Search results for 'Human subject research' (try it on Scholar)

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  1.  14
    Chapter11 Human (2012). Human Rights as Technologies of the Self: Creating the European Governmentable Subject of Rights. In Ben Golder (ed.), Re-Reading Foucault: On Law, Power and Rights. Routledge 229.
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  2.  50
    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 (...)
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  3.  23
    Judith Miller & B. J. Crigger (1992). Ethical Standards for Human Subject Research in Developing Countries. IRB: Ethics & Human Research 14 (3):7.
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  4.  23
    Dale E. Hammerschmidt (1996). " There is No Substantive Due Process Right to Conduct Human-Subject Research": The Saga of the Minnesota Gamma Hydroxybutyrate Study. IRB: Ethics & Human Research 19 (3-4):13-15.
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  5.  4
    Carl H. Coleman (2009). Vulnerability as a Regulatory Category in Human Subject Research. Journal of Law, Medicine & Ethics 37 (1):12-18.
    This article examines and critiques the use of the term “vulnerability” in U.S. and international regulations and guidelines on research ethics. After concluding that the term is currently used in multiple, often inconsistent, senses, it calls on regulators to differentiate between three distinct types of vulnerability: “consent-based vulnerability,”“risk-based vulnerability,” and “justice-based vulnerability.”.
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  6.  7
    Will C. van den Hoonaard (2016). The Censor's Hand: The Misregulation of Human-Subject Research by Carl E. Schneider. Kennedy Institute of Ethics Journal 25 (4):11-15.
    The Censor’s Hand invites us to explore the murky side of formal research-ethics review in the United States, as embodied in “Institutional Review Boards”. Amidst some 340 publications and several blogs that have taken formal research-ethics review to task, this book is the seventh detailed monograph on this topic—the others are Robert Klitzman’s The Ethics Police?, Zachary Schrag’s Ethical Imperialism, Laura Stark’s Behind Closed Doors, and my own works, Walking the Tightrope, The Seduction of Ethics, and The Ethics (...)
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  7.  9
    D. Hunter (2006). An Alternative University-Wide Model for the Ethical Review of Human Subject Research. Research Ethics 2 (2):47-50.
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  8. Leslie E. Wolf, Mayank J. Patel, Brett A. Williams Tarver, Jeffrey L. Austin, Lauren A. Dame & Laura M. Beskow (2015). Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice. Journal of Law, Medicine and Ethics 43 (3):594-609.
    The federal Certificate of Confidentiality plays an important role in research on sensitive topics by authorizing researchers to refuse to disclose identifiable research data in response to subpoenas in any legal setting. However, there is little known about how effective Certificates are in practice. This article draws on our legal and empirical research on this topic to fill this information gap. It includes a description of the purpose of Certificates, their legislative and regulatory history, and a summary (...)
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  9.  71
    David L. Evers, Carol B. Fowler, Jeffrey T. Mason & Rebecca K. Mimnall (2015). Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects. Science and Engineering Ethics 21 (4):1049-1064.
    Here we identify approximately 40,000 healthy human volunteers who were intentionally exposed to infectious pathogens in clinical research studies dating from late World War II to the early 2000s. Microbial challenge experiments continue today under contemporary human subject research requirements. In fact, we estimated 4,000 additional volunteers who were experimentally infected between 2010 and the present day. We examine the risks and benefits of these experiments and present areas for improvement in protections of participants with (...)
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  10. J. Wong (2000). Beyond Regulation. Ethics in Human Subject Research: Edited by Nancy M P King, Gail E Henderson and Jane Stein, Chapel Hill, The University of North Carolina Press, 1999, 279 Pages, US$ 39.95, (Hc) US$18.95 (Sc). [REVIEW] Journal of Medical Ethics 26 (6):484-484.
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  11.  7
    Justin M. List (2005). Histories of Mistrust and Protectionism: Disadvantaged Minority Groups and Human-Subject Research Policies. American Journal of Bioethics 5 (1):53 – 56.
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  12.  4
    Ann Freeman Cook & Helena Hoas (2014). Clinicians or Researchers, Patients or Participants: Exploring Human Subject Protection When Clinical Research Is Conducted in Non-Academic Settings. Ajob Empirical Bioethics 5 (1):3-11.
