Results for 'Clinical research'

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  1. Clinical Research: Should Patients Pay to Play?Ezekiel J. Emanuel, Steven Joffe, Christine Grady, David Wendler & Govind Persad - 2015 - Science Translational Medicine 7 (298):298ps16.
    We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.
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  2.  46
    Clinical Research Projects at a German Medical Faculty: Follow-Up From Ethical Approval to Publication and Citation by Others.A. Blumle, G. Antes, M. Schumacher, H. Just & E. von Elm - 2008 - Journal of Medical Ethics 34 (9):e20-e20.
    Background: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied.Methods: The protocols of clinical research projects submitted to the research ethics committee of the (...)
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  3.  34
    Clinical Research with Economically Disadvantaged Populations.C. C. Denny & C. Grady - 2007 - Journal of Medical Ethics 33 (7):382-385.
    Concerns about exploiting the poor or economically disadvantaged in clinical research are widespread in the bioethics community. For some, any research that involves economically disadvantaged individuals is de facto ethically problematic. The economically disadvantaged are thought of as “venerable” to exploitation, impaired decision making, or both, thus requiring either special protections or complete exclusion from research. A closer examination of the worries about vulnerabilities among the economically disadvantaged reveals that some of these worries are empirically or (...)
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  4.  59
    Reframing Consent for Clinical Research: A Function-Based Approach.Scott Y. H. Kim, David Wendler, Kevin P. Weinfurt, Robert Silbergleit, Rebecca D. Pentz, Franklin G. Miller, Bernard Lo, Steven Joffe, Christine Grady, Sara F. Goldkind, Nir Eyal & Neal W. Dickert - 2017 - American Journal of Bioethics 17 (12):3-11.
    Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first (...)
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  5.  8
    Clinical Research Should Not Be Permitted to Escape the Ethical Orbit of Clinical Care.David Steinberg - 2002 - American Journal of Bioethics 2 (2):27 – 28.
    (2002). Clinical Research Should Not Be Permitted to Escape the Ethical Orbit of Clinical Care. The American Journal of Bioethics: Vol. 2, No. 2, pp. 27-28.
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  6.  37
    Rethinking the Ethics of Clinical Research: Widening the Lens.Alan Wertheimer - 2010 - Oxford University Press.
    Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.
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  7.  76
    Ethics and Regulation of Clinical Research.Robert J. Levine - 1986 - Urban & Schwarzenberg.
    In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.
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  8.  26
    Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine.Jake Earl - 2019 - American Journal of Bioethics 19 (6):7-18.
    Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community (...)
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  9.  19
    Clinical Research in Context: Reexamining the Distinction Between Research and Practice.J. A. Anderson - 2010 - Journal of Medicine and Philosophy 35 (1):46-63.
    At least since the seminal work of the (US) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, a fundamental distinction between research and practice has underwritten both conceptual work in research ethics and regulations governing research involving human subjects. Notwithstanding its undoubted historical importance, I believe the distinction is problematic because it misrepresents clinical inquiry. In this essay, I aim to clarify the character of clinical inquiry (...)
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  10.  80
    Contextualizing Clinical Research: The Epistemological Role of Clinical Equipoise.James A. Anderson - 2009 - Theoretical Medicine and Bioethics 30 (4):269-288.
    Since its introduction in 1987, Benjamin Freedman’s principle of clinical equipoise has enjoyed widespread uptake in bioethics discourse. Recent years, however, have witnessed a growing consensus that the principle is fundamentally flawed. One of the most vocal critics has undoubtedly been Franklin Miller. In a 2008 paper, Steven Joffe and Miller build on this critical work, offering a new conception of clinical research ethics based on science, taking what they call a “scientific orientation” toward the ethics of (...)
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  11. Clinical Research Law in Jordan: An Ethical Analysis.Ibrahim Ramahi & Henry Silverman - 2009 - Developing World Bioethics 9 (1):26-33.
  12.  10
    Clinical Research: Up From 'Clinical Epidemiology'.Olli S. Miettinen, Lucas M. Bachmann & Johann Steurer - 2009 - Journal of Evaluation in Clinical Practice 15 (6):1208-1213.
