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Experimental Design: Ethics, Integrity and the Scientific Method

In Ron Iphofen (ed.), Handbook of Research Ethics and Scientific Integrity. Cham, Switzerland: pp. 459-474 (2020)

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  1. Harmonization of Ethics Policies in Pediatric Research.Valarie Blake, Steve Joffe & Eric Kodish - 2011 - Journal of Law, Medicine and Ethics 39 (1):70-78.
    The Food and Drug Administration and the European Medicines Agency have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use as a (...)
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  • Data Sharing and Dual-Use Issues.Louise Bezuidenhout - 2011 - Science and Engineering Ethics 19 (1):83-92.
    The concept of dual-use encapsulates the potential for well-intentioned, beneficial scientific research to also be misused by a third party for malicious ends. The concept of dual-use challenges scientists to look beyond the immediate outcomes of their research and to develop an awareness of possible future (mis)uses of scientific research. Since 2001 much attention has been paid to the possible need to regulate the dual-use potential of the life sciences. Regulation initiatives fall under two broad categories—those that develop the ethical (...)
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  • “Case Neisser”: Experimental Design, the Beginnings of Immunology, and Informed Consent.Thomas G. Benedek - 2014 - Perspectives in Biology and Medicine 57 (2):249-267.
    As etiologic concepts of diseases gradually changed from humoral to microbial in the 19th century, syphilis presented particularly great challenges to doctors and scientists. Was “syphilis” merely a synonym for “venereal disease,” and did all manifestations attributed to it have the same cause? The discovery in 1879 of the gonococcus by Albert L. Neisser , and of the cause of chancroid, or soft chancre, in 1890 by Augusto Ducrey , established that venereal disease and syphilis were not synonymous, but syphilis (...)
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  • Good intentions and dangerous assumptions: Research ethics committees and illicit drug use research.Kirsten Bell & Amy Salmon - 2012 - Research Ethics 8 (4):191-199.
    Illicit drug users are frequently identified as a ‘vulnerable population’ requiring ‘special protection’ and ‘additional safeguards’ in research. However, without specific guidance on how to enact these special protections and safeguards, research ethics committee (REC) members sometimes fall back on untested assumptions about the ethics of illicit drug use research. In light of growing calls for ‘evidence-based research ethics’, this commentary examines three common assumptions amongst REC members about what constitutes ethical research with drug users, and whether such assumptions are (...)
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  • Popular Culture, Digital Archives and the New Social Life of Data.David Beer & Roger Burrows - 2013 - Theory, Culture and Society 30 (4):47-71.
    Digital data inundation has far-reaching implications for: disciplinary jurisdiction; the relationship between the academy, commerce and the state; and the very nature of the sociological imagination. Hitherto much of the discussion about these matters has tended to focus on ‘transactional’ data held within large and complex commercial and government databases. This emphasis has been quite understandable – such transactional data does indeed form a crucial part of the informational infrastructures that are now emerging. However, in recent years new sources of (...)
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  • Research ethics and journalism in the academy: Identifying and resolving a conflict of culture.Carolyn Beasley & Lyndon Walker - 2014 - Research Ethics 10 (3):129-140.
    The difficulty faced by research ethics committees in evaluating ethical conduct in journalism can be considered a recent conundrum. Journalistic investigation has traditionally been seen as residing outside the need for ethics clearances owing to debates around its status as research and to the reluctance of journalism practitioners to subject their investigations to committee evaluation. The inclusion of creative industries in revamped definitions of research, however, means that if journalistic inquiry is to be tallied under national research reward schemes, it (...)
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  • Informed Consent: Its History, Meaning, and Present Challenges.Tom L. Beauchamp - 2011 - Cambridge Quarterly of Healthcare Ethics 20 (4):515-523.
    The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.
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  • Betwixt & Between: Peer Recruiter Proximity in Community-Based Research.Sally Bean & Diego S. Silva - 2010 - American Journal of Bioethics 10 (3):18-19.
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  • Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects.World Medical Association - 2009 - Jahrbuch für Wissenschaft Und Ethik 14 (1):233-238.
