Results for 'For the Clinical Sequencing Exploratory Research Group'

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  1.  49
    Addressing the Ethical Challenges in Genetic Testing and Sequencing of Children.Ellen Wright Clayton, Laurence B. McCullough, Leslie G. Biesecker, Steven Joffe, Lainie Friedman Ross, Susan M. Wolf & For the Clinical Sequencing Exploratory Research Group - 2014 - American Journal of Bioethics 14 (3):3-9.
    American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) (...)
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  2.  41
    Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants.Susan M. Wolf, Emily Scholtes, Barbara A. Koenig, Gloria M. Petersen, Susan A. Berry, Laura M. Beskow, Mary B. Daly, Conrad V. Fernandez, Robert C. Green, Bonnie S. LeRoy, Noralane M. Lindor, P. Pearl O'Rourke, Carmen Radecki Breitkopf, Mark A. Rothstein, Brian Van Ness & Benjamin S. Wilfond - 2018 - Journal of Law, Medicine and Ethics 46 (1):87-109.
    Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical (...) Exploratory Research Consortium. The authors then negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death. (shrink)
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  3.  15
    Ethical considerations about the collection of biological samples for genetic analysis in clinical trials.Inés Galende-Domínguez & Octavio M. Rivero-Lezcano - 2023 - Research Ethics 19 (2):220-226.
    Progress in precision medicine is being achieved through the design of clinical trials that use genetic biomarkers to guide stratification of patients and assignation to treatment or control groups. Genetic analysis of biomarkers is, therefore, essential to complete their objectives, and this involves the study of biological samples from donor patients that have been recruited according to criteria previously established in the design of the clinical trial. Nevertheless, it is becoming very common that, in the solicitation of biological (...)
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  4.  15
    Perspectives regarding privacy in clinical research among research professionals from the Arab region: an exploratory qualitative study.Latifa Adarmouch, Marwan Felaefel, Robert Wachbroit & Henry Silverman - 2020 - BMC Medical Ethics 21 (1):1-16.
    Background Protecting the privacy of research participants is widely recognized as one of the standard ethical requirements for clinical research. It is unknown, however, how research professionals regard concepts of privacy as well as the situations in the research setting that require privacy protections. The aim of this study was to explore the views of research professionals from Arab countries regarding concepts and scope of privacy that occur in clinical research. Methods We (...)
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  5.  69
    The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations.Gail E. Henderson, Susan M. Wolf, Kristine J. Kuczynski, Steven Joffe, Richard R. Sharp, D. Williams Parsons, Bartha M. Knoppers, Joon-Ho Yu & Paul S. Appelbaum - 2014 - Journal of Law, Medicine and Ethics 42 (3):344-355.
    Large-scale sequencing tests, including whole-exome and whole-genome sequencing, are rapidly moving into clinical use. Sequencing is already being used clinically to identify therapeutic opportunities for cancer patients who have run out of conventional treatment options, to help diagnose children with puzzling neurodevelopmental conditions, and to clarify appropriate drug choices and dosing in individuals. To evaluate and support clinical applications of these technologies, the National Human Genome Research Institute and National Cancer Institute have funded studies (...)
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  6.  82
    Human brain evolution and the "neuroevolutionary time-depth principle:" Implications for the reclassification of fear-circuitry-related traits in dsm-V and for studying resilience to warzone-related posttraumatic stress disorder.Dr H. Stefan Bracha - 2006 - Neuro-Psychopharmacology and Biological Psychiatry 30:827-853.
    The DSM-III, DSM-IV, DSM-IV-TR and ICD-10 have judiciously minimized discussion of etiologies to distance clinical psychiatry from Freudian psychoanalysis. With this goal mostly achieved, discussion of etiological factors should be reintroduced into the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. A research agenda for the DSM-V advocated the "development of a pathophysiologically based classification system". The author critically reviews the neuroevolutionary literature on stress-induced and fear circuitry disorders and related amygdala-driven, species-atypical fear behaviors of clinical (...)
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  7.  41
    Moral Distress Among Health System Managers: Exploratory Research in Two British Columbia Health Authorities. [REVIEW]Craig Mitton, Stuart Peacock, Jan Storch, Neale Smith & Evelyn Cornelissen - 2011 - Health Care Analysis 19 (2):107-121.
