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Informed Consent in Medicine

Edited by Ruchika Mishra (Program in Medicine and Human Values, California Pacific Medical Center)
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  1. Rona Abramovitch, Jonathan L. Freedman, Kate Henry & Michelle Van Brunschot (1995). Children's Capacity to Agree to Psychological Research: Knowledge of Risks and Benefits and Voluntariness. Ethics and Behavior 5 (1):25 – 48.
    A series of studies investigated the capacity of children between the ages of 7 and 12 to give free and informed consent to participation in psychological research. Children were reasonably accurate in describing the purpose of studies, but many did not understand the possible benefits or especially the possible risks of participating. In several studies children's consent was not affected by the knowledge that their parents had given their permission or by the parents saying that they would not be upset (...)
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  2. Terrence F. Ackerman (1984). Medical Ethics and the Two Dogmas of Liberalism. Theoretical Medicine and Bioethics 5 (1).
    Two dogmas of liberalism in the therapeutic setting are challenged: (1) that patients have a ready-made ability to act autonomously; and (2) that non-intervention by physicians is the best strategy for protecting the autonomy of patients. Recognition of the impact of illness upon autonomous behavior forms the basis of this challenge. It is suggested that autonomy is better conceived as a process of personal growth by which patients become better able to overcome the disruptive effects of illness. The physician is (...)
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  3. George J. Annas (1980). The Goals of Informed Consent. Journal of Law, Medicine and Ethics 8 (3):13-13.
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  4. George J. Annas (1973). Informed Consent": When "Good Medicine May Not Be Good Law. Journal of Law, Medicine and Ethics 1 (1):3-3.
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  5. Atsushi Asai, Motoki Ohnishi, Etsuyo Nishigaki, Miho Sekimoto, Shunichi Fukuhara & Tsuguya Fukui (2002). Attitudes of the Japanese Public and Doctors Towards Use of Archived Information and Samples Without Informed Consent: Preliminary Findings Based on Focus Group Interviews. [REVIEW] BMC Medical Ethics 3 (1):1-10.
    Background The purpose of this study is to explore laypersons' attitudes toward the use of archived (existing) materials such as medical records and biological samples and to compare them with the attitudes of physicians who are involved in medical research. Methods Three focus group interviews were conducted, in which seven Japanese male members of the general public, seven female members of the general public and seven physicians participated. Results It was revealed that the lay public expressed diverse attitudes towards the (...)
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  6. Lynn A. Baker (1988). "I Think I DO": Another Perspective on Consent and the Law. Journal of Law, Medicine and Ethics 16 (3-4):256-260.
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  7. Deborah Barnbaum (1999). Interpreting Surrogate Consent Using Counterfactuals. Journal of Applied Philosophy 16 (2):167–172.
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  8. Alfred D. Beasley & Glenn C. Graber (1984). The Range of Autonomy: Informed Consent in Medicine. Theoretical Medicine and Bioethics 5 (1).
    On the basis of the characterization of autonomy set out by Beauchamp and Childress in Principles of Biomedical Ethics, we first explore some of the parameters along which autonomy may vary in degree through a series of hypothetical examples drawn from various settings; and, second and in more detail, we examine how the range of autonomy is affected through informed consent to various medical diagnostic tests. Our conclusions are (1) that there are significant implications for patient autonomy inherent in new (...)
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  9. Tom L. Beauchamp (1994). Principles of Biomedical Ethics / Tom L. Beauchamp, James F. Childress. Oxford University Press.
    This is an extremely thorough revision of the leading textbook of bioethics. The authors have made many improvements in style, organization, argument and content. These changes reflect advances in the bioethics literature over the past five years. The most dramatic expansions of the text are in the comprehensiveness with which the authors treat different currents in ethical theory and the greater breadth and depth of their discussion of public policy and public health issues. In every chapter, readers will find new (...)
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  10. Henry K. Beecher (1970). Research and the Individual. Boston,Little, Brown.
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  11. Jessica Wilen Berg (1996). Legal and Ethical Complexities of Consent with Cognitively Impaired Research Subjects: Proposed Guidelines. Journal of Law, Medicine and Ethics 24 (1):18-35.
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  12. Ron Berghmans (2011). Voluntary Consent, Normativity, and Authenticity. American Journal of Bioethics 11 (8):23-24.
    The American Journal of Bioethics, Volume 11, Issue 8, Page 23-24, August 2011.
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  13. J. S. Blumenthal-Barby (2013). On Nudging and Informed Consent: Four Key Undefended Premises. American Journal of Bioethics 13 (6):31 - 33.
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  14. J. S. Blumenthal-Barby (2011). On the Concept and Measure of Voluntariness: Insights From Behavioral Economics and Cognitive Science. American Journal of Bioethics 11 (8):25-26.
