxidative-stress-responses-to-nanomaterials
#2
Helinor J Johnston, Rachel Verdon, Suzanne Gillies, David M Brown, Teresa F Fernandes, Theodore B Henry, Adriano G Rossi, Lang Tran, Carl Tucker, Charles R Tyler, Vicki Stone
Assessing the safety of engineered nanomaterials (NMs) is paramount to the responsible and sustainable development of nanotechnology, which provides huge societal benefits. Currently, there is no evidence that engineered NMs cause detrimental health effects in humans. However, investigation of NM toxicity using in vivo, in vitro, in chemico, and in silico models has demonstrated that some NMs stimulate oxidative stress and inflammation, which may lead to adverse health effects. Accordingly, investigation of these responses currently dominates NM safety assessments...
December 14, 2017: Critical Reviews in Toxicology
https://www.readbyqxmd.com/read/29157285/map-of-biomedical-research-in-cameroon-a-documentary-review-of-approved-protocols-from-1997-to-2012
#3
Ebile Akoh Walter, Ateudjieu Jerome, Djuidje Ngounoue Marceline, Martin Ndinakie Yakum, Watcho Pierre
BACKGROUND: Over the last decade, there has been a rapid increase in biomedical research in Cameroon. However, the question of whether these research projects target major health priorities, vulnerable populations and geographic locations at risk remains to be answered. The aim of this paper is to describe the state of biomedical research in Cameroon which is a key determinant that would guide future health care policies and promote equitable access to healthcare. METHODS: A documentary review of all approved protocols (proposals) of biomedical research projects, from 1997 through 2012, at the Cameroon National Ethics Committee...
November 21, 2017: Globalization and Health
https://www.readbyqxmd.com/read/29145766/environmental-samples-make-soiled-bedding-sentinels-dispensable-for-hygienic-monitoring-of-ivc-reared-mouse-colonies
#4
Manuel Miller, Markus Brielmeier
Accurate knowledge of the health status of experimental animals is pivotal to high scientific and ethical standards in biomedical research. Individually ventilated cages (IVCs) are becoming the predominant system for housing laboratory mice, as they prevent cage-to-cage infections. However, this feature constitutes a major drawback for hygienic monitoring of mouse colonies, as traditional screening programs build on reliable transmission of infectious agents from experimental animals to sentinel mice commonly tested as representatives for the mouse colonies...
January 1, 2017: Laboratory Animals
https://www.readbyqxmd.com/read/28980935/lactobacillus-acidophilus-versus-placebo-in-the-symptomatic-treatment-of-irritable-bowel-syndrome-the-lapibss-randomized-trial
#5
S Sadrin, S R Sennoune, B Gout, S Marque, J Moreau, J Grillasca, O Pons, J M Maixent
Irritable bowel syndrome is a chronic functional gastrointestinal disorder characterized by abdominal pain/discomfort and altered bowel habits. The use of Lactobacilli as probiotics during irritable bowel syndrome is based on their interesting mechanisms of action and their excellent safety profile but little is known about their clinical efficacy due to the lack of adequately designed clinical trials. The current clinical trial protocol aims to determine the effects of a mixture of Lactobacillus acidophilus NCFM and LAFTI L10 as probiotics to improve irritable bowel syndrome symptoms (LAPIBSS)...
September 30, 2017: Cellular and Molecular Biology
https://www.readbyqxmd.com/read/28963304/protocol-for-a-randomised-controlled-implementation-trial-of-point-of-care-viral-load-testing-and-task-shifting-the-simplifying-hiv-treatment-and-monitoring-stream-study
#6
Jienchi Dorward, Nigel Garrett, Justice Quame-Amaglo, Natasha Samsunder, Hope Ngobese, Noluthando Ngomane, Pravikrishnen Moodley, Koleka Mlisana, Torin Schaafsma, Deborah Donnell, Ruanne Barnabas, Kogieleum Naidoo, Salim Abdool Karim, Connie Celum, Paul K Drain
INTRODUCTION: Achieving the Joint United Nations Programme on HIV and AIDS 90-90-90 targets requires models of HIV care that expand antiretroviral therapy (ART) coverage without overburdening health systems. Point-of-care (POC) viral load (VL) testing has the potential to efficiently monitor ART treatment, while enrolled nurses may be able to provide safe and cost-effective chronic care for stable patients with HIV. This study aims to demonstrate whether POC VL testing combined with task shifting to enrolled nurses is non-inferior and cost-effective compared with laboratory-based VL monitoring and standard HIV care...
September 27, 2017: BMJ Open
https://www.readbyqxmd.com/read/28960139/how-should-we-deal-with-misattributed-paternity-a-survey-of-lay-public-attitudes
#7
Georgia Lowe, Jonathan Pugh, Guy Kahane, Louise Corben, Sharon Lewis, Martin Delatycki, Julian Savulescu
Backround: Increasing use of genetic technologies in clinical and research settings increases the potential for misattributed paternity to be identified. Yet existing guidance from the President's Commission for the Study of Ethical Problems in Biomedical and Behavioral Research and the Institute of Medicine (amongst others) offers contradictory advice. Genetic health professionals are thus likely to vary in their practice when misattributed paternity is identified, and empirical investigation into the disclosure of misattributed paternity is scarce...
