Results for 'Clinical trials Moral and ethical aspects.'

971 found
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  1.  79
    Ethical and regulatory aspects of clinical research: readings and commentary.Ezekiel J. Emanuel (ed.) - 2003 - Baltimore: 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 clinical (...)
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  2.  96
    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 (...)
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  3.  99
    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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  4.  22
    Chasing medical miracles: the promise and perils of clinical trials.Alex O'Meara - 2009 - New York: Walker & Co..
    Chasing Medical Miracles" is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment.
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  5.  20
    Ethical tensions in the informed consent process for randomized clinical trials in emergency obstetric and newborn care in low and middle-income countries.Dan K. Kaye, Gershom Chongwe & Nelson K. Sewankambo - 2019 - BMC Medical Ethics 20 (1):27.
    There is unanimous agreement regarding the need to ethically conduct research for improving therapy for patients admitted to hospital with acute conditions, including in emergency obstetric care. We present a conceptual analysis of ethical tensions inherent in the informed consent process for randomized clinical trials for emergency obstetric care and suggest ways in which these could be mitigated. A valid consenting process, leading to an informed consent, is a cornerstone of this aspect necessary for preservation and maintenance (...)
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  6.  13
    Clinical Trials and the African Person: A Quest to Re-Conceptualize Responsibility.Ike Valentine Iyioke - 2018 - Boston: Brill | Rodopi.
    _Clinical Trials and the African Person_ offers an account of the African notion of the self/person within the clinical trials context. As opposed to autonomy-based principlism, this other-regarding/communalist perspective is touted as the preferred alternative model particularly in multicultural settings.
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  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.  6
    Ethical considerations when preparing a clinical research protocol.Evan G. DeRenzo - 2020 - San Diego, CA: Academic Press, imprint Elsevier. Edited by Eric A. Singer & Joel Moss.
    Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of (...)
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  9. Ethical, legal and social aspects of brain-implants using nano-scale materials and techniques.Francois Berger, Sjef Gevers, Ludwig Siep & Klaus-Michael Weltring - 2008 - 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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  10.  10
    Research as development: biomedical research, ethics, and collaboration in Sri Lanka.Salla Sariola - 2019 - Ithaca: Cornell University Press. Edited by Bob Simpson.
    Shows how international biomedical researchers in Sri Lanka work across cultural, epistemic, economic, and power differences to accomplish clinical trials.
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  11. The ethics of biomedical research: an international perspective.Baruch A. Brody - 1998 - New York: Oxford University Press.
    A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.
  12.  69
    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 (...)
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  13.  17
    Ethical considerations and clinical trials during a pandemic: A blessing with a burden.Madhan Ramesh, Jehath Syed & Chalasani Sri Harsha - 2022 - Clinical Ethics 17 (4):331-333.
    Any healthcare systems during a pandemic undergo tremendous pressure in pursuit of effective treatment to treat and limit the spread of the disease and its implications. Conducting clinical trials to find the potential therapy is the only way to battle the current coronavirus disease-2019 pandemic. The majority of the countries have joined the cause and are carrying out clinical studies in various capacities. As a result, the ethical committees have encountered a sudden inflow of a large (...)
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  14.  38
    The Ethics of Clinical Trials Research in Severe Mood Disorders.Allison C. Nugent, Franklin G. Miller, Ioline D. Henter & Carlos A. Zarate - 2017 - Bioethics 31 (6):443-453.
    Mood disorders, including major depressive disorder and bipolar disorder, are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent (...)
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  15.  35
    Exploring the Potential for Moral Hazard When Clinical Trial Research is Conducted in Rural Communities: Do Traditional Ethics Concepts Apply?Ann Freeman Cook & Helena Hoas - 2015 - HEC Forum 27 (2):171-187.
    Over the past 20 years, clinical research has migrated from academic medical centers to community-based settings, including rural settings. This evolving research environment may present some moral hazards or challenges that could undermine traditionally accepted standards for the protection of human subjects. The study described in this article was designed to explore the influence of motives driving the decisions to conduct clinical trial research in rural community settings. The researchers conducted semi-structured interviews with 80 participants who conducted (...)
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  16.  12
    The ethics of clinical trials.J. K. Wing - 1975 - Journal of Medical Ethics 1 (4):174-175.
    In summary, the discussion by Professors Helmchen and Müller-Oerlinghausen of the morality of clinical trials has emphasized a point that is frequently overlooked. It is an essential to consider those situations in which it might be unethical not to conduct a trial as it is to be concerned about the ways in which trials might restrict the rights of the individuals taking part in them. They and I have dealt mainly with the first of these two issues (...)
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  17.  29
    Clinical Trial Application in Europe: What Will Change with the New Regulation?Viviana Giannuzzi, Annagrazia Altavilla, Lucia Ruggieri & Adriana Ceci - 2016 - Science and Engineering Ethics 22 (2):451-466.
