Results for 'clinical research ethics'

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  1.  81
    Clinical Ethics Committee in an Oncological Research Hospital: two-years Report.Marta Perin, Ludovica De Panfilis & on Behalf of the Clinical Ethics Committee of the Azienda Usl-Irccs di Reggio Emilia - 2023 - Nursing Ethics 30 (7-8):1217-1231.
    Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...
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  2.  49
    Addressing the Ethical Challenges in Genetic Testing and Sequencing of Children.Ellen Wright Clayton, Laurence B. McCullough, Leslie G. Biesecker, Steven Joffe, Lainie Friedman Ross, Susan M. Wolf & For the Clinical Sequencing Exploratory Research Group - 2014 - American Journal of Bioethics 14 (3):3-9.
    American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines (...)
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  3. 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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  4.  60
    The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative.Kathryn M. Porter, Marion Danis, Holly A. Taylor, Mildred K. Cho & Benjamin S. Wilfond - 2018 - American Journal of Bioethics 18 (1):39-45.
    The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 (...)
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  5.  29
    Subject Selection for Clinical Trials.American Medical Association Council on Ethical and Judicial Affairs - forthcoming - IRB: Ethics & Human Research.
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  6.  24
    Clinical research ethics in Irish healthcare: Diversity, dynamism and medicalization.S. L. Condell & C. Begley - 2012 - Nursing Ethics 19 (6):810-818.
    Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as (...)
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  7.  4
    Challenging cases in clinical research ethics.Benjamin Wilfond, Liza-Marie Johnson, Devan M. Duenas & Holly Ann Taylor (eds.) - 2023 - Boca Raton, FL: CRC Press.
    Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most (...)
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  8.  27
    What makes multinational clinical research ethical & how to minimize possible exploitation in host country?Md Ashraf Ali - 2012 - Bangladesh Journal of Bioethics 2 (2):20-23.
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  9. Aftercare for participants in clinical research: ethical considerations in an asthma drug trial.S. C. Harth & Y. H. Thong - 1995 - Journal of Medical Ethics 21 (4):225-228.
    The issue of aftercare for participants in clinical research was explored in the context of an asthma drug trial. Although there may be financial constraints and practical difficulties with implementation, the results show that it may be feasible for clinical investigators and commercial sponsors to take on some limited responsibility for the medical care of research subjects after clinical trials. However, the ethical implications for this practice remain unclear. On the one hand, society may have (...)
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  10.  14
    Perspective from Clinical Research: Ethical Issues in Alzheimer's Disease Research.Jacobo Mintzer - 2018 - Journal of Law, Medicine and Ethics 46 (3):699-703.
    This paper attempts to bring to the attention of the readers a concept that broadens ethical considerations for Alzheimer's disease research. We propose we move away from the ethical paradigm that focuses on avoidance of coercion for participation in studies as well as privacy and safety to a more inclusive paradigm that will not only include the principles outlined above but will also guarantee access to new treatments for individuals that participate in research and other members of society. (...)
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  11.  53
    Ethics in Medicine: Historical Perspectives and Contemporary Concerns.Stanley Joel Reiser, Mary B. Saltonstall Professor of Population Ethics Arthur J. Dyck, Arthur J. Dyck & William J. Curran - 1977 - Cambridge: Mass. : MIT Press.
    This book is a comprehensive and unique text and reference in medical ethics. By far the most inclusive set of primary documents and articles in the field ever published, it contains over 100 selections. Virtually all pieces appear in their entirety, and a significant number would be difficult to obtain elsewhere. The volume draws upon the literature of history, medicine, philosophical and religious ethics, economics, and sociology. A wide range of topics and issues are covered, such as law (...)
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  12.  12
    Aftercare for participants in clinical research: ethical considerations in an asthma drug trial.S. C. Harth and Y. H. Thong - 1995 - Journal of Medical Ethics 21 (4):225.
  13.  64
    A Research Ethics Framework for the Clinical Translation of Healthcare Machine Learning.Melissa D. McCradden, James A. Anderson, Elizabeth A. Stephenson, Erik Drysdale, Lauren Erdman, Anna Goldenberg & Randi Zlotnik Shaul - 2022 - American Journal of Bioethics 22 (5):8-22.
    The application of artificial intelligence and machine learning technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surro...
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  14.  12
    Public Health Research Ethics and Clinical Research Ethics. How we differentiate?Zoheb Rafique - 2019 - Bangladesh Journal of Bioethics 9 (2):22-25.
    This article talks about both clinical research ethics and public health research ethics. Clinical research ethics are defined as set of relevant ethics considered necessary for the conduct of clinical trials in field of the clinical research. While public health research ethics is mainly aimed at finding out what is best for the communities and the populations rather than the individuals. Research ethics is mainly (...)