    In their article “The Concept of Voluntary Consent,” Robert Nelson and colleagues (2011) argue for two necessary and jointly sufficient conditions for voluntary action: intentionality, and substantial freedom from controlling influences. They propose an instrument to empirically measure voluntariness, the Decision Making Control Instrument. I argue that (1) their conceptual analysis of intentionality and controlling influences needs expansion in light of the growing use of behavioral economics principles to change individual and public health behaviors (growing in part by the designation (...)
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  15. J. Blustein, W. Robinson, G. S. Loeben & B. S. Wilfond (1997). Case Vignette: Placebos and Informed Consent. Ethics and Behavior 8 (1):89-98.
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  16. Ellen B. Braaten & Michael M. Handelsman (1997). Client Preferences for Informed Consent Information. Ethics and Behavior 7 (4):311 – 328.
    Thirty-five current therapy clients, 47 former clients, and 42 college students with no therapy experience rated 27 items in terms of importance for inclusion in informed consent discussions. The current and former client samples rated information about inappropriate therapeutic techniques, confidentiality, and the risks of alternative treatments as most important, and information about the personal characteristics of the therapist and the therapist's degree as least important. The results of this study provide evidence for differential informed consent disclosure practices.
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  17. Margaret Brazier & Mary Lobjoit (eds.) (1991). Protecting the Vulnerable: Autonomy and Consent in Health Care. Routledge.
    Protecting the Vulnerable explores the reality of patient control and choice in health care and analyzes how decisions should be made on behalf of those deemed incapable of making decisions. The contributors, distinguished experts from the disciplines of medicine, ethics, theology, and law, look at the complex problem of autonomy and consent in health care and clinical research today from an illuminating perspective--its impact on the vulnerable members of society. The essays move from the exploration of lingering paternalism in health (...)
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  18. Troyen A. Brennan (1988). Silent Decisions: Limits of Consent and the Terminally III Patient. Journal of Law, Medicine and Ethics 16 (3-4):204-209.
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  19. Frederic Bretzner, Frederic Gilbert, Françoise Baylis & Robert M. Brownstone (2011). Target Populations for First-In-Human Embryonic Stem Cell Research in Spinal Cord Injury. Cell Stem Cell 8 (5):468-475.
    Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a safety trial, subacute (...)
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  20. Janet L. Brody, John P. Cluck & Alfredo S. Aragon (1997). Participants' Understanding of the Process of Psychological Research: Informed Consent. Ethics and Behavior 7 (4):285 – 298.
    Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41 % were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of the time. However, (...)
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  21. Danielle Bromwich (2012). Plenty to Worry About: Consent, Control, and Anxiety. American Journal of Bioethics 12 (3):35-36.
    The American Journal of Bioethics, Volume 12, Issue 3, Page 35-36, March 2012.
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  22. Danielle Bromwich & Joseph Millum (forthcoming). Disclosure and Consent to Medical Research Participation. Journal of Moral Philosophy.
    Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...)
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  23. Danielle Bromwich & Annette Rid (forthcoming). Can Informed Consent to Research Be Adapted to Risk? Journal of Medical Ethics.
    The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for (...)
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  24. Laura Buccini, Donald Iverson, Peter Caputi & Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.
    The aims of this study were to measure the readability of Australian based informed consent documents and determine whether informed consent readability guidelines have been established by Australian human research ethics committees (HRECs). A total of 20 informed consent documents, 10 HIV/AIDS and 10 type 2 diabetes, were measured for readability using the Simple Measure of Gobbledygook (SMOG) and Gunning Fog Index (Fog). Published guidelines and policy statements of the two local HREC who approved the 20 clinical trials under study (...)
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  25. Susan Bull & Graham Charles Lindegger (2011). Ensuring Consent to Research is Voluntary: How Far Do We Need to Go? American Journal of Bioethics 11 (8):27-29.
    The American Journal of Bioethics, Volume 11, Issue 8, Page 27-29, August 2011.
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  26. Emma Bullock (2010). Informed Consent as Waiver: The Doctrine Rethought? Ethical Perspectives 17 (4):529-555.
    Neil Manson and Onora O’Neill have recently defended an original theory of informed consent in their book Rethinking Informed Consent in Bioethics (2007). The development of their ‘waiver’ model is premised on the failings of the theory of informed consent as disclosure, which is rejected on two counts: firstly, the disclosure model’s implicit reliance upon a ‘conduit-container’ model of communication means that the regulatory requirements of informed consent can rarely be achieved; secondly, the model’s purported ethical justification via a principle (...)
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  27. Sylvia Burrow (2012). On The Cutting Edge: Ethical Responsiveness to Cesarean Section Rates. American Journal of Bioethics 12 (7):44-52.