    The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout (...)
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  18.  57
    Ethical Considerations for Nurses in Clinical Trials.Kathleen Oberle & Marion Allen - 2006 - 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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  19.  20
    The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies’ Soft Impacts into Account.Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel & Johannes J. M. van Delden - forthcoming - Health Care Analysis:1-12.
    Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT (...)
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  20.  7
    Etički i pravni položaj ljudi kao subjekata biomedicinskih istraživanja i kliničkih ogleda.Vesna Klajn-Tatić - 2012 - Beograd: Institut društvenih nauka, Centar za pravna istraživanja.
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  21.  39
    Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards.Vilma Lukaseviciene, Joerg Hasford, Dirk Lanzerath & Eugenijus Gefenas - 2021 - Journal of Medical Ethics 47 (12):e82-e82.
    The upcoming Regulation No 536/2014 on clinical trials on medicinal products for human use, which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the (...)
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  22. Integrity of randomized clinical trials: how to prevent research misconduct and ensure transparency.Khalid Saeed Khan - 2025 - Boca Raton: CRC Press.
    Today scientists are expected to be more accountable and transparent than at any time in history. Globally the pursuit of knowledge creation enjoys a place of distinction, and the public expects to reap considerable benefit from the innovative contributions made by researchers. It is therefore more important than ever that ethics, transparency and professionalism explicitly guide research integrity. Despite the clear importance of acquiring a fundamental understanding of clinical trials in the context of health research and innovation, medical (...)
     
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  23.  42
    Coercive treatment in psychiatry: clinical, legal and ethical aspects.Thomas W. Kallert, Juan E. Mezzich & John Monahan (eds.) - 2011 - Hoboken, NJ: 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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  24.  42
    'Moral taint' or ethical responsibility? Unethical information and the problem of HIV clinical trials in developing countries.Deborah Zion - 1998 - Journal of Applied Philosophy 15 (3):231–239.
    Clinical trials in developing countries are often beset by ethical problems that would be considered unresolvable in countries like Australia and the U.S. Nevertheless, such trials continue to go ahead throughout Asia, Africa and South America, and are often conducted in ways that could be considered to be unethical. In this article I discuss two issues, focussing on an HIV preventative trial of a vaginal gel, the Nonoxynol 9 phase three trial being held in Kenya. The (...)
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  25.  7
    Contemporary issues for protecting patients in cancer research: workshop summary.Sharyl J. Nass - 2014 - Washington, D.C.: The National Academies Press. Edited by Margie Patlak.
    In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable (...)
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  26. Manual for research ethics committees.Sue Eckstein (ed.) - 2003 - New York: 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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  27.  20
    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 clinical relevance across all (...)
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  28. Comparison of COVID‐19 studies registered in the clinical trial platforms: A research ethics analysis perspective.Banu Buruk, Muberra Devrim Guner, Perihan Elif Ekmekci & Aksuyek Savas Celebi - 2021 - Developing World Bioethics 22 (4):217-230.
    BackgroundThe coronavirus disease (COVID-19) treatment must be based on scientific methods such as clinical trials. Trials involving human subjects and those requiring a risk-benefit analysis may occasionally face challenges owing to the time limitations in the pandemic. MethodologyThis study analyses the WHO's International Clinical Trials Registry Platform and clinicaltrials.gov, where most COVID-19 clinical trials are registered, according to ethical criteria including study design, conflicts of interest, enrollment of healthcare workers, study locations, site-, (...)
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  29. Psychosocial and Ethical Aspects in Non-Invasive EEG-Based BCI Research—A Survey Among BCI Users and BCI Professionals.Gerd Grübler, Abdul Al-Khodairy, Robert Leeb, Iolanda Pisotta, Angela Riccio, Martin Rohm & Elisabeth Hildt - 2013 - Neuroethics 7 (1):29-41.
    In this paper, the results of a pilot interview study with 19 subjects participating in an EEG-based non-invasive brain–computer interface (BCI) research study on stroke rehabilitation and assistive technology and of a survey among 17 BCI professionals are presented and discussed in the light of ethical, legal, and social issues in research with human subjects. Most of the users were content with study participation and felt well informed. Negative aspects reported include the long and cumbersome preparation procedure, discomfort with (...)
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  30. Reasons Why Post-Trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review.N. Sofaer & D. Strech - 2011 - Public Health Ethics 4 (2):160-184.
    Background : researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial (...)
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  31.  29
    Bioindustry Ethics.David Finegold (ed.) - 2005 - Elsevier Academic Press.
    This book is the first systematic, detailed treatment of the approaches to ethical issues taken by biotech and pharmaceutical companies. The application of genetic/genomic technologies raises a whole spectrum of ethical questions affecting global health that must be addressed. Topics covered in this comprehensive survey include considerations for bioprospecting in transgenics, genomics, drug discovery, and nutrigenomics, as well as how to improve stakeholder relations, design ethical clinical trials, avoid conflicts of interest, and establish ethics advisory (...)