    Moral distress is a concept used to date in clinical literature to describe the experience of staff in circumstances in which they are prevented from delivering the kind of bedside care they believe is expected of them, professionally and ethically. Our research objective was to determine if this concept has relevance in terms of key health care managerial functions, such as priority setting and resource allocation. We conducted interviews and focus groups with mid- and senior-level managers in two (...)
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  8.  46
    Returning Genetic Research Results to Individuals: Points‐to‐Consider.Gaile Renegar, Christopher J. Webster, Steffen Stuerzebecher, Lea Harty, Susan E. Ide, Beth Balkite, Taryn A. Rogalski‐Salter, Nadine Cohen, Brian B. Spear & Diane M. Barnes - 2006 - Bioethics 20 (1):24-36.
    This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research (...)
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  9.  18
    Parents and Provider Perspectives on the Return of Genomic Findings for Cleft Families in Africa.Abimbola M. Oladayo, Sydney Prochaska, Tamara Busch, Wasiu L. Adeyemo, Lord J. J. Gowans, Mekonen Eshete, Waheed Awotoye, Veronica Sule, Azeez Alade, Adebowale A. Adeyemo, Peter A. Mossey, Anya Prince, Jeffrey C. Murray & Azeez Butali - 2024 - AJOB Empirical Bioethics 15 (2):133-146.
    Background Inadequate knowledge among health care providers (HCPs) and parents of affected children limits the understanding and utility of secondary genetic findings (SFs) in under-represented populations in genomics research. SFs arise from deep DNA sequencing done for research or diagnostic purposes and may burden patients and their families despite their potential health importance. This study aims to evaluate the perspective of both groups regarding SFs and their choices in the return of results from genetic testing in the (...)
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  10.  41
    Returning genetic research results to individuals: Points-to-consider.Gaile Renegar, Christopher J. Webster, Steffen Stuerzebecher, Lea Harty, I. D. E. E., Beth Balkite, Taryn A. Rogalski-salter, Nadine Cohen, Brian B. Spear, Diane M. Barnes & Celia Brazell - 2005 - Bioethics 20 (1):24–36.
    ABSTRACT This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for (...) participants to be permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)
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  11.  32
    Reflections on Governance Models for the Clinical Translation of Stem Cells.Jeremy Sugarman - 2010 - Journal of Law, Medicine and Ethics 38 (2):251-256.
    Acentral promise of human embryonic stem cell research is the potential to develop viable therapeutic approaches to a range of devastating diseases and conditions. Despite excitement over such advances, there are scientific and medical reasons to be cautious as stem cells and their products are introduced into patients. In response to such concerns, the International Society for Stem Cell Research as well as ad hoc groups and individuals have offered approaches to governance of this research. While there (...)
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  12.  31
    Recruitment of minority ethnic groups into clinical cancer research trials to assess adherence to the principles of the Department of Health Research Governance Framework: national sources of data and general issues arising from a study in one hospital trust in England.S. Godden, G. Ambler & A. M. Pollock - 2010 - Journal of Medical Ethics 36 (6):358-362.
    Background This article describes the issues encountered when designing a study to evaluate recruitment of minority ethnic groups into clinical cancer research in order to monitor adherence to the principles for good practice set out in the Department of Health, Research Governance Framework, England. Methods (i) A review of routine data sources to determine whether their usefulness as a source of data on prevalence of cancer in the population by ethnic category. (ii) A local case study at (...)
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  13.  50
    What is the best standard for the standard of care in clinical research?Rieke van der Graaf & Johannes J. M. van Delden - 2009 - American Journal of Bioethics 9 (3):35 – 43.
    During the past decennium, one of the main issues discussed in research ethics has been focused on the care that should be provided to the control group in a clinical trial. This discussion is also called the standard of care debate . Current international research ethics guidelines contain a wide variety of standards for the standard of care—including the provision of the highest attainable, the best available, the best current, a proven , and an established effective (...)
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  14.  24
    A survey in Mexico about ethics dumping in clinical research.Novoa-Heckel Germán & Bernabe Rosemarie - 2019 - BMC Medical Ethics 20 (1):38.