    Cesarean delivery rates have been steadily increasing worldwide. In response, many countries have introduced target goals to reduce rates. But a focus on target goals fails to address practices embedded in standards of care that encourage, rather than discourage, cesarean sections. Obstetrical standards of care normalize use of technology, creating an imperative to use technology during labor and birth. A technological imperative is implicated in rising cesarean rates if physicians or patients fear refusing use of technology. Reproductive autonomy is at (...)
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  28. Sylvia Burrow (2012). Reproductive Autonomy and Reproductive Technology. Techne 16 (1):31-45.
    This paper presents a relational account of autonomy showing that a technological imperative impedes autonomy through undermining women’s capacity to resist use of technology in the context of labor and birth. A technological imperative encourages dependence on technology for reassurance whenever possible through creating a (i) separation of maternal and fetal interests; and (ii) perceived need to use technology whenever possible. In response I offer an account of how women might promote autonomy through cultivating self-trust and self-confidence. Autonomy is not (...)
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  29. Leslie Cannold (1997). "There Is No Evidence to Suggest...": Changing the Way We Judge Information for Disclosure in the Informed Consent Process. Hypatia 12 (2):165 - 184.
    Feminist health activists and medical researchers frequently disagree on the adequacy of the informed consent processes in clinical trials. I argue for an informed consent process that reflects the central importance of patient-participant autonomy. Such a standard may raise concerns for medical researchers about their capacity to control the quantity and quality of the information they disclose to potential participants. These difficulties might be addressed by presenting potential participants with differently sized disclosure packages.
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  30. Vanessa Carbonell (2014). Amnesia, Anesthesia, and Warranted Fear. Bioethics 28 (5):245-254.
    Is a painful experience less bad for you if you will not remember it? Do you have less reason to fear it? These questions bear on how we think about medical procedures and surgeries that use an anesthesia regimen that leaves patients conscious – and potentially in pain – but results in complete ‘drug-induced amnesia’ after the fact. I argue that drug-induced amnesia does not render a painful medical procedure a less fitting object of fear, and thus the prospect of (...)
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  31. Mary E. Carr & Alda L. Moettus (2010). Developing a Policy for Sexual Assault Examinations on Incapacitated Patients and Patients Unable to Consent. Journal of Law, Medicine and Ethics 38 (3):647-653.
    Sexual assault examinations consist of a medical evaluation and forensic evidence collection. Usually the patient signs a consent form allowing the examination to occur. Occasionally circumstances exist that render a patient unable to give consent for this examination. Such circumstances include young age, mental health disease, cognitive delay, or drug/alcohol ingestion. This article provides suggestions for developing a policy allowing a sexual assault examination to be conducted without patient consent. A sample of such a policy is provided.
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  32. Katherine Carroll & Catherine Waldby (2012). Informed Consent and Fresh Egg Donation for Stem Cell Research. Journal of Bioethical Inquiry 9 (1):29-39.
    This article develops a model of informed consent for fresh oöcyte donation for stem cell research, during in vitro fertilisation (IVF), by building on the importance of patients’ embodied experience. Informed consent typically focuses on the disclosure of material information. Yet this approach does not incorporate the embodied knowledge that patients acquire through lived experience. Drawing on interview data from 35 patients and health professionals in an IVF clinic in Australia, our study demonstrates the uncertainty of IVF treatment, and the (...)
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  33. Larry R. Churchill, Myra L. Collins, Nancy M. R. King, Stephen G. Pemberton & Keith A. Wailoo (1998). Genetic Research as Therapy: Implications of "Gene Therapy" for Informed Consent. Journal of Law, Medicine and Ethics 26 (1):38-47.
  34. Eric Chwang (2010). A Puzzle About Consent in Research and in Practice. Journal of Applied Philosophy 27 (3):258-272.
    In this paper, I will examine a puzzling discrepancy between the way clinicians are allowed to treat their patients and the way researchers are allowed to treat their subjects: in certain cases, researchers are legally required to disclose quite a bit more information when obtaining consent from prospective subjects than clinicians are when obtaining consent from prospective patients. I will argue that the proper resolution of this puzzling discrepancy must appeal to a pragmatic criterion of disclosure for informed consent: that (...)
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  35. Peter A. Clark (2002). Placebo Surgery for Parkinson's Disease: Do the Benefits Outweigh the Risks? Journal of Law, Medicine and Ethics 30 (1):58-68.
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  36. Steve Clarke (2013). The Neuroscience of Decision Making and Our Standards for Assessing Competence to Consent. Neuroethics 6 (1):189-196.
    Rapid advances in neuroscience may enable us to identify the neural correlates of ordinary decision making. Such knowledge opens up the possibility of acquiring highly accurate information about people’s competence to consent to medical procedures and to participate in medical research. Currently we are unable to determine competence to consent with accuracy and we make a number of unrealistic practical assumptions to deal with our ignorance. Here I argue that if we are able to detect competence to consent and if (...)