September 29, 2017: AJOB Empirical Bioethics
https://www.readbyqxmd.com/read/28948585/-innovative-prenatal-testing-clinical-applications-and-ethical-considerations
#8
Mei-Chih Huang, Shio-Jean Lin, Chih-Ling Chen, Tzu-Jung Huang
The biomedical technology related to prenatal screen/diagnosis has developed rapidly in recent decades. Many prenatal genetic examinations are now available to assist pregnant women to better understand the status and development of their fetus. Moreover, many commercial advertisements for innovative prenatal examinations are now shown in the media. Cell-free DNA Screening (cfDNA screening), a non-invasive prenatal testing (NIPT) procedure, is a safe and high accuracy test that may be done at an earlier gestational age to screen for fetal aneuploidy...
October 2017: Hu Li za Zhi the Journal of Nursing
https://www.readbyqxmd.com/read/28928344/knowledge-of-scientific-misconduct-in-publication-among-medical-students
#9
Syed Muhammad Mubeen, Rabia Ghayas, Syed Hasan Adil Rizvi, Sohaib Ahmed Khan
BACKGROUND: Publication is a central element in research dissemination and scientific misconduct in publication is relatively ignored in biomedical research. This study is to assess the knowledge of scientific misconduct in publication among private and public sector medical students. METHODS: A questionnaire-based cross-sectional study was carried in four (two public and two private) medical colleges of Karachi in 2015. After ethical approval, data were collected through convenient sampling and analyzed in SPSS 16...
May 2017: Education for Health: Change in Training & Practice
https://www.readbyqxmd.com/read/28696950/the-role-of-stigma-and-denormalization-in-suicide-prevention-laws-in-east-asia-a-sociocultural-historical-and-ethical-perspective
#10
Justin A Chen, Andrew Courtwright, Kevin Chien-Chang Wu
In many Western countries, the criminalization and stigmatization of suicide has given way to a biomedical approach aimed at destigmatizing suicide and treating underlying mental illness. By contrast, in many East Asian countries, suicide has never historically been criminalized or stigmatized. High rates of suicide in Japan, South Korea, and Taiwan have recently led policy makers in those countries to pursue innovative suicide-prevention strategies. The intentional denormalization of harmful behaviors has been discussed in the public health and ethics literatures, particularly with regard to smoking cessation, and could represent a novel mechanism for preventing suicides in East Asia...
September 2017: Harvard Review of Psychiatry
https://www.readbyqxmd.com/read/28686333/ehealth-provides-a-novel-opportunity-to-exploit-the-advantages-of-the-nordic-countries-in-psychiatric-genetic-research-building-on-the-public-health-care-system-biobanks-and-registries
#11
REVIEW
Ole A Andreassen
Nordic countries have played an important role in the recent progress in psychiatric genetics, both with large well-characterized samples and expertise. The Nordic countries have research advantages due to the organization of their societies, including system of personal identifiers, national health registries with information about diseases, treatment and prescriptions, and a public health system with geographical catchment areas. For psychiatric genetic research, the large biobanks and population surveys are a unique added value...
July 7, 2017: American Journal of Medical Genetics. Part B, Neuropsychiatric Genetics
https://www.readbyqxmd.com/read/28587631/bacterial-etiologic-agents-causing-neonatal-sepsis-and-associated-risk-factors-in-gondar-northwest-ethiopia
#12
Tsehaynesh G/Eyesus, Feleke Moges, Setegn Eshetie, Biruk Yeshitela, Ebba Abate
BACKGROUND: Neonatal sepsis is a blood stream infection which is seen in the first month of life of the neonate. Bacterial profile of neonatal septicemia is constantly changing thus, current knowledge on the patterns of bacterial isolates, its antibiotic resistance profile, and associated factors, are essential to design and implement appropriate interventions. Therefore, the aim of this study was to identify bacterial etiologic agents, their antimicrobial susceptibility pattern and associated risk factors of neonatal sepsis among neonates...
June 6, 2017: BMC Pediatrics
https://www.readbyqxmd.com/read/28543738/crispr-editing-in-biological-and-biomedical-investigation
#13
Xing-Da Ju, Jing Xu, Zhong Sheng Sun
The CRISPR (clustered regularly interspaced short palindromic repeat)-Cas (CRISPR-associated protein) system, a prokaryotic RNA-based adaptive immune system against viral infection, is emerging as a powerful genome editing tool in broad research areas. To further improve and expand its functionality, various CRISPR delivery strategies have been tested and optimized, and key CRISPR system components such as Cas protein have been engineered with different purposes. Benefiting from more in-depth understanding and further development of CRISPR, versatile CRISPR-based platforms for genome editing have been rapidly developed to advance investigations in biology and biomedicine...
May 20, 2017: Journal of Cellular Biochemistry
https://www.readbyqxmd.com/read/28399664/ethical-considerations-surrounding-germline-next-generation-sequencing-of-children-with-cancer
#14
REVIEW
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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...
April 2017: Pharmaceutical Research
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