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  13.  22
    Jack Schwartz (forthcoming). Oversight of Human Subject Research: The Role of the States. National Bioethics Advisory Commission 6705 Rockledge Drive, Suite 700, Bethesda, Maryland 20892-7979 Telephone: 301-402-4242• Fax: 301-480-6900• Website: Www. Bioethics. Gov.
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  14. Carl H. Coleman (2009). Vulnerability as a Regulatory Category in Human Subject Research. Journal of Law, Medicine and Ethics 37 (1):12-18.
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  15.  20
    I. Glenn Cohen (2000). Administrative Developments: New Human Subject Research Guidelines for IRBs. Journal of Law, Medicine & Ethics 28 (3):305.
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  16. Anthony Vernillo (2008). Pragmatism as a Complementary Approach to Legislation: Closing Regulatory Gaps in Human Subject Research. American Journal of Bioethics 8 (11):15 – 17.
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  17.  1
    Stuart G. Finder (2004). Vulnerability in Human Subject Research: Existential State, Not Category Designation. American Journal of Bioethics 4 (3):68-70.
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  18.  5
    Larry Gostin (1991). Ethical Principles for the Conduct of Human Subject Research: Population-Based Research and Ethics. Journal of Law, Medicine & Ethics 19 (3-4):191-201.
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  19. Larry Gostin (1991). Ethical Principles for the Conduct of Human Subject Research: Population-Based Research and Ethics. Journal of Law, Medicine and Ethics 19 (3-4):191-201.
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  20.  5
    Toby Schonfeld, Joseph S. Brown, N. Jean Amoura & Bruce Gordon (2011). “You Don't Know Me, But …”: Access to Patient Data and Subject Recruitment in Human Subjects Research. American Journal of Bioethics 11 (11):31-38.
    The American Journal of Bioethics, Volume 11, Issue 11, Page 31-38, November 2011.
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  21.  7
    Toby Schonfeld, Joseph S. Brown, N. Jean Amoura & Bruce Gordon (2012). Protecting Patient Privacy Redux: Response to Open Peer Commentaries on “'You Don't Know Me, But …': Access to Patient Data and Subject Recruitment in Human Subjects Research”. American Journal of Bioethics 12 (1):W1 - W2.
    The American Journal of Bioethics, Volume 12, Issue 1, Page W1-W2, January 2012.
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  22.  3
    Kathryn Toner & Robert Schwartz (2003). Why a Teenager Over Age 14 Should Be Able to Consent, Rather Than Merely Assent, to Participation as a Human Subject of Research. American Journal of Bioethics 3 (4):38-40.
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  23.  3
    Frederick Grinnell (2004). Subject Vulnerability: The Precautionary Principle of Human Research. American Journal of Bioethics 4 (3):72-74.
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  24.  12
    Amy Bruckman (2002). Studying the Amateur Artist: A Perspective on Disguising Data Collected in Human Subjects Research on the Internet. Ethics and Information Technology 4 (3):217-231.
    In the mid-1990s, the Internet rapidly changedfrom a venue used by a small number ofscientists to a popular phenomena affecting allaspects of life in industrialized nations. Scholars from diverse disciplines have taken aninterest in trying to understand the Internetand Internet users. However, as a variety ofresearchers have noted, guidelines for ethicalresearch on human subjects written before theInternet's growth can be difficult to extend toresearch on Internet users.In this paper, I focus on one ethicalissue: whether and to what extent to (...)
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  25.  3
    Lawrence Burns (2008). What is the Scope for the Interpretation of Dignity in Research Involving Human Subjects? Medicine, Health Care and Philosophy 11 (2):191-208.
    Drawing on Lennart Nordenfelt’s distinction between the four distinct senses of dignity, I elucidate the meaning of dignity in the context of research involving human subjects. I acknowledge that different interpretations of the personal senses of dignity may be acceptable in human subject research, but that inherent dignity (Menschenwürde) is not open to interpretation in the same way. In order to map out the grounds for interpreting dignity, I examine the unique application of the principle (...)
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  26.  68
    Rebecca L. Walker (2006). Human and Animal Subjects of Research: The Moral Significance of Respect Versus Welfare. Theoretical Medicine and Bioethics 27 (4):305-331.
