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  1. Paul B. Miller & Charles Weijer (forthcoming). Moral Solutions in Assessing Research Risk. Irb.
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  2. Paul B. Miller & Charles Weijer, Trust and Exploitation in Clinical Research.
    This chapter attempts to derive, define, and specify norms governing the relationship between physician-researcher and patient-subject, and to explore their interconnection. It argues that rooting the relationship between physician-researcher and patient-subject in a normative theory of trust is promising. It enables the derivation, definition, and specification of norms governing the relationship and appreciation of their interconnection.
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  3. Paul B. Miller & Charles Weijer (2008). Beyond Consent : The Trust-Based Obligations of Physicians to Patients in Clinical Research. In Oonagh Corrigan (ed.), The Limits of Consent: A Socio-Ethical Approach to Human Subject Research in Medicine. Oxford University Press.
     
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  4. Paul B. Miller & Charles Weijer (2007). Equipoise and the Duty of Care in Clinical Research: A Philosophical Response to Our Critics. 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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  5. Paul B. Miller & Charles Weijer, Evaluating Benefits and Harms in Clinical Research.
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  6. Paul B. Miller & Charles Weijer (2007). Revisiting Equipoise: A Response to Gifford. Kennedy Institute of Ethics Journal 17 (3):227-246.
    : The authors respond to objections Fred Gifford has raised against their paper "Rehabilitating Equipoise." They situate this exchange in the wider context of recent debate over equipoise, highlighting substantial points of agreement between themselves and Gifford. The authors offer a brief restatement of "Rehabilitating Equipoise" in which they amplify some of its core arguments. They then assess Gifford's objections. Finding each to be unfounded, they argue that there is no justification for "pulling the plug" on clinical equipoise.
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  7. Charles Weijer & Paul B. Miller, Evaluating Benefits and Harms in Intensive Care Research.
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  8. Charles Weijer & Paul B. Miller (2007). Refuting the Net Risks Test: A Response to Wendler and Miller's "Assessing Research Risks Systematically". Journal of Medical Ethics 33 (8):487-490.
    Earlier in the pages of this journal (p 481), Wendler and Miller offered the "net risks test" as an alternative approach to the ethical analysis of benefits and harms in research. They have been vocal critics of the dominant view of benefit-harm analysis in research ethics, which encompasses core concepts of duty of care, clinical equipoise and component analysis. They had been challenged to come up with a viable alternative to component analysis which meets five criteria. The alternative must (1) (...)
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  9. Paul B. Miller & Charles Weijer (2006). Fiduciary Obligation in Clinical Research. Journal of Law, Medicine and Ethics 34 (2):424-440.
    Heated debate surrounds the question whether the relationship between physician-researcher and patient-subject is governed by a duty of care. Miller and Weijer argue that fiduciary law provides a strong legal foundation for this duty, and for articulating the terms of the relationship between physician-researcher and patient-subject.
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  10. Paul B. Miller & Charles Weijer (2006). Trust Based Obligations of the State and Physician-Researchers to Patient-Subjects. Journal of Medical Ethics 32 (9):542-547.
    When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust-based obligations of the state and the physician-researcher respectively to the patient-subject. The state relies on the voluntarism of patient-subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent-neutral interests of patient-subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit-harm evaluation by research (...)
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  11. Paul B. Miller & Charles Weijer, Evaluating Risks of Non-Therapeutic Research in Children.
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  12. Charles Weijer & Paul B. Miller, When Are Research Risks Reasonable in Relation to Anticipated Benefits?
    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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  13. Trudo Lemmens & Paul B. Miller (2003). The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives. Journal of Law, Medicine and Ethics 31 (3):398-418.
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  14. Paul B. Miller & Charles Weijer (2003). Rehabilitating Equipoise. Kennedy Institute of Ethics Journal 13 (2):93-118.
    : When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist a state of (...)
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  15. Paul B. Miller & Charles Weijer (2003). Will the Real Charles Fried Please Stand Up? Kennedy Institute of Ethics Journal 13 (4):353-357.
    : In response to the preceding commentary by Jerry Menikoff in this issue of the Journal , the authors argue that Fried's central concern is not that randomized clinical trials (RCTs) are conducted without consent, but rather that various aspects of the design and conduct of RCTs are in tension with physicians' duties of personal care to their patients. Although Fried does argue that the existence of equipoise cannot justify failure to obtain consent from research subjects, informed consent by itself (...)
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  16. Charles Weijer & Paul B. Miller, Therapeutic Obligation in Clinical Research.
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  17. Trudo Lemmens & Paul B. Miller (2002). Avoiding a Jekyll-and-Hyde Approach to the Ethics of Clinical Research and Practice. American Journal of Bioethics 2 (2):14 – 17.
    (2002). Avoiding a Jekyll-And-Hyde Approach to the Ethics of Clinical Research and Practice. The American Journal of Bioethics: Vol. 2, No. 2, pp. 14-17.
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  18. Paul B. Miller & Nuala P. Kenny (2002). Walking the Moral Tightrope: Respecting and Protecting Children in Health-Related Research. Cambridge Quarterly of Healthcare Ethics 11 (03):217-229.
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