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  15.  59
    Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others.A. Blumle, G. Antes, M. Schumacher, H. Just & E. von Elm - 2008 - Journal of Medical Ethics 34 (9):e20-e20.
    Background: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied.Methods: The protocols of clinical research projects submitted to the research ethics committee of (...)
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  16.  51
    Review of The Oxford Textbook of Clinical Research Ethics, by D. Wendler, C. Grady, R. Crouch, R. Lie, F. Miller, and E. Emanuel.Roger Stanev - 2012 - Theoretical Medicine and Bioethics 33 (3):221-226.
    When is clinical research ethical? The difficulty in answering this question lies in the dual nature of research on human subjects, which yields two somewhat conflicting sets of obligations. On the one hand, there is the traditional view of science that includes the idea of an obligation to learn about the world. On the other hand, there is the obligation of care on the part of researchers towards individual participants in the research ...
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  17. Clinical research law in Jordan: An ethical analysis.Ibrahim Ramahi & Henry Silverman - 2007 - Developing World Bioethics 9 (1):26-33.
    ABSTRACT An ethical analysis of Jordan's Clinical Research Law, which became effective in 2001, was performed. Accordingly, this paper discusses the major components, key strengths and weaknesses of this law. As an initial effort, the Law addresses important aspects of research ethics and, hence, should serve as an example for other Arab Countries in the Middle East. Unique aspects of the Law include the requirement that those conducting any study have insurance that can compensate for (...) injuries and a system of fines and punishments for noncompliance with the Law. There are, however, some key items missing in the Jordanian Law. For example, the Law does not mention the requirement of a favourable assessment of risks and benefits, the fair selection of subjects, or articles regarding the protection of the rights and welfare of children and other vulnerable subjects participating in research. The paper concludes with the suggestion that new amendments should be considered for future revisions of the Clinical Research Law in Jordan. (shrink)
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  18.  62
    Ethical Guidelines for Human Embryonic Stem Cell Research (A Recommended Manuscript).Chinese National Human Genome Center at Shanghai Ethics Committee - 2004 - Kennedy Institute of Ethics Journal 14 (1):47-54.
    In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- (...)
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  19. A plea for pragmatism in clinical research ethics.David H. Brendel & Franklin G. Miller - 2008 - American Journal of Bioethics 8 (4):24 – 31.
    Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation (...)
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  20. The Ethics of Public Policy Experiments: Lessons from Clinical Research Ethics.Douglas MacKay - 2020 - In Ana S. Iltis & Douglas MacKay (eds.), The Oxford Handbook of Research Ethics. New York, NY, USA: Oxford University Press.
    Social scientists and research ethicists have begun, somewhat belatedly, to confront and address the ethical challenges raised by public policy experiments. In doing so however, they have not fully availed themselves of the large and sophisticated literature on the ethics of clinical research which has developed over the past 40 years. While clinical and public policy research are different, I argue that the clinical research ethics literature yields valuable insights for discussions (...)
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  21.  8
    Understanding and attitudes of the Jordanian public about clinical research ethics.Mera A. Ababneh, Sayer I. Al-Azzam, Karem Alzoubi, Abeer Rababa’H. & Saddam Al Demour - 2020 - Research Ethics 17 (2):228-241.
    In Jordan, research ethics committees exist in most health settings. However, little is known about Jordanian public views regarding the ethics of clinical research. This study aimed to evaluate Jordanian public understanding and attitudes about ethics in clinical research. A questionnaire was used to collect information that included demographics, public knowledge, and attitudes towards ethics in clinical research. It was administered via face-to-face interviews in two major cities in Jordan (...)
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  22.  8
    Clinical Research Law in Jordan: An Ethical Analysis.Henry Silverman Ibrahim Ramahi - 2009 - Developing World Bioethics 9 (1):26-33.
    An ethical analysis of Jordan's Clinical Research Law, which became effective in 2001, was performed. Accordingly, this paper discusses the major components, key strengths and weaknesses of this law. As an initial effort, the Law addresses important aspects of research ethics and, hence, should serve as an example for other Arab Countries in the Middle East. Unique aspects of the Law include the requirement that those conducting any study have insurance that can compensate for research (...)
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  23.  23
    Back to basics in clinical research ethics.Bridget Haire - 2009 - American Journal of Bioethics 9 (3):48 – 49.
  24.  23
    Controversies in Clinical Research Ethics.Robert M. Sade - 2017 - Journal of Law, Medicine and Ethics 45 (3):291-294.
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  25. Guidelines for Research Ethics in Science and Technology.National Committee For Research Ethics In Science And Technology - 2009 - Jahrbuch für Wissenschaft Und Ethik 14 (1):255-266.
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  26.  43
    Should research ethics triumph over clinical ethics?Michael H. Kottow - 2007 - Journal of Evaluation in Clinical Practice 13 (4):695-698.
