Search results for 'Clinical trials Moral and ethical aspects' (try it on Scholar)

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  1.  22
    Frédéric Gilbert & Susan Dodds (2014). Is There a Moral Obligation to Develop Brain Implants Involving NanoBionic Technologies? Ethical Issues for Clinical Trials. NanoEthics 8 (1):49-56.
    In their article published in Nanoethics, “Ethical, Legal and Social Aspects of Brain-Implants Using Nano-Scale Materials and Techniques”, Berger et al. suggest that there may be a prima facie moral obligation to improve neuro implants with nanotechnology given their possible therapeutic advantages for patients [Nanoethics, 2:241–249]. Although we agree with Berger et al. that developments in nanomedicine hold the potential to render brain implant technologies less invasive and to better target neural stimulation to respond to brain impairments (...)
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  2. Ezekiel J. Emanuel (ed.) (2003). Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Johns Hopkins University Press.
    All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the (...) trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested. (shrink)
     
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  3.  5
    Alex O'Meara (2009). Chasing Medical Miracles: The Promise and Perils of Clinical Trials. Walker & Co..
    Journalist Alex O’Meara is one of the more than twenty million Americans enrolled in a clinical trial—three times as many people as a decade ago. Indeed, clinical trials have become a $24 billion industry that is reshaping every aspect of health-care development and delivery in the United States and around the world. As O’Meara chronicles, twentieth-century medical trials have led to epic advances in health care, from asthma inhalers and insulin pumps to heart valves and pacemakers. (...)
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  4.  4
    Deborah Zion (1998). 'Moral Taint' or Ethical Responsibility? Unethical Information and the Problem of HIV Clinical Trials in Developing Countries. Journal of Applied Philosophy 15 (3):231–239.
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  5.  30
    Ezekiel J. Emanuel (ed.) (2008). The Oxford Textbook of Clinical Research Ethics. 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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  6.  61
    C. M. Ashton, N. P. Wray, A. F. Jarman, J. M. Kolman, D. M. Wenner & B. A. Brody (2011). A Taxonomy of Multinational Ethical and Methodological Standards for Clinical Trials of Therapeutic Interventions. Journal of Medical Ethics 37 (6):368-373.
    Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental (...)
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  7.  85
    Jane Barrett (2006). Ethics in Clinical Research. Icr Pub..
    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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  8.  7
    B. W. Dunlop & J. Banja (2009). A Renewed, Ethical Defense of Placebo-Controlled Trials of New Treatments for Major Depression and Anxiety Disorders. Journal of Medical Ethics 35 (6):384-389.
    The use of placebo as a control condition in clinical trials of major depressive disorder and anxiety disorders continues to be an area of ethical concern. Typically, opponents of placebo controls argue that they violate the beneficent-based, “best proven diagnostic and therapeutic method” that the original Helsinki Declaration of 1964 famously asserted participants are owed. A more consequentialist, oppositional argument is that participants receiving placebo might suffer enormously by being deprived of their usual medication(s). Nevertheless, recent findings (...)
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  9.  16
    Thomas W. Kallert, Juan E. Mezzich & John Monahan (eds.) (2011). Coercive Treatment in Psychiatry: Clinical, Legal and Ethical Aspects. Wiley-Blackwell.
    This book considers coercion within the healing and ethical framework of therapeutic relationships and partnerships at all levels, and addresses the universal ...
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  10.  10
    Bernard Lo & Lindsay Parham (2010). Resolving Ethical Issues in Stem Cell Clinical Trials: The Example of Parkinson Disease. Journal of Law, Medicine & Ethics 38 (2):257-266.
    Clinical trials of stem cell transplantation raise ethical issues that are intertwined with scientific and design issues, including choice of control group and intervention, background interventions, endpoints, and selection of subjects. We recommend that the review and IRB oversight of stem cell clinical trials should be strengthened. Scientific and ethics review should be integrated in order to better assess risks and potential benefits. Informed consent should be enhanced by assuring that participants comprehend key aspects (...)
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  11.  14
    M. Ruiz-Canela (2001). Methodological Quality and Reporting of Ethical Requirements in Clinical Trials. Journal of Medical Ethics 27 (3):172-176.
    Objectives—To assess the relationship between the approval of trials by a research ethics committee and the fact that informed consent from participants was obtained, with the quality of study design and methods.Design—Systematic review using a standardised checklist.Main measures—Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials (...)