    Human beings with diminished decision-making capacities are usually thought to require greater protections from the potential harms of research than fully autonomous persons. Animal subjects of research receive lesser protections than any human beings regardless of decision-making capacity. Paradoxically, however, it is precisely animals’ lack of some characteristic human capacities that is commonly invoked to justify using them for human purposes. In other words, for humans lesser capacities correspond to greater protections but for animals (...)
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  27.  5
    Benjamin Sachs (2010). The Case for Evidence-Based Rulemaking in Human Subjects Research. American Journal of Bioethics 10 (6):3-13.
    Here I inquire into the status of the rules promulgated in the canonical pronouncements on human subjects research, such as the Declaration of Helsinki and the Belmont Report. The question is whether they are ethical rules or rules of policy. An ethical rule is supposed to accurately reflect the ethical fact (the fact that the action the rule prescribes is ethically obligatory), whereas rules of policy are implemented to achieve a goal. We should be skeptical, I argue, that (...)
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  28.  27
    Ruth W. Grant & Jeremy Sugarman (2004). Ethics in Human Subjects Research: Do Incentives Matter? Journal of Medicine and Philosophy 29 (6):717 – 738.
    There is considerable confusion regarding the ethical appropriateness of using incentives in research with human subjects. Previous work on determining whether incentives are unethical considers them as a form of undue influence or coercive offer. We understand the ethical issue of undue influence as an issue, not of coercion, but of corruption of judgment. By doing so we find that, for the most part, the use of incentives to recruit and retain research subjects is innocuous. But there (...)
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  29.  5
    Angela Ales Bello (2008). Edmund Husserl and Edith Stein: The Question of the Human Subject. American Catholic Philosophical Quarterly 82 (1):143-159.
    The goal of this article is to analyze the way in which Edith Stein describes the human subject throughout her research, including her phenomenological phaseand the period of her Christian philosophy. In order to do this, I trace essential moments in Husserl’s philosophy, showing both Stein’s reliance upon Husserl andher originality. Both thinkers believe that an analysis of the human being can be carried out by examining consciousness and its lived experiences. Through suchan examination Stein arrives (...)
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  30.  18
    William P. Cheshire (2004). Human Embryo Research and the Language of Moral Uncertainty. American Journal of Bioethics 4 (1):1 – 5.
    In bioethics as in the sciences, enormous discussions often concern the very small. Central to public debate over emerging reproductive and regenerative biotechnologies is the question of the moral status of the human embryo. Because news media have played a prominent role in framing the vocabulary of the debate, this study surveyed the use of language reporting on human embryo research in news articles spanning a two-year period. Terminology that devalued moral status - for (...)
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  31.  2
    S. B. Bhat (2006). Ethical International Research on Human Subjects Research in the Absence of Local Institutional Review Boards. Journal of Medical Ethics 32 (9):535-536.
    International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified—external oversight, local oversight and subject involvement—and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local (...)
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  32.  13
    SteveAnthony FleetwoodHesketh (2006). Prediction in Social Science - The Case of Research on the Human Resource Management-Organisational Performance Link. [REVIEW] Journal of Critical Realism 5 (2):228-250.
    _ Source: _Volume 5, Issue 2, pp 228 - 250 Despite inroads made by critical realism against the ‘scientific method’ in social science, the latter remains strong in subject-areas like human resource management. One argument for the alleged superiority of the scientific method lies in the taken-for-granted belief that it alone can formulate empirically testable predictions. Many of those who employ the scientific method are, however, confused about the way they understand and practice prediction. This paper takes as (...)
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  33.  29
    Stephen Napier (2013). Challenging Research on Human Subjects: Justice and Uncompensated Harms. Theoretical Medicine and Bioethics 34 (1):29-51.
    Ethical challenges to certain aspects of research on human subjects are not uncommon; examples include challenges to first-in-human trials (Chapman in J Clin Res Bioethics 2(4):1–8, 2011), certain placebo controlled trials (Anderson in J Med Philos 31:65–81, 2006; Anderson and Kimmelman in Kennedy Inst Ethics J 20(1):75–98, 2010) and “sham” surgery (Macklin in N Engl J Med 341:992–996, 1999). To date, however, there are few challenges to research when the subjects are competent and the research (...)
