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  1. Subjects' views of obligations to ensure post-trial access to drugs, care and information: qualitative results from the Experiences of Participants in Clinical Trials (EPIC) study.N. Sofaer, C. Thiessen, S. D. Goold, J. Ballou, K. A. Getz, G. Koski, R. A. Krueger & J. S. Weissman - 2009 - Journal of Medical Ethics 35 (3):183-188.
    Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial drug, (...)
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  • Rethinking informed consent in bioethics.Neil C. Manson - 2007 - New York: Cambridge University Press. Edited by Onora O'Neill.
    Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent needs distinctive communicative transactions, by which (...)
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  • (1 other version)Global Health and the Scientific Research Agenda.James H. Flory & Philip Kitcher - 2004 - Philosophy and Public Affairs 32 (1):36-65.
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  • The obligation to ensure access to beneficial treatments for research participants at the conclusion of clinical trials.J. V. Lavery - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 697--710.
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  • RAC Oversight of Gene Transfer Research: A Model Worth Extending?Nancy M. P. King - 2002 - Journal of Law, Medicine and Ethics 30 (3):381-389.
    Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by the same (...)
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  • Justice and the Human Development Approach to International Research.Alex John London - 2005 - Hastings Center Report 35 (1):24.
    The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice.
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  • Responsiveness to Host Community Health Needs.Alex John London - unknown
    There is near universal agreement within the scientific and ethics communities that a necessary condition for the moral permissibility of cross-national, collaborative research is that it be responsive to the health needs of the host community. It has proven difficult, however, to leverage or capitalize on this consensus in order to resolve lingering disputes about the ethics of international medical research. This is largely because different sides in these debates have sometimes provided different interpretations of what this requirement amounts to (...)
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  • Expedited Industry-Sponsored Translational Research: A Seductive but Hazardous Cocktail?Jonathan H. Marks - 2008 - American Journal of Bioethics 8 (3):56-58.
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  • Harm, ethics committees and the gene therapy death.Julian Savulescu - 2001 - Journal of Medical Ethics 27 (3):148-150.
    The recent tragic and widely publicised death of Jesse Gelsinger in a gene therapy trial has many important lessons for those engaged in the ethical review of research. One of the most important lessons is that ethics committees can give too much weight to ensuring informed consent and not enough attention to minimising the harm associated with participation in research. The first responsibility of ethics committees should be to ensure that the expected harm associated with participation is reasonable. Jesse was (...)
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  • The ethos and ethics of translational research.Jane Maienschein, Mary Sunderland, Rachel A. Ankeny & Jason Scott Robert - 2008 - American Journal of Bioethics 8 (3):43 – 51.
    Calls for the “translation” of research from bench to bedside are increasingly demanding. What is translation, and why does it matter? We sketch the recent history of outcome-oriented translational research in the United States, with a particular focus on the Roadmap Initiative of the National Institutes of Health (Bethesda, MD). Our main example of contemporary translational research is stem cell research, which has superseded genomics as the translational object of choice. We explore the nature of and obstacles to translational research (...)
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  • Exploitation in clinical research.Alan Wertheimer - 2008 - In Ezekiel J. Emanuel (ed.), The Oxford textbook of clinical research ethics. New York: Oxford University Press. pp. 201--10.
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  • Clinical trials and scid row: The ethics of phase 1 trials in the developing world.Jonathan Kimmelman - 2007 - Developing World Bioethics 7 (3):128–135.
    ABSTRACTRelatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer’s most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear to have complied with (...)
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  • AZT Trials and Tribulations.Robert A. Crouch & John D. Arras - 1998 - Hastings Center Report 28 (6):26-34.
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  • Translational Research: A New Social Contract That Still Leaves Out Public Health?Karine Morin - 2008 - American Journal of Bioethics 8 (3):62-64.
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  • Exploitation and developing countries: The ethics of clinical research.Jennifer S. Hawkins & Ezekiel J. Emanuel - 2008 - Princeton, NJ, USA: Princeton Univ Pr.
    This book was inspired originally by the debates at the turn of the century about placebo controlled trials of antiretrovirals in HIV positive pregnant women in developing countries. Moving forward from this one limited example, the book includes several additional controversial cases of clinical research conducted in developing countries, and asks probing philosophical questions about the ethics of such trials. All clinical research by its very nature uses people to acquire generalizable knowledge to help future people. But what sorts of (...)
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  • Stem cell stories: from bedside to bench.S. Woods - 2008 - Journal of Medical Ethics 34 (12):845-848.
    The stem cell story is not a simple story but a complex narrative: one that requires careful analysis in order to identify major themes and plots. This paper offers an analysis of the ethics of the clinical application of stem cells and argues that even quite risky therapies can be ethical. These arguments cannot be used to justify all aspects of contemporary stem cell science, including human embryonic stem cell science, which remains theoretical and speculative. It is argued that the (...)
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  • Points to Consider for Ethics Committees in Human Gene Therapy Trials.Ulrich Dettweiler & Perikles Simon - 2001 - Bioethics 15 (5-6):491-500.
    Recent political developments and disclosures of serious adverse events in human gene therapy (HGT) with the death of 18‐year old Jesse Gelsinger in the USA have shown that the clinical application of HGT raises some severe ethical issues. These have either been neglected or not yet been discussed to a satisfactory extent. In this paper, we will address this deficiency and develop strategies for a safer application of HGT. Such a study must first look closely at the science of HGT (...)
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