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Franklin G. Miller [118]Franklin Gerber Miller [1]
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  1.  11
    Robert D. Truog & Franklin G. Miller (2014). Changing the Conversation About Brain Death. American Journal of Bioethics 14 (8):9-14.
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  2.  8
    Franklin G. Miller & Howard Brody (2003). A Critique of Clinical Equipoise: Therapeutic Misconception in the Ethics of Clinical Trials. Hastings Center Report 33 (3):19-28.
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  3.  65
    Franklin G. Miller & Alan Wertheimer (2007). Facing Up to Paternalism in Research Ethics. 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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  4.  65
    David H. Brendel & Franklin G. Miller (2008). A Plea for Pragmatism in Clinical Research Ethics. American Journal of Bioethics 8 (4):24 – 31.
    Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one (...)
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  5.  31
    Steven Joffe & Franklin G. Miller (2008). Bench to Bedside: Mapping the Moral Terrain of Clinical Research. Hastings Center Report 38 (2):30-42.
    : Medical research is widely thought to have a fundamentally therapeutic orientation, in spite of the fact that clinical research is thought to be ethically distinct from medical care. We need an entirely new conception of clinical research ethics—one that looks to science instead of the doctor-patient relationship.
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  6.  35
    Franklin G. Miller & Alan Wertheimer (eds.) (2010). The Ethics of Consent: Theory and Practice. Oxford University Press.
    This book assembles the contributions of a distinguished group of scholars concerning the ethics of consent in theory and practice.
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  7.  48
    Franklin G. Miller & Howard Brody (2002). What Makes Placebo-Controlled Trials Unethical? American Journal of Bioethics 2 (2):3 – 9.
    The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. (...)
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  8.  18
    Franklin G. Miller & Robert D. Truog (2008). Rethinking the Ethics of Vital Organ Donations. Hastings Center Report 38 (6):38-46.
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  9.  7
    Emily A. Largent, Steven Joffe & Franklin G. Miller (2011). Can RESEARCH and CARE Be Ethically Integrated? Hastings Center Report 41 (4):37-46.
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  10. Ori Lev, Franklin G. Miller & Ezekiel J. Emanuel (2010). The Ethics of Research on Enhancement Interventions. Kennedy Institute of Ethics Journal 20 (2):101-113.
    Traditionally, biomedical research has been devoted to improvement in the understanding and treatment or prevention of disease. Building on the knowledge generated by the long history of disease-oriented research, the next few decades will witness an explosion of biomedical enhancements to make people faster, stronger, smarter, less forgetful, happier, prettier, and live longer (Turner et al. 2003; Vastag 2004; Rose 2002). As with other biomedical interventions, research to assess the safety and efficacy of these enhancements in humans should be conducted (...)
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  11.  22
    Howard Brody & Franklin G. Miller (2003). The Clinician-Investigator: Unavoidable but Manageable Tension. Kennedy Institute of Ethics Journal 13 (4):329-346.
    : The "difference position" holds that clinical research and therapeutic medical practice are sufficiently distinct activities to require different ethical rules and principles. The "similarity position" holds instead that clinical investigators ought to be bound by the same fundamental principles that govern therapeutic medicine—specifically, a duty to provide the optimal therapeutic benefit to each patient or subject. Some defenders of the similarity position defend it because of the overlap between the role of attending physician and the role of investigator in (...)
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  12.  34
    Franklin G. Miller & Alan Wertheimer (2011). The Fair Transaction Model of Informed Consent: An Alternative to Autonomous Authorization. Kennedy Institute of Ethics Journal 21 (3):201-218.
    Prevailing ethical thinking about informed consent to clinical research is characterized by theoretical confidence and practical disquiet. On the one hand, bioethicists are confident that informed consent is a fundamental norm. And, for the most part, they are confident that what makes consent to research valid is that it constitutes an autonomous authorization by the research participant. On the other hand, bioethicists are uneasy about the quality of consent in practice. One major source of this disquiet is substantial evidence of (...)
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  13.  10
    Franklin G. Miller, Michelle M. Mello & Steven Joffe (2008). Incidental Findings in Human Subjects Research: What Do Investigators Owe Research Participants? Journal of Law, Medicine & Ethics 36 (2):271-279.
    The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental fndings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental fndings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of (...)
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  14.  55
    Franklin G. Miller & Luana Colloca (2011). The Placebo Phenomenon and Medical Ethics: Rethinking the Relationship Between Informed Consent and Risk–Benefit Assessment. Theoretical Medicine and Bioethics 32 (4):229-243.
