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  1. Human Rights and Global Mental Health: Reducing the Use of Coercive Measures.Kelso Cratsley, Marisha Wickremsinhe & Timothy K. Mackey - 2021 - In A. Dyer, B. Kohrt & P. J. Candilis (eds.), Global Mental Health: Ethical Principles and Best Practices. pp. 247-268.
    The application of human right frameworks is an increasingly important part of efforts to accelerate progress in global mental health. Much of this has been driven by several influential legal and policy instruments, most notably the United Nations’ Convention on the Rights of Persons with Disabilities, as well as the World Health Organization’s QualityRights Tool Kit and Mental Health Action Plan. Despite these significant developments, however, much more needs to be done to prevent human rights violations. This chapter focuses on (...)
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  • Quality Improvement Ethics: Lessons From the SUPPORT Study.Benjamin S. Wilfond - 2013 - American Journal of Bioethics 13 (12):14-19.
    The Office of Human Research Protections was not justified in issuing findings against the SUPPORT Institutions. Our community can learn from the evolving healthcare transformation into learning health systems by thinking about the novel ethical issues about standard of care research raised by the SUPPORT with the same spirit of quality improvement. The current regulatory framework and the concept of foreseeable research risks is insufficient to advance the debate about the ethics of randomization of standard clinical interventions. This article uses (...)
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  • Loss of Possession: Concussions, Informed Consent, and Autonomy.Richard Robeson & Nancy M. P. King - 2014 - Journal of Law, Medicine and Ethics 42 (3):334-343.
    The principle of informed consent is so firmly established in bioethics and biomedicine that the term was soon bowdlerized in common practice, such that engaging in the informed decision-making process with patients or research subjects is now often called “consenting” them. This evolution, from the original concept to the rather questionable coinage that makes consent a verb, reveals not only a loss of rhetorical precision but also a fundamental shift in the potential meaning, value, and implementation of the informed consent (...)
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  • Translating Stem Cell Research: Challenges at the Research Frontier.David Magnus - 2010 - Journal of Law, Medicine and Ethics 38 (2):267-276.
    There are many kinds of clinical trials. The regulatory framework within which most drug development takes place appears to be the one that is to be applied to the development of novel stem cell-based clinical trials. In the standard drug development model, appropriate pre-clinical research is conducted, and investigators or research sponsors submit an investigational new drug application to the Food and Drug Administration.If approved, typical clinical trials start with Phase I, which is usually a trial to determine the maximum (...)
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  • Nanomedicine First-in-Human Research: Challenges for Informed Consent.Nancy M. P. King - 2012 - Journal of Law, Medicine and Ethics 40 (4):823-830.
    First-in-human research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.It is essential, as a starting point, to recognize that the consent form (...)
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  • Key Information in the New Common Rule: Can It Save Research Consent?Nancy M. P. King - 2019 - Journal of Law, Medicine and Ethics 47 (2):203-212.
    Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and (...)
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  • Trust in early phase research: therapeutic optimism and protective pessimism.Scott Y. H. Kim, Robert G. Holloway, Samuel Frank, Renee Wilson & Karl Kieburtz - 2008 - Medicine, Health Care and Philosophy 11 (4):393-401.
    Bioethicists have long been concerned that seriously ill patients entering early phase (‘phase I’) treatment trials are motivated by therapeutic benefit even though the likelihood of benefit is low. In spite of these concerns, consent forms for phase I studies involving seriously ill patients generally employ indeterminate benefit statements rather than unambiguous statements of unlikely benefit. This seeming mismatch between attitudes and actions suggests a need to better understand research ethics committee members’ attitudes toward communication of potential benefits and risks (...)
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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.
    This essay examines conceptual difficulties with one of the ways in which justice has been understood and applied the ethical and regulatory review of human research. Justice requires the fair distribution of the benefits and burdens of research. Class membership is seen as justifying inclusion in higher hazard-no benefit research from which members of potentially vulnerable classes, such as children, typically would be excluded. I argue that class membership does not do the justificatory work it is thought to do and (...)