    Clinical research must be understood to be the foundation of scientific medicine of the clinical type. But the essence of scientific clinical medicine remains a matter of profound confusion, even in clinical academia, and so does the essence of clinical research. The confusion now revolves, principally, around ‘clinical epidemiology’. We address clinical research in the meaning of quintessentially ‘applied’ clinical research, which we take to be the foundation of (...)
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  13.  46
    Placebo Orthodoxy in Clinical Research II: Ethical, Legal, and Regulatory Myths.Benjamin Freedman, Kathleen Cranley Glass & Charles Weijer - 1996 - Journal of Law, Medicine and Ethics 24 (3):252-259.
    Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical (...)
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  14. The Oxford Textbook of Clinical Research Ethics.Ezekiel J. Emanuel (ed.) - 2008 - Oxford University Press.
    Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.
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  15.  34
    The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative.Kathryn M. Porter, Marion Danis, Holly A. Taylor, Mildred K. Cho & Benjamin S. Wilfond - 2018 - American Journal of Bioethics 18 (1):39-45.
    The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with (...)
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  16.  70
    Developing Clinical Research Relationship: Views From Within.Olga Zvonareva & Lloyd Akrong - 2015 - Developing World Bioethics 15 (3):257-266.
    The nature of the relationship between clinical investigator and research participant continues to be contested. The related discussions have largely focused on the doctor-researcher dichotomy thought to permeate the work of a clinical investigator with research participants, whom in turn occupy two corresponding roles: patient and subject. This paper contributes to current debates on the topic by providing a voice to research participants, whose perspectives have been largely invisible. It draws on 42 in-depth interviews conducted (...)
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  17. Clinical Research Consultation: A Casebook.Marion Danis (ed.) - 2012 - Oxford University Press.
    Starting research -- Enrolling research participants -- Protecting research participants -- Conducting research with vulnerable populations -- Balancing clinical research and clinical care -- Navigating interpersonal difficulties -- Ending research.
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  18.  27
    Linking International Clinical Research with Stateless Populations to Justice in Global Health.Bridget Pratt, Deborah Zion, Khin M. Lwin, Phaik Y. Cheah, Francois Nosten & Bebe Loff - 2014 - BMC Medical Ethics 15 (1):49.
    In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework—‘research for health justice’—was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. (...)
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  19.  22
    Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths.Benjamin Freedman, Charles Weijer & Kathleen Cranley Glass - 1996 - Journal of Law, Medicine and Ethics 24 (3):243-251.
    The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of (...)
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  20.  27
    Can Clinical Research Be Both Ethical and Scientific? A Commentary Inspired by Rosser and Marquis.Helen Bequaert Holmes - 1989 - Hypatia 4 (2):156-168.
    Problems with clinical research that create conflicts between doctors' therapeutic and research obligations may be fueled by a rigid view of science as determiner of truth, a heavy reliance on statistics, and certain features of randomized clinical trials. I suggest some creative, feminist approaches to such research and explore ways to provide choice for patients and to use values in directing both therapy and science - to enhance the effectiveness of each.
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  21.  32
    Clinical Research Without Consent in Adults in the Emergency Setting: A Review of Patient and Public Views. [REVIEW]Jan Lecouturier, Helen Rodgers, Gary A. Ford, Tim Rapley, Lynne Stobbart, Stephen J. Louw & Madeleine J. Murtagh - 2008 - BMC Medical Ethics 9 (1):9.
    In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and (...)
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  22.  10
    Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths.Benjamin Freedman, Charles Weijer & Kathleen Cranley Glass - 1996 - Journal of Law, Medicine and Ethics 24 (3):243-251.
    The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of (...)
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  23.  46
    Clinical Research Methods for the New Millennium.Bruce G. Charlton Md - 1999 - Journal of Evaluation in Clinical Practice 5 (2):251-263.
  24.  39
    Avoiding Exploitation in Clinical Research.Solomon R. Benatar - 2000 - Cambridge Quarterly of Healthcare Ethics 9 (4):562-565.