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  12.  8
    Kathleen Oberle & Marion Allen (2006). Ethical Considerations for Nurses in Clinical Trials. Nursing Ethics 13 (2):180-186.
    Ethical issues arise for nurses involved in all phases of clinical trials regardless of whether they are caregivers, research nurses, trial co-ordinators or principal investigators. Potential problem areas centre on nurses’ moral obligation related to methodological issues as well as the notions of beneficence/non-maleficence and autonomy. These ethical concerns can be highly upsetting to nurses if they are not addressed, so it is imperative that they are discussed fully prior to the initiation of a trial. (...)
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  13. Heather J. Sutherland Eric M. Meslin (1995). Principlism and the Ethical Appraisal of Clinical Trials. Bioethics 9 (4):399-418.
    For nearly two decades, the process of reviewing the ethical merit of research involving human subjects has been based on the application of principles initially described in the U.S. National Commission's Belmont Report, and later articulated more fully by Beauchamp and Childress in their Principles of Biomedical Ethics. Recently, the use of ethical principles for deliberating about moral problems in medicine and research, referred to in the pejorative sense as “principlism”, has come under scrutiny. In this paper (...)
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  14.  18
    John C. Fletcher (1985). Ethical Issues in and Beyond Prospective Clinical Trials of Human Gene Therapy. Journal of Medicine and Philosophy 10 (3):293-310.
    As the potential for the first human trials of somatic cell gene therapy nears, two ethical issues are examined: (1) problems of moral choice for members of institutional review boards who consider the first protocols, for parents, and for the clinical researchers, and the special protections that may be required for the infants and children to be involved, and (2) ethical objections to somatic cell therapy made by those concerned about a putative inevitable progression of (...)
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  15.  85
    Francois Berger, Sjef Gevers, Ludwig Siep & Klaus-Michael Weltring (2008). Ethical, Legal and Social Aspects of Brain-Implants Using Nano-Scale Materials and Techniques. NanoEthics 2 (3):241-249.
    Nanotechnology is an important platform technology which will add new features like improved biocompatibility, smaller size, and more sophisticated electronics to neuro-implants improving their therapeutic potential. Especially in view of possible advantages for patients, research and development of nanotechnologically improved neuro implants is a moral obligation. However, the development of brain implants by itself touches many ethical, social and legal issues, which also apply in a specific way to devices enabled or improved by nanotechnology. For researchers developing nanotechnology (...)
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  16.  33
    A. Herxheimer (1993). Clinical Trials: Two Neglected Ethical Issues. Journal of Medical Ethics 19 (4):211-218.
    Ethical reasons are presented for requiring 1) that a proposal for a clinical trial should be accompanied by a thorough review of all previous trials that have examined the same and closely related questions, and 2) that a trial should be approved by a research ethics committee only if the investigator undertakes to register it in an appropriate register of clinical trials as soon as one exists.
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  17.  11
    Lorys F. Oddi, Virginia R. Cassidy & Cheryl Fisher (1995). Nurses' Sensitivity To the Ethical Aspects of Clinical Practice. Nursing Ethics 2 (3):197-209.
    The purpose of this study was to describe the extent to which nurses perceive the ethical dimensions of clinical practice situations involving patients, families and health care professionals. Using the composite theory of basic moral principles and the professional standard of care established by legal custom as a framework, situations involving ethical dilemmas were gleaned from the nursing literature. They were reviewed for content validity, clarity and representativeness in a two-stage process by expert panels. The situations (...)
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  18.  11
    Anna C. Mastroianni, Ruth R. Faden & Daniel D. Federman (eds.) (1994). Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. National Academy Press.
    Executive Summary There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given ...
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  19.  7
    William J. Ellos (1990). Ethical Practice in Clinical Medicine. Routledge.
    This textbook develops the issue of ethics to a philosophical level complex enough to be applicable to students of philosophy and applied ethics courses. It is the first book to address clinical problems from a classical perspective. This title available in eBook format. Click here for more information . Visit our eBookstore at: www.ebookstore.tandf.co.uk.
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  20.  12
    Peter Graeme Hobbins (2005). Compromised Ethical Principles in Randomised Clinical Trials of Distant, Intercessory Prayer. Journal of Bioethical Inquiry 2 (3):142-152.
    The effects of distant, intercessory prayer on health outcomes have been studied in a range of randomised, blinded clinical trials. However, while seeking the evidentiary status accorded this ‘gold standard’ methodology, many prayer studies fall short of the requirements of the World Medical Association's Declaration of Helsinki for the ethical conduct of trials involving human subjects. Within a sample of 15 such studies published in the medical literature, many were found to have ignored or waived key (...)
