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  1. Can the Regulatory Response to SUPPORT Be Supported?David Hunter - 2013 - American Journal of Bioethics 13 (12):37-39.
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  • Randomization Should Be Disclosed to Potential Research Subjects.Ariella Binik & Mark Sheehan - 2013 - American Journal of Bioethics 13 (12):35-37.
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  • Therapeutic Beneficence and Patient Recruitment in Randomized Controlled Clinical Trials.Howard Mann - 2002 - American Journal of Bioethics 2 (2):35 – 36.
    (2002). Therapeutic Beneficence and Patient Recruitment in Randomized Controlled Clinical Trials. The American Journal of Bioethics: Vol. 2, No. 2, pp. 35-36.
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  • Exploiting Subjects in Placebo-Controlled Trials.Nancy S. Jecker - 2002 - American Journal of Bioethics 2 (2):19 – 20.
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  • What Makes Placebo-Controlled Trials Unethical?Franklin G. Miller & Howard Brody - 2002 - American Journal of Bioethics 2 (2):3 – 9.
    The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. (...)
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  • Are Concerns About the Ethics of Placebos a Stalking Horse for Other Issues?David Healy - 2002 - American Journal of Bioethics 2 (2):17 – 19.
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  • Eliminating the Daily Life Risks Standard From the Definition of Minimal Risk.D. B. Resnik - 2005 - Journal of Medical Ethics 31 (1):35-38.
    The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort anticipated in research (...)
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  • Aspectos éticos de la investigación etnográfica en salud. El papel del comité de ética de la investigación.Fernando Suárez-Obando & Carlos Gómez-Restrepo - 2017 - Persona y Bioética 21 (2).
    La presencia e integración de la investigación cualitativa a los protocolos de investigación biomédica ha cobrado cada vez mayor relevancia, por la importancia de la antropología cultural. El caso particular de la etnografía adquiere aún más preeminencia en relación con la definición de riesgo para el sujeto de investigación. El presente artículo expone las principales características de la investigación etnográfica que deben ser evaluadas por un comité de ética de la investigación, y define una serie de recomendaciones para la evaluación (...)
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  • The Risk-Benefit Task of Research Ethics Committees: An Evaluation of Current Approaches and the Need to Incorporate Decision Studies Methods.D. L. C. Bernabe Rosemarie, J. M. W. van Thiel Ghislaine, A. M. Raaijmakers Jan & J. M. van Delden Johannes - 2012 - BMC Medical Ethics 13 (1):6.
    Background Research ethics committees are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis. Discussion By looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit (...)
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  • International Variation in Ethics Committee Requirements: Comparisons Across Five Westernised Nations. [REVIEW]Felicity Goodyear-Smith, Brenda Lobb, Graham Davies, Israel Nachson & Sheila Seelau - 2002 - BMC Medical Ethics 3 (1):1-8.
    Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable (...)
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  • News Media Coverage of Euthanasia: A Content Analysis of Dutch National Newspapers. [REVIEW]Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. Van Thiel, Jan A. M. Raaijmakers & Johannes J. M. Van Delden - 2013 - BMC Medical Ethics 14 (1):6-.
    BackgroundThe Netherlands is one of the few countries where euthanasia is legal under strict conditions. This study investigates whether Dutch newspaper articles use the term ‘euthanasia’ according to the legal definition and determines what arguments for and against euthanasia they contain.MethodsWe did an electronic search of seven Dutch national newspapers between January 2009 and May 2010 and conducted a content analysis.ResultsOf the 284 articles containing the term ‘euthanasia’, 24% referred to practices outside the scope of the law, mostly relating to (...)
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  • Benefits to Research Subjects in International Trials: Do They Reduce Exploitation or Increase Undue Inducement?Angela Ballantyne - 2008 - Developing World Bioethics 8 (3):178-191.
    There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on research subjects' behaviour and (...)
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  • Deliberate Microbial Infection Research Reveals Limitations to Current Safety Protections of Healthy Human Subjects.David L. Evers, Carol B. Fowler, Jeffrey T. Mason & Rebecca K. Mimnall - 2015 - Science and Engineering Ethics 21 (4):1049-1064.