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  32.  30
    Navigating ethical challenges of conducting randomized clinical trials on COVID-19.Dan Kabonge Kaye - 2022 - Philosophy, Ethics, and Humanities in Medicine 17 (1):1-11.
    BackgroundThe contemporary frameworks for clinical research require informed consent for research participation that includes disclosure of material information, comprehension of disclosed information and voluntary consent to research participation. There is thus an urgent need to test, and an ethical imperative, to test, modify or refine medications or healthcare plans that could reduce patient morbidity, lower healthcare costs or strengthen healthcare systems.MethodsConceptual review.DiscussionAlthough some allocation principles seem better than others, no single moral principle allocates interventions justly, necessitating combining (...)
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  33.  35
    Roche’s Clinical Trials with Organs from Prisoners: Does Profit Trump Morals?Judith Schrempf-Stirling - 2014 - Journal of Business Ethics 121 (2):315-328.
    This case study discusses the economic, legal, and ethical considerations for conducting clinical trials in a controversial context. In 2010, pharmaceutical giant Roche received a shame award by the Swiss non-governmental organization Berne Declaration and Greenpeace for conducting clinical trials with organs taken from executed prisoners in China. The company respected local regulations and industry ethical standards. However, medical associations condemned organs from executed prisoners on moral grounds. Human rights organizations demanded that Roche (...)
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  34.  18
    International Ethical Regulations on Placebo‐Use in Clinical Trials: A Comparative Analysis.Hans-jörg Ehni & Urban Wiesing - 2008 - Bioethics 22 (1):64-74.
    The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo, is still missing. The central issue in the ongoing controversy is the justification of placebo‐use, if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant details. (...)
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  35.  52
    Disputing the ethics of research: The challenge from bioethics and patient activism to the interpretation of the declaration of helsinki in clinical trials.Simon Woods & Pauline Mccormack - 2012 - Bioethics 27 (5):243-250.
    In this paper we argue that the consensus around normative standards for the ethics of research in clinical trials, strongly influenced by the Declaration of Helsinki, is perceived from various quarters as too conservative and potentially restrictive of research that is seen as urgent and necessary. We examine this problem from the perspective of various challengers who argue for alternative approaches to what ought or ought not to be permitted. Key themes within this analysis will examine these claims (...)
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  36.  3
    Navigating the future of clinical trial management – insights on the transformative role of AI.Lara Bernasconi & Regina Grossmann - forthcoming - Research Ethics.
    This study addresses the current lack of empirical data on the experiences and attitudes of clinical research professionals towards AI-powered clinical trial management tools. Clinical research professionals affiliated with various Swiss and international clinical research networks were invited to participate in an online survey. The survey focused on nine use cases of AI-powered clinical trial management tools. Participants were asked to share their ethical considerations, and their experiences were assessed at both the individual and (...)
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  37.  66
    Principlism and the ethical appraisal of clinical trials.Eric M. Meslin, Heather J. Sutherland, James V. Lavery & James E. Till - 1995 - 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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  38.  59
    International ethical regulations on placebo-use in clinical trials: A comparative analysis.Hans-jörg Ehni & Urban Wiesing - 2007 - Bioethics 22 (1):64–74.
    ABSTRACT The ethical aspects of placebo control in clinical trials have been extensively and controversially debated in the last decade. However, a thorough analytical comparison of the different existing international regulations, their terminologies and their ethical principles concerning placebo, is still missing. The central issue in the ongoing controversy is the justification of placebo‐use, if proven treatment exists. All present versions of the examined guidelines propose such justifications, but each guideline differs from the others in relevant (...)
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  39. Patient-Physician Relationship for Conducting a Clinical Trial A Look on Ethical Aspects and Role of Statistical Designs.Gopaldeb Chattopadhyay - 2007 - In Ratna Dutta Sharma & Sashinungla (eds.), Patient-physician relationship. New Delhi: D.K. Printworld. pp. 174.
     
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  40.  30
    Altruistic reasoning in adolescent-parent dyads considering participation in a hypothetical sexual health clinical trial for adolescents.Noé Rubén Chávez, Camille Y. Williams, Lisa S. Ipp, Marina Catallozzi, Susan L. Rosenthal & Carmen Radecki Breitkopf - 2016 - Research Ethics 12 (2):68-79.
    Altruism is a well-established reason underlying research participation. Less is known about altruism in adolescent-parent decision-making about clinical trials enrolling healthy adolescents. This qualitative investigation focused on identifying spontaneous statements of altruism within adolescent-parent (dyadic) discussions of participation in a hypothetical phase I clinical trial related to adolescent sexual health. Content analysis revealed several response patterns to each other’s altruistic reasoning. Across 70 adolescent-parent dyads in which adolescents were 14 to 17 years of age and 91% of (...)