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  37. Steve Clarke (2001). Informed Consent in Medicine in Comparison with Consent in Other Areas of Human Activity. Southern Journal of Philosophy 39 (2):169-187.
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  38. Ellen Wright Clayton (2005). Informed Consent and Biobanks. Journal of Law, Medicine and Ethics 33 (1):15-21.
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  39. Flora Colledge, Kirsten Persson, Bernice Elger & David Shaw (2014). Sample and Data Sharing Barriers in Biobanking: Consent, Committees, and Compromises. Annals of Diagnostic Pathology 18 (2):78-81.
    The ability to exchange samples and data is crucial for the rapidly growth of biobanking. However, sharing is based on the assumption that the donor has given consent to a given use of her or his sample. Biobanking stakeholders, therefore, must choose 1 of 3 options: obtain general consent enabling multiple future uses before taking a sample from the donor, try to obtain consent again before sharing a previously obtained sample, or look for a legally endorsed way to share a (...)
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  40. Mike Collins (2009). Consent for Organ Retrieval Cannot Be Presumed. HEC Forum 21 (1):71-106.
  41. Oonagh Corrigan (ed.) (2009). The Limits of Consent: A Socio-Ethical Approach to Human Subject Research in Medicine. Oxford University Press.
    Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may have significant bearing (...)
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  42. Dena S. Davis (2012). The 21st Century Challenge to Autonomy and Informed Consent. Les Ateliers de l'Éthique / the Ethics Forum 7 (3):45-58.
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  43. Angus Dawson (ed.) (2009). The Philosophy of Public Health. Ashgate.
    A number of theoretical ideas have emerged recently in the legal, bioethical and philosophical fields that could usefully be applied to these and other issues ...
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  44. Howard B. Degenholtz, Lisa S. Parker & I. I. I. Charles F. Reynolds (2002). Trial Design and Informed Consent for a Clinic-Based Study with a Treatment as Usual Control Arm. Ethics and Behavior 12 (1):43-62.
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  45. Howard B. Degenholtz, Lisa S. Parker & Charles F. Reynolds (2002). Trial Design and Informed Consent for a Clinic-Based Study With a Treatment as Usual Control Arm. Ethics and Behavior 12 (1):43-62.
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  46. Ezio Di Nucci (2013). Habits, Nudges, and Consent. American Journal of Bioethics 13 (6):27 - 29.
    I distinguish between 'hard nudges' and 'soft nudges', arguing that it is possible to show that the latter can be compatible with informed consent - as Cohen has recently suggested; but that the real challenge is the compatibility of the former. Hard nudges are the more effective nudges because they work on less than conscious mechanisms such as those underlying our habits: whether those influences - which are often beyond the subject's awareness - can be reconciled with informed consent in (...)
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  47. Andrea Dörries (2009). The 4-Step Approach. Ethics Case Discussion in Hospitals. Diametros 22:39-46.
    The goal of an ethics case discussion is to find the best decision for the patient and the other persons involved (relatives, doctors, nurses and others) from an ethical point of view, in a communicative respect and from a psychosocial view. In the end, it may not mean changing one’s view or even one’s own position, but rather to exchange arguments, weight them and come to a consensus as to further action. The latter is important as the topics concern patients (...)
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  48. Katherine Drabiak-Syed (2011). Currents in Contemporary Bioethics: Waiving Informed Consent to Prenatal Screening and Diagnosis? Problems with Paradoxical Negotiation in Surrogacy Contracts. Journal of Law, Medicine and Ethics 39 (3):559-564.
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  49. Dennis Drotar, Victoria Miller, Victoria Willard, Kyle Anthony & Eric Kodish (2004). Correlates of Parental Participation During Informed Consent for Randomized Clinical Trials in the Treatment of Childhood Leukemia. Ethics and Behavior 14 (1):1 – 15.
    This study described parent participation in the informed consent conference for randomized clinical trials (RCTs) in childhood leukemia and documented the relationship of physician communication to parent participation. Parents of 140 children with newly diagnosed leukemia who were eligible for RCTs were studied at six sites using comprehensive methods involving direct observation and transcripts of parent-physician communication based on audiotapes. Parent participation during the informed consent conference reflected a wide range of content categories. Consistent with hypotheses, Physician Rapport and Partnership (...)
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  50. Brian D. Earp (2013). Criticising Religious Practices. The Philosophers' Magazine 63:15-17.
    In 2012, a German court ruled that religious circumcision of male minors constitutes criminal bodily assault. Muslim and Jewish groups responded with outrage, with some commentators pegging the ruling to Islamophobic and anti-Semitic motivations. In doing so, these commentators failed to engage with any of the legal and ethical arguments actually given by the court in its landmark decision. In this brief commentary, I argue that a firm distinction must be drawn between criticisms of religious practices that stem from irrational (...)
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