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  • Synthetic Biology between Self-Regulation and Public Discourse: Ethical Issues and the Many Roles of the Ethicist.Gardar Arnason - 2017 - Cambridge Quarterly of Healthcare Ethics 26 (2):246-256.
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  • Uneasy Access: Privacy for Women in a Free Society.Anita L. Allen - 1988 - Rowman & Littlefield Publishers.
    'Anita L. Allen breaks new ground...A stunning indictment of women's status in contemporary society, her book provides vital original scholarly research and insight.' |s-NEW DIRECTIONS FOR WOMEN.
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  • Equipoise as a means of managing uncertainty: personal, communal and proxy.P. Alderson - 1996 - Journal of Medical Ethics 22 (3):135-139.
    Equipoise is advocated as a means of achieving high scientific and ethical standards in randomised trials. As used in the context of research the word describes a state of uncertainty characterised by the belief that in a trial no arm is known to offer greater harm or benefit than any other arm. Clinicians who lack personal equipoise are advised to accept clinical or communal equipoise, based on current unresolved disagreement among the medical profession. Equipoise is mainly discussed in the literature (...)
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  • Improving Informed Consent: A Comparison of Four Consent Tools.Patricia Agre & Bruce Rapkin - 2003 - IRB: Ethics & Human Research 25 (6):1.
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  • The Dappled World: A Study of the Boundaries of Science.Nancy Cartwright - 2001 - Erkenntnis 54 (3):411-415.
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  • Respecting sources; confidentiality : critical but not absolute.Aaron Quinn - 2010 - In Christopher Meyers (ed.), Journalism ethics: a philosophical approach. New York: Oxford University Press.
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  • Characterizing the robustness of science: after the practice turn in philosophy of science.Lena Soler (ed.) - 2012 - New York: Springer Verlag.
    Featuring contributions from the world’s leading experts on the subject and based partly on several detailed case studies, this volume is the first comprehensive analysis of the scientific notion of robustness as well as of the general ...
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  • The ethics of anthropology and Amerindian research: reporting on environmental degradation and warfare.Richard J. Chacon & Ruben G. Mendoza (eds.) - 2012 - New York: Springer.
    This work documents the ethical dilemmas faced by anthropologists and researchers in general when investigating Amerindian communities.
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  • Behavioral and Social Science Research.Felice J. Levine & Paula R. Skedsvold - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 336.
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  • An ethical framework for biomedical research.Ezekiel J. Emanuel, David Wendler & C. Grady - 2008 - In The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 123--135.
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  • Medical experimentation: personal integrity and social policy.Charles Fried - 2016 - New York, NY: Oxford University Press. Edited by Franklin G. Miller & Alan Wertheimer.
    This new edition of Charles Fried's 'Medical Experimentation' includes a general introduction by Franklin Miller and the late Alan Wertheimer, a reprint of the 1974 text, an in-depth analysis by Harvard Law School scholars I. Glenn Cohen and D. James Greiner, and a new essay by Fried reflecting on the original text and how it applies to the contemporary landscape of medicine and medical experimentation.
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  • Coming clean but playing dirtier : the shortcomings of disclosure as a solution to conflicts of interest.Daylian M. Cain, George Loewenstein & Don A. Moore - 2005 - In Don A. Moore (ed.), Conflicts of interest: challenges and solutions in business, law, medicine, and public policy. New York: Cambridge University Press. pp. 104.
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  • Bounded ethicality as a psychological barrier to recognizing conflicts of interest.Dolly Chugh, Max H. Bazerman & Mahzarin R. Banaji - 2005 - In Don A. Moore (ed.), Conflicts of interest: challenges and solutions in business, law, medicine, and public policy. New York: Cambridge University Press.
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  • The multiplicity of experimental protocols: A challenge to reductionist and non-reductionist models of the unity of neuroscience.Jacqueline A. Sullivan - 2009 - Synthese 167 (3):511-539.
    Descriptive accounts of the nature of explanation in neuroscience and the global goals of such explanation have recently proliferated in the philosophy of neuroscience and with them new understandings of the experimental practices of neuroscientists have emerged. In this paper, I consider two models of such practices; one that takes them to be reductive; another that takes them to be integrative. I investigate those areas of the neuroscience of learning and memory from which the examples used to substantiate these models (...)