    It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for risk–benefit assessment (...)
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  15.  26
    Joseph J. Fins, Matthew D. Bacchetta & Franklin G. Miller (1997). Clinical Pragmatism: A Method of Moral Problem Solving. Kennedy Institute of Ethics Journal 7 (2):129-143.
    : This paper presents a method of moral problem solving in clinical practice that is inspired by the philosophy of John Dewey. This method, called "clinical pragmatism," integrates clinical and ethical decision making. Clinical pragmatism focuses on the interpersonal processes of assessment and consensus formation as well as the ethical analysis of relevant moral considerations. The steps in this method are delineated and then illustrated through a detailed case study. The implications of clinical pragmatism for the use of principles in (...)
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  16. Franklin G. Miller (2005). William James, Faith, and the Placebo Effect. Perspectives in Biology and Medicine 48 (2):273-281.
  17.  18
    Franklin G. Miller & Robert Truog (2011). Death, Dying, and Organ Donation: Reconstructing Medical Ethics at the End of Life. Oxford University Press.
    This book challenges fundamental doctrines of established medical ethics. It is argued that the routine practice of stopping life support technology causes the death of patients and that donors of vital organs (hearts, liver, lungs, and both kidneys) are not really dead at the time that their organs are removed for life-saving transplantation. Although these practices are ethically legitimate, they are not compatible with traditional medical ethics: they conflict with the norms that doctors must not intentionally cause the death of (...)
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  18.  35
    Franklin G. Miller & Howard Brody (2001). The Internal Morality of Medicine: An Evolutionary Perspective. Journal of Medicine and Philosophy 26 (6):581 – 599.
    A basic question of medical ethics is whether the norms governing medical practice should be understood as the application of principles and rules of the common morality to medicine or whether some of these norms are internal or proper to medicine. In this article we describe and defend an evolutionary perspective on the internal morality of medicine that is defined in terms of the goals of clinical medicine and a set of duties that constrain medical practice in pursuit of these (...)
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  19.  16
    Franklin G. Miller, Luana Colloca & Ted J. Kaptchuk (2009). The Placebo Effect: Illness and Interpersonal Healing. Perspectives in Biology and Medicine 52 (4):518-539.
  20.  13
    Franklin G. Miller & Robert D. Truog (2009). The Incoherence of Determining Death by Neurological Criteria: A Commentary on Controversies in the Determination of Death, A White Paper by the President's Council on Bioethics. Kennedy Institute of Ethics Journal 19 (2):185-193.
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  21. Franklin G. Miller (2004). Research Ethics and Misguided Moral Intuition. Journal of Law, Medicine & Ethics 32 (1):111-116.
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  22.  8
    Franklin G. Miller & Andrew F. Short (forthcoming). Adverstising for Clinical Research. IRB: Ethics & Human Research.
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  23.  11
    Franklin G. Miller & Luke Gelinas (2013). Nudging, Autonomy, and Valid Consent: Context Matters. American Journal of Bioethics 13 (6):12-13.
  24.  91
    Franklin G. Miller, Robert D. Truog & Dan W. Brock (2010). Moral Fictions and Medical Ethics. Bioethics 24 (9):453-460.
    Conventional medical ethics and the law draw a bright line distinguishing the permitted practice of withdrawing life-sustaining treatment from the forbidden practice of active euthanasia by means of a lethal injection. When clinicians justifiably withdraw life-sustaining treatment, they allow patients to die but do not cause, intend, or have moral responsibility for, the patient's death. In contrast, physicians unjustifiably kill patients whenever they intentionally administer a lethal dose of medication. We argue that the differential moral assessment of these two practices (...)
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  25.  16
    Franklin G. Miller & Robert D. Truog (2008). An Apology for Socratic Bioethics. American Journal of Bioethics 8 (7):3 – 7.
    Bioethics is a hybrid discipline. As a theoretical enterprise it stands for untrammeled inquiry and argument. Yet it aims to influence medical practice and policy. In this article we explore tensions between these two dimensions of bioethics and examine the merits and perils of a “Socratic” approach to bioethics that challenges “the conventional wisdom.”.
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  26.  6
    Franklin G. Miller & Howard Brody (1995). Professional Integrity and Physician‐Assisted Death. Hastings Center Report 25 (3):8-17.
