Results for 'Clinical Trials as Topic'

999 found
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  1.  94
    A Taxonomy of Multinational Ethical and Methodological Standards for Clinical Trials of Therapeutic Interventions.C. M. Ashton, N. P. Wray, A. F. Jarman, J. M. Kolman, D. M. Wenner & B. A. Brody - 2011 - 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 and other (...)
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  2.  56
    Clinical Trials: Two Neglected Ethical Issues.A. Herxheimer - 1993 - 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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  3.  17
    A Clinical Trials Manual From the Duke Clinical Research Institute: Lessons From a Horse Named Jim.Margaret B. Liu - 2010 - Wiley-Blackwell.
    As the_number of clinical trials continues to grow, there is an increasing need for education and training in the field. The clinical research climate is less forgiving of errors and oversights and therefore requires more knowledge of regulations and requirements. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records (...)
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  4.  10
    Chasing Medical Miracles: The Promise and Perils of Clinical Trials.Alex O'Meara - 2009 - 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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  5.  18
    Efficacy Testing as a Primary Purpose of Phase 1 Clinical Trials: Is It Applicable to First-in-Human Bionics and Optogenetics Trials?Frederic Gilbert, Alexander R. Harris & Robert M. I. Kapsa - 2012 - American Journal of Bioethics Neuroscience 3 (2):20-22.
    In her article, Pascale Hess raises the issue of whether her proposed model may be extrapolated and applied to clinical research fields other than stem cell-based interventions in the brain (SCBI-B) (Hess 2012). Broadly summarized, Hess’s model suggests prioritizing efficacy over safety in phase 1 trials involving irreversible interventions in the brain, when clinical criteria meet the appropriate population suffering from “degenerative brain diseases” (Hess 2012). Although there is a need to reconsider the traditional phase 1 model, (...)
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  6.  20
    A Renewed, Ethical Defense of Placebo-Controlled Trials of New Treatments for Major Depression and Anxiety Disorders.B. W. Dunlop & J. Banja - 2009 - 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 of (...)
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  7.  4
    Nonconsensual Clinical Trials: A Foreseeable Risk of Offshoring Under Global Corporatism.Bethany Spielman - 2015 - Journal of Bioethical Inquiry 12 (1):101-106.
    This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be (...)
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  8.  34
    What Do Our Patients Understand About Their Trial Participation? Assessing Patients' Understanding of Their Informed Consent Consultation About Randomised Clinical Trials.C. Behrendt, T. Gölz, C. Roesler, H. Bertz & A. Wünsch - 2011 - Journal of Medical Ethics 37 (2):74-80.
    Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated in (...)
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  9.  40
    Composition, Training Needs and Independence of Ethics Review Committees Across Africa: Are the Gate-Keepers Rising to the Emerging Challenges?A. Nyika, W. Kilama, R. Chilengi, G. Tangwa, P. Tindana, P. Ndebele & J. Ikingura - 2009 - Journal of Medical Ethics 35 (3):189-193.
    Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan Africa (...)
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  10.  11
    Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries.Avram Denburg, Carlos Rodriguez-Galindo & Steven Joffe - 2016 - American Journal of Bioethics 16 (6):3-11.
    Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a “trial effect,” however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure—the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research—may function as a quality improvement lever, improving (...)
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  11.  66
    Against a Priori Judgements of Bad Methodology: Questioning Double-Blinding as a Universal Methodological Virtue of Clinical Trials.Jeremy Howick - unknown
    The feature of being ‘double blind’, where neither patients nor physicians are aware of who receives the experimental treatment, is universally trumpeted as being a virtue of clinical trials. The rationale for this view is unobjectionable: double blinding rules out the potential confounding influences of patient and physician beliefs. Nonetheless, viewing successfully double blind trials as necessarily superior leads to the paradox that very effective experimental treatments will not be supportable by best (double-blind) evidence. It seems strange (...)
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  12.  22
    Ethical Issues at the Interface of Clinical Care and Research Practice in Pediatric Oncology: A Narrative Review of Parents' and Physicians' Experiences.Martine C. de Vries, Mirjam Houtlosser, Jan M. Wit, Dirk P. Engberts, Dorine Bresters, Gertjan Jl Kaspers & Evert van Leeuwen - 2011 - BMC Medical Ethics 12 (1):18.
    BackgroundPediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians.MethodologyAn empirical ethical approach, combining a narrative review of qualitative studies on parents' and physicians' experiences of the pediatric oncology research (...)
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  13.  65
    Evaluating the First-in-Human Clinical Trial of a Human Embryonic Stem Cell-Based Therapy.Audrey R. Chapman & Courtney C. Scala - 2012 - Kennedy Institute of Ethics Journal 22 (3):243-261.
    The transition of novel and potentially promising medical therapies into their initial human clinical trials can engender conflicting pressures. On the one side, because Phase I trials raise greater ethical and human protection challenges than later stage clinical trials, there is a need to proceed cautiously. This is particularly the case for Phase I trials with a novel therapy being tested in humans for the first time, usually termed first-in-human (FIH) trials, especially if (...)
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  14.  19
    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.Virginia Sanchini, Michele Reni, Giliola Calori, Elisabetta Riva & Massimo Reichlin - 2014 - 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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  15.  28
    Convergent Ethical Issues in HIV/AIDS, Tuberculosis and Malaria Vaccine Trials in Africa: Report From the WHO/UNAIDS African AIDS Vaccine Programme's Ethics, Law and Human Rights Collaborating Centre Consultation, 10-11 February 2009, Durban, South Africa. [REVIEW]Nicole Mamotte, Douglas Wassenaar, Jennifer Koen & Zaynab Essack - 2010 - BMC Medical Ethics 11 (1):3-.
    BackgroundAfrica continues to bear a disproportionate share of the global HIV/AIDS, tuberculosis (TB) and malaria burden. The development and distribution of safe, effective and affordable vaccines is critical to reduce these epidemics. However, conducting HIV/AIDS, TB, and/or malaria vaccine trials simultaneously in developing countries, or in populations affected by all three diseases, is likely to result in numerous ethical challenges.MethodsIn order to explore convergent ethical issues in HIV/AIDS, TB and malaria vaccine trials in Africa, the Ethics, Law and (...)
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  16.  30
    Research Biopsies in Phase I Studies: Views and Perspectives of Participants and Investigators.R. D. Pentz, R. D. Harvey, M. White, Z. L. Farmer, O. Dashevskaya, Z. Chen, C. Lewis, T. K. Owonikoko & F. R. Khuri - 2012 - IRB: Ethics & Human Research 34 (2):1-8.
    In many research studies, tumor biopsies are an unavoidable requirement for achieving key scientific aims. Yet some commentators view mandatory research biopsies as coercive and suggest they should be optional, or at least optional until further data are obtained regarding their scientific usefulness. Further complicating the ethical picture is the fact that some research biopsies offer a potential for clinical benefit to trial participants. We interviewed and surveyed a convenience sample of participants in phase I clinical trials (...)
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  17.  18
    Views of the Process and Content of Ethical Reviews of Hiv Vaccine Trials Among Members of Us Institutional Review Boards and South African Research Ethics Committees.Robert Klitzman - 2008 - Developing World Bioethics 8 (3):207-218.
    ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended to be (...)
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  18.  10
    Resource and Needs of Research Ethics Committees in Africa: Preparations for HIV Vaccine Trials.C. Milford, D. Wassenaar & C. Slack - 2005 - IRB: Ethics & Human Research 28 (2):1-9.
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  19.  12
    The Remote Prayer Delusion: Clinical Trials That Attempt to Detect Supernatural Intervention Are as Futile as They Are Unethical.G. Paul - 2008 - Journal of Medical Ethics 34 (9):e18-e18.
    Extreme rates of premature death prior to the advent of modern medicine, very low rates of premature death in First World nations with low rates of prayer, and the least flawed of a large series of clinical trials indicate that remote prayer is not efficacious in treating illness. Mass contamination of sample cohorts renders such clinical studies inherently ineffectual. The required supernatural and paranormal mechanisms render them implausible. The possibility that the latter are not benign, and the (...)
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  20. Post‐Trial Access to Antiretrovirals: Who Owes What to Whom?Joseph Millum - 2011 - Bioethics 25 (3):145-154.