    The exportation of unethical practices to low- and middle-income countries has been conceived as a prevalent practice which needs to be examined more closely. Such a practice might point towards the exploitation of vulnerable population groups. We conducted a survey among Mexican research ethics committee members to explore the issue of ethics dumping in Mexico by understanding how its existence and contributing factors and norms are perceived by these ethics committee members. We designed an exploratory survey based on (...)
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  15. Proposing a clinical quantification framework of macro-linguistic structures in aphasic narratives.Reres Adam, Kong Anthony Pak Hin & Whiteside Janet D. - 2014 - Frontiers in Psychology 5.
    Background Analysis of aphasic narratives can be a challenge for clinicians. Previous studies have mainly employed measures that categorized speech samples at the word level. They included quantification of the use and misuse of different word classes, presence and absence of narrative contents and errors, paraphasias, and perseverations, as well as morphological structures and errors within a narrative. In other words, a great amount of research has been conducted in the aphasiology literature focusing on micro-linguistic structures of oral narratives. (...)
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  16.  22
    An Update to Returning Genetic Research Results to Individuals: Perspectives of the Industry Pharmacogenomics Working Group.Sandra K. Prucka, Lester J. Arnold, John E. Brandt, Sandra Gilardi, Lea C. Harty, Feng Hong, Joanne Malia & David J. Pulford - 2014 - Bioethics 29 (2):82-90.
    The ease with which genotyping technologies generate tremendous amounts of data on research participants has been well chronicled, a feat that continues to become both faster and cheaper to perform. In parallel to these advances come additional ethical considerations and debates, one of which centers on providing individual research results and incidental findings back to research participants taking part in genetic research efforts. In 2006 the Industry Pharmacogenomics Working Group offered some ‘Points-to-Consider’ on this topic (...)
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  17.  45
    An exploratory study for analyzing interactional processes of group discussion: the case of a focus group interview.Kana Suzuki, Ikuyo Morimoto, Etsuo Mizukami, Hiroko Otsuka & Hitoshi Isahara - 2009 - AI and Society 23 (2):233-249.
    The purposes of this study are (a) to establish a measurement for evaluating conversational impressions of group discussions, and (b) to make an exploratory investigation on their interactional processes which may affect to form those impressions. The impression rating and factor analysis undertaken first give us four factors concerning conversational impressions of “focus group interviews (FGIs)”: conversational activeness, conversational sequencing, the attitudes of participants and the relationships of participants. In relation to the factors of conversational activeness (...)
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  18.  12
    The ICMJE and URM: Providing Independent Advice for the Conduct of Biomedical Research and Publication.Martin B. Van der Weyden - 2007 - Mens Sana Monographs 5 (1):15.
    The International Committee of Medical Journal Editors is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedical research and the ethical tenets underpinning these activities. This advice is detailed in the Committee's Uniform Requirements (...)
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  19.  54
    Proceedings of the 4th World Conference on Research Integrity: Brazil, Rio de Janeiro. 31 May - 3 June 2015.Lex Bouter, Melissa S. Anderson, Ana Marusic, Sabine Kleinert, Susan Zimmerman, Paulo S. L. Beirão, Laura Beranzoli, Giuseppe Di Capua, Silvia Peppoloni, Maria Betânia de Freitas Marques, Adriana Sousa, Claudia Rech, Torunn Ellefsen, Adele Flakke Johannessen, Jacob Holen, Raymond Tait, Jillon Van der Wall, John Chibnall, James M. DuBois, Farida Lada, Jigisha Patel, Stephanie Harriman, Leila Posenato Garcia, Adriana Nascimento Sousa, Cláudia Maria Correia Borges Rech, Oliveira Patrocínio, Raphaela Dias Fernandes, Laressa Lima Amâncio, Anja Gillis, David Gallacher, David Malwitz, Tom Lavrijssen, Mariusz Lubomirski, Malini Dasgupta, Katie Speanburg, Elizabeth C. Moylan, Maria K. Kowalczuk, Nikolas Offenhauser, Markus Feufel, Niklas Keller, Volker Bähr, Diego Oliveira Guedes, Douglas Leonardo Gomes Filho, Vincent Larivière, Rodrigo Costas, Daniele Fanelli, Mark William Neff, Aline Carolina de Oliveira Machado Prata, Limbanazo Matandika, Sonia Maria Ramos de Vasconcelos & Karina de A. Rocha - 2016 - Research Integrity and Peer Review 1 (Suppl 1).
