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46Informed consent to future research on stored tissue samples: the views of researchers, ethics review committee members and policy makers in five non-Western countriesAsian Bioethics Review 1 (4): 401-416. 2009.
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39The importance of epistemology for clinical practiceTheoretical Medicine and Bioethics 12 (1): 87-90. 1991.
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4Philosophical justifications of informed consent in researchIn Ezekiel J. Emanuel (ed.), The Oxford textbook of clinical research ethics, Oxford University Press. 2008.
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92Following the giant’s paces: Governance issues and bioethical reflections in ChinaBMC Medical Ethics 15 (1): 1-9. 2014.China has become a global player in the field of biosamples research and analysis of genetic data. The Beijing Genomics Institute is a genetics factory where enormous amounts of biosamples/data from all over the world are being analyzed. Most of the global bioethics discussions focused on research conducted by scientists from industrialized countries with subjects from poorer countries. Today, however, samples from industrialized nations are being analyzed in China on an unprecedented scale. Thi…Read more
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68Eugenics and Mandatory Informed Prenatal Genetic Testing: A Unique Perspective from ChinaDeveloping World Bioethics 16 (2): 107-115. 2015.The application of genetic technologies in China, especially in the area of prenatal genetic testing, is rapidly increasing in China. In the wealthy regions of China, prenatal genetic testing is already very widely adopted. We argue that the government should actively promote prenatal genetic testing to the poor areas of the country. In fact, the government should prioritize resources first to make prenatal genetic testing a standard routine care with an opt-out model in these area. Healthcare p…Read more
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7Obligations of poor countries in ensuring global justice: The case of UgandaEtikk I Praksis - Nordic Journal of Applied Ethics 2 82-96. 2014.Obligations of global justice rest mainly on the global rich but also to a lesser extent on the global poor. The governments of poor countries are obliged to fulfill requirements of non-aggression, good governance and decency, along with all other requirements which facilitate the achievement of global justice. So far, obligations of poor countries seem to be taken as given yet the behavior of governments in poor countries and occurrences therein attest to the contrary;this suggests a need to ma…Read more
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40Comparative effectiveness research: what to do when experts disagree about risksBMC Medical Ethics 18 (1): 42. 2017.Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees should evaluate the risks of comparative effectiveness research. We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives.…Read more
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51Aiming at a moving target: research ethics in the context of evolving standards of care and preventionJournal of Medical Ethics 39 (11): 699-702. 2013.In rapidly evolving medical fields where the standard of care or prevention changes frequently, guidelines are increasingly likely to conflict with what participants receive in research. Although guidelines typically set the standard of care, there are some cases in which research can justifiably deviate from guidelines. When guidelines conflict with research, an ethical issue only arises if guidelines are rigorous and should be followed. Next, it is important that the cumulative evidence and th…Read more
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17Questions have been raised over the acceptability of conducting human challenge studies in low and middle income countries. Most of these concerns are based on theoretical considerations and there exists little data on the attitudes of stakeholders in these countries. This study examines the view of researchers and REC members in Thailand regarding the design and conduct of challenge studies in the country. A questionnaire was developed based on ethical frameworks for human challenge studies. Th…Read more
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16Should a Country Follow WHO’s Guidelines on the Pathway to Universal Health Coverage? A Case Illustration with the Chinese Healthcare SystemAsian Bioethics Review 10 (3): 171-187. 2018.The WHO Consultative Group on Equity and Universal Health Coverage published a comprehensive report titled “Making Fair Choices on the Path to Universal Health Coverage” detailing strategies that countries should adopt when moving towards providing healthcare coverage to the entire population. The report provides detailed guidelines on how to expand coverage to more people, what services should be covered, and how to prioritize these healthcare resources in achieving universal healthcare coverag…Read more
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32The term “globalization” was popularized by Marshall McLuhan in War and Peace in the Global Village. In the book, McLuhan described how the global media shaped current events surrounding the Vietnam War [1] and also predicted how modern information and communication technologies would accelerate world progress through trade and knowledge development. Globalization now refers to a broad range of issues regarding the movement of goods and services through trade liberalization, and the movement of …Read more
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35Enhancing Research Quality with Updated and Controversial Ethical Issues: Summary and RecommendationsAsian Bioethics Review 9 (1-2): 157-167. 2017.
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Theory Change in Cardiovascular ResearchDissertation, University of Minnesota. 1987.This dissertation is an attempt to develop a model of rational theory change which can be used to elucidate the shift in theories which occurred in cardiology during the 1920s. I examine in detail the introduction of the coronary theory of angina pectoris, and the introduction of the disease entity acute myocardial infarction. With regard to angina pectoris, I argue that the chief rival to the coronary theory, an aortic theory proposed by such investigators as Allbutt and Wenchebach, was not ref…Read more
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The Ethics of the Physician-Patient relationship: The Anglo-American Approach in the European ContextIn Reidar Krummradt Lie (ed.), Healthy thoughts: European perspectives on health care ethics, Peeters. 2002.