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  • Foundations of the metaphysics of morals.Immanuel Kant - 2000 - In Steven M. Cahn (ed.), Exploring Philosophy: An Introductory Anthology. New York, NY, United States of America: Oxford University Press USA.
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  • Hunting Causes and Using Them: Approaches in Philosophy and Economics.Nancy Cartwright (ed.) - 2007 - New York: Cambridge University Press.
    Hunting Causes and Using Them argues that causation is not one thing, as commonly assumed, but many. There is a huge variety of causal relations, each with different characterizing features, different methods for discovery and different uses to which it can be put. In this collection of new and previously published essays, Nancy Cartwright provides a critical survey of philosophical and economic literature on causality, with a special focus on the currently fashionable Bayes-nets and invariance methods - and it exposes (...)
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  • Engaging with Ethics: Ethical inquiry for teachers.Mark Freakley & Gilbert Burgh - 2000 - Katoomba NSW 2780, Australia: Social Sciences Press.
    This book adopts a ‘community of inquiry’ approach to the teaching of professional ethics to pre-service teachers. It is designed to assist students to bridge the gap between ethical theories and their practical experiences as beginning professionals. The first part of the book articulates the framework for the approach taken while the second part provides a series of fictional ethical vignettes set consisting of school teachers and their students in a local school.
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  • The Structure of Scientific Revolutions.Thomas S. Kuhn - 1962 - Chicago, IL: University of Chicago Press. Edited by Ian Hacking.
    Thomas S. Kuhn's classic book is now available with a new index.
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  • Considered Judgment.Catherine Z. Elgin - 1999 - Princeton University Press.
    Philosophy long sought to set knowledge on a firm foundation, through derivation of indubitable truths by infallible rules. For want of such truths and rules, the enterprise foundered. Nevertheless, foundationalism's heirs continue their forbears' quest, seeking security against epistemic misfortune, while their detractors typically espouse unbridled coherentism or facile relativism. Maintaining that neither stance is tenable, Catherine Elgin devises a via media between the absolute and the arbitrary, reconceiving the nature, goals, and methods of epistemology. In Considered Judgment, she argues (...)
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  • The Ethics of Research with Human Subjects: Protecting People, Advancing Science, Promoting Trust.David B. Resnik - 2018 - Cham: Springer Verlag.
    This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, (...)
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  • Group privacy.Bart van der Sloot, Luciano Floridi & Linnet Taylor (eds.) - 2016 - Springer Verlag.
    The goal of the book is to present the latest research on the new challenges of data technologies. It will offer an overview of the social, ethical and legal problems posed by group profiling, big data and predictive analysis and of the different approaches and methods that can be used to address them. In doing so, it will help the reader to gain a better grasp of the ethical and legal conundrums posed by group profiling. The volume first maps the (...)
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  • Ethics Dumping: Case Studies from North-South Research Collaborations.Doris Schroeder, Julie Cook, François Hirsch, Solveig Fenet & Vasantha Muthuswamy (eds.) - 2017 - New York: Springer.
    This open access book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well (...)
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  • Virtue Ethics in the Conduct and Governance of Social Science Research.Nathan Emmerich (ed.) - 2018 - Emerald.
    This collection focuses on virtue theory and the ethics of social science research. A moral philosophy that has been relatively neglected in the domain of research ethics, virtue ethics has much to offer those who wish to go beyond the difficulties generated by the biomedical model of research ethics and positively engage with the ethics of social scientific research. As the chapters contained in this volume show, the perspective provided by virtue ethics also exhibits a certain affinity with the emerging (...)
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  • In a Different Voice: Psychological Theory and Women's Development.Carol Gilligan - 1982 - Cambridge, MA: Harvard University Press.
    In a Different Voice is the little book that started a revolution, making women's voices heard, in their own right and with their own integrity, for virtually the first time in social scientific theorizing about women. Its impact was immediate and continues to this day, in the academic world and beyond.
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  • Medical Nihilism.Jacob Stegenga - 2018 - Oxford, United Kingdom: Oxford University Press.
