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

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  1. 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.score: 520.0
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  2. Oonagh Corrigan (ed.) (2009). The Limits of Consent: A Socio-Ethical Approach to Human Subject Research in Medicine. Oxford University Press.score: 381.0
    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. 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.score: 378.0
    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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  4. 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.score: 365.0
    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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  5. 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.score: 349.0
    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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  6. Elizabeth H. Bassett & Kate O'Riordan (2002). Ethics of Internet Research: Contesting the Human Subjects Research Model. Ethics and Information Technology 4 (3):233-247.score: 284.7
    The human subjects researchmodel is increasingly invoked in discussions ofethics for Internet research. Here we seek toquestion the widespread application of thismodel, critiquing it through the two themes ofspace and textual form. Drawing on ourexperience of a previous piece ofresearch, we highlightthe implications of re-considering thetextuality of the Internet in addition to thespatial metaphors that are more commonlydeployed to describe Internet activity. Weargue that the use of spatial metaphors indescriptions of the Internet has shaped theadoption of the (...) subjects research model.Whilst this model is appropriate in some areasof Internet research such as emailcommunication, we feel that researchers, whennavigating the complex terrain of Internetresearch ethics, need also to consider theInternet as cultural production of texts. (shrink)
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  7. D. Hunter (2006). An Alternative University-Wide Model for the Ethical Review of Human Subject Research. Research Ethics 2 (2):47-50.score: 279.0
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  8. Joseph B. Walther (2002). Research Ethics in Internet-Enabled Research: Human Subjects Issues and Methodological Myopia. [REVIEW] Ethics and Information Technology 4 (3):205-216.score: 277.3
    As Internet resources are usedmore frequently for research on social andpsychological behavior, concerns grow aboutwhether characteristics of such research affecthuman subjects protections. Early efforts toaddress such concerns have done more toidentify potential problems than to evaluatethem or to seek solutions, leaving bodiescharged with human subjects oversight in aquagmire. This article critiques some of theseissues in light of the US Code of FederalRegulations' policies for the Protection ofHuman Subjects, and argues that some of theissues have no pertinence when (...)
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  9. I. Glenn Cohen (2000). Administrative Developments: New Human Subject Research Guidelines for IRBs. Journal of Law, Medicine and Ethics: A Journal of the American Society of Law, Medicine & Ethics 28 (3):305.score: 270.0
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  10. 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 19 (3-4):13-15.score: 270.0
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  11. 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.score: 270.0
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  12. Judith Miller & B. J. Crigger (1992). Ethical Standards for Human Subject Research in Developing Countries. Irb 14 (3):7.score: 270.0
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  13. 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.score: 270.0
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  14. 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.score: 270.0
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  15. Carl H. Coleman (2009). Vulnerability as a Regulatory Category in Human Subject Research. Journal of Law, Medicine and Ethics 37 (1):12-18.score: 270.0
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  16. Shawn H. E. Harmon (2006). Solidarity: A (New) Ethic for Global Health Policy. [REVIEW] Health Care Analysis 14 (4):215-236.score: 270.0
    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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  17. 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.score: 270.0
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  18. Stuart G. Finder (2004). Vulnerability in Human Subject Research: Existential State, Not Category Designation. American Journal of Bioethics 4 (3):68-70.score: 270.0
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  19. 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.score: 270.0
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  20. 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.score: 264.0
    The American Journal of Bioethics, Volume 12, Issue 1, Page W1-W2, January 2012.
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  21. 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.score: 264.0
    The American Journal of Bioethics, Volume 11, Issue 11, Page 31-38, November 2011.