    Table of contentsI1 Proceedings of the 4th World Conference on Research IntegrityConcurrent Sessions:1. Countries' systems and policies to foster research integrityCS01.1 Second time around: Implementing and embedding a review of responsible conduct of research policy and practice in an Australian research-intensive universitySusan Patricia O'BrienCS01.2 Measures to promote research integrity in a university: the case of an Asian universityDanny Chan, Frederick Leung2. Examples of research integrity education programmes in different countriesCS02.1 Development of a state-run “cyber (...)
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  20.  13
    The ICMJE and URM: Providing Independent Advice for the Conduct of Biomedical Research and Publication.M. B. Weyden - 2007 - Mens Sana Monographs 5 (1):15.
    _The International Committee of Medical Journal Editors (ICMJE) is a working group of editors of selected medical journals that meets annually. Founded in Vancouver, Canada, in 1978, it currently consists of 11 member journals and a representative of the US National Library of Medicine. The major purpose of the Committee is to address and provide guidance for the conduct and publishing of biomedical research and the ethical tenets underpinning these activities. This advice is detailed in the Committee's _ (...)
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  21.  6
    Enlivening the Self: The First Year, Clinical Enrichment, and the Wandering Mind.Joseph D. Lichtenberg, Frank M. Lachmann & James L. Fosshage - 2015 - Routledge.
    In psychoanalysis, enlivenment is seen as residing in a sense of self, and this sense of self is drawn from and shaped by lived experience. _Enlivening the Self: The First Year, Clinical Enrichment, and the Wandering Mind _describes the vitalizing and enrichment of self-experience throughout the life cycle and shows how active experience draws on many fundamental functional capacities, and these capacities come together in support of systems of motivation; that is, organized dynamic grouping of affects, intentions, and goals. (...)
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  22. Ontology as the core discipline of biomedical informatics: Legacies of the past and recommendations for the future direction of research.Barry Smith & Werner Ceusters - 2007 - In Gordana Dodig Crnkovic & Susan Stuart (eds.), Computation, Information, Cognition: The Nexus and the Liminal. Cambridge Scholars Publishing. pp. 104-122.
    The automatic integration of rapidly expanding information resources in the life sciences is one of the most challenging goals facing biomedical research today. Controlled vocabularies, terminologies, and coding systems play an important role in realizing this goal, by making it possible to draw together information from heterogeneous sources – for example pertaining to genes and proteins, drugs and diseases – secure in the knowledge that the same terms will also represent the same entities on all occasions of use. In (...)
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  23.  29
    The Poster Child for the Need for Central Review of Research Protocols: The Children's Oncology Group.Rebecca D. Pentz & Anita F. Khayat - 2004 - Cambridge Quarterly of Healthcare Ethics 13 (4):359-365.
    Multiple groups, including the National Bioethics Advisory Commission, the American Society of Clinical Oncology, the National Coalition of Comprehensive Cancer Centers, Workgroup 6 of the Summit Series on Cancer, PRIM&R, the Bell Report, and prominent ethicists have called for replacing the current system of local institutional review with central review for multisite national trials. We argue that this need is particularly acute in pediatric oncology, as shown by the experience of the Children's Oncology Group.
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  24.  32
    Views of the process and content of ethical reviews of hiv vaccine trials among members of us institutional review boards and south african research ethics committees.Robert Klitzman - 2007 - Developing World Bioethics 8 (3):207-218.
    ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended to (...)
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  25.  86
    Genome Editing Technologies and Human Germline Genetic Modification: The Hinxton Group Consensus Statement.Sarah Chan, Peter J. Donovan, Thomas Douglas, Christopher Gyngell, John Harris, Robin Lovell-Badge, Debra J. H. Mathews, Alan Regenberg & On Behalf of the Hinxton Group - 2015 - American Journal of Bioethics 15 (12):42-47.
