Results for 'human subjects'

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  1.  23
    Paying Human Subjects in Research: Where Are We, How Did We Get Here, and Now What?Ari VanderWalde & Seth Kurzban - 2011 - Journal of Law, Medicine and 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 grounds (...)
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  2.  62
    Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations.Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Jeffrey P. Kahn, Mildred K. Cho, Ellen Wright Clayton, Joel G. Fletcher, Michael K. Georgieff, Dale Hammerschmidt, Kathy Hudson, Judy Illes, Vivek Kapur, Moira A. Keane, Barbara A. Koenig, Bonnie S. LeRoy, Elizabeth G. McFarland, Jordan Paradise, Lisa S. Parker, Sharon F. Terry, Brian Van Ness & Benjamin S. Wilfond - 2008 - Journal of Law, Medicine and Ethics 36 (2):219-248.
    No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude (...)
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  3.  38
    Human Subjects Protections in Biomedical Enhancement Research: Assessing Risk and Benefit and Obtaining Informed Consent.Maxwell J. Mehlman & Jessica W. Berg - 2008 - Journal of Law, Medicine and Ethics 36 (3):546-549.
    The protection of human subjects in biomedical research relies on two principal mechanisms: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects' informed consent. While these have been discussed extensively in the literature, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual appearance, performance, or capability rather than to prevent, cure, or mitigate disease . This essay (...)
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  4.  9
    Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide.Kate Crawford & Jacob Metcalf - 2016 - Big Data and Society 3 (1).
    There are growing discontinuities between the research practices of data science and established tools of research ethics regulation. Some of the core commitments of existing research ethics regulations, such as the distinction between research and practice, cannot be cleanly exported from biomedical research to data science research. Such discontinuities have led some data science practitioners and researchers to move toward rejecting ethics regulations outright. These shifts occur at the same time as a proposal for major revisions to the Common Rule—the (...)
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  5.  11
    Human Subjects Protections in Biomedical Enhancement Research: Assessing Risk and Benefit and Obtaining Informed Consent.Maxwell J. Mehlman & Jessica W. Berg - 2008 - Journal of Law, Medicine and Ethics 36 (3):546-559.
    There are two critical steps in determining whether a medical experiment involving human subjects can be conducted in an ethical manner: assessing risks and potential benefits and obtaining potential subjects’ informed consent. Although an extensive literature on both of these aspects exists, virtually nothing has been written about human experimentation for which the objective is not to prevent, cure, or mitigate a disease or condition, but to enhance human capabilities. One exception is a 2004 article (...)
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  6.  27
    Paying Human Subjects in Research: Where Are We, How Did We Get Here, and Now What?Ari VanderWalde & Seth Kurzban - 2011 - Journal of Law, Medicine and Ethics 39 (3):543-558.
    On November 14, 1996, an in-depth report on the recruiting and testing practices of Lilly Pharmaceuticals appeared in the Wall Street Journal. Laurie Cohen reported that most pharmaceutical companies had difficulty recruiting healthy subjects to participate in testing of “untried and potentially dangerous” drugs. These companies often had to pay subjects up to $250 a day to ensure adequate enrollment, and some even gave referral bonuses to doctors who sent potential subjects their way. Cohen then exposed how (...)
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  7.  2
    Human Subjects in Medical Experimentation: A Sociological Study of the Conduct and Regulation of Clinical Research.Bradford H. Gray - 1981 - R.E. Krieger Pub. Co..
  8.  12
    Human Subject Research: Erika Dyck and Larry Stewart : The Uses of Human Experiment: Perspectives From the 17th to the 20th Century Leiden, Brill, 2016, Xii+297pp, €117 HB.Piers Hale - 2019 - Metascience 28 (2):297-300.
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  9.  48
    Ethics in Human Subjects Research: Do Incentives Matter?Ruth W. Grant & Jeremy Sugarman - 2004 - 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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  10.  5
    Human Subjects Research Without Consent: Duties to Return Individual Findings When Participation Was Non-Consensual.Nina Varsava - 2020 - American Journal of Bioethics 20 (1):28-30.
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  11.  7
    The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives.Trudo Lemmens & Paul B. Miller - 2003 - Journal of Law, Medicine and Ethics 31 (3):398-418.
    Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the (...)
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  12.  40
    Protecting Human Subjects From Harm Through Improved Risk Judgments.Eric M. Meslin - 1990 - IRB: Ethics & Human Research 12 (1):7.
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  13.  6
    The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives.Trudo Lemmens & Paul B. Miller - 2003 - Journal of Law, Medicine and Ethics 31 (3):398-418.
    Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the (...)
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  14. Human Subjects Research : Ethics and Compliance.Ana Smith Iltis - 2006 - In Research Ethics. Routledge.
     
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  15.  16
    Are Transplant Recipients Human Subjects When Research Is Conducted on Organ Donors?Kate Gallin Heffernan & Alexandra K. Glazier - 2017 - Hastings Center Report 47 (5):10-14.
    Interventional research on deceased organ donors and donor organs prior to transplant holds the promise of reducing the number of patients who die waiting for an organ by expanding the pool of transplantable organs and improving transplant outcomes. However, one of the key challenges researchers face is an assumption that someone who receives an organ that was part of an interventional research protocol is always a human subject of that same study. The consequences of this assumption include the need (...)
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  16.  25
    Human Subjects Research with Prisoners: Putting the Ethical Question in Context.Osagie K. Obasogie & Keramet A. Reiter - 2011 - Bioethics 25 (1):55-56.
  17.  24
    Incidental Findings in Human Subjects Research: What Do Investigators Owe Research Participants?Franklin G. Miller, Michelle M. Mello & Steven Joffe - 2008 - Journal of Law, Medicine and Ethics 36 (2):271-279.
    The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental fndings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental fndings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of (...)
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  18.  73
    Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field.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 - Journal of Law, Medicine and Ethics 40 (4):716-750.
    Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger (...)
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  19. Ontology with Human Subjects Testing: An Empirical Investigation of Geographic Categories.Barry Smith & David M. Mark - 1998 - American Journal of Economics and Sociology 58 (2):245–272.
    Ontology, since Aristotle, has been conceived as a sort of highly general physics, a science of the types of entities in reality, of the objects, properties, categories and relations which make up the world. At the same time ontology has been for some two thousand years a speculative enterprise. It has rested methodologically on introspection and on the construction and analysis of elaborate world-models and of abstract formal-ontological theories. In the work of Quine and others this ontological theorizing in abstract (...)
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  20.  16
    Human Subjects, Research Use Of.Robert Wachbroit - 2013 - In Hugh LaFollette (ed.), The International Encyclopedia of Ethics. Wiley-Blackwell.
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  21.  49
    Equipose and International Human-Subjects Research.Alex John London - 2001 - Bioethics 15 (4):312–332.
    This paper examines the role of equipoise in evaluating international research. It distinguishes two possible formulations of the equipoise requirement that license very different evaluations of international research proposals. The interpretation that adopts a narrow criterion of similarity between clinical contexts has played an important role in one recent controversy, but it suffers from a number of problems. An alternative interpretation that adopts a broader criterion of similarity does a better job of avoiding both exploitation of the brute fact of (...)
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  22.  18
    The Ethics of Research with Human Subjects: Protecting People, Advancing Science, Promoting Trust.David B. Resnik - 2018 - Springer Verlag.
    This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human (...) that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust. (shrink)
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  23. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects.World Medical Association - 2009 - Jahrbuch für Wissenschaft Und Ethik 14 (1):233-238.
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  24.  13
    An Assessment of the Human Subjects Protection Review Process for Exempt Research.Jonathan D. Loe, D. Alex Winkelman & Christopher T. Robertson - 2016 - Journal of Law, Medicine and Ethics 44 (3):481-491.
    Medical and public health research includes surveys, interviews, and biospecimens — techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this (...)
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  25. Revolution or Reform in Human Subjects Research Oversight.Steven Joffe - 2012 - Journal of Law, Medicine and Ethics 40 (4):922-929.
    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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  26.  40
    The Problematics of Human Subjectivity: Gilles Deleuze and the Deweyan Legacy.Inna Semetsky - 2003 - Studies in Philosophy and Education 22 (3/4):211-225.
