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  1. The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation.George J. Annas - 1992 - Oxford University Press USA.
    This important new work surveys the source and ramifications of the famed Nuremburg Code -- recognized around the world as one of the cornerstones of modern bioethics.
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  • Walter Reed and the yellow fever experiments.Susan E. Lederer - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 9--17.
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  • Making Risk-Benefit Assessments of Medical Research Protocols.Alex Rajczi - 2004 - Journal of Law, Medicine and Ethics 32 (2):338-348.
    An axiom of medical research ethics is that a protocol is moral only if it has a “favorable risk-benefit ratio”. This axiom is usually interpreted in the following way: a medical research protocol is moral only if it has a positive expected value -- that is, if it is likely to do more good (to both subjects and society) than harm. I argue that, thus interpreted, the axiom has two problems. First, it is unusable, because it requires us to know (...)
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  • In Loco Parentis Minimal Risk as an Ethical Threshold for Research upon Children.Benjamin Freedman, Abraham Fuks & Charles Weijer - 1993 - Hastings Center Report 23 (2):13-19.
    To what risks may children participating in research be subjected? Institutional review boards can stand surrogate for parents by filtering out studies whose risk is unacceptably high.
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  • (1 other version)Ethics and regulation of clinical research.Robert J. Levine - 1986 - Baltimore: Urban & Schwarzenberg.
    In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.
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  • The ambiguity and the exigency: Clarifying 'standard of care' arguments in international research.Alex John London - 2000 - Journal of Medicine and Philosophy 25 (4):379 – 397.
    This paper examines the concept of a 'standard of care' as it has been used in recent arguments over the ethics of international human-subjects research. It argues that this concept is ambiguous along two different axes, with the result that there are at least four possible standard of care arguments that have not always been clearly distinguished. As a result, it has been difficult to assess the implications of opposing standard of care arguments, to recognize important differences in their supporting (...)
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  • So-called "clinical equipoise" and the argument from design.Fred Gifford - 2007 - Journal of Medicine and Philosophy 32 (2):135 – 150.
    In this article, I review and expand upon arguments showing that Freedman's so-called "clinical equipoise" criterion cannot serve as an appropriate guide and justification for the moral legitimacy of carrying out randomized clinical trials. At the same time, I try to explain why this approach has been given so much credence despite compelling arguments against it, including the fact that Freedman's original discussion framed the issues in a misleading way, making certain things invisible: Clinical equipoise is conflated with community equipoise, (...)
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  • Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for "Minimal" Risks.David Wendler - 2005 - Hastings Center Report 35 (5):37.
    When children and incapacitated adults are enrolled in research that cannot directly benefit them, they can be exposed to no more than “minimal” risks, according to guidelines accepted around the world. We need a new standard for what “minimal” risks are, however—one that recognizes that participating in nonbeneficial research is like participating in a charitable activity. Such a standard appears likely to provide more stringent protections for these vulnerable populations.
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  • (1 other version)Judgment under Uncertainty: Heuristics and Biases.Amos Tversky & Daniel Kahneman - 1974 - Science 185 (4157):1124-1131.
    This article described three heuristics that are employed in making judgements under uncertainty: representativeness, which is usually employed when people are asked to judge the probability that an object or event A belongs to class or process B; availability of instances or scenarios, which is often employed when people are asked to assess the frequency of a class or the plausibility of a particular development; and adjustment from an anchor, which is usually employed in numerical prediction when a relevant value (...)
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  • Limits to Health Care: Fair Procedures, Democratic Deliberation, and the Legitimacy Problem for Insurers.Norman Daniels & James Sabin - 1997 - Philosophy and Public Affairs 26 (4):303-350.
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  • Limits to research risks.F. G. Miller & S. Jofe - 2009 - Journal of Medical Ethics 35 (7):445-449.
    Risk–benefit assessment is a routine requirement for research ethics committees that review and oversee biomedical research with human subjects. Nevertheless, it remains unclear how to weigh and balance risks to research participants against the social benefits that flow from generating biomedical knowledge. In this article, we address the question of whether there are any reasonable criteria for defining the limit of permissible risks to individuals who provide informed consent for research participation. We argue against any a priori limit to permissible (...)