    Medical nihilism is the view that we should have little confidence in the effectiveness of medical interventions. Jacob Stegenga argues persuasively that this is how we should see modern medicine, and suggests that medical research must be modified, clinical practice should be less aggressive, and regulatory standards should be enhanced.
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  • “But the data is already public”: on the ethics of research in Facebook.Michael Zimmer - 2010 - Ethics and Information Technology 12 (4):313-325.
    In 2008, a group of researchers publicly released profile data collected from the Facebook accounts of an entire cohort of college students from a US university. While good-faith attempts were made to hide the identity of the institution and protect the privacy of the data subjects, the source of the data was quickly identified, placing the privacy of the students at risk. Using this incident as a case study, this paper articulates a set of ethical concerns that must be addressed (...)
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  • Research integrity in china: Problems and prospects.Weiqin Zeng & David Resnik - 2010 - Developing World Bioethics 10 (3):164-171.
    In little more than 30 years, China has recovered from the intellectual stagnation brought about by the Cultural Revolution to become a global leader in science and technology. Like other leading countries in science and technology, China has encountered some ethical problems related to the conduct of research. China 's leaders have taken some steps to respond to these problems, such as developing ethics policies and establishing oversight committees. To keep moving forward, China needs to continue to take effective action (...)
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  • The Role of Engineering Ethics on Concrete Fire Safety.Javad Yahaghi & Shahryar Sorooshian - 2018 - Science and Engineering Ethics 24 (2):819-820.
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  • Trust and Trustworthiness.Stephen Wright - 2010 - Philosophia 38 (3):615-627.
    What is it to trust someone? What is it for someone to be trustworthy? These are the two main questions that this paper addresses. There are various situations that can be described as ones of trust, but this paper considers the issue of trust between individuals. In it, I suggest that trust is distinct from reliance or cases where someone asks for something on the expectation that it will be done due to the different attitude taken by the trustor. I (...)
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  • What evidence in evidence-based medicine?John Worrall - 2002 - Proceedings of the Philosophy of Science Association 2002 (3):S316-S330.
    Evidence-Based Medicine is a relatively new movement that seeks to put clinical med- icine on a firmer scientific footing. I take it as uncontroversial that medical practice should be based on best evidence-the interesting questions concern the details. This paper tries to move towards a coherent and unified account of best evidence in medicine, by exploring in particular the EBM position on RCTs (randomized controlled trials).
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  • What Evidence in Evidence‐Based Medicine?John Worrall - 2002 - Philosophy of Science 69 (S3):S316-S330.
    Evidence-Based Medicine is a relatively new movement that seeks to put clinical medicine on a firmer scientific footing. I take it as uncontroversial that medical practice should be based on best evidence—the interesting questions concern the details. This paper tries to move towards a coherent and unified account of best evidence in medicine, by exploring in particular the EBM position on RCTs.
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  • Why There’s No Cause to Randomize.John Worrall - 2007 - British Journal for the Philosophy of Science 58 (3):451-488.
    The evidence from randomized controlled trials (RCTs) is widely regarded as supplying the ‘gold standard’ in medicine—we may sometimes have to settle for other forms of evidence, but this is always epistemically second-best. But how well justified is the epistemic claim about the superiority of RCTs? This paper adds to my earlier (predominantly negative) analyses of the claims produced in favour of the idea that randomization plays a uniquely privileged epistemic role, by closely inspecting three related arguments from leading contributors (...)
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  • Evidence in medicine and evidence-based medicine.John Worrall - 2007 - Philosophy Compass 2 (6):981–1022.
    It is surely obvious that medicine, like any other rational activity, must be based on evidence. The interest is in the details: how exactly are the general principles of the logic of evidence to be applied in medicine? Focussing on the development, and current claims of the ‘Evidence-Based Medicine’ movement, this article raises a number of difficulties with the rationales that have been supplied in particular for the ‘evidence hierarchy’ and for the very special role within that hierarchy of randomized (...)
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  • Inducements revisited.Martin Wilkinson & Andrew Moore - 1999 - Bioethics 13 (2):114–130.