    This article is part of alarger project exploring the continuity betweentwo philosophical positions – that of Frenchpoststructuralist Gilles Deleuze (1925–1995)and John Dewey – that appear at first sight tobe separated by time, place and culture. Thescope of the present paper is necessarilylimited and focuses on one aspect of theproject, namely: the problematics ofsubjectivity, or subject formation, inDeleuze's philosophy. Deleuze's position isestablished as pragmatic by virtue of itssharing the value allotted by Dewey toexperiential and experimental inquiry inphilosophy. By drawing initial parallels (...)
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  27. Ethics of Internet Research: Contesting the Human Subjects Research Model.Elizabeth H. Bassett & Kate O'Riordan - 2002 - Ethics and Information Technology 4 (3):233-247.
    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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  28.  8
    Must Research Benefit Human Subjects If It is to Be Permissible?Daniel Wikler - 2017 - Journal of Medical Ethics 43 (2):114-117.
  29.  3
    A Feeling for the Human Subject: Margaret Lasker and the Genetic Puzzle of Pentosuria.Nurit Kirsh & L. Joanne Green - 2021 - Journal of the History of Biology 54 (2):247-274.
    In 1933 Margaret Lasker, a biochemist who worked at the labs of Montefiore Hospital in New York, developed an accurate method for the differentiation between pentosuria and diabetes. Research into pentosuria, and mostly its genetic aspects, became Lasker’s lifelong passion. Since research was not part of her job description, she conducted the chief part of her study in her home kitchen. Lasker’s extensive and personal correspondence with her patients and their families may be the secret key for her success in (...)
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  30.  10
    Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice.Leslie E. Wolf, Mayank J. Patel, Brett A. Williams Tarver, Jeffrey L. Austin, Lauren A. Dame & Laura M. Beskow - 2015 - Journal of Law, Medicine and Ethics 43 (3):594-609.
    Answering important public health questions often requires collection of sensitive information about individuals. For example, our understanding of how HIV is transmitted and how to prevent it only came about with people's willingness to share information about their sexual and drug-using behaviors. Given the scientific need for sensitive, personal information, researchers have a corresponding ethical and legal obligation to maintain the confidentiality of data they collect and typically promise in consent forms to restrict access to it and not to publish (...)
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  31. 'Psychological Man' and Human Subjectivity in Historical Perspective.Irmingard Staeuble - 1991 - History of the Human Sciences 4 (3):417-432.
  32.  19
    Re-Consenting Human Subjects: Ethical, Legal and Practical Issues.D. B. Resnik - 2009 - Journal of Medical Ethics 35 (11):656-657.
    Informed consent is one of the foundational ethical and legal requirements of research with human subjects. The Nuremberg Code, the Helsinki Declaration, the Belmont Report, the Common Rule and many other laws and codes require that research subjects make a voluntary, informed choice to participate in research.12345 Informed consent is based on the moral principle of respect for autonomy, which holds that rational individuals have a right to make decisions and take actions that reflect their values and (...)
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  33.  32
    Research Ethics in Internet-Enabled Research: Human Subjects Issues and Methodological Myopia. [REVIEW]Joseph B. Walther - 2002 - Ethics and Information Technology 4 (3):205-216.
    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 (...)
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  34.  1
    Research with Human Subjects:Humility and Deception.Nancy M. P. King - 2018 - IRB: Ethics & Human Research 40 (2):12-14.
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  35.  25
    Undergraduate Research Involving Human Subjects Should Not Be Granted Ethical Approval Unless It is Likely to Be of Publishable Quality.Cathal T. Gallagher, Lisa J. McDonald & Niamh P. McCormack - 2014 - HEC Forum 26 (2):169-180.
    Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals cannot, (...)
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  36.  4
    Revolution or Reform in Human Subjects Research Oversight.Steven Joffe - 2012 - Journal of Law, Medicine and Ethics 40 (4):922-929.
    Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New (...)
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  37. Democratic Deliberation and the Ethical Review of Human Subjects Research.Govind Persad - 2014 - In I. Glenn Cohen & Holly Fernandez Lynch (eds.), Human Subjects Research Regulation: Perspectives on the Future. MIT Press. pp. 157-72.
