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Based on the fact that patients are assigned to standard care interventions, no informed consent is sought either in low-risk pragmatic RCTs [17] or in prompted optional randomisation trials [18, 19].
Sep 20, 2024
Aug 5, 2024 · They argued that specific written informed consent should not be mandatory for all randomized trials provided that (1) all treatments can be offered outside ...
Jan 18, 2024 · The authors argue that informed consent is ethically necessary in pragmatic trials that randomly assign individual patients to treatments, ...
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Mar 11, 2024 · (4) Finally, waiver of informed consent process or simplification of the process is routinely acceptable in pragmatic clinical trials that rely on registries ...
Dec 21, 2023 · This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human ...
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Oct 15, 2024 · If only regarding consent as necessary to inform about added risks of experimentation, consent may be waived or simplified in pragmatic trials between low-risk ...
Aug 1, 2024 · Importantly, an alteration or waiver of consent does not necessarily mean that investigators have no obligations to address collateral findings. As ...
Aug 21, 2024 · Low risk pragmatic trials do not always require participants' informed consent. BMJ 2019;364:l1092. [PubMed: 30917969]. [14]. https://www.pcori.org/funding ...
Aug 19, 2024 · This study shows that e-consent was acceptable and accessible as a method for written informed consent in busy EDs if an electronic device is available for use.
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Aug 6, 2024 · First, pragmatic trials are mostly minimal risk research; often, participants can read the materials and consent remotely without the presence of a clinician ...
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