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  1. SUPPORT: Risks, Harms, and Equipoise.Robert M. Nelson - 2015 - Hastings Center Report 45 (1):40-42.
    The debate about the ethics of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) often focuses on the assumptions made by the different parties involved, failing to note the lack of a necessary connection between those assumptions and the main criticism of the study—that the parents appear to have been poorly informed. The fact that the target ranges of oxygen saturation (SpO2) used in SUPPORT were within the range recommended as an appropriate “standard of care” does not mean that (...)
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  • Informed Consent for Comparative Effectiveness Research Should Not Consider the Risks of the Standard Therapies That Are Being Studied as Risks of the Research.John D. Lantos - 2017 - Journal of Law, Medicine and Ethics 45 (3):365-374.
    There is a debate at the highest levels of government about how to classify the risks of research studies that evaluate therapies that are in widespread use. Should the risks of those therapies be considered as risks of research that is designed to evaluate those therapies? Or not? The Common Rule states, “In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research.” ). By contrast, the Office of Human Research Protections, (...)
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  • Where Did Informed Consent for Research Come From?Alexander Morgan Capron - 2018 - Journal of Law, Medicine and Ethics 46 (1):12-29.
    To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.
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