  27.  42
    The Clinical Research of Nanomedicine: A New Ethical Challenge?Urban Wiesing & Jens Clausen - 2014 - NanoEthics 8 (1):19-28.
    Nanomedicine promises unprecedented innovations for diagnosis and therapy as well as for predicting and preventing diseases. On the other hand it raises fears linked to new and unknown characteristics of nanoscale materials. Both, promises and fears, are closely linked to the realm of uncertainty. To a large extent it is currently not known which expectations could become reality and which suspected adverse events might come true. Medicine is quite familiar with decision-making under uncertainty. Rules and regulations for clinical (...) have been developed to reduce possible harm for research participants without abandoning necessary investigations. Here we examine whether clinical research trials of nanomedicine need new regulations and conclude that the established rules should suffice. (shrink)
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  28.  18
    Clinical Research Subject Selection during Public Health Disasters: Reconceptualizing Fairness in a Global Ethical Context.Ikeolu O. Afolabi, Stephen O. Sodeke & Michael O. S. Afolabi - 2020 - American Journal of Bioethics 20 (2):38-41.
    Volume 20, Issue 2, February 2020, Page 38-41.
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  29.  18
    Clinical research should not be permitted to escape the ethical orbit of clinical care.David Steinberg - 2002 - American Journal of Bioethics 2 (2):27 – 28.
    (2002). Clinical Research Should Not Be Permitted to Escape the Ethical Orbit of Clinical Care. The American Journal of Bioethics: Vol. 2, No. 2, pp. 27-28.
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  30.  54
    Rethinking the ethics of clinical research: widening the lens.Alan Wertheimer - 2011 - New York: Oxford University Press.
    Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.
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  31.  32
    Can Clinical Research Be Both Ethical and Scientific? A Commentary inspired by Rosser and Marquis.Helen Bequaert Holmes - 1989 - Hypatia 4 (2):156-168.
    Problems with clinical research that create conflicts between doctors' therapeutic and research obligations may be fueled by a rigid view of science as determiner of truth, a heavy reliance on statistics, and certain features of randomized clinical trials. I suggest some creative, feminist approaches to such research and explore ways to provide choice for patients and to use values in directing both therapy and science - to enhance the effectiveness of each.
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  32.  42
    A Critical Analysis and Discussion of Clinical Research Ethics in the Russian Federation and Their Implications for Western Sponsored Trials.Christopher Leintz - 2012 - Bioethics 28 (5):263-268.
    Globalization, political upheavals, and Western economic struggles have caused a geographical reprioritization in the realm of drug development and human clinical research. Regulatory and cost hurdles as well as a saturation of research sites and subjects in Western countries have forced the pharmaceutical industry to place an unprecedented level of importance on emerging markets, injecting Western corporate initiatives into cultures historically and socially isolated from Western-centric value systems. One of the greatest recipients of this onslaught of Western (...)
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  33.  99
    Ethics and regulation of clinical research.Robert J. Levine - 1981 - Baltimore: Urban & Schwarzenberg.
    In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.
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  34. Should research ethics triumph over clinical ethics?Jane Collier & Rafael Esteban - forthcoming - Journal of Evaluation in Clinical Practice.
     
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  35.  13
    Ethical Challenges in Clinical Research During the COVID-19 Pandemic.B. E. Bierer, S. A. White, J. M. Barnes & L. Gelinas - 2020 - Journal of Bioethical Inquiry 17 (4):717-722.
    The sudden emergence of the COVID-19 pandemic brought global disruption to every aspect of society including healthcare, supply chain, the economy, and social interaction. Among the many emergent considerations were the safety and public health of the public, patients, essential workers, and healthcare professionals. In certain locations, clinical research was halted—or terminated—in deference to the immediate needs of patient care, and clinical trials focusing on the treatment and prevention of coronavirus infection were prioritized over studies focusing on (...)
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  36.  51
    Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine.Jake Earl - 2019 - American Journal of Bioethics 19 (6):7-18.
    Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community (...)
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  37.  47
    Women and health research: ethical and legal issues of including women in clinical studies.Anna C. Mastroianni, Ruth R. Faden & Daniel D. Federman (eds.) - 1994 - Washington, D.C.: 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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  38.  47
    Ethical challenges experienced by clinical research nurses:: A qualitative study.Mary E. Larkin, Brian Beardslee, Enrico Cagliero, Catherine A. Griffith, Kerry Milaszewski, Marielle T. Mugford, Joanna M. Myerson, Wen Ni, Donna J. Perry, Sabune Winkler & Elizabeth R. Witte - 2019 - Nursing Ethics 26 (1):172-184.