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  22. Benjamin Sachs (2010). The Case for Evidence-Based Rulemaking in Human Subjects Research. American Journal of Bioethics 10 (6):3-13.score: 262.0
    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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  23. 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.score: 261.0
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  24. Stephen Napier (2013). Challenging Research on Human Subjects: Justice and Uncompensated Harms. Theoretical Medicine and Bioethics 34 (1):29-51.score: 260.0
    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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  25. Ruth W. Grant & Jeremy Sugarman (2004). Ethics in Human Subjects Research: Do Incentives Matter? Journal of Medicine and Philosophy 29 (6):717 – 738.score: 257.0
    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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  26. Frederick Grinnell (2004). Subject Vulnerability: The Precautionary Principle of Human Research. American Journal of Bioethics 4 (3):72-74.score: 243.0
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  27. 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 and Ethics 39 (3):543-558.score: 242.0
    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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  28. Dianne Quigley (forthcoming). Promoting Human Subjects Training for Place-Based Communities and Cultural Groups in Environmental Research: Curriculum Approaches for Graduate Student/Faculty Training. Science and Engineering Ethics:1-18.score: 239.3
    A collaborative team of environmental sociologists, community psychologists, religious studies scholars, environmental studies/science researchers and engineers has been working together to design and implement new training in research ethics, culture and community-based approaches for place-based communities and cultural groups. The training is designed for short and semester-long graduate courses at several universities in the northeastern US. The team received a 3 year grant from the US National Science Foundation’s Ethics Education in Science and Engineering in 2010. This manuscript details (...)
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  29. B. Brown & M. W. Merritt (2012). A Global Public Incentive Database for Human Subjects Research. Irb 35 (2):14-17.score: 232.0
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  30. M. Groman & J. Sugarman (2012). The Presidential Bioethics Commission's Database of Human Subjects Research. Irb 35 (2):18-19.score: 232.0
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  31. William P. Cheshire (2004). Human Embryo Research and the Language of Moral Uncertainty. American Journal of Bioethics 4 (1):1 – 5.score: 213.0
    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 example, the descriptors (...)
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  32. Angela Ales Bello (2008). Edmund Husserl and Edith Stein: The Question of the Human Subject. American Catholic Philosophical Quarterly 82 (1):143-159.score: 213.0
    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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  33. Sami Alsmadi (2008). Marketing Research Ethics: Researcher's Obligations Toward Human Subjects. Journal of Academic Ethics 6 (2):153-160.score: 212.0
    This paper addresses the growing concern over violation of research ethics in marketing, in particular rights of human subjects in fieldwork, notably the right to informed consent; right to privacy and confidentiality; and right not to be deceived or harmed as a result of participation in a research. The paper highlights the interaction of the three main parties involved in most marketing research: the sponsoring organization (client or user), researcher, and participant in the survey, focusing on (...)
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  34. Professor John R. Williams (2006). The Physician's Role in the Protection of Human Research Subjects. Science and Engineering Ethics 12 (1):5-12.score: 208.0
    Responsibility for the protection of human research subjects is shared by investigators, research ethics committees, sponsors/funders, research institutions, governments and, the focus of this article, physicians who enrol patients in clinical trials. The article describes the general principles of the patient-physician relationship that should regulate the participation of physicians in clinical trials and proposes guidelines for determining when and how such participation should proceed. The guidelines deal with the following stages of the trial: when first considering (...)
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  35. 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).score: 207.0
    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. 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.score: 207.0
    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. Janet Borgerson (2005). Addressing the 'Global Basic Structure' in the Ethics of International Health Research Involving Human Subjects. Journal of Philosophical Research 30:235-249.score: 201.0
    The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process of (...)
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  38. Bradford H. Gray (1981). Human Subjects in Medical Experimentation: A Sociological Study of the Conduct and Regulation of Clinical Research. R.E. Krieger Pub. Co..score: 200.3
     
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  39. 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 and Ethics 41 (2):454-469.score: 198.0
    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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  40. Heather A. Kitchin (2003). The Tri-Council Policy Statement and Research in Cyberspace: Research Ethics, the Internet, and Revising a 'Living Document'. [REVIEW] Journal of Academic Ethics 1 (4):397-418.score: 198.0
    Increasingly, the Internet is proving to be an important research tool. Today, cyberspace affords researchers easy access to traditionally difficult to reach populations, a host of virtual communities, and a wealth of data created through computer-mediated-communication. This newfound research frontier brings with it, however, a multiplicity of ethical concerns, including: (1) whether the Internet constitutes a private or public space; (2) whether the human subject paradigm is appropriate when considering the ethics of Internet research; and (...)
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  41. Lisa Eckenwiler (2001). Moral Reasoning and the Review of Research Involving Human Subjects. Kennedy Institute of Ethics Journal 11 (1):37-69.score: 195.0
    : The model of moral reasoning used in Institutional Review Board review fails to uphold ethical ideals for research participants for it does not adequately acknowledge the particular context of research or of subjects, including their gender, their socioeconomic status, and the communities in which they lead their lives. The ethical review of research needs to take seriously the particularities of the research context as well as the situations of potential participants. A variety of conclusions are (...)