    The prospect of using genome technologies to modify the human germline has raised profound moral disagreement but also emphasizes the need for wide-ranging discussion and a well-informed policy response. The Hinxton Group brought together scientists, ethicists, policymakers, and journal editors for an international, interdisciplinary meeting on this subject. This consensus statement formulated by the group calls for support of genome editing research and the development of a scientific roadmap for safety and efficacy; recognizes the ethical challenges involved (...)
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  26.  13
    Portfolios of Worth: Capitalizing on Basic and Clinical Problems in Biomedical Research Groups.Sarah de Rijcke, Thomas Franssen & Alexander Rushforth - 2019 - Science, Technology, and Human Values 44 (2):209-236.
    How are “interesting” research problems identified and made durable by academic researchers, particularly in situations defined by multiple evaluation principles? Building on two case studies of research groups working on rare diseases in academic biomedicine, we explore how group leaders arrange their groups to encompass research problems that latch onto distinct evaluation principles by dividing and combining work into “basic-oriented” and “clinical-oriented” spheres of inquiry. Following recent developments in the sociology of valuation comparing academics to (...)
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  27.  9
    Exploratory Investigation of Brain MRI Lesions According to Whole Sample and Visual Function Subtyping in Children With Cerebral Visual Impairment.Hanna Sakki, Naomi J. Dale, Kshitij Mankad, Jenefer Sargent, Giacomo Talenti & Richard Bowman - 2022 - Frontiers in Human Neuroscience 15.
    Background: There is limited research on brain lesions in children with cerebral visual impairment of heterogeneous etiologies and according to associated subtyping and vision dysfunctions. This study was part of a larger project establishing data-driven subtypes of childhood CVI according to visual dysfunctions. Currently there is no consensus in relation to assessment, diagnosis and classification of CVI and more information about brain lesions may be of potential diagnostic value.Aim: This study aimed to investigate overall patterns of brain lesions and (...)
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  28.  51
    How is informed consent related to emotions and empathy? An exploratory neuroethical investigation.Alexander Supady, Antonie Voelkel, Joachim Witzel, Udo Gubka & Georg Northoff - 2011 - Journal of Medical Ethics 37 (5):311-317.
    Context Informed consent is crucial in daily clinical practice and research in medicine and psychiatry. A recent neuroethical investigation explored the psychological factors that are crucial in determining whether or not subjects give consent. While cognitive functions have been shown to play a central role, the impact of empathy and emotions on subjects' decisions in informed consent remains unclear. Objective To evaluate the impact of empathy and emotions on subjects' decision in informed consent in an exploratory study. (...)
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  29.  37
    The advocacy role of nurses in cardiopulmonary resuscitation.Verónica Tíscar-González, Montserrat Gea-Sánchez, Joan Blanco-Blanco, María Teresa Moreno-Casbas & Elizabeth Peter - 2020 - Nursing Ethics 27 (2):333-347.
    Background:The decision whether to initiate cardiopulmonary resuscitation may sometimes be ethically complex. While studies have addressed some of these issues, along with the role of nurses in cardiopulmonary resuscitation, most have not considered the importance of nurses acting as advocates for their patients with respect to cardiopulmonary resuscitation.Research objective:To explore what the nurse’s advocacy role is in cardiopulmonary resuscitation from the perspective of patients, relatives, and health professionals in the Basque Country (Spain).Research design:An exploratory critical qualitative study (...)
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  30.  11
    Priority setting at the clinical level: the case of nusinersen and the Norwegian national expert group.Reidun Førde, Sean Wallace, Magnhild Rasmussen & Morten Magelssen - 2021 - BMC Medical Ethics 22 (1):1-8.
    BackgroundNusinersen is one of an increasing number of new, expensive orphan drugs to receive authorization. These drugs strain public healthcare budgets and challenge principles for resource allocation. Nusinersen was introduced in the Norwegian public healthcare system in 2018. A national expert group consisting of physicians was formed to oversee the introduction and continuation of treatment in light of specific start and stop criteria.MethodsWe have studied experiences within the expert group with a special emphasis on their application of the (...)