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  41. 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 (...)
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  42.  35
    Morally Relevant Similarities and Differences Between Children and Dementia Patients as Research Subjects: Representation in Legal Documents and Ethical Guidelines.Karin Jongsma, Wendy Bos & Suzanne Vathorst - 2015 - Bioethics 29 (9):662-670.
    Children and adults with dementia are vulnerable populations. Both groups are also relatively seldom included in biomedical research. However, including them in clinical trials is necessary, since both groups are in need of scientific innovation and new therapies. Their dependence and limited decision-making capacities increase their vulnerability, necessitating extra precautions when including them in clinical trials. Beside these similarities there are also many differences between the groups. The most obvious one is that children have an entire (...)
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  43.  53
    Nurses' Sensitivity To the Ethical Aspects of Clinical Practice.Lorys F. Oddi, Virginia R. Cassidy & Cheryl Fisher - 1995 - 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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  44.  33
    Do Clinicians Have a Duty to Participate in Pragmatic Clinical Trials?Andrew Garland, Stephanie Morain & Jeremy Sugarman - 2022 - American Journal of Bioethics 23 (8):22-32.
    Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve substantive deviation from their ordinary care practices. However, a variety of countervailing reasons may excuse clinicians from this duty in particular cases. Yet because there is a moral default in favor of participating, clinicians who wish to opt out (...)
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  45.  19
    Morally Relevant Similarities and Differences Between Children and Dementia Patients as Research Subjects: Representation in Legal Documents and Ethical Guidelines.Karin Jongsma, Wendy Bos & Suzanne van de Vathorst - 2015 - Bioethics 29 (9):662-670.
    Children and adults with dementia are vulnerable populations. Both groups are also relatively seldom included in biomedical research. However, including them in clinical trials is necessary, since both groups are in need of scientific innovation and new therapies. Their dependence and limited decision‐making capacities increase their vulnerability, necessitating extra precautions when including them in clinical trials. Beside these similarities there are also many differences between the groups. The most obvious one is that children have an entire (...)
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  46.  6
    Risky first-in-human clinical trials on medically fragile persons: owning the moral cost.Christopher Bobier - 2024 - Theoretical Medicine and Bioethics 45 (6):447-459.
    The purpose of a first-in-human (FIH) clinical trial is to gather information about how the drug or device affects and interacts with the human body: its safety, side effects, and (potential) dosage. As such, the primary goal of a FIH trial is not participant benefit but to gain knowledge of drug or device efficacy, i.e., baseline human safety knowledge. Some FIH clinical trials carry _significant_ foreseeable risk to participants with little to no foreseeable participant benefit. Participation in (...)
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  47.  91
    Neonatal extracorporeal membrane oxygenation (ECMO): clinical trials and the ethics of evidence.V. Mike, A. N. Krauss & G. S. Ross - 1993 - 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 the (...)
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  48.  33
    Neurophilosophical and Ethical Aspects of Virtual Reality Therapy in Neurology and Psychiatry.Philipp Kellmeyer - 2018 - Cambridge Quarterly of Healthcare Ethics 27 (4):610-627.
    Abstract:Highly immersive virtual reality (VR) systems have been introduced into the consumer market in recent years. The improved technological capabilities of these systems as well as the combination with biometric sensors, for example electroencephalography (EEG), in a closed-loop hybrid VR-EEG, opens up a range of new potential medical applications. This article first provides an overview of the past and current clinical applications of VR systems in neurology and psychiatry and introduces core concepts in neurophilosophy and VR research (such as (...)
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  49. Clinical equipoise: Why still the gold standard for randomized clinical trials?Charlemagne Asonganyi Folefac & Hugh Desmond - 2024 - Clinical Ethics 19 (1):1-11.
    The principle of clinical equipoise has been variously characterized by ethicists and clinicians as fundamentally flawed, a myth, and even a moral balm. Yet, the principle continues to be treated as the de facto gold standard for conducting randomized control trials in an ethical manner. Why do we hold on to clinical equipoise, despite its shortcomings being widely known and well-advertised? This paper reviews the most important arguments criticizing clinical equipoise as well as what (...)
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    At what level of collective equipoise does a clinical trial become ethical?N. Johnson, R. J. Lilford & W. Brazier - 1991 - Journal of Medical Ethics 17 (1):30-34.
    It has often been argued that if a clinician cannot decide which of two treatments to offer, a trial may be ethical, but it is unethical if she/he has a preference. Since individual clinicians usually have a preference, most trials could be judged unethical according to this line of argument. A recent important article in the New England Journal of Medicine argued that individual preferences are not as important as the collective uncertainty of informed clinicians. If clinicians are (...)
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