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  • Minimal risk as an international ethical standard in research.Loretta M. Kopelman - 2004 - Journal of Medicine and Philosophy 29 (3):351 – 378.
    Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold out (...)
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  • A tale of two studies: Ethics, bioterrorism, and the censorship of science.Michael J. Selgedid - 2007 - Hastings Center Report 37 (3):35-43.
    : Some scientific research should not be published. The risks to national security and public health override the social benefits of disseminating scientific results openly. Unfortunately, scientists themselves are not in a position to know which studies to withhold from public view, as the National Research Council has proposed. Yet neither can government alone be trusted to balance the competing interests at stake.
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  • Medical research, risk, and bystanders.Jonathan Kimmelman - 2005 - IRB: Ethics & Human Research 27 (4):1.
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  • The Exceptional Ethics of the Investigator-Subject Relationship.B. Sachs - 2010 - Journal of Medicine and Philosophy 35 (1):64-80.
    This article concerns the validity of six canonical rules that institutional review boards use to constrain the behavior of investigators. These rules require investigators to design their studies in a scientifically valid way, not pay their subjects to take risks, minimize risks to their subjects, secure for their subjects access to effective interventions post-trial, not pay their subjects too much and allow their subjects to withdraw from the study unconditionally. Enforcement of these rules is problematic because there are other relationships (...)
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  • Non-therapeutic research with minors: how do chairpersons of German research ethics committees decide?C. Lenk - 2004 - Journal of Medical Ethics 30 (1):85-87.
    Objectives: Clinical trials in humans in Germany—as in many other countries—must be approved by local research ethics committees . The current study has been designed to document and evaluate decisions of chairpersons of RECs in the problematic field of non-therapeutic research with minors. The authors’ purpose was to examine whether non-therapeutic research was acceptable for chairpersons at all, and whether there was certainty on how to decide in research trials involving more than minimal risk.Design: In a questionnaire, REC chairpersons had (...)
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  • Rethinking the ethics of clinical research: widening the lens.Alan Wertheimer - 2011 - New York: Oxford University Press.
    Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.
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  • Third-Party Risks in Research: Should IRBs Address Them?Daniel Hausman - 2007 - IRB: Ethics & Human Research 29 (3).
    The risks to groups posed by research involving human beings—including genetics research—should be conceived of as a species of third-party risks. The important task of protecting third parties from the risks posed by the conduct and the findings of research should not be assigned to IRBs because they are not designed or equipped to handle such a broad responsibility. The serious problems raised by third-party risks require an integration of policy-making and regulation that is beyond the scope and competence of (...)
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  • A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials.Franklin G. Miller & Howard Brody - 2003 - Hastings Center Report 33 (3):19-28.
    A predominant ethical view holds that physician‐investigators should conduct their research with therapeutic intent. And since a physician offering a therapy wouldn't prescribe second‐rate treatments, the experimental intervention and the best proven therapy should appear equally effective. "Clinical equipoise" is necessary. But this perspective is flawed. The ethics of research and of therapy are fundamentally different, and clinical equipoise should be abandoned.
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  • Equipoise and the duty of care in clinical research: A philosophical response to our critics.Paul B. Miller & Charles Weijer - 2007 - Journal of Medicine and Philosophy 32 (2):117 – 133.
    Franklin G. Miller and colleagues have stimulated renewed interest in research ethics through their work criticizing clinical equipoise. Over three years and some twenty articles, they have also worked to articulate a positive alternative view on norms governing the conduct of clinical research. Shared presuppositions underlie the positive and critical dimensions of Miller and colleagues' work. However, recognizing that constructive contributions to the field ought to enjoy priority, we presently scrutinize the constructive dimension of their work. We argue that it (...)
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  • Uncertainty in Clinical Research.Robert J. Levine - 1988 - Journal of Law, Medicine and Ethics 16 (3-4):174-182.
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  • (2 other versions)Theory of Justice.John Rawls - 1972 - Journal of Philosophy 69 (18):556-557.
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  • The Paradoxical Case of Payment as Benefit to Research Subjects.Ruth Macklin - 1989 - IRB: Ethics & Human Research 11 (6):1.