    Clinical research has become a burgeoning activity in recent years, largely stimulated by the pharmaceutical industry's interest in new drugs with high marketing profiles. Several other forces fuel this thrust: the increasing dependence of academic medical institutions on research funding from industry; the need for large, efficient multicenter trials to obtain reliable and statistically significant results in the shortest possible time for drug registration purposes; and access to research subjects in countries. The intense interest in HIV/AIDS (...)
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  25.  21
    Conducting Clinical Research in Polish Conditions.Marek Labon - 2006 - Science and Engineering Ethics 12 (1):185-188.
    This paper comments on Polish legal guarantees for diseased persons with reference to the hazards that accompany experimental treatment. While acknowledging that participation in a clinical research program provides patients with additional opportunities for advanced treatment, the paper also points out that systems for monitoring patients participating in experimental treatment require improvement.
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  26.  89
    Hard Paternalism, Fairness and Clinical Research: Why Not?Sarah J. L. Edwards & James Wilson - 2012 - Bioethics 26 (2):68 - 75.
    Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons.First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be (...)
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  27.  20
    Monitoring Clinical Research: An Obligation Unfulfilled.Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Cranley Glass & Myriam Skrutkowska - unknown
    The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of (...)
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  28.  30
    The Clinical Research of Nanomedicine: A New Ethical Challenge?Urban Wiesing & Jens Clausen - 2014 - NanoEthics 8 (1):19-28.
    Nanomedicine promises unprecedented innovations for diagnosis and therapy as well as for predicting and preventing diseases. On the other hand it raises fears linked to new and unknown characteristics of nanoscale materials. Both, promises and fears, are closely linked to the realm of uncertainty. To a large extent it is currently not known which expectations could become reality and which suspected adverse events might come true. Medicine is quite familiar with decision-making under uncertainty. Rules and regulations for clinical (...) have been developed to reduce possible harm for research participants without abandoning necessary investigations. Here we examine whether clinical research trials of nanomedicine need new regulations and conclude that the established rules should suffice. (shrink)
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  29.  4
    Clinical Research Projects at a German Medical Faculty: Follow-Up From Ethical Approval to Publication and Citation by Others.A. Blumle, G. Antes, M. Schumacher, H. Just & E. von Elm - 2008 - Journal of Medical Ethics 34 (9):20-20.
    Background: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied. Methods: The protocols of clinical research projects submitted to the research ethics committee of (...)
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  30.  17
    Clinical Research Is a Team Sport.Ross E. McKinney - 2019 - American Journal of Bioethics 19 (4):22-23.
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  31.  25
    Justice in International Clinical Research.Bridget Pratt & Bebe Loff - 2011 - Developing World Bioethics 11 (2):75-81.
    Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global (...)
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  32. International Clinical Research and Justice in the Belmont Report.Joseph Millum - 2020 - Perspectives in Biology and Medicine 63 (2):374-388.
    The Belmont Report was written by a US Commission charged by the US Congress to advise on research supported by the US government. Its focus was understandably domestic. In the 40 years since its publication, clinical research has become increasingly international. Many clinical trials have sites in multiple countries, and many of the host countries are relatively impoverished. Such research raises some distinctive ethical issues. This paper outlines some of the key ethical challenges that have (...)
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  33.  16
    Fiduciary Obligation in Clinical Research.Paul B. Miller & Charles Weijer - 2006 - Journal of Law, Medicine and Ethics 34 (2):424-440.
    Bioethics is currently witnessing unprecedented debate over the moral and legal norms governing the conduct of clinical research. At the center of this debate is the duty of care in clinical research, and its most widely accepted specification, clinical equipoise. In recent work, we have argued that equipoise and cognate concepts central to the ethics of clinical research have been left unnecessarily vulnerable to criticism. We have suggested that the vulnerability lies in the (...)
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  34.  18
    Clinical Research Involving Pregnant Women Ed. By Françoise Baylis and Angela Ballantyne. [REVIEW]Elizabeth Victor - 2019 - International Journal of Feminist Approaches to Bioethics 12 (1):175-179.