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36Moral Standards for Research in Developing Countries from "Reasonable Availability" to "Fair Benefits"Hastings Center Report 34 (3): 17. 2004.
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34Reassessing Diagrams of Cardiac Mechanics: From Otto Frank and Ernest Starling to Hiroyuki SugaPerspectives in Biology and Medicine 59 (4): 471-490. 2016.The main topic of this article is Otto Frank's forgotten notion of the pressure-volume diagram of the cardiac ventricle as a means to assess the external mechanical work of the heart. Developed by Frank at the end of the 19th century, this idea was reenvisioned as pressure-volume area about 70 to 80 years later by Hiroyuki Suga. This notion now serves as a perspective for defining cardiac contractility and thus enabling the controlled clinical application of cardiac assist devices. We begin our …Read more
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24Methodological and Conceptual Issues in Health Care System Comparisons: Canada, Norway, and the United StatesJournal of Medicine and Philosophy 18 (5): 437-463. 1993.There is a growing interest in comparison of international health care data with the hope that such studies will enable individual systems to learn from other systems. Such comparisons, however, presuppose that there exist common criteria for evaluating health care systems. The main thesis of this paper is that these comparative studies are misleading because they employ inappropriate operationalizations of these criteria because the operarionalizations are based upon mistaken global conceptuali…Read more
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42The standard of care debate: the Declaration of Helsinki versus the international consensus opinionJournal of Medical Ethics 30 (2): 190-193. 2004.The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Fin…Read more
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29Research ethics and evidence based medicineJournal of Medical Ethics 30 (2): 122-125. 2004.In this paper, the author argues that the requirement to conduct randomised clinical trials to inform policy in cases where one wants to identify a cheaper alternative to known effective but expensive interventions raises an important ethical issue. This situation will eventually arise whenever there are resource constraints, and a policy decision has been made not to fund an intervention on cost effectiveness grounds. It has been thought that this is an issue only in extremely resource poor set…Read more
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22Healthy thoughts: European perspectives on health care ethics (edited book)Peeters. 2002.This book, edited by a team of leading European bioethicists, is in all respects an innovative publication.
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36The 'borderzone zone' controversy a study of theory structure in biomedicineTheoretical Medicine and Bioethics 7 (3). 1986.This paper gives an account of theory structure in the biomedical sciences with particular emphasis on cardiology. Rather than regarding theories as axiomatizable sets of statements (the so-called received view), theories are regarded as answers to questions which are accepted as legitimate and interesting by scientists within a field of investigation at a given time. This account of theory structure is used to distinguish between theories which are quite liable to be revised during the course o…Read more
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58Evidence-Based Medicine as an Instrument for Rational Health PolicyHealth Care Analysis 10 (3): 261-275. 2002.This article tries to present a broad view on the values and ethicalissues that are at stake in efforts to rationalize health policy on thebasis of economic evaluations (like cost-effectiveness analysis) andrandomly controlled clinical trials. Though such a rationalization isgenerally seen as an objective and `value free' process, moral valuesoften play a hidden role, not only in the production of `evidence', butalso in the way this evidence is used in policy making. For example, thedefinition o…Read more
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70Principles versus procedures in making health care coverage decisions: Addressing inevitable conflictsTheoretical Medicine and Bioethics 29 (2): 73-85. 2008.It has been suggested that focusing on procedures when setting priorities for health care avoids the conflicts that arise when attempting to agree on principles. A prominent example of this approach is “accountability for reasonableness.” We will argue that the same problem arises with procedural accounts; reasonable people will disagree about central elements in the process. We consider the procedural condition of appeal process and three examples of conflicts over coverage decisions: a patient…Read more
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10The absolute ethical requirement of individual, informed consent: A commentary on Barrett and ParkerMonash Bioethics Review 22 (3): 18-22. 2003.
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47An examination and critique of Harsanyi's version of utilitarianismTheory and Decision 21 (1): 65-83. 1986.
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59Obligations of low income countries in ensuring equity in global health financingBMC Medical Ethics 16 (1): 1-11. 2015.Background. Despite common recognition of joint responsibility for global health by all countries particularly to ensure justice in global health, current discussions of countries’ obligations for global health largely ignore obligations of developing countries. This is especially the case with regards to obligations relating to health financing. Bearing in mind that it is not possible to achieve justice in global health without achieving equity in health financing at both domestic and global le…Read more
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34The use of interval estimators as a basis for decision-making in medicineTheoretical Medicine and Bioethics 5 (3). 1984.Decision analysts sometimes use the results of clinical trials in order to evaluate treatment alternatives. I discuss some problems associated with this, and in particular I point out that it is not valid to use the estimates from clinical trials as the probabilities of events which are needed for decision analysis. I also attempt to show that an approach based on objective statistical theory may have advantages over commonly used methods based on decision theory. These advantages include the re…Read more
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19Medical Ethics in China: A Transcultural Interpretation (review)Asian Bioethics Review 4 (3): 240-246. 2012.