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  31. Creating a Controlled Vocabulary for the Ethics of Human Research: Towards a biomedical ethics ontology.David Koepsell, Robert Arp, Jennifer Fostel & Barry Smith - 2009 - Journal of Empirical Research on Human Research Ethics 4 (1):43-58.
    Ontologies describe reality in specific domains in ways that can bridge various disciplines and languages. They allow easier access and integration of information that is collected by different groups. Ontologies are currently used in the biomedical sciences, geography, and law. A Biomedical Ethics Ontology would benefit members of ethics committees who deal with protocols and consent forms spanning numerous fields of inquiry. There already exists the Ontology for Biomedical Investigations (OBI); the proposed BMEO would interoperate with OBI, creating a powerful (...)
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  32. Human Genome Research in an Interdependent World.Alexander Morgan Capron - 1991 - Kennedy Institute of Ethics Journal 1 (3):247-251.
    In lieu of an abstract, here is a brief excerpt of the content:Human Genome Research in an Interdependent WorldAlexander Morgan Capron (bio)This has been the year of agenda-setting conferences for the ambitious ELSI (ethical, legal and social issues) program of the Human Genome Project (HGP). But of the dozen or more major meetings of this sort held across the country, the one held at the National Institutes of Heakh (NIH) in Bethesda, MD, June 2-4, 1991, was distinctive in several (...)
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  33.  27
    Research or clinical care: what’s the difference?Nina Hallowell - 2018 - Journal of Medical Ethics 44 (6):359-360.
    In 1979 the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research in the US delivered a set of guidelines for the ethical conduct of research on human research subjects.1 In developing these guidelines, subsequently known as The Belmont Report, the Commission was “...directed to consider: the boundaries between biomedical and behavioural research and the accepted and routine practice of medicine”; and outline a set of ethical principles which would specifically govern (...) activities. The Report notes that maintaining this distinction is important to ensure that all research activities are subjected to ethical review and, while it acknowledges that distinguishing research and clinical care is less easy in some cases, it suggests that this is a relatively simple and straightforward task. Forty years later, biomedical activities appear more complex: clinical activities are hybridised, trial design is no longer solely aimed at improving the evidence base, but at fostering closer integration with clinical activities and learning health systems reuse individuals’ health data to generate real-time improvements in patient care.2 In short, the conceptual boundaries between research and clinical care do not appear to be as distinct as the Belmont Report implies. Two papers in this issue and Ballantyne and Schaefer ) address some of the ethical challenges generated by merging of research and clinical care. The UK’s 100 000 Genomes Project is an example of a biomedical development in which research and clinical care are no longer understood as distinct activities. Patients in the 100kGP are offered clinical genomic sequencing on the understanding that their health data will be used for research purposes. Dheensa et al note that the 100kGP was designed with the dual purpose of providing patients with …. (shrink)
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  34.  15
    Incidental Findings in Magnetic Resonance Imaging (MRI) Brain Research.Charles A. Nelson - 2008 - Journal of Law, Medicine and Ethics 36 (2):315-319.
    Magnetic resonance imaging is a noninvasive imaging tool that utilizes a strong magnetic field and radio frequency waves to visualize in great detail organs, soft tissue, and bone. Unlike conventional x-rays, there is no exposure to ionizing radiation and at most field strengths the procedure is considered safe for nearly every age group. Because it is non-invasive and possesses excellent spatial resolution, the use of MRI as a research tool has increased exponentially over the past decade. Uses have (...)
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  35.  8
    The psychological profile of parents who volunteer their children for clinical research: a controlled study.Y. H. Thong S. C. Harth, R. R. Johnstone - 1992 - Journal of Medical Ethics 18 (2):86.
    Three standard psychometric tests were administered to parents who volunteered their children for a randomised, double-blind placebo-controlled trial of a new asthma drug and to a control group of parents whose children were eligible for the trial but had declined the invitation. The trial took place at a children's hospital in Australia. The subjects comprised 68 parents who had volunteered their children and 42 who had not, a participation rate of 94 per cent and 70 per cent, respectively. The (...)
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  36.  37
    The psychological profile of parents who volunteer their children for clinical research: a controlled study.S. C. Harth, R. R. Johnstone & Y. H. Thong - 1992 - Journal of Medical Ethics 18 (2):86-93.
