Results for 'human subjects'

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  1.  42
    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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  2.  63
    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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  3.  19
    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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  4.  16
    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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  5.  4
    What is the Scope for the Interpretation of Dignity in Research Involving Human Subjects?Lawrence Burns - 2008 - 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 of respect (...)
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  6.  10
    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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  7.  9
    Shock for Right and Wrong Responses During Learning and Extinction in Human Subjects.Cecil M. Freeburne & Marvin Schneider - 1955 - Journal of Experimental Psychology 49 (3):181.
  8.  9
    Sensory Pre-Conditioning and Incidental Learning in Human Subjects.Harry W. Karn - 1947 - Journal of Experimental Psychology 37 (6):540.
  9.  8
    Decremental and Incremental Effects of Distracting Stimuli Upon the Salivary CR's of 24 Adult Human Subjects (Inhibition and Disinhibition?).G. H. S. Razran - 1939 - Journal of Experimental Psychology 24 (6):647.
  10.  7
    A Test of the "Units Hypothesis" Employing Wave-Length Generalization in Human Subjects.David R. Thomas & Richard H. Hiss - 1963 - Journal of Experimental Psychology 65 (1):59.
  11.  5
    The Effect of Instructions Upon Sensory Pre-Conditioning of Human Subjects.Rube Chernikoff & W. J. Brogden - 1949 - Journal of Experimental Psychology 39 (2):200.
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  12. Human and Animal Subjects of Research: The Moral Significance of Respect Versus Welfare.Rebecca L. Walker - 2006 - 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 the (...)
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  13.  15
    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 & 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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  14.  11
    The Presidential Bioethics Commission's Database of Human Subjects Research.M. Groman & J. Sugarman - 2013 - IRB: Ethics & Human Research 35 (2):18-19.
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  15.  10
    The Physician's Role in the Protection of Human Research Subjects.Professor John R. Williams - 2006 - Science and Engineering Ethics 12 (1):5-12.
    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 participation, when (...)
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  16.  7
    A Global Public Incentive Database for Human Subjects Research.B. Brown & M. W. Merritt - 2013 - IRB: Ethics & Human Research 35 (2):14-17.
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  17. Marketing Research Ethics: Researcher's Obligations Toward Human Subjects.Sami Alsmadi - 2008 - Journal of Academic Ethics 6 (2):153-160.
    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 researcher’s ethical (...)
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  18. Research on Human Subjects: Ethics, Law, and Social Policy.David N. Weisstub (ed.) - 1998 - Pergamon Press.
    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 human (...)
     
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  19. Moving Beyond Compliance: Measuring Ethical Quality to Enhance the Oversight of Human Subjects Research.Holly Taylor - 2007 - IRB: Ethics & Human Research 29 (5).
    A robust measure of whether local oversight of human subjects research is achieving the ethical goals of research oversight has never been developed. Assessing whether the local review process is achieving the ethical goals of research oversight will allow institutions to monitor their own human subjects protection programs and guide the investment of funds to improve performance. Without a measure of ethical quality, institutions, institutional review boards, regulators, and the public have no way of knowing if (...)
     