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  21.  18
    Suzanne Shale (2012). Moral Leadership in Medicine: Building Ethical Healthcare Organizations. Cambridge University Press.
    Machine generated contents note: Preface; Acknowledgements; 1. Why medicine needs moral leaders; 2. Creating an organizational narrative; 3. Understanding normative expectations in medical moral leadership; Prologue to chapters four and five; 4. Expressing fiduciary, bureaucratic and collegial propriety; 5. Expressing inquisitorial and restorative propriety; Epilogue to chapters four and five; 6. Understanding organizational moral narrative; 7. Moral leadership for ethical organizations; Appendix 1. How the research was done; Appendix 2. Accountability for clinical performance: individuals (...)
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  22.  1
    Laurie J. Legocki, William J. Meurer, Shirley Frederiksen, Roger J. Lewis, Valerie L. Durkalski, Donald A. Berry, William G. Barsan & Michael D. Fetters (2015). Clinical Trialist Perspectives on the Ethics of Adaptive Clinical Trials: A Mixed-Methods Analysis. BMC Medical Ethics 16 (1):27.
    In an adaptive clinical trial , key trial characteristics may be altered during the course of the trial according to predefined rules in response to information that accumulates within the trial itself. In addition to having distinguishing scientific features, adaptive trials also may involve ethical considerations that differ from more traditional randomized trials. Better understanding of clinical trial experts’ views about the ethical aspects of adaptive designs could assist those planning ACTs. Our aim (...)
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  23.  18
    Sharon Kaur & Choong Yeow Choy (2012). Ethical Considerations in Clinical Trials: A Critique of the ICH-GCP Guideline. Developing World Bioethics 12 (3):20-28.
    This article examines issues relating to ethics decision-making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of the ICH-GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existing ICH-GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in (...)
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  24. Erik Malmqvist, Niklas Juth, Niels Lynöe & Gert Helgesson (2011). Early Stopping of Clinical Trials: Charting the Ethical Terrain. Kennedy Institute of Ethics Journal 21 (1):51-78.
    Randomized and double-blind clinical trials are widely regarded as the most reliable way of studying the effects of medical interventions. According to received wisdom, if a new drug or treatment is to be accepted in clinical practice, its safety and efficacy must first be demonstrated in such trials. For ethical and scientific reasons, it is generally considered necessary to monitor a trial in various ways as it proceeds and to analyze data as they accumulate. Monitoring (...)
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  25.  8
    M. R. N. Bruijnis, V. Blok, E. N. Stassen & H. G. J. Gremmen (2015). Moral “Lock-In” in Responsible Innovation: The Ethical and Social Aspects of Killing Day-Old Chicks and Its Alternatives. Journal of Agricultural and Environmental Ethics 28 (5):939-960.
    The aim of this paper is to provide a conceptual framework that will help in understanding and evaluating, along social and ethical lines, the issue of killing day-old male chicks and two alternative directions of responsible innovations to solve this issue. The following research questions are addressed: Why is the killing of day-old chicks morally problematic? Are the proposed alternatives morally sound? To what extent do the alternatives lead to responsible innovation? The conceptual framework demonstrates clearly that there is (...)
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  26.  9
    L. Trommelmans, J. Selling & K. Dierickx (2008). Ethical Reflections on Clinical Trials with Human Tissue Engineered Products. Journal of Medical Ethics 34 (9):e1-e1.
    Ex-vivo tissue engineering is an emerging medical technology. Its aim is to regenerate tissues and organs and to restore them to full physiological activity. Some clinical trials with human tissue engineered products have been conducted and others will follow. These trials not only have to confirm the therapeutic value of the HTEP, they also have to provide insight in its regenerative activity, its safety and long-term effects. The development of these trials is aggravated by the complexity (...)
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  27.  61
    Kirstin Borgerson (2013). Are Explanatory Trials Ethical? Shifting the Burden of Justification in Clinical Trial Design. Theoretical Medicine and Bioethics 34 (4):293-308.
    Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals (...)
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  28.  14
    Joseph B. Kadane (1986). Progress Toward a More Ethical Method for Clinical Trials. Journal of Medicine and Philosophy 11 (4):385-404.