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  • The Incommensurability of Research Risks and Benefits: Practical Help for Research Ethics Committees.Douglas K. Martin, Eric M. Meslin, Nitsa Kohut & Peter A. Singer - 1995 - IRB: Ethics & Human Research 17 (2):8.
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  • Assessing research risks systematically: the net risks test.D. Wendler & F. G. Miller - 2007 - Journal of Medical Ethics 33 (8):481-486.
    Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are (...)
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  • The Ethics of Altruism in Clinical Research.Lynn A. Jansen - 2009 - Hastings Center Report 39 (4):26-36.
    If people sometimes participate in research because of altruism—because they want to help in the search for treatments—should we revise our views about what kinds of experiments are ethical? If participants act out of altruism, we might let them accept greater risks than we would if they are motivated only by a desire for personal gain. But how can we know when participants are genuinely altruistic?
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  • (1 other version)Defining and Describing Benefit Appropriately in Clinical Trials.Nancy M. P. King - 2000 - Journal of Law, Medicine and Ethics 28 (4):332-343.
    Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction (...)
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  • Exploitation and developing countries: The ethics of clinical research.Jennifer S. Hawkins & Ezekiel J. Emanuel - 2008 - Princeton, NJ, USA: Princeton Univ Pr.
    This book was inspired originally by the debates at the turn of the century about placebo controlled trials of antiretrovirals in HIV positive pregnant women in developing countries. Moving forward from this one limited example, the book includes several additional controversial cases of clinical research conducted in developing countries, and asks probing philosophical questions about the ethics of such trials. All clinical research by its very nature uses people to acquire generalizable knowledge to help future people. But what sorts of (...)
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  • Facing up to paternalism in research ethics.Franklin G. Miller & Alan Wertheimer - 2007 - Hastings Center Report 37 (3):24-34.
    : Bioethicists have failed to understand the pervasively paternalistic character of research ethics. Not only is the overall structure of research review and regulation paternalistic in some sense; even the way informed consent is sought may imply paternalism. Paternalism has limits, however. Getting clear on the paternalism of research ethics may mean some kinds of prohibited research should be reassessed.
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  • The irrelevance of equipoise.Robert M. Veatch - 2007 - Journal of Medicine and Philosophy 32 (2):167 – 183.
    It is commonly believed in research ethics that some form of equipoise is a necessary condition for justifying randomized clinical trials, that without it clinicians are violating the moral duty to do what is best for the patient. Recent criticisms have shown how complex the concept of equipoise is, but often retain the commitment to some form of equipoise for randomization to be justified. This article rejects that claim. It first asks for what one should be equally poised (scientific or (...)
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  • Eliminating the daily life risks standard from the definition of minimal risk.D. B. Resnik - 2005 - Journal of Medical Ethics 31 (1):35-38.
    The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort anticipated in research (...)
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  • Clinical equipoise and the incoherence of research ethics.Franklin G. Miller & Howard Brody - 2007 - Journal of Medicine and Philosophy 32 (2):151 – 165.
    The doctrine of clinical equipoise is appealing because it appears to permit physicians to maintain their therapeutic obligation to offer optimal medical care to patients while conducting randomized controlled trials (RCTs). The appearance, however, is deceptive. In this article we argue that clinical equipoise is defective and incoherent in multiple ways. First, it conflates the sound methodological principle that RCTs should begin with an honest null hypothesis with the questionable ethical norm that participants in these trials should never be randomized (...)
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  • When Are Research Risks Reasonable in Relation to Anticipated Benefits?Charles Weijer & Paul B. Miller - unknown
    The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of risk (...)
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  • Guidelines to Prevent Malevolent Use of Biomedical Research.Shane K. Green, Sara Taub, Karine Morin & Daniel Higginson - 2006 - Cambridge Quarterly of Healthcare Ethics 15 (4):432-439.
    In February 1975, a group of leading scientists, physicians, and policymakers convened at Asilomar, California, to consider the safety of proceeding with recombinant DNA research. The excitement generated by the promise of this new technology was counterbalanced by concerns regarding dangers that might arise from it, including the potential for accidental release of genetically modified organisms into the environment. Guidelines developed at the conference to direct future research endeavors had several consequences. They permitted research to resume, bringing to an end (...)
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