    Three standard psychometric tests were administered to parents who volunteered their children for a randomised, double-blind placebo-controlled trial of a new asthma drug and to a control group of parents whose children were eligible for the trial but had declined the invitation. The trial took place at a children's hospital in Australia. The subjects comprised 68 parents who had volunteered their children and 42 who had not, a participation rate of 94 per cent and 70 per cent, respectively. The (...)
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  37. Development of the ethical decision-making competence scale.Hsiang-Chu Pai & Lien-Jen Hwu - forthcoming - Nursing Ethics.
    Background Developing confident capacity for ethical decision-making is vital in nursing education. However, no tool examines nursing students’ competence in ethical decision-making. Aim This study aimed to develop an Ethical Decision-Making Competence Scale (EDM-CS) to assess ethical care decision-making competencies in nursing students. Participants and research context Original items were obtained by employing a focus group and the Delphi method. A cross-sectional design was used to confirm the items remained on the scale. Additionally, the scale’s reliability and validity (...)
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  38.  4
    Ethical decision-making confidence scale for nurse leaders: Psychometric evaluation.Lorri Birkholz, Patrick Kutschar, Firuzan Sari Kundt & Margitta Beil-Hildebrand - 2022 - Nursing Ethics 29 (4):988-1002.
    Background Ethical decision-making confidence develops from clinical expertise and is a core competency for nurse leaders. No tool exists to measure confidence levels in nurse leaders based upon an ethical decision-making framework. Aims The objective of this research was to compare ethical decision-making among nurse leaders in the U.S. and three German-speaking countries in Europe by developing and testing a newly constructed Ethical Decision-Making Confidence (EDMC) scale. Methods The cross-sectional survey included 18 theory-derived questions on ethical decision-making confidence (...)
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  39.  13
    No research for the decisionally-impaired mentally ill: a view from Montenegro.Tea Dakić - 2020 - BMC Medical Ethics 21 (1):1-9.
    BackgroundMany of the important elements of a valid informed consent – comprehension, voluntariness, and capacity – can be compromised or unmet in the context of psychiatric research. The inability to protect their own interests puts mentally ill subjects at an increased likelihood of being wronged or harmed and makes them particularly vulnerable in the context of clinical research. Therefore, they are due extra protection. Sometimes, these additional safeguards can significantly limit the possibilities for research involving subjects (...)
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  40.  13
    Development and Psychometric Properties of the DASS-Youth (DASS-Y): An Extension of the Depression Anxiety Stress Scales (DASS) to Adolescents and Children.Marianna Szabo & Peter F. Lovibond - 2022 - Frontiers in Psychology 13.
    The Depression Anxiety Stress Scales is a set of psychometrically sound scales that is widely used to assess negative emotional states in adults. In this project, we developed the Depression Anxiety Stress Scales for Youth and tested its psychometric properties. Data were collected from 2,121 Australian children and adolescents aged 7–18. This sample was split randomly into a calibration group and a cross-validation group. First, we used Confirmatory Factor Analysis on the calibration group to test the 3-factor (...)
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  41.  10
    Revised Short Screening Version of the Profile of Mood States (POMS) From the German General Population.Katja Petrowski, Cornelia Albani, Markus Zenger, Elmar Brähler & Bjarne Schmalbach - 2021 - Frontiers in Psychology 12.
    The present study was conducted with the aim of constructing and validating a short form of the Profile of Mood States. The POMS is a widely-applied measure for the assessment of an individual's mood. Thus, it is of great relevance for many research questions in clinical and social psychology. To develop the short scale, we first examined psychometric properties and found the optimal 16-item solution among all valid combinations of the full POMS in an exploratory subsample of (...)
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  42.  22
    Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in western Kenya.D. N. Shaffer - 2006 - Journal of Medical Ethics 32 (1):55-60.
    Objectives: To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or “what is fair” for study participants in an HIV/AIDS clinical drug trial. Design: Qualitative study with focus groups. Setting: Teaching and referral hospital and rural health centre in western Kenya. Participants: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators. Results: Eighty nine individuals participated in a total of 11 focus groups over a (...)
