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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. Elmer D. Abbo & Angelo E. Volandes (2006). Rare but Routine: The Physician's Obligation to Protect Third Parties. American Journal of Bioethics 6 (2):34 – 36.
  2. P.-A. Abboud (2006). What Determines Whether Patients Are Willing to Participate in Resuscitation Studies Requiring Exception From Informed Consent? Journal of Medical Ethics 32 (8):468-472.
    Objectives: To examine the willingness of patients to participate in a resuscitation study that requires exception from informed consent and to determine if willingness to participate is associated with demographic and other characteristics.Methods: Adult patients in an emergency department and in a geriatric outpatient clinic were surveyed. Patients were asked to imagine that they presented to an emergency department with cardiac arrest and asked about their willingness to receive a new drug outside of a study, receive a new drug as (...)
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  3. A. Abou-Zeid, H. Silverman, M. Shehata, M. Shams, M. Elshabrawy, T. Hifnawy, S. A. Rahman, B. Galal, H. Sleem, N. Mikhail & N. Moharram (2010). Collection, Storage and Use of Blood Samples for Future Research: Views of Egyptian Patients Expressed in a Cross-Sectional Survey. Journal of Medical Ethics 36 (9):539-547.
    Objective To determine the attitudes of Egyptian patients regarding their participation in research and with the collection, storage and future use of blood samples for research purposes. Design Cross-sectional survey. Study population Adult Egyptian patients (n=600) at rural and urban hospitals and clinics. Results Less than half of the study population (44.3%) felt that informed consent forms should provide research participants the option to have their blood samples stored for future research. Of these participants, 39.9% thought that consent forms should (...)
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  4. 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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  5. 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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  6. Terrence F. Ackerman (1982). Why Doctors Should Intervene. Hastings Center Report 12 (4):14-17.
  7. Terrence F. Ackerman (1980). Moral Duties of Parents and Nontherapeutic Clinical Research Procedures Involving Children. Bioethics Quarterly 2 (2):94-111.
    Shared views regarding the moral respect which is owed to children in family life are used as a guide in determining the moral permissibility of nontherapeutic clinical research procedures involving children. The comparison suggests that it is not appropriate to seek assent from the preadolescent child. The analogy with interventions used in family life is similarly employed to specify the permissible limit of risk to which children may be exposed in nontherapeutic research procedures. The analysis indicates that recent writers misconceive (...)
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  8. Terrence F. Ackerman (1980). The Limits of Beneficence: Jehovah's Witnesses & Childhood Cancer. Hastings Center Report 10 (4):13-18.
  9. D. Adamis (2005). Capacity, Consent, and Selection Bias in a Study of Delirium. Journal of Medical Ethics 31 (3):137-143.
    Objectives: To investigate whether different methods of obtaining informed consent affected recruitment to a study of delirium in older, medically ill hospital inpatients.Design: Open randomised study.Setting: Acute medical service for older people in an inner city teaching hospital.Participants: Patients 70 years or older admitted to the unit within three days of hospital admission randomised into two groups.Intervention: Attempted recruitment of subjects to a study of the natural history of delirium. This was done by either a formal test of capacity, followed (...)
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  10. Adamu Addissie, Gail Davey, Yeweyenhareg Feleke, Thomas Addissie, Hayley Macgregor, Melanie Newport & Bobbie Farsides, A Mixed-Methods Study on Perceptions Towards Use of Rapid Ethical Assessment to Improve Health Research Informed Consent Processes in a Low-Income Setting.
    Background Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia. Methods Mixed methods research using a sequential explanatory approach was conducted from July to September 2012, including 241 cross-sectional, self-administered and 19 qualitative, in-depth interviews among (...)
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  11. Patricia Agre, Frances A. Campbell, Barbara D. Goldman, Maria L. Boccia, Nancy Kass, Laurence B. McCullough, Jon F. Merz, Suzanne M. Miller, Jim Mintz & Bruce Rapkin (forthcoming). Improving Informed Consent: The Medium is Not the Message. IRB: Ethics & Human Research.