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  42. T. Phillips (2011). From the Ideal Market to the Ideal Clinic: Constructing a Normative Standard of Fairness for Human Subjects Research. Journal of Medicine and Philosophy 36 (1):79-106.score: 194.7
    Preventing exploitation in human subjects research requires a benchmark of fairness against which to judge the distribution of the benefits and burdens of a trial. This paper proposes the ideal market and its fair market price as a criterion of fairness. The ideal market approach is not new to discussions about exploitation, so this paper reviews Wertheimer's inchoate presentation of the ideal market as a principle of fairness, attempt of Emanuel and colleagues to apply the ideal market to (...)
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  43. Charles Weijer, The Ethical Analysis of Risks and Potential Benefits in Human Subjects Research: History, Theory, and Implications for U.S. Regulation.score: 194.7
    This paper addresses three questions central to the ethical analysis of risks and potential benefits in human subjects research: 1. How was the ethical analysis of risk understood by the members of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)? 2. What conceptual framework should guide the ethical analysis of risk? 3. What changes to U.S. regulations would the implementation of such a framework require?
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  44. Steven Joffe (2012). Revolution or Reform in Human Subjects Research Oversight. Journal of Law, Medicine and Ethics 40 (4):922-929.score: 194.7
    The contemporary system of prospective oversight of human subjects research has been criticized as inefficient and ineffective. Plausible approaches to research oversight range from no prospective review, to review-and-comment, to the current review-and-approve regime. Articulating this spectrum offers an opportunity to consider systematically the strengths and disadvantages of each.
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  45. Brandon Brown, Janni Kinsler, Morenike O. Folayan, Karen Allen & Carlos F. Cáceres (2014). Post-Approval Monitoring and Oversight of U.S.-Initiated Human Subjects Research in Resource-Constrained Countries. Journal of Bioethical Inquiry 11 (2):119-123.score: 194.7
    The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of (...)
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  46. Leili Fatehi, Susan M. Wolf, Jeffrey McCullough, Ralph Hall, Frances Lawrenz, Jeffrey P. Kahn, Cortney Jones, Stephen A. Campbell, Rebecca S. Dresser, Arthur G. Erdman, Christy L. Haynes, Robert A. Hoerr, Linda F. Hogle, Moira A. Keane, George Khushf, Nancy M. P. King, Efrosini Kokkoli, Gary Marchant, Andrew D. Maynard, Martin Philbert, Gurumurthy Ramachandran, Ronald A. Siegel & Samuel Wickline (2012). Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field. Journal of Law, Medicine and Ethics 40 (4):716-750.score: 194.7
    The nanomedicine field is fast evolving toward complex, “active,” and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR (...)
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  47. Alexander Kon (2010). Ethical Rules for Human Subjects Research: A Case Where the “Is” Must Inform the “Ought”. American Journal of Bioethics 10 (6):14-15.score: 194.7
    (2010). Ethical Rules for Human Subjects Research: A Case Where the “Is” Must Inform the “Ought”. The American Journal of Bioethics: Vol. 10, No. 6, pp. 14-15.
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  48. Mark Sheehan, Vernon Marti & Tony Roberts (2014). Ethical Review of Research on Human Subjects at Unilever: Reflections on Governance. Bioethics 28 (6):284-292.score: 194.0
    This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research.
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  49. David N. Weisstub (ed.) (1998). Research on Human Subjects: Ethics, Law, and Social Policy. Pergamon.score: 194.0
    There have been serious controversies in the latter part of the 20th century about the roles and functions of scientific and medical research. In whose interests are medical and biomedical experiments conducted and what are the ethical implications of experimentation on subjects unable to give competent consent? From the decades following the Second World War and calls for the global banning of medical research to the cautious return to the notion that in controlled circumstances, medical research on (...)
     
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  50. Julie M. Aultman (2013). Abuses and Apologies: Irresponsible Conduct of Human Subjects Research in Latin America. Journal of Law, Medicine and Ethics 41 (1):353-368.score: 191.0
    This paper explores the vulnerability of Latin American human subjects, and how their vulnerability is ignored due to the complexities and inconsistencies of oversight committees and institutional policies. Secondly, the concept of apology is examined and its meaning to victims of past research abuses.
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