    Here we identify approximately 40,000 healthy human volunteers who were intentionally exposed to infectious pathogens in clinical research studies dating from late World War II to the early 2000s. Microbial challenge experiments continue today under contemporary human subject research requirements. In fact, we estimated 4,000 additional volunteers who were experimentally infected between 2010 and the present day. We examine the risks and benefits of these experiments and present areas for improvement in protections of participants with respect to safety. These are (...)
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  • The Risk-Benefit Task of Research Ethics Committees: An Evaluation of Current Approaches and the Need to Incorporate Decision Studies Methods. [REVIEW]Johannes J. M. Van Delden Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. Van Thiel, Jan A. M. Raaijmakers - 2012 - BMC Medical Ethics 13 (1):6.
    BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, (...)
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  • Paternalism and Fairness in Clinical Research.Lynn A. Jansen & Steven Wall - 2009 - Bioethics 23 (3):172-182.
    In this paper, we defend the ethics of clinical research against the charge of paternalism. We do so not by denying that the ethics of clinical research is paternalistic, but rather by defending the legitimacy of paternalism in this context. Our aim is not to defend any particular set of paternalistic restrictions, but rather to make a general case for the permissibility of paternalistic restrictions in this context. Specifically, we argue that there is no basic liberty-right to participate in clinical (...)
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  • Pharmacogenetics: The Bioethical Problem of DNA Investment Banking.Oonagh P. Corrigan & Bryn Williams-Jones - 2006 - Studies in History and Philosophy of Science Part C 37 (3):550-565.
    Concern about the ethics of clinical drug trials research on patients and healthy volunteers has been the subject of significant ethical analysis and policy development—protocols are reviewed by Research Ethics Committees and subjects are protected by informed consent procedures. More recently attention has begun to be focused on DNA banking for clinical and pharmacogenetics research. It is, however, surprising how little attention has been paid to the commercial nature of such research, or the unique issues that present when subjects are (...)
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  • Minimal Risk in Research Involving Pregnant Women and Fetuses.Carson Strong - 2011 - Journal of Law, Medicine and Ethics 39 (3):529-538.
    The concept of minimal risk plays a key role in federal regulations on the protection of human research subjects. Although there has been considerable discussion of the meaning of minimal risk, the question of how this concept should be interpreted in research involving pregnant women and fetuses has not been addressed. This essay reviews the literature on minimal risk and argues for an interpretation of that concept in the context of research involving pregnant women and fetuses.
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  • I Need a Placebo Like I Need a Hole in the Head.Charles Weijer - 2002 - Journal of Law, Medicine and Ethics 30 (1):69-72.
  • I Need a Placebo Like I Need a Hole in the Head.Charles Weijer - 2002 - Journal of Law, Medicine and Ethics 30 (1):69-72.
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  • 'Sham Surgery' Control Groups: Ethics and Context.Teresa Swift - 2011 - Research Ethics 7 (4):148-155.
    The use of placebo controls in surgical research, or ‘sham surgery’ as it sometimes described, raises a number of ethical issues. Despite such issues, sham surgery is presently being employed, albeit very rarely, in surgical research. In this paper, the ethical implications of such control groups are discussed in the context of research into various conditions, including Parkinson's Disease and arthritis. Conflicting ethical considerations include: i) patients' best interests in relation to the harms and risks involved; ii) the need for (...)
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  • Justice, Fairness, and Membership in a Class: Conceptual Confusions and Moral Puzzles in the Regulation of Human Subjects Research.Ana S. Iltis - 2011 - Journal of Law, Medicine and Ethics 39 (3):488-501.
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  • Minimal Risk in Research Involving Pregnant Women and Fetuses.Carson Strong - 2011 - Journal of Law, Medicine and Ethics 39 (3):529-538.
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  • Restricted Treatments, Inducements, and Research Participation.Sarah J. L. Edwards - 2006 - Bioethics 20 (2):77–91.
  • The Role of Research Ethics Committees in Making Decisions About Risk.Allison Ross & Nafsika Athanassoulis - 2014 - HEC Forum 26 (3):203-224.
    Most medical research and a substantial amount of non-medical research, especially that involving human participants, is governed by some kind of research ethics committee (REC) following the recommendations of the Declaration of Helsinki for the protection of human participants. The role of RECs is usually seen as twofold: firstly, to make some kind of calculation of the risks and benefits of the proposed research, and secondly, to ensure that participants give informed consent. The extent to which the role of the (...)
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