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.  71
    Developing Clinical Research Relationship: Views from Within.Olga Zvonareva & Lloyd Akrong - 2014 - 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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  3.  1
    Clinical Research Involving Pregnant Women.Françoise Baylis & Angela Ballantyne (eds.) - 2016 - Cham: Imprint: Springer.
    This book discusses 'how' to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons 'why' the inclusion of pregnant women in clinical research is necessary - viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to (...)
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  4.  2
    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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  5.  14
    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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  6.  8
    Clinical Research: Auditory Stimulation in the Disorders of Consciousness.Jiajie Zhu, Yifan Yan, Wei Zhou, Yajun Lin, Zheying Shen, Xuanting Mou, Yan Ren, Xiaohua Hu & Haibo Di - 2019 - Frontiers in Human Neuroscience 13.
  7. The Oxford textbook of clinical research ethics.Ezekiel J. Emanuel (ed.) - 2008 - New York: 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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  8.  89
    Ethics and regulation of clinical research.Robert J. Levine - 1981 - Baltimore: 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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  9. Clinical research in plastic surgery.B. Coghlan - forthcoming - Bulletin of Medical Ethics.
     
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  10.  8
    For clinical research: a formula for improved prognosis.K. A. Gruber - 1988 - Perspectives in Biology and Medicine 31 (4):612.
  11.  14
    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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  12. Clinical Research on the Subject with Dementia.Nina M. Mirarchi - 2005 - Penn Bioethics Journal 1 (1).
     
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  13.  3
    Clinical research involving children.R. E. Kauffman - 2000 - Bioethics Forum 16 (4):45.
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  14.  36
    Addressing the Ethical Challenges in Genetic Testing and Sequencing of Children.Ellen Wright Clayton, Laurence B. McCullough, Leslie G. Biesecker, Steven Joffe, Lainie Friedman Ross, Susan M. Wolf & For the Clinical Sequencing Exploratory Research Group - 2014 - American Journal of Bioethics 14 (3):3-9.
    American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines (...)
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  15. Clinical research and the physician–patient relationship: the dual roles of physician and researcher.Nancy Mp King & Larry R. Churchill - 2008 - In Peter A. Singer & A. M. Viens (eds.), The Cambridge Textbook of Bioethics. Cambridge University Press.
     