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  20.  74
    Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects.David L. Evers, Carol B. Fowler, Jeffrey T. Mason & Rebecca K. Mimnall - 2015 - 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 respect to safety. (...)
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  21.  38
    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.
    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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  22.  14
    The Case for Evidence-Based Rulemaking in Human Subjects Research.Benjamin Sachs - 2010 - 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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  23.  32
    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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  24.  29
    From the Ideal Market to the Ideal Clinic: Constructing a Normative Standard of Fairness for Human Subjects Research.T. Phillips - 2011 - Journal of Medicine and Philosophy 36 (1):79-106.
    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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  25.  21
    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 & 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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  26.  46
    Abuses and Apologies: Irresponsible Conduct of Human Subjects Research in Latin America.Julie M. Aultman - 2013 - Journal of Law, Medicine & Ethics 41 (1):353-368.
    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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  27.  56
    Post-Approval Monitoring and Oversight of U.S.-Initiated Human Subjects Research in Resource-Constrained Countries.Brandon Brown, Janni Kinsler, Morenike O. Folayan, Karen Allen & Carlos F. Cáceres - 2014 - Journal of Bioethical Inquiry 11 (2):119-123.
    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 research regulatory (...)
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  28.  18
    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 & 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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  29. Revolution or Reform in Human Subjects Research Oversight.Steven Joffe - 2012 - Journal of Law, Medicine & 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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  30. Addressing the 'Global Basic Structure' in the Ethics of International Health Research Involving Human Subjects.Janet Borgerson - 2005 - Journal of Philosophical Research 30:235-249.
    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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  31.  14
    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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  32. Finetuning NLG Through Experiments with Human Subjects: The Case of Vague Descriptions.Kees van Deemter - unknown
    This discussion paper describes a sequence of experiments with human subjects aimed at finding out how an nlg system should choose between the different forms of a gradable adjective. This case study highlights some general questions that one faces when trying to base nlg systems on empirical evidence: one question is what task to set a subject so as to obtain the most useful information about that subject, another question has to do with differences between subjects.
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  33.  29
    A Comparative Analysis of Biomedical Research Ethics Regulation Systems in Europe and Latin America with Regard to the Protection of Human Subjects.E. Lamas, M. Ferrer, A. Molina, R. Salinas, A. Hevia, A. Bota, D. Feinholz, M. Fuchs, R. Schramm, J. -C. Tealdi & S. Zorrilla - 2010 - Journal of Medical Ethics 36 (12):750-753.
    The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on (...)
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  34.  2
    Ethical Rules for Human Subjects Research: A Case Where the “Is” Must Inform the “Ought”.Alexander 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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  35.  36
    I. Glenn Cohen and Holly F. Lynch : Human Subjects Research Regulation: Perspectives on the Future.Lydia Stewart Ferreira - 2015 - Theoretical Medicine and Bioethics 36 (2):171-174.
    Human subjects research is an annual $10 billion dollar global activity. In May 2012, Harvard Law School hosted a conference on human subjects research . The conference critically examined HSR relative to the proposed American regulatory framework for federally funded research. The conference did not question the need for human subjects research. Rather, it discussed the need to balance the protection of human subjects from possible research risks while not hindering research—an epic, (...)
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  36.  52
    Challenging Research on Human Subjects: Justice and Uncompensated Harms.Stephen Napier - 2013 - 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 is (...)
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  37.  14
    The Case for a New System for Oversight of Research on Human Subjects.K. Jamrozik - 2000 - Journal of Medical Ethics 26 (5):334-339.
    The increasing emphasis on evidence-based clinical practice has thrown into sharp focus multiple deficiencies in current systems of ethical review. This paper argues that a complete overhaul of systems for ethical oversight of studies involving human subjects is now required as developments in medical, epidemiological and genetic research have outstripped existing structures for ethical supervision. It shows that many problems are now evident and concludes that sequential and piecemeal amendments to present arrangements are inadequate to address these. At (...)
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  38.  4
    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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  39.  28
    Ethical Review of Research on Human Subjects at Unilever: Reflections on Governance.Mark Sheehan, Vernon Marti & Tony Roberts - 2014 - Bioethics 28 (6):284-292.
    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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  40.  19
    A Policy in Flux: New York State's Evolving Approach to Human Subjects Research Involving Individuals Who Lack Consent Capacity.Valerie Gutmann Koch - 2014 - Journal of Law, Medicine & Ethics 42 (3):383-388.
    American history has been rife with human subjects research scandals, particularly those that involve “vulnerable” populations. State and federal laws and regulations often do not provide any special oversight mechanisms or protections to ensure the ethical and safe inclusion of cognitively impaired adults in research. At the New York State level, repeated efforts have been made to regulate research involving individuals who lack consent capacity. In January 2014, the New York State Task Force on Life and the Law (...)
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  41.  9
    Exploitation in the Use of Human Subjects for Medical Experimentation: A Re-Examination of Basic Issues.Leonardo D. de Castro - 1995 - Bioethics 9 (3):259–268.
    Relatively subtle forms of exploitation of human subjects may arise from the inefficiency or incompetence of a researcher, from the existence of a power imbalance between principal and subject, or from the uneven distribution of research risks among various segments of the population. A powerful and knowledgeable person (or institution) may perpetrate the exploitation of an unempowered and ignorant individual even without intending to. There is an ethical burden on the former to protect the interests of the vulnerable. (...)
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  42.  36
    The Ethical Analysis of Risks and Potential Benefits in Human Subjects Research: History, Theory, and Implications for U.S. Regulation.Charles Weijer - unknown
    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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  43.  20
    Ethical and Legal Issues in Enhancement Research on Human Subjects.Maxwell J. Mehlman, Jessica W. Berg, Eric T. Juengst & Eric Kodish - 2011 - Cambridge Quarterly of Healthcare Ethics 20 (1):30--45.
    The United States, along with other nations and international organizations, has developed an elaborate system of ethical norms and legal rules to govern biomedical research using human subjects. These policies govern research that might provide direct health benefits to participants and research in which there is no prospect for participant health benefits. There has been little discussion, however, about how well these rules would apply to research designed to improve participants’ capabilities or characteristics beyond the goal of good (...)
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  44.  18
    Photographing Human Subjects in Biomedical Disciplines: An Islamic Perspective.S. 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.  1
    Responsible Conduct of Human Subjects Research in Islamic Communities.Aceil Al-Khatib & Michael Kalichman - forthcoming - Science and Engineering Ethics:1-14.
    In order to increase understanding of the ethical implications of biomedical, behavioral and clinical research, the Fogarty International Center, part of the United States National Institutes of Health, established an International Research Ethics Education and Curriculum Development Award to support programs in low- and middle-income countries. To develop research ethics expertise in Jordan, the University of California San Diego fellowship program in collaboration with Jordan University of Science and Technology provides courses that enable participants to develop skills in varied research (...)
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  46.  15
    Research Monitoring by US Medical Institutions to Protect Human Subjects: Compliance or Quality Improvement?J. P. de Jong, M. C. B. van Zwieten & D. L. Willems - 2013 - Journal of Medical Ethics 39 (4):236-241.
    In recent years, to protect the rights and welfare of human subjects, institutions in the USA have begun to set up programmes to monitor ongoing medical research. These programmes provide routine, onsite oversight, and thus go beyond existing oversight such as investigating suspected misconduct or reviewing paperwork provided by investigators. However, because of a lack of guidelines and evidence, institutions have had little guidance in setting up their programmes. To help institutions make the right choices, we used interviews (...)
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  47.  11
    Monitoring Research with Human Subjects.J. Sugarman - 2013 - Journal of Medical Ethics 39 (4):242-242.
    Active monitoring of research with human subjects is no longer reserved for especially complex research or investigating research alleged to be problematic. Rather, many human research subjects’ protection programmes now engage in routine monitoring. Although limited data concerning such monitoring are available, the Association for the Accreditation of Human Research Protection Programs , reports that in 2011 its accredited organisations conducted many routine audits .1 While accredited organisations currently represent a small subset of human (...)
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  48.  12
    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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  49.  4
    Ethical International Research on Human Subjects Research in the Absence of Local Institutional Review Boards.S. B. Bhat - 2006 - 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 institutional (...)
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  50.  6
    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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