    Background:Clinical investigation is a growing field employing increasing numbers of nurses. This has created a new specialty practice defined by aspects unique to nursing in a clinical research context: the objectives, setting, and nature of the nurse–participant relationship. The clinical research nurse role may give rise to feelings of ethical conflict between aspects of protocol implementation and the duty of patient advocacy, a primary nursing responsibility. Little is known about whether research nurses experience unique (...)
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  39.  26
    Canadian research ethics board members’ attitudes toward benefits from clinical trials.Kori Cook, Jeremy Snyder & John Calvert - 2015 - BMC Medical Ethics 16 (1):1-7.
    BackgroundWhile ethicists have for many years called for human subject trial participants and, in some cases, local community members to benefit from participation in pharmaceutical and other intervention-based therapies, little is known about how these discussions are impacting the practice of research ethics boards that grant ethical approval to many of these studies.MethodsTelephone interviews were conducted with 23 REB members from across Canada, a major funder country for human subject research internationally. All interviews were digitally recorded and (...)
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  40.  10
    Is Clinical Research and Ethics a Zero-sum Game?Charles Weijer - unknown
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  41.  31
    The Role of Patient Perspectives in Clinical Research Ethics and Policy: Response to Open Peer Commentaries on “Patient Perspectives on the Learning Health System”.Maureen Kelley, Cyan James, Stephanie Alessi Kraft, Diane Korngiebel, Isabelle Wijangco, Steven Joffe, Mildred K. Cho, Benjamin Wilfond & Sandra Soo-Jin Lee - 2016 - American Journal of Bioethics 16 (2):7-9.
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  42. Clinical research: Should patients pay to play?Ezekiel J. Emanuel, Steven Joffe, Christine Grady, David Wendler & Govind Persad - 2015 - Science Translational Medicine 7 (298):298ps16.
    We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.
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  43.  47
    Education of research ethics for clinical investigators with Moodle tool.Arja Halkoaho, Mari Matveinen, Ville Leinonen, Kirsi Luoto & Tapani Keränen - 2013 - BMC Medical Ethics 14 (1):53.
    In clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: an initial (...)
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  44.  30
    Defining the Scope and Improving the Quality of Clinical Research Ethics Consultation: Response to Open Peer Commentaries About the National Collaborative.Kathryn M. Porter, Marion Danis, Holly A. Taylor, Mildred K. Cho & Benjamin S. Wilfond - 2018 - American Journal of Bioethics 18 (2):13-15.
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  45.  95
    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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  46.  19
    Ethics and Clinical Research” in Biographical Perspective.Susan E. Lederer - 2016 - Perspectives in Biology and Medicine 59 (1):18-36.
    Fifty years ago, Henry Knowles Beecher published his essay on clinical research ethics in the New England Journal of Medicine. The culmination of more than a decade and a half’s rumination and reflection on the use of patients and “captive populations” in research, Beecher’s 1966 article understandably casts a large shadow in American bioethics. In 1976, the Institute of Society, Ethics and the Life Sciences established the Henry Knowles Beecher Award for Contributions to Ethics (...)
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  47. Viewpoint: developing a research ethics consultation service to foster responsive and responsible clinical research.Inmaculada de Melo-Martin, Li Palmer & Jj Fins - 2007 - Academic Medicine 82 (9):900-4.
     
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  48.  16
    Ethical Considerations for Clinical Research and Off-label Use of Ketamine to Treat Mood Disorders: The Balance Between Risks and Benefits.Roger C. Ho & Melvyn W. Zhang - 2017 - Ethics and Behavior 27 (8):681-699.
    Previous research conducted in 1999 highlighted ethical concerns behind challenge studies inducing psychosis with ketamine and made recommendations to enhance ethical standards. Recently, a plethora of clinical trials have evaluated the efficacy of ketamine to treat mood disorders, which lead to complex ethical issues. Pharmaceutical companies and researchers hope to profit by developing patentable variations on ketamine for treating depression. Media have labeled ketamine as a “miracle” antidepressant. Some clinics offer expensive off-label use of ketamine to treat mood (...)
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  49.  12
    Ethics status of clinical research and trials in developing countries.Yuanyuan Liu - 2015 - Eubios Journal of Asian and International Bioethics 25 (4):124-127.
    With the development of economic globalization, more and more clinical research and trials shift from developed countries to developing countries. The globalization of clinical trials also brings some ethical and scientific concerns. This paper discussed some ethical problems of clinical trials in the developing countries including 1) "golden rice" event in China; 2) Informed consent in clinical trials in developing countries; 3) Ethical consciousness in clinical research and trials in developing countries. The essay (...)
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  50.  49
    Clinical Ethics Consultation and Research Ethics Consultation: A Call for Italy.Ludovica De Panfilis, Domenico Franco Merlo, Roberto Satolli, Teresa Coppola, Luca Ghirotto & Massimo Costantini - 2018 - American Journal of Bioethics 18 (1):63-64.
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