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  43.  9
    Taking a Closer Look: An Exploratory Analysis of Successful and Unsuccessful Strategy Use in Complex Problems.Matthias Stadler, Frank Fischer & Samuel Greiff - 2019 - Frontiers in Psychology 10:424920.
    Influencing students’ educational achievements first requires understanding the underlying processes that lead to variation in students’ performance. Researchers are therefore increasingly interested in analyzing the differences in behavior displayed in educational assessments rather than merely assessing their outcomes. Such analyses provide valuable information on the differences between successful and unsuccessful students and help to design appropriate interventions. Complex problem solving (CPS) tasks have proven to provide particularly rich process data as they allow for a multitude of behaviors several of which (...)
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  44.  33
    News from the president's council on bioethics.F. Daniel Davis & Diane M. Gianelli - 2006 - Kennedy Institute of Ethics Journal 16 (4):375-377.
    In lieu of an abstract, here is a brief excerpt of the content:News from the President’s Council on BioethicsF. Daniel Davis (bio) and Diane M. Gianelli (bio)As most readers of this column already know, the President's Council on Bioethics went through a major transition during the past year when Leon Kass—in October 2005—handed the chairman's gavel over to Georgetown University's Edmund Pellegrino. Dr. Kass has remained on the Council as a member.1When the gavel change took place, the Council's phone started (...)
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  45.  19
    Hypocrisy Around Medical Patient Data: Issues of Access for Biomedical Research, Data Quality, Usefulness for the Purpose and Omics Data as Game Changer.Erwin Tantoso, Wing-Cheong Wong, Wei Hong Tay, Joanne Lee, Swati Sinha, Birgit Eisenhaber & Frank Eisenhaber - 2019 - Asian Bioethics Review 11 (2):189-207.
    Whether due to simplicity or hypocrisy, the question of access to patient data for biomedical research is widely seen in the public discourse only from the angle of patient privacy. At the same time, the desire to live and to live without disability is of much higher value to the patients. This goal can only be achieved by extracting research insight from patient data in addition to working on model organisms, something that is well understood by many patients. (...)
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  46.  35
    The Ethics of Clinical Trials Research in Severe Mood Disorders.Allison C. Nugent, Franklin G. Miller, Ioline D. Henter & Carlos A. Zarate - 2017 - Bioethics 31 (6):443-453.
    Mood disorders, including major depressive disorder and bipolar disorder, are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent (...)
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  47.  25
    Teaching & Learning Guide for: Full Disclosure of the ‘Raw Data’ of Research on Humans: Citizens’ Rights, Product Manufacturers’ Obligations and the Quality of the Scientific Database.Dennis J. Mazur - 2011 - Philosophy Compass 6 (2):152-157.
    This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of (...)
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  48.  11
    An exploratory study on motivations in meaningful internship experience: what is in it for the supervisors?Roy Ying - forthcoming - Asian Journal of Business Ethics:1-29.
    In today’s competitive economy, the war for talent has intensified. Organizations are increasingly investing in student engagement initiatives to build a robust talent pipeline. Among these initiatives, the offering of internship placements is a popular choice as it not only helps identify suitable talent, students can also benefit with valuable opportunities to develop work-related skills and gain experience. However, ensuring mutually beneficial outcomes for all stakeholders involved remains a challenge due to diverging expectations among stakeholder groups. This study aims to (...)
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    The Ad Hoc Advisory Group's proposals for research ethics committees: a mixture of the timid, the revolutionary, and the bizarre.A. J. Dawson - 2005 - Journal of Medical Ethics 31 (8):435-436.
    The Report of the Ad Hoc Adivisory Group on the Operation of NHS Research Ethics Committees has resulted in a strange mixture of the timid, the revolutionary, and the bizarre.The Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees is a curious document.1 The remit of the review was focused on the workings and effectiveness of NHS research ethics committees and the multicentre committees ). The Group was primarily (...)
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  50.  8
    Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project.Adriana Ceci, Giorgio Reggiardo, Bianca Tempesta, Slaheddine Fattoum, Lamis Ragab, George Papanikolaou, Hugo Devlieger, Donato Bonifazi, Mariagrazia Felisi & Viviana Giannuzzi - 2021 - BMC Medical Ethics 22 (1):1-11.
    BackgroundWe describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions (...)
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