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  34. SteveAnthony FleetwoodHesketh (2006). Prediction in Social Science - The Case of Research on the Human Resource Management-Organisational Performance Link. Journal of Critical Realism 5 (2):228-250.
    _ Source: _Volume 5, Issue 2, pp 228 - 250 Despite inroads made by critical realism against the ‘scientific method’ in social science, the latter remains strong in subject-areas like human resource management. One argument for the alleged superiority of the scientific method lies in the taken-for-granted belief that it alone can formulate empirically testable predictions. Many of those who employ the scientific method are, however, confused about the way they understand and practice prediction. This paper takes as (...)
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  35.  18
    Gabriela Marodin, Paulo Henrique Condeixa de França, Jennifer Braathen Salgueiro, Marcia Luz da Motta, Gysélle Saddi Tannous & Anibal Gil Lopes (2012). Alternatives of Informed Consent for Storage and Use of Human Biological Material for Research Purposes: Brazilian Regulation. Developing World Bioethics 12 (3):127-131.
    Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and (...)
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  36.  11
    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 (...)
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  37.  10
    Shawn H. E. Harmon (2006). Solidarity: A (New) Ethic for Global Health Policy. [REVIEW] Health Care Analysis 14 (4):215-236.
    This article explores solidarity as an ethical concept underpinning rules in the global health context. First, it considers the theoretical conceptualisation of the value and some specific duties it supports (ie: its expression in the broadest sense and its derivative action-guiding duties). Second, it considers the manifestation of solidarity in two international regulatory instruments. It concludes that, although solidarity is represented in these instruments, it is often incidental. This fact, their emphasis on other values and their internal weaknesses diminishes the (...)
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  38.  25
    Diane E. Hoffmann, J. Dennis Fortenberry & Jacques Ravel (2013). Are Changes to the Common Rule Necessary to Address Evolving Areas of Research? A Case Study Focusing on the Human Microbiome Project. Journal of Law, Medicine & Ethics 41 (2):454-469.
    This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a “reference catalogue” of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes (...)
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  39.  25
    P. M. Rosoff (2011). I'll Be a Monkey's Uncle: A Moral Challenge to Human Genetic Enhancement Research. Journal of Medical Ethics 37 (10):611-615.
    The potential for genetic engineering of enhancements to complex human traits has been the subject of vigorous debate for a number of years. Most of the discussion has centered on the possible moral consequences of pursuing enhancements, especially those that might affect complex behaviours and components of personality. Little has been written on the actual process of implementing this technology. This paper presents a ‘thought experiment’ about the likely form of final preclinical testing for a technology to enhance (...)
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  40.  17
    Ari VanderWalde & Seth Kurzban (2011). Paying Human Subjects in Research: Where Are We, How Did We Get Here, and Now What? Journal of Law, Medicine & Ethics 39 (3):543-558.
    Both international and federal regulations exist to ensure that scientists perform research on human subjects in an environment free of coercion and in which the benefits of the research are commensurate with the risks involved. Ensuring that these conditions hold is difficult, and perhaps even more so when protocols include the issue of monetary compensation of research subjects. The morality of paying human research subjects has been hotly debated for over 40 years, and the (...)
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  41.  8
    Deng Rui (2015). A Family-Oriented Decision-Making Model for Human Research in Mainland China. Journal of Medicine and Philosophy 40 (4):400-417.
    This essay argues that individual-oriented informed consent is inadequate to protect human research subjects in mainland China. The practice of family-oriented decision-making is better suited to guide moral research conduct. The family’s role in medical decision-making originates from the mutual benevolence that exists among family members, and is in accordance with family harmony, which is the aim of Confucian society. I argue that the practice of informed consent for medical research on human subjects ought to (...)
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  42. James G. Leachman (ed.) (2009). The Liturgical Subject: Subject, Subjectivity, and the Human Person in Contemporary Liturgical Discussion and Critique. University of Notre Dame Press.
    "This collection of essays makes a significant contribution to the field of liturgical studies. Many are original in the best sense that theological work can be: grounded in the authentic tradition, perceptive, imaginative, and capable of giving readers new insights into, and a fresh appreciation of, timeless truths. Taken together they will attract readers from a variety of disciplines, in the first place because worship is an essential aspect of every Christian life, and in the second because the essays are (...)