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  16. Consent in Clinical Research.Collin O'Neill - 2018 - In Andreas Müller & Peter Schaber (eds.), The Routledge Handbook of the Ethics of Consent. New York, USA: Routledge. pp. 297-310.
    This article addresses two areas of continuing controversy about consent in clinical research: the question of when consent to low risk research is necessary, and the question of when consent to research is valid. The article identifies a number of considerations relevant to determining whether consent is necessary, chief of which is whether the study would involve subjects in ways that would (otherwise) infringe their rights. When consent is necessary, there is a further question of under (...)
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  17.  39
    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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  18.  10
    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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  19.  8
    Critical thinking in clinical research: applied theory and practice using case studies.Felipe Fregni & Ben M. W. Illigens (eds.) - 2018 - New York, NY: Oxford University Press.
    Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on (...) relevance across all medical specialties. (shrink)
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  20.  24
    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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  21.  24
    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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  22.  19
    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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  23.  83
    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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  24.  6
    Clinical Ethics Committee in an Oncological Research Hospital: two-years Report.Marta Perin, Ludovica De Panfilis & on Behalf of the Clinical Ethics Committee of the Azienda Usl-Irccs di Reggio Emilia - 2023 - Nursing Ethics 30 (7-8):1217-1231.
    Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...
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  25. Clinical research law in Jordan: An ethical analysis.Ibrahim Ramahi & Henry Silverman - 2007 - Developing World Bioethics 9 (1):26-33.
    ABSTRACT An ethical analysis of Jordan's Clinical Research Law, which became effective in 2001, was performed. Accordingly, this paper discusses the major components, key strengths and weaknesses of this law. As an initial effort, the Law addresses important aspects of research ethics and, hence, should serve as an example for other Arab Countries in the Middle East. Unique aspects of the Law include the requirement that those conducting any study have insurance that can compensate for research (...)
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  26. 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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  27.  48
    Clinical research methods for the new millennium.Bruce G. Charlton Md - 1999 - Journal of Evaluation in Clinical Practice 5 (2):251-263.
  28.  54
    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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  29.  2
    Modern Clinical Research: Guidelines for the Practicing Clinician or Source of Confusion?Ilia Volkov - 2013 - Journal of Clinical Ethics 24 (4):395-396.
    There is a dilemma in modern medicine, and, as a general family practitioner, this dilemma has great impact on me as a professional with a responsibility to my patients, and on the treatments I prescribe. Every day we receive a lot of updated information about relevant issues in treatment of various conditions we encounter in our daily practice. There is a great deal of interesting, serious research; however, frequently results and conclusions are very different and at times, contradictory. It (...)
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  30.  34
    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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  31.  30
    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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  32.  7
    Ethics status of clinical research and trials in developing countries.Yuanyuan Liu - 2015 - Eubios Journal of Asian and International Bioethics 25 (4):124-127.
    With the development of economic globalization, more and more clinical research and trials shift from developed countries to developing countries. The globalization of clinical trials also brings some ethical and scientific concerns. This paper discussed some ethical problems of clinical trials in the developing countries including 1) "golden rice" event in China; 2) Informed consent in clinical trials in developing countries; 3) Ethical consciousness in clinical research and trials in developing countries. The essay (...)
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  33.  22
    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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  34.  88
    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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  35.  4
    Clinical Research Law in Jordan: An Ethical Analysis.Henry Silverman Ibrahim Ramahi - 2009 - Developing World Bioethics 9 (1):26-33.
    An ethical analysis of Jordan's Clinical Research Law, which became effective in 2001, was performed. Accordingly, this paper discusses the major components, key strengths and weaknesses of this law. As an initial effort, the Law addresses important aspects of research ethics and, hence, should serve as an example for other Arab Countries in the Middle East. Unique aspects of the Law include the requirement that those conducting any study have insurance that can compensate for research injuries (...)
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  36.  11
    Financial conflicts and clinical research.Karin Meyers - 2009 - IRB: Ethics & Human Research 31 (4):17.
    “Financial Conflicts and Clinical Research’”: a letter from Karin Meyers about “Community Hospital Oversight of Clinical Investigators’ Financial Relationships ”.
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  37.  23
    Clinical Research before Informed Consent.Franklin G. Miller - 2014 - Kennedy Institute of Ethics Journal 24 (2):141-157.
    The results of the first randomized controlled trial of a medical treatment were reported in 1947. The antibiotic streptomycin was demonstrated to be dramatically superior to bed rest alone in treating tuberculosis. Looking back on this trial in 1990, A. B. Hill, the distinguished medical statistician who played a prominent role in the use of randomization in this study, made a telling statement about the moral climate of clinical research at the time: "Of course, there were no ethical (...)
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  38.  9
    Key Topics in Clinical Research.Alice James & Anna Robeson Burr - 2003 - CRC Press.
    Key Topics in Clinical Research aims to provide a short, clear, highlighted reference to guide trainees and trainers through research and audit projects, from first idea, through to data collection and statistical analysis, to presentation and publication. This book is also designed to assist trainees in preparing for their specialty examinations by providing comprehensive, concise, easily accessible and easily understandable information on all aspects of clinical research and audit.
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  39.  47
    Rethinking the ethics of clinical research: widening the lens.Alan Wertheimer - 2011 - New York: 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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  40.  16
    Clinical research ethics in Irish healthcare: Diversity, dynamism and medicalization.S. L. Condell & C. Begley - 2012 - Nursing Ethics 19 (6):810-818.
    Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as (...)
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  41.  14
    Diversity in clinical research: public health and social justice imperatives.Tanvee Varma, Camara P. Jones, Carol Oladele & Jennifer Miller - 2023 - Journal of Medical Ethics 49 (3):200-203.
    It is well established that demographic representation in clinical research is important for understanding the safety and effectiveness of novel therapeutics and vaccines in diverse patient populations. In recent years, the National Institutes of Health and Food and Drug Administration have issued guidelines and recommendations for the inclusion of women, older adults, and racial and ethnic minorities in research. However, these guidelines fail to provide an adequate explanation of why racial and ethnic representation in clinical (...) is important. This article aims to both provide the missing arguments for why adequate representation of racial and ethnic minorities in clinical research is essential and to articulate a number of recommendations for improving diversity going forward.Appropriate racial and ethnic representation and fair inclusion help (1) increase the generalisability of clinical trial results, (2) equitably distribute any benefits of clinical research and (3) enable trust in the research enterprise. (shrink)
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  42.  37
    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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  43.  92
    Ethics in clinical research.Jane Barrett - 2006 - Marlow, Buckinghamshire, U.K.: ICR.
    Chapter One: Introduction “The ethical basis of all [medical] research is that information gained from one patient's experience should, where feasible, ...
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  44. Justice in international clinical research.Bridget Pratt & Beatrice Loff - unknown
  45.  16
    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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  46.  18
    Clinical Research Is a Team Sport.Ross E. McKinney - 2019 - American Journal of Bioethics 19 (4):22-23.
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  47.  36
    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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  48.  42
    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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  49.  38
    Clinical research law in Jordan.Imad M. Treish - 2009 - Developing World Bioethics 9 (2):97-97.
  50.  19
    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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