    As a feminist bioethicist, I have frequently wondered why the exclusion of pregnant women has been the default position for most clinical research and how social values have influenced this decision. Relatedly, I wonder what responsible research involving pregnant women would look like. As a theorist who conducts research on the concept of vulnerability, I have often wanted to know why there has been so little research into the harmful effects of the routine exclusion of (...)
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  35.  39
    Litigation in Clinical Research: Malpractice Doctrines Versus Research Realities.E. Haavi Morreim - 2004 - Journal of Law, Medicine and Ethics 32 (3):474-484.
    Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in (...) research trials that now are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)
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  36.  57
    Paternalism and Fairness in Clinical Research.Lynn A. Jansen & Steven Wall - 2009 - Bioethics 23 (3):172-182.
    In this paper, we defend the ethics of clinical research against the charge of paternalism. We do so not by denying that the ethics of clinical research is paternalistic, but rather by defending the legitimacy of paternalism in this context. Our aim is not to defend any particular set of paternalistic restrictions, but rather to make a general case for the permissibility of paternalistic restrictions in this context. Specifically, we argue that there is no basic liberty-right (...)
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  37.  31
    Ethical Challenges Experienced by Clinical Research Nurses:: A Qualitative Study.Mary E. Larkin, Brian Beardslee, Enrico Cagliero, Catherine A. Griffith, Kerry Milaszewski, Marielle T. Mugford, Joanna M. Myerson, Wen Ni, Donna J. Perry, Sabune Winkler & Elizabeth R. Witte - 2019 - Nursing Ethics 26 (1):172-184.
    Background:Clinical investigation is a growing field employing increasing numbers of nurses. This has created a new specialty practice defined by aspects unique to nursing in a clinical research context: the objectives, setting, and nature of the nurse–participant relationship. The clinical research nurse role may give rise to feelings of ethical conflict between aspects of protocol implementation and the duty of patient advocacy, a primary nursing responsibility. Little is known about whether research nurses experience unique (...)
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  38.  12
    The Social Value of Clinical Research.Michelle Gjl Habets, Johannes Jm van Delden & AnneLien L. Bredenoord - 2014 - BMC Medical Ethics 15 (1):66.
    International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is (...)
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  39.  43
    Clarifying the Ethics of Clinical Research: A Path Toward Avoiding the Therapeutic Misconception.Paul S. Appelbaum - 2002 - American Journal of Bioethics 2 (2):22 – 23.
    (2002). Clarifying the Ethics of Clinical Research: A Path toward Avoiding the Therapeutic Misconception. The American Journal of Bioethics: Vol. 2, No. 2, pp. 22-23.
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  40.  2
    Perspectives Regarding Privacy in Clinical Research Among Research Professionals From the Arab Region: An Exploratory Qualitative Study.Latifa Adarmouch, Marwan Felaefel, Robert Wachbroit & Henry Silverman - 2020 - BMC Medical Ethics 21 (1):1-16.
    Background Protecting the privacy of research participants is widely recognized as one of the standard ethical requirements for clinical research. It is unknown, however, how research professionals regard concepts of privacy as well as the situations in the research setting that require privacy protections. The aim of this study was to explore the views of research professionals from Arab countries regarding concepts and scope of privacy that occur in clinical research. Methods We (...)
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  41.  23
    Reconsidering Paternalism in Clinical Research.Lynn A. Jansen & Steven Wall - 2018 - Bioethics 32 (1):50-58.
    The ethical standards that regulate clinical research have multiple rationales. Among them is the need to protect potential subjects from making imprudent decisions, which extends beyond the soft paternalistic concern to protect people from making uninformed decisions to participate in trials. This article argues that a plausible risk/benefit restriction on clinical trials is presumptively justified by hard paternalism, which in turn is supported by a deeper fairness-based rationale. This presumptive case for hard paternalism in research is (...)
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  42.  9
    Clinical Research Subject Selection During Public Health Disasters: Reconceptualizing Fairness in a Global Ethical Context.Ikeolu O. Afolabi, Stephen O. Sodeke & Michael O. S. Afolabi - 2020 - American Journal of Bioethics 20 (2):38-41.
    Volume 20, Issue 2, February 2020, Page 38-41.