    Methodology for conducting clinical trials of new drugs and treatments on people need not be regarded as fixed. After reviewing the currently most popular method (randomization) and its ethical problems, this paper explores the possibilities of a new method for conducting such trials. It relies on new Bayesian technology for eliciting the opinions of medical experts. These opinions are conditioned on specific predictor variables, and are held in a computer. At any stage in a trial, these (...)
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  29.  7
    Don Marquis, How to Resolve an Ethical Dilemma Concerning Randomized Clinical Trials.
    An apparent ethical dilemma arises when physicians consider enrolling their patients in randomized clinical trials. Suppose that a randomized clinical trial comparing two treatments is in progress, and a physician has an opinion about which treatment is better. The physician has a duty to promote the patient's best medical interests and therefore seems to be obliged to advise the patient to receive the treatment that the physician prefers. This duty creates a barrier to the enrollment of (...)
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  30.  27
    Jennifer Alvidrez & Patricia A. Areán (2002). Psychosocial Treatment Research with Ethnic Minority Populations: Ethical Considerations in Conducting Clinical Trials. Ethics and Behavior 12 (1):103 – 116.
    Because of historical mistreatment of ethnic minorities by research and medical institutions, it is particularly important for researchers to be mindful of ethical issues that arise when conducting research with ethnic minority populations. In this article, we focus on the ethical issues related to the inclusion of ethnic minorities in clinical trials of psychosocial treatments. We highlight 2 factors, skepticism and mistrust by ethnic minorities about research and current inequities in the mental health care system, that (...)
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  31.  14
    William Colby, Constance Dahlin, John Lantos, John Carney & Myra Christopher (2010). The National Consensus Project for Quality Palliative Care Clinical Practice Guidelines Domain 8: Ethical and Legal Aspects of Care. [REVIEW] HEC Forum 22 (2):117-131.
    In 2001, leaders with palliative care convened to discuss the standardization of palliative care and formed the National Consensus Project for Quality Palliative Care. In 2004, the National Consensus Project for Quality Palliative Care produced the first edition of Clinical Guidelines for Quality Palliative Care. The Guidelines were developed by leaders in the field who examined other national and international standards with the intent to promote consistent, accessible, comprehensive, optimal palliative care through the health care spectrum. Within the guidelines (...)
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  32.  1
    E. BenGershom (1983). Ethical Aspects of Clinical Chemistry. Journal of Medical Ethics 9 (4):207-210.
    The work performed by the clinical chemist may deeply affect the decisions of the doctor and the well-being of the patient. Yet in contrast to the doctor and to the nurse the clinical chemist usually has no personal relationship with the patient. Being encumbered by much technology and anonymity is itself a reason for scrutinising his involvement in issues of health care ethics. This is an attempt at clarifying some major aspects: the relationship of his professional ethics (...)
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  33.  13
    Lisa R. Stines & Norah C. Feeny (2008). Unique Ethical Concerns in Clinical Trials Comparing Psychosocial and Psychopharmalogical Interventions. Ethics and Behavior 18 (2 & 3):234 – 246.
    In recent years, there has been a particular emphasis placed on conducting randomized controlled trials (RCTs) that compare the relative efficacy of psychosocial and pharmacological interventions. This article addresses relevant ethical considerations in the conduct of these treatment trials, with a focus on RCTs with children. Ethical concerns, including therapeutic misconception, treatment preference, therapeutic equipoise, structure of treatments, and balancing risks versus benefits, are introduced through a clinical scenario and discussed as they relate to psychotherapy (...)
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  34.  7
    Chryssoula Lemonidou, Elizabeth Papathanassoglou, Margarita Giannakopoulou, Elisabeth Patiraki & Danai Papadatou (2004). Moral Professional Personhood: Ethical Reflections During Initial Clinical Encounters in Nursing Education. Nursing Ethics 11 (2):122-137.
    Moral agency is an important constituent of the nursing role. We explored issues of ethical development in Greek nursing students during clinical practice at the beginning of their studies. Specifically, we aimed to explore students’ lived experience of ethics, and their perceptions and understanding of encountered ethical conflicts through phenomenological analysis of written narratives. The process of developing an awareness of personal values through empathizing with patients was identified as the core theme of the students’ experience. (...)
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  35.  15
    H. Colby William, John Lantos Constance Dahlin & Myra Christopher John Carney (forthcoming). The National Consensus Project for Quality Palliative Care Clinical Practice Guidelines Domain 8: Ethical and Legal Aspects of Care. HEC Forum.
