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  1. What is the best standard for the standard of care in clinical research?Rieke van der Graaf & Johannes J. M. van Delden - 2009 - American Journal of Bioethics 9 (3):35 – 43.
    During the past decennium, one of the main issues discussed in research ethics has been focused on the care that should be provided to the control group in a clinical trial. This discussion is also called the standard of care debate . Current international research ethics guidelines contain a wide variety of standards for the standard of care—including the provision of the highest attainable, the best available, the best current, a proven , and an established effective treatment. In this article, (...)
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  • Developing ethics guidance for HIV prevention research: the HIV Prevention Trials Network approach.Stuart Rennie & Jeremy Sugarman - 2010 - Journal of Medical Ethics 36 (12):810-815.
    More than 25 years into the HIV epidemic, in excess of 2 million new infections continue to occur each year. HIV prevention research is crucial for groups at heightened risk for HIV, but the design and conduct of HIV prevention research with vulnerable populations worldwide raises considerable ethical challenges. The HIV Prevention Trials Network (HPTN) is a global collaborative network that conducts clinical and behavioural studies on non-vaccine interventions to reduce the transmission of HIV. In 2003, the HPTN developed ethical (...)
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  • Paper: The challenge of defining standards of prevention in HIV prevention trials.Sean Philpott, Lori Heise, Elizabeth McGrory, Lynn Paxton & Catherine Hankins - 2011 - Journal of Medical Ethics 37 (4):244-248.
    As new HIV prevention tools are developed, researchers face a number of ethical and logistic questions about how and when to include novel HIV prevention strategies and tools in the standard prevention package of ongoing and future HIV prevention trials. Current Joint United Nations Programme on HIV/AIDS /World Health Organization guidance recommends that participants in prevention trials receive ‘access to all state of the art HIV risk reduction methods’, and that decisions about adding new tools to the prevention package be (...)
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  • Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi. [REVIEW]Paul M. Ndebele, Douglas Wassenaar, Esther Munalula & Francis Masiye - 2012 - BMC Medical Ethics 13 (1):29-.
    Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n= 124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used (...)
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  • Fiduciary Obligation in Clinical Research.Paul B. Miller & Charles Weijer - 2006 - Journal of Law, Medicine and Ethics 34 (2):424-440.
    Heated debate surrounds the question whether the relationship between physician-researcher and patient-subject is governed by a duty of care. Miller and Weijer argue that fiduciary law provides a strong legal foundation for this duty, and for articulating the terms of the relationship between physician-researcher and patient-subject.
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  • Fiduciary Obligation in Clinical Research.Paul B. Miller & Charles Weijer - 2006 - Journal of Law, Medicine and Ethics 34 (2):424-440.
    Bioethics is currently witnessing unprecedented debate over the moral and legal norms governing the conduct of clinical research. At the center of this debate is the duty of care in clinical research, and its most widely accepted specification, clinical equipoise. In recent work, we have argued that equipoise and cognate concepts central to the ethics of clinical research have been left unnecessarily vulnerable to criticism. We have suggested that the vulnerability lies in the conspicuous absence of an articulated foundation in (...)
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  • HIV prevention research and global inequality: steps towards improved standards of care.K. Shapiro - 2005 - Journal of Medical Ethics 31 (1):39-47.
    Next SectionIntensification of poverty and degradation of health infrastructure over recent decades in countries most affected by HIV/AIDS present formidable challenges to clinical research. This paper addresses the overall standard of health care (SOC) that should be provided to research participants in developing countries, rather than the narrow definition of SOC that has characterised the international debate on standards of health care. It argues that contributing to sustainable improvements in health by progressively ratcheting the standard of care upwards for research (...)
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  • How Good Is “Good Enough”? The Case for Varying Standards of Evidence According to Need for New Interventions in HIV Prevention.Bridget Haire, John Kaldor & Christopher Fc Jordens - 2012 - American Journal of Bioethics 12 (6):21-30.
    In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. (...)
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