    In the United States, the Presidential Commission for the Study of Bioethical Issues has proposed deliberative democracy as an approach for dealing with ethical issues surrounding synthetic biology. Deliberative democracy might similarly help us as we update the regulation of human subjects research. This paper considers how the values that deliberative democratic engagement aims to realize can be realized in a human subjects research context. Deliberative democracy is characterized by an ongoing exchange of ideas between participants, (...)
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  38.  40
    Urge Overkill: Protecting Deidentified Human Subjects at What Price?Misha Angrist - 2010 - American Journal of Bioethics 10 (9):17-18.
  39.  16
    Experimentation with Human Subjects: A Critique of the Views of Hans Jonas.A. Schafer - 1983 - Journal of Medical Ethics 9 (2):76-79.
    The ethics of experimentation on human subjects has become the subject of much debate among medical scientists and philosophers. Ethical problems and conflicts of interest become especially serious when research subjects are recruited from the class of patients. Are patients who are ill and suffering in a position to give voluntary and informed consent? Are there inevitable conflicts of interest and moral obligation when a personal physician recruits his own patients for an experiment designed partly to advance (...)
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  40.  6
    Ethical Rules for Human Subjects Research: A Case Where the “Is” Must Inform the “Ought”.Alexander A. Kon - 2010 - American Journal of Bioethics 10 (6):14-15.
    (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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  41.  96
    On Being a Human Subject: Interest and Obligation in the Experimental Treatment of Incurable Disease.Andrew Feenberg - 1992 - Philosophical Forum 23 (3):213-230.
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  42.  33
    Bilateral Transfer of the Conditioned Response in the Human Subject.J. J. Gibson, E. G. Jack & G. Raffel - 1932 - Journal of Experimental Psychology 15 (4):416.
  43.  23
    Peirce's Approach to the Self: A Semiotic Perspective on Human Subjectivity.Vincent M. Colapietro - 1988 - State University of New York Press.
    Based on a careful study of his unpublished manuscripts as well as his published work, this book explores Peirce's general theory of signs and the way in which Peirce himself used this theory to understand subjectivity.
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  44.  24
    Photographing Human Subjects in Biomedical Disciplines: An Islamic Perspective.Salilah Saidun - 2013 - Journal of Medical Ethics 39 (2):84-88.
    Visual recording of human subjects is commonly used in biomedical disciplines for clinical, research, legal, academic and even personal purposes. Guidelines on practice standards of biomedical recording have been issued by certain health authorities, associations and journals, but none of the literature discusses this from an Islamic perspective. This article begins with a discussion on the general rules associated with visual recording in Islam, followed by modesty issues in biomedical recording and issues of informed consent and confidentiality. In (...)
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  45.  29
    International Ethical Guidelines for Biomedical Research Involving Human Subjects.C. G. Foster - 1994 - Journal of Medical Ethics 20 (2):123-124.
  46.  3
    Experimentation with Human Subjects.Paul Abraham Freund - 1972 - London: Allen & Unwin.
  47.  22
    Studying the Amateur Artist: A Perspective on Disguising Data Collected in Human Subjects Research on the Internet.Amy Bruckman - 2002 - 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 (...)
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  48.  24
    Promoting Human Subjects Training for Place-Based Communities and Cultural Groups in Environmental Research: Curriculum Approaches for Graduate Student/Faculty Training.Dianne Quigley - 2015 - Science and Engineering Ethics 21 (1):209-226.
    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 the (...)
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  49.  15
    Community Members as Recruiters of Human Subjects: Ethical Considerations.Christian Simon & Maghboeba Mosavel - 2010 - American Journal of Bioethics 10 (3):3-11.
    Few studies have considered in detail the ethical issues surrounding research in which investigators ask community members to engage in research subject recruitment within their own communities. Peer-driven recruitment and its variants are useful for accessing and including certain populations in research, but also have the potential to undermine the ethical and scientific integrity of community-based research. This paper examines the ethical implications of utilizing community members as recruiters of human subjects in the context of PDR, as well (...)
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  50.  23
    Learned Helplessness in Human Subjects.Jerry W. Thornton & Paul D. Jacobs - 1971 - Journal of Experimental Psychology 87 (3):367-372.
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