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  12. Ilene Albala, Margaret Doyle & Paul Appelbaum (2010). The Evolution of Consent Forms for Research: A Quarter Century of Changes. IRB: Ethics & Human Research 32 (3):7-11.
    Institutional review boards and researchers have struggled to ensure that subjects receive sufficient information to make knowledgeable decisions about study participation. But the quality of the consent forms that are a key component of this process has rarely been evaluated. We reviewed 215 consent forms approved by an IRB serving a major academic department from 1978–2002 and discovered two trends: greater consistency in the description of risks, and an increase in the length of consent forms. However, despite data indicating that (...)
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  13. Robert Amdur, Natalie Bachir & Elizabeth Stanton (forthcoming). Selecting a Surrogate to Consent to Medical Research. IRB: Ethics & Human Research.
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  14. George J. Annas (1980). The Goals of Informed Consent. Journal of Law, Medicine & Ethics 8 (3):13-13.
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  15. George J. Annas (1973). Informed Consent": When "Good Medicine May Not Be Good Law. Journal of Law, Medicine & Ethics 1 (1):3-3.
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  16. 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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  17. Lynn A. Baker (1988). "I Think I DO": Another Perspective on Consent and the Law. Journal of Law, Medicine & Ethics 16 (3-4):256-260.
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  18. R. Barcaro (2000). H. Jonas, Tecnica, medicina ed etica. Prassi del principio responsabilità. [REVIEW] Epistemologia 23 (2):360-3490.
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  19. Rosangela Barcaro & Paolo Becchi (2011). La filosofia di fronte ai limiti della vita: i problemi della bioetica [Philosophy and the borders of life: some bioethical problems]. In La ricerca del sapere. 3. Da Schopenhauer alla filosofia contemporanea, edited by Santino Mele. 643-660.
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  20. Deborah Barnbaum (1999). Interpreting Surrogate Consent Using Counterfactuals. Journal of Applied Philosophy 16 (2):167–172.
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  21. 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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  22. Tom L. Beauchamp (2009). The Concept of Paternalism in Biomedical Ethics. Jahrbuch für Wissenschaft Und Ethik 14 (1):77-92.
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  23. 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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  24. Henry K. Beecher (1970). Research and the Individual. Boston,Little, Brown.
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  25. Jessica Wilen Berg (1996). Legal and Ethical Complexities of Consent with Cognitively Impaired Research Subjects: Proposed Guidelines. Journal of Law, Medicine & Ethics 24 (1):18-35.
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  26. 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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  27. 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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  28. 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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  29. 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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  30. 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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  31. 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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  32. Troyen A. Brennan (1988). Silent Decisions: Limits of Consent and the Terminally III Patient. Journal of Law, Medicine & Ethics 16 (3-4):204-209.
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  33. 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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  34. D. Brock, E. J. Emanuel, C. Grady, R. Lie, F. Miller & D. Wendler (2008). Philosophical Justifications of Informed Consent in Research. In Ezekiel J. Emanuel (ed.), The Oxford Textbook of Clinical Research Ethics. Oxford University Press
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  35. 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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  36. 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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  37. Danielle Bromwich & Joseph Millum (2013). Disclosure and Consent to Medical Research Participation. Journal of Moral Philosophy 10 (4):195-219.
    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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  38. 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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  39. 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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  40. 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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  41. Emma C. Bullock (2014). Free Choice and Patient Best Interests. Health Care Analysis:1-19.
    In medical practice, the doctrine of informed consent is generally understood to have priority over the medical practitioner’s duty of care to her patient. A common consequentialist argument for the prioritisation of informed consent above the duty of care involves the claim that respect for a patient’s free choice is the best way of protecting that patient’s best interests; since the patient has a special expertise over her values and preferences regarding non-medical goods she is ideally placed to make a (...)
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  42. Emma C. 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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  43. 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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  44. 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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  45. 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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  46. 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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  47. 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 & 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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  48. 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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  49. 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 & Ethics 26 (1):38-47.
  50. 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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