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  27. Franklin G. Miller & Robert D. Truog (2009). The Incoherence of Determining Death by Neurological Criteria: Reply to John Lizza. Kennedy Institute of Ethics Journal 19 (4):397-399.
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  28.  13
    Anne Barnhill & Franklin G. Miller (2015). Placebo and Deception: A Commentary. Journal of Medicine and Philosophy 40 (1):69-82.
    In a recent article in this Journal, Shlomo Cohen and Haim Shapiro introduce the concept of “comparable placebo treatments” —placebo treatments with biological effects similar to the drugs they replace—and argue that doctors are not being deceptive when they prescribe or administer CPTs without revealing that they are placebos. We critique two of Cohen and Shapiro’s primary arguments. First, Cohen and Shapiro argue that offering undisclosed placebos is not lying to the patient, but rather is making a self-fulfilling prophecy—telling a (...)
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  29.  18
    Howard Brody & Franklin G. Miller (1998). The Internal Morality of Medicine: Explication and Application to Managed Care. Journal of Medicine and Philosophy 23 (4):384 – 410.
    Some ethical issues facing contemporary medicine cannot be fully understood without addressing medicine's internal morality. Medicine as a profession is characterized by certain moral goals and morally acceptable means for achieving those goals. The list of appropriate goals and means allows some medical actions to be classified as clear violations of the internal morality, and others as borderline or controversial cases. Replies are available for common objections, including the superfluity of internal morality for ethical analysis, the argument that internal morality (...)
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  30.  21
    Franklin G. Miller & Steven Joffe (2006). Evaluating the Therapeutic Misconception. Kennedy Institute of Ethics Journal 16 (4):353-366.
    : The "therapeutic misconception," described by Paul Appelbaum and colleagues more than 20 years ago, refers to the tendency of participants in clinical trials to confuse the design and conduct of research with personalized medical care. Although the "therapeutic misconception" has become a term of art in research ethics, little systematic attention has been devoted to the ethical significance of this phenomenon. This article examines critically the way in which Appelbaum and colleagues formulate what is at stake in the therapeutic (...)
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  31.  1
    Alan Wertheimer & Franklin G. Miller (2008). Payment for Research Participation: A Coercive Offer? Journal of Medical Ethics 34 (5):389-392.
    Payment for research participation has raised ethical concerns, especially with respect to its potential for coercion. We argue that characterising payment for research participation as coercive is misguided, because offers of benefit cannot constitute coercion. In this article we analyse the concept of coercion, refute mistaken conceptions of coercion and explain why the offer of payment for research participation is never coercive but in some cases may produce undue inducement.
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  32.  22
    Paul Litton & Franklin G. Miller (2005). A Normative Justification for Distinguishing the Ethics of Clinical Research From the Ethics of Medical Care. Journal of Law, Medicine & Ethics 33 (Fall 2005):566-74.
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  33. Franklin G. Miller, Michelle M. Mello & Steven Joffe (2008). Incidental Findings in Human Subjects Research: What Do Investigators Owe Research Participants? Journal of Law, Medicine and Ethics 36 (2):271-279.
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  34.  20
    David Buchanan & Franklin G. Miller (2005). Principles of Early Stopping of Randomized Trials for Efficacy: A Critique of Equipoise and an Alternative Nonexploitation Ethical Framework. Kennedy Institute of Ethics Journal 15 (2):161-178.
    : Recent controversial decisions to terminate several large clinical trials have called attention to the need for developing a sound ethical framework to determine when trials should be stopped in light of emerging efficacy data. Currently, the fundamental rationale for stopping trials early is based on the principle that equipoise has been disturbed. We present an analysis of the ethical and practical problems with the "equipoise disturbed" position and describe an alternative ethical framework based on the principle of nonexploitation. This (...)
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  35.  8
    Franklin G. Miller (2005). Does Research Ethics Rest on a Mistake? American Journal of Bioethics 5 (1):34 – 36.
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  36.  16
    Collin C. O'Neil & Franklin G. Miller (2009). When Scientists Deceive: Applying the Federal Regulations. Journal of Law, Medicine & Ethics 37 (2):344-350.
    Deception is a useful methodological device for studying attitudes and behavior, but deceptive studies fail to fulfill the informed consent requirements in the U.S. federal regulations. This means that before they can be approved by Institutional Review Boards, they must satisfy the four regulatory conditions for a waiver or alteration of these requirements. To illustrate our interpretation, we apply the conditions to a recent study that used deception to show that subjects judged the same wine as more enjoyable when they (...)