    The paper defends the permissibility of paying inducements to research subjects against objections not covered in an earlier paper in Bioethics. The objections are that inducements would cause inequity, crowd out research, and undesirably commercialize the researcher‐subject relationship. The paper shows how these objections presuppose implausible factual and/or normative claims. The final position reached is a qualified defence of freedom of contract which not only supports the permissibility of inducements but also offers guidance to ethics committees in dealing with practical (...)
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  • Inducement in Research.Martin Wilkinson & Andrew Moore - 1997 - Bioethics 11 (5):373-389.
    Opposition to inducement payments for research subjects is an international orthodoxy amongst writers of ethics committee guidelines. We offer an argument in favour of these payments. We also critically evaluate the best arguments we can find or devise against such payments, and except in one very limited range of circumstances, we find these unconvincing.
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  • Epistemic Trust in Science.Torsten Wilholt - 2013 - British Journal for the Philosophy of Science 64 (2):233-253.
    Epistemic trust is crucial for science. This article aims to identify the kinds of assumptions that are involved in epistemic trust as it is required for the successful operation of science as a collective epistemic enterprise. The relevant kind of reliance should involve working from the assumption that the epistemic endeavors of others are appropriately geared towards the truth, but the exact content of this assumption is more difficult to analyze than it might appear. The root of the problem is (...)
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  • Bias and values in scientific research.Torsten Wilholt - 2009 - Studies in History and Philosophy of Science Part A 40 (1):92-101.
    When interests and preferences of researchers or their sponsors cause bias in experimental design, data interpretation or dissemination of research results, we normally think of it as an epistemic shortcoming. But as a result of the debate on science and values, the idea that all extra-scientific influences on research could be singled out and separated from pure science is now widely believed to be an illusion. I argue that nonetheless, there are cases in which research is rightfully regarded as epistemologically (...)
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  • What Constitutes Research Ethics in Sport and Exercise Science?Julia West, Karen Bill & Louise Martin - 2010 - Research Ethics 6 (4):147-153.
    Prior to any research data collection a proposal outlining methods and protocols is required to undergo ethical scrutiny. The issues surrounding a research ethics review process within sport and exercise science departments are not dissimilar to other subject areas. In particular, the ethical review process may be unclear to the researcher and can either present a difficult and time-consuming challenge or be merely perceived as a tick-box exercise. The aim of this study was to explore and compare research ethics processes (...)
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  • Rethinking Relational Autonomy.Andrea C. Westlund - 2009 - Hypatia 24 (4):26-49.
    John Christman has argued that constitutively relational accounts of autonomy, as defended by some feminist theorists, are problematically perfectionist about the human good. I argue that autonomy is constitutively relational, but not in a way that implies perfectionism: autonomy depends on a dialogical disposition to hold oneself answerable to external, critical perspectives on one's action-guiding commitments. This type of relationality carries no substantive value commitments, yet it does answer to core feminist concerns about autonomy.
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  • Scientific Imperialism and the Proper Relations between the Sciences.Steve Clarke & Adrian Walsh - 2009 - International Studies in the Philosophy of Science 23 (2):195-207.
    John Dupr argues that 'scientific imperialism' can result in 'misguided' science being considered acceptable. 'Misguided' is an explicitly normative term and the use of the pejorative 'imperialistic' is implicitly normative. However, Dupr has not justified the normative dimension of his critique. We identify two ways in which it might be justified. It might be justified if colonisation prevents a discipline from progressing in ways that it might otherwise progress. It might also be justified if colonisation prevents the expression of important (...)
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  • Science journal editors' views on publication ethics: results of an international survey.E. Wager, S. Fiack, C. Graf, A. Robinson & I. Rowlands - 2009 - Journal of Medical Ethics 35 (6):348-353.
    Background: Breaches of publication ethics such as plagiarism, data fabrication and redundant publication are recognised as forms of research misconduct that can undermine the scientific literature. We surveyed journal editors to determine their views about a range of publication ethics issues. Methods: Questionnaire sent to 524 editors-in-chief of Wiley-Blackwell science journals asking about the severity and frequency of 16 ethical issues at their journals, their confidence in handling such issues, and their awareness and use of guidelines. Results: Responses were obtained (...)
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