    ABSTRACTMany recent articles argue that participants who seroconvert during HIV prevention trials deserve treatment when they develop AIDS, and there is a general consensus that the participants in HIV/AIDS treatment trials should have continuing post‐trial access. As a result, the primary concern of many ethicists and activists has shifted from justifying an obligation to treat trial participants, to working out mechanisms through which treatment could be provided. In this paper I argue that this shift frequently conceals an important (...)
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  21.  34
    Women's Views About Participating in Research While Pregnant.A. D. Lyerly, E. E. Namey, B. Gray, G. Swamy & R. R. Faden - 2012 - IRB: Ethics & Human Research 34 (4):1-8.
    Pregnant women and their interests have been underrepresented in health research. Little is known about issues relevant to women considering research participation during pregnancy. We performed in-depth interviews with 22 women enrolled in either one of two trials sponsored by the National Institutes of Health to assess the safety and immunogenicity of the H1N1 vaccine during pregnancy. Three themes characterized women’s decisions to participate in research: they valued early access to the vaccine, they perceived a safety advantage when participating (...)
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  22.  29
    Comprehension of a Simplified Assent Form in a Vaccine Trial for Adolescents.S. Lee, B. G. Kapogiannis, P. M. Flynn, B. J. Rudy, J. Bethel, S. Ahmad, D. Tucker, S. E. Abdalian, D. Hoffman, C. M. Wilson & C. K. Cunningham - 2013 - Journal of Medical Ethics 39 (6):410-412.
    Introduction Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general. Methods Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative. Results 123 youth completed the questionnaire (mean (...)
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  23.  28
    Destabilizing the 'Equipoise' Framework in Clinical Trials: Prioritizing Non-Exploitation as an Ethical Framework in Clinical Research.Douglas E. Schlichting - 2010 - Nursing Philosophy 11 (4):271-279.
  24.  38
    Payment for Research Participation: A Coercive Offer?A. Wertheimer & F. G. Miller - 2008 - Journal of Medical Ethics 34 (5):389-392.
    Payment for research participation has raised ethical concerns, especially with respect to its potential for coercion. We argue that characterising payment for research participation as coercive is misguided, because offers of benefit cannot constitute coercion. In this article we analyse the concept of coercion, refute mistaken conceptions of coercion and explain why the offer of payment for research participation is never coercive but in some cases may produce undue inducement.
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  25. Clinical Trials as Nomological Machines: Implications for Evidence-Based Medicine.Robyn Bluhm - 2007 - In Harold Kincaid Jennifer McKitrick (ed.), Establishing Medical Reality: Essays In The Metaphysics And Epistemology Of Biomedical Science. Springer.
  26.  12
    Social Media as an Ethical Tool for Retention in Clinical Trials.Luke Gelinas & Barbara E. Bierer - 2019 - American Journal of Bioethics 19 (6):62-64.
    Volume 19, Issue 6, June 2019, Page 62-64.
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  27. Re-Focusing the Ethical Discourse on Personalized Medicine: A Qualitative Interview Study with Stakeholders in the German Healthcare System.Sebastian Schleidgen & Georg Marckmann - 2013 - BMC Medical Ethics 14 (1):20.
    In recent years, personalized medicine (PM) has become a highly regarded line of development in medicine. Yet, it is still a relatively new field. As a consequence, the discussion of its future developments, in particular of its ethical implications, in most cases can only be anticipative. Such anticipative discussions, however, pose several challenges. Nevertheless, they play a crucial role for shaping PM’s further developments. Therefore, it is vital to understand how the ethical discourse on PM is conducted, i.e. on what (...)
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  28.  33
    Electroconvulsive Therapy, the Placebo Effect and Informed Consent.C. R. Blease - 2013 - Journal of Medical Ethics 39 (3):166-170.
    Major depressive disorder is not only the most widespread mental disorder in the world, it is a disorder on the rise. In cases of particularly severe forms of depression, when all other treatment options have failed, the use of electroconvulsive therapy (ECT) is a recommended treatment option for patients. ECT has been in use in psychiatric practice for over 70 years and is now undergoing something of a restricted renaissance following a sharp decline in its use in the 1970s. Despite (...)
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  29.  15
    Getting Personal: Ethics and Identity in Global Health Research.Christian Simon & Maghboeba Mosavel - 2011 - Developing World Bioethics 11 (2):82-92.