    In 2001, leaders with palliative care convened to discuss the standardization of palliative care and formed the National Consensus Project for Quality Palliative Care. In 2004, the National Consensus Project for Quality Palliative Care produced the first edition of Clinical Guidelines for Quality Palliative Care. The Guidelines were developed by leaders in the field who examined other national and international standards with the intent to promote consistent, accessible, comprehensive, optimal palliative care through the health care spectrum. Within the guidelines (...)
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  36. Roger Stanev (forthcoming). Quantitative Framework for Retrospective Assessment of Interim Decisions in Clinical Trials. Medical Decision Making.
    This article presents a quantitative way of modeling the interim decisions of clinical trials. While statistical approaches tend to focus on the epistemic aspects of statistical monitoring rules, often overlooking ethical considerations, ethical approaches tend to neglect key epistemic dimension. The proposal is a second-order decision theoretic framework. The framework provides means for retrospective assessment of interim decisions based on a clear and consistent set of criteria that combines both ethical and epistemic considerations. The (...)
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  37.  23
    Sue Eckstein (ed.) (2003). Manual for Research Ethics Committees. Cambridge University Press.
    The sixth edition of the Manual for Research Ethics Committees is a unique compilation of legal and ethical guidance which will prove invaluable for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy. Presented in a clear and authoritative form, it incorporates the key legal and ethical guidelines and specially written chapters on major topics in bioethics by leading academic authors and practitioners, pharmaceutical (...)
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  38.  4
    Professor Dennis V. Parke (1995). Ethical Aspects of the Safety of Medicines and Other Social Chemicals. Science and Engineering Ethics 1 (3):283-298.
    The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological (...)
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  39.  11
    Donna Coch (2007). Neuroimaging Research with Children: Ethical Issues and Case Scenarios. Journal of Moral Education 36 (1):1-18.
    There are few available resources for learning and teaching about ethical issues in neuroimaging research with children, who constitute a special and vulnerable population. Here, a brief review of ethical issues in developmental research, situated within the emerging field of neuroethics, highlights the increasingly interdisciplinary nature of research with children. Traditional boundaries between behavioural, psychological, neuroscientific and educational research are being blurred by multidisciplinary studies of learning and human development. Developmental and educational researchers need to be aware of (...)
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  40. Donald Evans (1996). A Decent Proposal: Ethical Review of Clinical Research. Wiley.
     
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  41.  8
    Insoo Hyun (2010). Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges. Journal of Law, Medicine & Ethics 38 (2):277-285.
    This paper discusses exceptional circumstances under which patients outside of clinical trials are likely to receive innovative stem cell-based interventions. These circumstances involve: (1) stem cell interventions not initially amenable to a clinical trials approach; (2) expanded access to investigational stem cell products (“compassionate use”); and (3) off-label uses of FDA approved stem cell products. This paper proposes a new approach to regulating these exceptional cases.
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  42.  30
    Jacek Spławiński & Jerzy Kuźniar (2004). Clinical Trials: Active Control Vs Placebo — What is Ethical? Science and Engineering Ethics 10 (1):73-79.
    The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs: superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of μ (the difference between a tested drug and comparator) ≤ 0 against μ > 0; the latter tests the null hypothesis of μ ≤ - Δ against, μ > - Δ, where Δ is the clinical difference from the comparator. In a (...)
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  43.  7
    Loretta Kopelman (1986). Consent and Randomized Clinical Trials: Are There Moral or Design Problems? Journal of Medicine and Philosophy 11 (4):317-345.
    The purpose of this paper is to examine whether randomized clinical trial (RCT) methods are necessarily morally problematic. If they are intrinsically problematic, then there may be a dilemma such that tragic choices might have to be made between this socially very useful method for making medical progress on the one hand, and patients' rights and welfare, or physicans' duties on the other. It is argued that the dilemma may be avoided if RCTs can sometimes be viewed as an (...)
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  44.  55
    Jacob M. Kolman, Nelda P. Wray, Carol M. Ashton, Danielle M. Wenner, Anna F. Jarman & Baruch A. Brody (2012). Conflicts Among Multinational Ethical and Scientific Standards for Clinical Trials of Therapeutic Interventions. Journal of Law, Medicine & Ethics 40 (1):99-121.
    Utilizing a sorted compendium of international clinical trial standards, investigators identified 15 conflicts among ethical and methodological guidance. Analysis distinguishes interpretational issues, lack of clarity, and contradiction as factors to be addressed if international trial guidance is to be improved.
