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  1. 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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  • Reconceptualising Risk–Benefit Analyses: The Case of HIV Cure Research.Robert Steel - 2020 - Journal of Medical Ethics 46 (3):212-219.
    Modern antiretroviral therapies are capable of suppressing HIV in the bloodstream to undetectable levels. Nonetheless, people living with HIV must maintain lifelong adherence to ART to avoid the re-emergence of the infection. So despite the existence and efficacy of ART, there is still substantial interest in development of a cure. But HIV cure trials can be risky, their success is as of yet unlikely, and the medical gain of being cured is limited against a baseline of ART access. The medical (...)
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  • Limits to Research Risks.F. G. Miller & S. Joffe - 2009 - Journal of Medical Ethics 35 (7):445-449.
    Risk–benefit assessment is a routine requirement for research ethics committees that review and oversee biomedical research with human subjects. Nevertheless, it remains unclear how to weigh and balance risks to research participants against the social benefits that flow from generating biomedical knowledge. In this article, we address the question of whether there are any reasonable criteria for defining the limit of permissible risks to individuals who provide informed consent for research participation. We argue against any a priori limit to permissible (...)
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  • A Framework for Risk-Benefit Evaluations in Biomedical Research.Wendler Annette Rid David - 2011 - Kennedy Institute of Ethics Journal 21 (2):141-179.
    One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to (...)
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  • Supporting Controlled Non-Heart-Beating Donation.David Price & Jo Samanta - 2013 - Cambridge Quarterly of Healthcare Ethics 22 (1):22-32.
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