    ‘Researcher identity’ affects global health research in profound and complex ways. Anthropologists in particular have led the way in portraying the multiple, and sometimes tension-generating, identities that researchers ascribe to themselves, or have ascribed to them, in their places of research. However, the central importance of researcher identity in the ethical conduct of global health research has yet to be fully appreciated. The capacity of researchers to respond effectively to the ethical tensions surrounding their identities is hampered by lack of (...)
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  30.  76
    Bioethics, Vulnerability, and Protection.Ruth Macklin - 2003 - Bioethics 17 (5-6):472--486.
    What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. Second is the situation of women, who are (...)
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  31.  18
    Coercive Offers and Research Participation: A Comment on Wertheimer and Miller.J. McMillan - 2010 - Journal of Medical Ethics 36 (7):383-384.
    Concepts such as ‘coercion’ and ‘inducement’ are often used within bioethics without much reflection upon what they mean. This is particularly so in research ethics where they are assumed to imply that payment for research participation is unethical. Wertheimer and Miller advance our thinking about these concepts and research ethics in a significant way, specifically by questioning the possibility of genuine offers ever being coercive. This commentary argues that they are right to question this assumption, however, more needs to be (...)
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  32.  46
    The Gambler's Fallacy, the Therapeutic Misconception, and Unrealistic Optimism.Don Swekoski & Deborah Barnbaum - 2013 - IRB: Ethics & Human Research 35 (2):1-6.
    The Therapeutic Misconception (TM) is a cognitive error with similarities to another cognitive error -- the Gambler's Fallacy (GF). This paper examines the similarities between TM and GF in an attempt to further illuminate the nature of TM, and to distinguish it from another cognitive error, Unrealistic Optimism (UO). Many cases of UO and mis-classified as TM.
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  33.  21
    Reciprocity‐Based Reasons for Benefiting Research Participants: Most Fail, the Most Plausible is Problematic.Neema Sofaer - 2014 - Bioethics 28 (9):456-471.
    A common reason for giving research participants post-trial access to the trial intervention appeals to reciprocity, the principle, stated most generally, that if one person benefits a second, the second should reciprocate: benefit the first in return. Many authors consider it obvious that reciprocity supports PTA. Yet their reciprocity principles differ, with many authors apparently unaware of alternative versions. This article is the first to gather the range of reciprocity principles. It finds that: most are false. The most plausible principle, (...)
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  34.  36
    Informed Consent Procedures: Responsibilities of Researchers in Developing Countries.Soledad Sanchez, Gloria Salazar, Marcia Tijero & Soledad Diaz - 2001 - Bioethics 15 (5-6):398-412.
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  35.  18
    Public Engagement with Science? Local Understandings of a Vaccine Trial in the Gambia.James Fairhead, Melissa Leach & Mary Small - 2006 - Journal of Biosocial Science 38 (1):103-116.
    This paper considers how parents engage with a large, internationally supported childhood pneumococcal vaccine trial in The Gambia. Current analysis and professional reflection on public engagement is strongly shaped by the imperatives of public health and research institutions, and is thus couched in terms of acceptance and refusal, and . In contrast Gambian parents in the extreme, of free medical treatment, versus onepublic engagement with science’ in a globalized context might be recast, with implications for debates in biomedical ethics, and (...)
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  36.  23
    Research Ethics Committee Audit: Differences Between Committees.M. E. Redshaw, A. Harris & J. D. Baum - 1996 - Journal of Medical Ethics 22 (2):78-82.
    The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and decision-making. The (...)
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  37.  32
    Health Researchers' Ancillary Care Obligations in Low-Resource Settings: How Can We Tell What is Morally Required?Maria W. Merritt - 2011 - Kennedy Institute of Ethics Journal 21 (4):311-347.
    Health researchers working in low-resource settings routinely encounter serious unmet health needs for which research participants have, at best, limited treatment options through the local health system (Taylor, Merritt, and Mullany 2011). A recent case discussion features a study conducted in Bamako, Mali (Dickert and Wendler 2009). The study objective was to see whether children with severe malaria develop pulmonary hypertension in order to improve the general understanding of morbidity and mortality associated with malaria. In the study team's interactions with (...)
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  38.  33
    Exploring the Ethics and Psychological Impact of Deception in Psychological Research.M. H. Boynton, D. B. Portnoy & B. T. Johnson - 2013 - IRB: Ethics & Human Research 35 (2):7-13.