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  37.  67
    Franklin G. Miller, Howard Brody & Kevin C. Chung (2000). Cosmetic Surgery and the Internal Morality of Medicine. Cambridge Quarterly of Healthcare Ethics 9 (3):353-364.
    Cosmetic surgery is a fast-growing medical practice. In 1997 surgeons in the United States performed the four most common cosmetic procedures443,728 times, an increase of 150% over the comparable total for 1992. Estimated total expenditures for cosmetic surgery range from $1 to $2 billion. As managed care cuts into physicians' income and autonomy, cosmetic surgery, which is not covered by health insurance, offers a financially attractive medical specialty.
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  38.  15
    Franklin G. Miller (2004). Sham Surgery: An Ethical Analysis. Science and Engineering Ethics 10 (1):41-48.
    Surgical clinical trials have seldom used a “sham” or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken, and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic (...)
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  39.  10
    Howard Brody, Franklin G. Miller & Elizabeth Bogdan-Lovis (2005). Evidence-Based Medicine: Watching Out for Its Friends. Perspectives in Biology and Medicine 48 (4):570-584.
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  40.  12
    Franklin G. Miller, John P. Gluck Jr & David Wendler (2008). Debriefing and Accountability in Deceptive Research. Kennedy Institute of Ethics Journal 18 (3):235-251.
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  41.  5
    Joseph J. Fins, Franklin G. Miller & Matthew D. Bacchetta (1998). Clinical Pragmatism: Bridging Theory and Practice. Kennedy Institute of Ethics Journal 8 (1):37-42.
    : This response to Lynn Jansen's critique of clinical pragmatism concentrates on two themes: (1) contrasting approaches to moral epistemology and (2) the connection between theory and practice in clinical ethics. Particular attention is paid to the status of principles and the role of consensus, with some closing speculations on how Dewey might view the current state of bioethics.
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  42.  5
    Roseanna Sommers & Franklin G. Miller (2013). Forgoing Debriefing in Deceptive Research: Is It Ever Ethical? Ethics and Behavior 23 (2):98-116.
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  43.  2
    Emily A. Largent, Franklin G. Miller & Steven Joffe (2013). A Prescription for Ethical Learning. Hastings Center Report 43 (s1):28-29.
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  44.  1
    Franklin G. Miller (2010). Striking the Right Balance in Research Ethics and Regulation. American Journal of Bioethics 10 (8):65-65.
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  45. Howard Brody & Franklin G. Miller (2013). The Research‐Clinical Practice Distinction, Learning Health Systems, and Relationships. Hastings Center Report 43 (5):41-47.
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  46.  56
    Franklin G. Miller & Luana Colloca (2010). Semiotics and the Placebo Effect. Perspectives in Biology and Medicine 53 (4):509-516.
    Despite growing scientific interest in the placebo effect and increasing understanding of neurobiological mechanisms (Finniss et al. 2010), theoretical conceptualization of the placebo effect remains primitive (Miller, Colloca, and Kaptchuk 2009). Mechanistic research on this phenomenon appears largely free-floating, with little guidance by any systematic theoretical paradigm. A partial explanation is the pervasive conceptual confusion that characterizes thinking about the placebo effect. The philosopher of science Adolf Grunbaum noted that "the medical and psychiatric literature on placebos and their effects is (...)
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  47.  11
    Franklin G. Miller (2008). Research on Medical Records Without Informed Consent. Journal of Law, Medicine & Ethics 36 (3):560-566.
    Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.
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  48.  12
    Franklin G. Miller & Scott Y. H. Kim (2016). Personal Care in Learning Health Care Systems. Kennedy Institute of Ethics Journal 25 (4):419-435.
    The “learning health care system” is being heralded as offering great potential for improving the quality and cost-worthiness of medical care by closely integrating the care of patients with the accumulation of aggregate data that can guide evidence-based medicine. By using electronic medical records, routine patient care and administrative data will be available for systematic observational studies. With the aid of these electronic medical records, quality-improvement studies of institutional practices and pragmatic, comparative effectiveness randomized trials of individual treatments could become (...)
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  49.  6
    Franklin G. Miller (2012). Homage to Henry Beecher (1904-1976). Perspectives in Biology and Medicine 55 (2):218-229.
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  50. Franklin G. Miller (2008). Research on Medical Records Without Informed Consent. Journal of Law, Medicine and Ethics 36 (3):560-566.
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