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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.
    Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services, to require that investigators follow the same rules for conducting human research., though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the (...)
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  • Beyond informed consent: the therapeutic misconception and trust.Inmaculada de Melo-Martin & A. Ho - 2008 - Journal of Medical Ethics 34 (3):202-205.
    The therapeutic misconception has been seen as presenting an ethical problem because failure to distinguish the aims of research participation from those receiving ordinary treatment may seriously undermine the informed consent of research subjects. Hence, most theoretical and empirical work on the problems of the therapeutic misconception has been directed to evaluate whether, and to what degree, this confusion invalidates the consent of subjects. We argue here that this focus on the understanding component of informed consent, while important, might be (...)
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  • Advancing neuroregenerative medicine: A call for expanded collaboration between scientists and ethicists.Jocelyn Grunwell, Judy Illes & Katrina Karkazis - 2008 - Neuroethics 2 (1):13-20.
    To date, ethics discussions about stem cell research overwhelmingly have centered on the morality and acceptability of using human embryonic stem cells. Governments in many jurisdictions have now answered these “first-level questions” and many have now begun to address ethical issues related to the donation of cells, gametes, or embryos for research. In this commentary, we move beyond these ethical concerns to discuss new themes that scientists on the forefront of NRM development anticipate, providing a preliminary framework for further discussion (...)
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  • First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless.Rebecca Dresser - 2009 - Journal of Law, Medicine and Ethics 37 (1):38-50.
    The 21st-century translational science campaign could lead to an increase in first-in-human trials. As tests of investigational interventions move from the laboratory to human research, scientists, officials, and review committees should address ongoing concerns about the ethics of FIH trials. In this article, I describe three ethical considerations relevant to all FIH trials: the requirement for adequate preclinical research; study design safeguards; and choice of subject population. I also examine specific ethical considerations relevant to the three subject populations involved in (...)
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  • First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless.Rebecca Dresser - 2009 - Journal of Law, Medicine and Ethics 37 (1):38-50.
    Translational science is a 21st century mission. Government officials and industry leaders are making huge investments in an attempt to transform more basic science discoveries into therapeutic applications. Scientists and policymakers express great excitement about the medical advances that could come with the current bench-to-bedside campaign.A key step in translational science is the move from animal and other preclinical studies to initial human testing. Researchers ability to predict human effects is limited, and first-in-human tests present significant uncertainty. Participants in this (...)
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  • The Meaning of Informed Consent: Genome Editing Clinical Trials for Sickle Cell Disease.Stacy Desine, Brittany M. Hollister, Khadijah E. Abdallah, Anitra Persaud, Sara Chandros Hull & Vence L. Bonham - 2020 - AJOB Empirical Bioethics 11 (4):195-207.
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  • Clinicians or Researchers, Patients or Participants: Exploring Human Subject Protection When Clinical Research Is Conducted in Non-academic Settings.Ann Freeman Cook & Helena Hoas - 2014 - AJOB Empirical Bioethics 5 (1):3-11.
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  • Research ethics and international epidemic response: The case of ebola and marburg hemorrhagic fevers.Philippe Calain, Nathalie Fiore, Marc Poncin & Samia A. Hurst - 2009 - Public Health Ethics 2 (1):7-29.
    Institute for Biomedical Ethics, Geneva University Medical School * Corresponding author: Médecins Sans Frontières (OCG), rue de Lausanne 78, CH-1211 Geneva 21, Switzerland. Tel.: +41 (0)22 849 89 29; Fax: +41 (0)22 849 84 88; Email: philippe_calain{at}hotmail.com ' + u + '@' + d + ' '//--> Abstract Outbreaks of filovirus (Ebola and Marburg) hemorrhagic fevers in Africa are typically the theater of rescue activities involving international experts and agencies tasked with reinforcing national authorities in clinical management, biological diagnosis, sanitation, (...)
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  • Informed consent to HIV cure research.Danielle Bromwich & Joseph R. Millum - 2017 - Journal of Medical Ethics 43 (2):108-113.
    Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; and (...)
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