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  43.  38
    Consent to Clinical Research--Adequately Voluntary or Substantially Influenced?S. Hewlett - 1996 - Journal of Medical Ethics 22 (4):232-237.
    In clinical research the giving of consent by the patient often lies within the context of illness or the doctor/patient relationship. On exploration of these issues it would appear unlikely that the patient's consent is free of substantial influences, some of which may be strong enough to be controlling. Five categories of consent are suggested: voluntary, involuntary, coerced, enforced and partially voluntary. It is argued that consent in clinical research is substantially influenced and thus only partially (...)
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  44.  7
    Litigation in Clinical Research: Malpractice Doctrines Versus Research Realities.E. Haavi Morreim - 2004 - Journal of Law, Medicine and Ethics 32 (3):474-484.
    Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in (...) research trials that now are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)
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  45.  35
    Misunderstanding in Clinical Research: Distinguishing Therapeutic Misconception, Therapeutic Misestimation, & Therapeutic Optimism.Sam Horng & Christine Grady - 2003 - IRB: Ethics & Human Research 25 (1):11.
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  46.  2
    Therapeutic Misconception in Clinical Research: Frequency and Risk Factors.Paul S. Appelbaum, Charles W. Lidz & Thomas Grisso - 2004 - IRB: Ethics & Human Research 26 (2):1.
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  47.  10
    The Clinical Research. A first approach.Tatiana Marañon Cardonne & León Robaina - 2015 - Humanidades Médicas 15 (1):163-184.
    La investigación clínica es la actividad encaminada a conocer el resultado de una intervención o un producto para el diagnóstico o la terapéutica en los seres humanos. El ensayo clínico es el principal exponente de la investigación clínica y toda evaluación experimental de una sustancia o medicamento en seres humanos. En Cuba, existe un desarrollo importante de la biotecnología y de los centros de investigación que necesitan de ensayos clínicos según estándares nacionales e internacionales. En el presente trabajo se exponen (...)
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  48.  14
    Clinical Research in Times of Pandemics.S. -A. Chong, B. J. Capps, M. Subramaniam, T. C. Voo & A. V. Campbell - 2010 - Public Health Ethics 3 (1):35-38.
    During a pandemic, where there is widespread human infection, various and varying measures are taken that are targeted at public health objectives. During the early stages of a pandemic, these objectives may focus on containing the disease and minimizing its spread, but they may switch to mitigation as the emergent infectious disease takes hold in a population. There has been considerable debate and elucidation of the ethical principles and framework for the various responses including the need to fast track (...) and vaccine development. However, the measures imposed during a pandemic would have unintended and untoward effect on ongoing clinical research. For example, precautionary measures, such as social distancing, may hamper ongoing clinical research, because recruitment and participation of patients and healthy volunteers is a potential source of virus spread. In this paper, we argue that a framework is needed to ensure the continuity of such research. Such a framework that considers the pertinent issues would need the ‘buy in’ of the key stakeholders (policy makers, funding agencies, institutional authorities, researchers and subjects) to ensure that the issues that are ethically relevant to pandemic planning would not be neglected or overlooked. (shrink)
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  49.  4
    Stakeholder Engagement: Clinical Research Cases.Sybille Sachs, Johanna Kujala & R. Freeman (eds.) - 2017 - Springer Verlag.
    This book offers a case-study approach to stakeholder theory that moves beyond theoretical analysis to the applied. As stakeholder theory has moved into the mainstream of management thinking in business ethics and a number of the management disciplines, there is an increasing need to explore the subtleties of stakeholder engagement via examples from practice. The case studies in this volume explore a number of aspects of the idea of stakeholder engagement, via the method of clinical case studies. Edited by (...)
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  50.  15
    Reasonable Risks In Clinical Research: A Critique and a Proposal for the Integrative Approach.Alex John London - unknown
    Before participants can be enrolled in a clinical trial, an institutional review board must determine that the risks that the research poses to participants are ‘reasonable.’ This paper examines the two dominant frameworks for assessing research risks and argues that each approach suffers from significant shortcomings. It then considers what issues must be addressed in order to construct a framework for risk assessment that is grounded in a compelling normative foundation and might provide more operationally precise guidance (...)
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