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  45.  1
    V. Sanchini, M. Reni, G. Calori, E. Riva & M. Reichlin (2014). Informed Consent as an Ethical Requirement in Clinical Trials: An Old, but Still Unresolved Issue. An Observational Study to Evaluate Patient's Informed Consent Comprehension. Journal of Medical Ethics 40 (4):269-275.
    We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one (...)
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  46.  35
    V. Mike, A. N. Krauss & G. S. Ross (1993). Neonatal Extracorporeal Membrane Oxygenation (ECMO): Clinical Trials and the Ethics of Evidence. Journal of Medical Ethics 19 (4):212-218.
    Neonatal extracorporeal membrane oxygenation (ECMO), a technology for the treatment of respiratory failure in newborns, is used as a case study to examine statistical and ethical aspects of clinical trials and to illustrate a proposed 'ethics of evidence', an approach to medical uncertainty within the context of contemporary biomedical ethics. Discussion includes the twofold aim of the ethics of evidence: to clarify the role of uncertainty and scientific evidence in medical decision-making, and to call attention to (...)
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  47.  9
    Pérez Arianna Hernández, Oslay Mijail Tirado Martínez, María del Carmen Rivas Canino, Mayelín Sureda Martínez & Catherine Hernández Cedeño (2013). Bioethics and clinical trials in patients with Proliferative Diabetic Retinopathy. Humanidades Médicas 13 (1):88-111.
    La Segunda Guerra Mundial y las atrocidades cometidas en investigaciones con los prisioneros en los campos de concentración nazis y japoneses, despertaron la conciencia por el desarrollo de los derechos humanos que se habían conquistado paulatinamente a lo largo de la historia. Por ello se conforman una serie de leyes, normas y declaraciones donde se tratan los aspectos bioéticos en los ensayos clínicos. Se debe prestar vital atención a la relación médico-paciente en el curso de las investigaciones y considerar la (...)
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  48.  2
    M. W. Ross (1989). Psychosocial Ethical Aspects of AIDS. Journal of Medical Ethics 15 (2):74-81.
    The psychosocial morbidity associated with HIV infection and responses to such infection may exceed morbidity associated with medical sequelae of such infection. This paper argues that negative judgements on those with HIV infection or in groups associated with such infection will cause avoidable psychological and social distress. Moral judgements made regarding HIV infection may also harm the common good by promoting conditions which may increase the spread of HIV infection. This paper examines these two lines of argument with regard (...)
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  49. David J. Pulford, Philipp Harter, Anne Floquet, Catherine Barrett, Dong Hoon Suh, Michael Friedlander, José Angel Arranz, Kosei Hasegawa, Hiroomi Tada, Peter Vuylsteke, Mansoor R. Mirza, Nicoletta Donadello, Giovanni Scambia, Toby Johnson, Charles Cox, John K. Chan, Martin Imhof, Thomas J. Herzog, Paula Calvert, Pauline Wimberger, Dominique Berton-Rigaud, Myong Cheol Lim, Gabriele Elser, Chun-Fang Xu & Andreas du Bois (2016). Communicating BRCA research results to patients enrolled in international clinical trials: lessons learnt from the AGO-OVAR 16 study. BMC Medical Ethics 17 (1):63.
    The focus on translational research in clinical trials has the potential to generate clinically relevant genetic data that could have importance to patients. This raises challenging questions about communicating relevant genetic research results to individual patients. An exploratory pharmacogenetic analysis was conducted in the international ovarian cancer phase III trial, AGO-OVAR 16, which found that patients with clinically important germ-line BRCA1/2 mutations had improved progression-free survival prognosis. Mechanisms to communicate BRCA results were evaluated, because these findings may be (...)
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  50.  17
    Ronald K. F. Fung & Ian H. Kerridge (2013). Uncertain Translation, Uncertain Benefit and Uncertain Risk: Ethical Challenges Facing First-in-Human Trials of Induced Pluripotent Stem (Ips) Cells. Bioethics 27 (2):89-96.
    The discovery of induced pluripotent stem (iPS) cells in 2006 was heralded as a major breakthrough in stem cell research. Since then, progress in iPS cell technology has paved the way towards clinical application, particularly cell replacement therapy, which has refueled debate on the ethics of stem cell research. However, much of the discourse has focused on questions of moral status and potentiality, overlooking the ethical issues which are introduced by the clinical testing of iPS cell (...)
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