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  43.  2
    Teemu Suorsa (2015). Solution-Focused Therapy and Subject-Scientific Research Into the Personal Conduct of Everyday Living. Outlines. Critical Practice Studies 16 (2):126-138.
    Subject-scientific and solution-focused approaches share several critical concerns with regard to mainstream psychological concepts and therapeutic practices. Also, the alternatives presented have certain obvious similarities, such as 1) respecting subjective experience and everyday practices, 2) accentuating cooperation and 3) articulating possibilities. The articulation of the societal mediatedness of human experience and action has not, however, been an important theme in solution-focused therapy. Whereas it is justifiable to leave the societal mediation unarticulated in conversations with some clients, it is (...)
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  44.  2
    Teemu Suorsa (2015). Solution-Focused Therapy and Subject-Scientific Research Into the Personal Conduct of Everyday Living. Outlines. Critical Practice Studies 16 (2):126-138.
    Subject-scientific and solution-focused approaches share several critical concerns with regard to mainstream psychological concepts and therapeutic practices. Also, the alternatives presented have certain obvious similarities, such as 1) respecting subjective experience and everyday practices, 2) accentuating cooperation and 3) articulating possibilities. The articulation of the societal mediatedness of human experience and action has not, however, been an important theme in solution-focused therapy. Whereas it is justifiable to leave the societal mediation unarticulated in conversations with some clients, it is (...)
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  45.  1
    Dominique Lestel (2014). The Question of the Animal Subject: Thoughts on the Fourth Wound to Human Narcissism. Angelaki 19 (3):113-125.
    To the three classic wounds to human narcissism – that of Copernicus, Darwin, and Freud – there must be appended a fourth wound: man is not the only subject in the universe. While most philoso- phers are unwilling to accept it, ethological research shows that animals are also subjects; indeed, in human/animal hybrid communities, certain animals can become individuals or even persons. Through animal biography, anec- dotes, and other often disqualified but nonethe- less empirical forms of (...)
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  46.  3
    Guoping Zhao (2012). Human Science for Human Freedom? Piaget's Developmental Research and Foucault's Ethical Truth Games. Educational Studies 48 (5):450-464.
    The construction of the modern subject and the pursuit of human freedom and autonomy, as well as the practice of human science has been pivotal in the development of modern education. But for Foucault, the subject is only the effect of discourses and power?knowledge arrangements, and modern human science is part of the very arrangement that has given birth to the subject who is thoroughly subjected. In his final years, however, a strong passion for (...)
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  47.  6
    L. Schwartz (2003). Parallel Experience: How Art and Art Theory Can Inform Ethics in Human Research. Medical Humanities 29 (2):59-64.
    Trends in ethical research involving humans emphasise the importance of collaboration, of involving research subjects, alongside the researchers in the construction and implementation of research. This paper will explore parallels derived from another tradition of investigation of the human: art and art theory. An artist’s inquiry into the problems of human research will be described, followed by the application of arguments from art theory to research practice. Recently artist Christine Borland has provided examples (...)
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  48.  1
    Ann Freeman Cook & Helena Hoas (2015). Exploring the Potential for Moral Hazard When Clinical Trial Research is Conducted in Rural Communities: Do Traditional Ethics Concepts Apply? HEC Forum 27 (2):171-187.
    Over the past 20 years, clinical research has migrated from academic medical centers to community-based settings, including rural settings. This evolving research environment may present some moral hazards or challenges that could undermine traditionally accepted standards for the protection of human subjects. The study described in this article was designed to explore the influence of motives driving the decisions to conduct clinical trial research in rural community settings. The researchers conducted semi-structured interviews with 80 participants who (...)
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  49.  1
    C. D. Herrera (1997). The Other Human-Subject Experiments. Journal of Medicine and Philosophy 22 (2):161-171.
    Although deceptive psychology experiments receive less attention than some forms of medical research, they pose similar moral challenges. These challenges mainly concern the use of human subjects and intentional deception. Psychologists provide an argument to justify this deception. But what is an essentially utilitarian argument too often includes faulty comparisons and dubious accounts of risks and benefits. Commentators in other areas of humansubject research might examine this argument and the assumptions behind it. Bioethics commentators seem especially well-positioned (...)
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  50. Nathan Rotenstreich (1966). On the Human Subject. Springfield, Ill.,Thomas.
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