  39.  5
    Voluntariness of Consent to Research: A Preliminary Empirical Investigation.P. S. Appelbaum, C. W. Lidz & R. Klitzman - 2008 - IRB: Ethics & Human Research 31 (6):10-14.
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  40.  21
    The Presidential Bioethics Commission's Database of Human Subjects Research.M. Groman & J. Sugarman - 2013 - IRB: Ethics & Human Research 35 (2):18-19.
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  41.  14
    Clarification, Continued.M. Groman & J. Sugarman - 2013 - IRB: Ethics & Human Research 35 (4):19-19.
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  42.  14
    A Global Public Incentive Database for Human Subjects Research.B. Brown & M. W. Merritt - 2013 - IRB: Ethics & Human Research 35 (2):14-17.
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  43.  4
    Clarification About ClinicalTrials. Gov.Deborah A. Zarin & Tony Tse - 2013 - IRB: Ethics & Human Research 35 (3):19-19.
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  44. Failures in Clinical Trials in the European Union: Lessons From the Polish Experience.Marcin Waligora - 2013 - Science and Engineering Ethics 19 (3):1087-1098.
    When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good (...) Practice, these irregularities occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed. (shrink)
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  45.  47
    Is There a Moral Obligation to Develop Brain Implants Involving NanoBionic Technologies? Ethical Issues for Clinical Trials.Frédéric Gilbert & Susan Dodds - 2014 - 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 in the near (...)
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  46.  51
    Patient Expectations of Benefit From Phase I Clinical Trials: Linguistic Considerations in Diagnosing a Therapeutic Misconception.K. P. Weinfurt, Daniel P. Sulmasy, Kevin A. Schulman & Neal J. Meropol - 2003 - Theoretical Medicine and Bioethics 24 (4):329-344.
    The ethical treatment of cancer patientsparticipating in clinical trials requiresthat patients are well-informed about thepotential benefits and risks associated withparticipation. When patients enrolled in phaseI clinical trials report that their chance ofbenefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple (...)
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  47.  13
    Regulating Trust in Pediatric Clinical Trials.Wim Pinxten, Herman Nys & Kris Dierickx - 2008 - Medicine, Health Care and Philosophy 11 (4):439-444.
    The participation of minors in clinical trials is essential to provide safe and effective medical care to children. Because few drugs have been tested in children, pediatricians are forced to prescribe medications off-label with uncertain efficacy and safety. In this article, we analyze how the enrollment of minors in clinical trials is negotiated within relationships of mutual trust between clinicians, minors, and their parents. After a brief description of the problems associated with involving minors in (...) research, we consider how existing “relationships of trust” can be used as a place where the concerns of research subjects can be more fully discussed and addressed. Building on the tacit recognition of trust found in The European Clinical Trials Directive we make policy recommendations that allow for clearer, more ethically informed guidelines for enrolling minors in clinical research. (shrink)
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  48.  15
    Placebo-Controlled Clinical Trials: How Trial Documents Justify the Use of Randomisation and Placebo.Tapani Keränen, Arja Halkoaho, Emmi Itkonen & Anna-Maija Pietilä - 2015 - BMC Medical Ethics 16 (1):2.
    Randomised clinical trials involve procedures such as randomisation, blinding, and placebo use, which are not part of standard medical care. Patients asked to participate in RCTs often experience difficulties in understanding the meaning of these and their justification.
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  49.  45
    A Unified Framework for Building Ontological Theories with Application and Testing in the Field of Clinical Trials.Heller Barbara, Herre Heinrich & Barry Smith - 2001 - In IFOMIS Reports. Leipzig: University of Leipzig.
    The objective of this research programme is to contribute to the establishment of the emerging science of Formal Ontology in Information Systems via a collaborative project involving researchers from a range of disciplines including philosophy, logic, computer science, linguistics, and the medical sciences. The re­searchers will work together on the construction of a unified formal ontology, which means: a general framework for the construction of ontological theories in specific domains. The framework will be constructed using the axiomatic-deductive method of modern (...)
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  50.  42
    The Protection of Patients' Rights in Clinical Trials.Marek Czarkowski - 2006 - Science and Engineering Ethics 12 (1):131-138.
    The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct (...)
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