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They argued that specific written informed consent should not be mandatory for all randomized trials provided that (1) all treatments can be offered outside of the trial; (2) there is minimal additional risk or certainly no risk greater than that encountered in daily life; (3) clinical equipoise exists; (4) a “ ...
Aug 5, 2024
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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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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6 days ago · 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 ...
Dec 11, 2023 · This study explores the ethical challenges encountered by CRNs in the process of obtaining informed consent for clinical research.
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 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 ...
Apr 26, 2024 · • 13% of trials did not require informed consent before enrollment. • 89% of patients (>3 million patients) in trials that did not require informed consent.
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Jan 23, 2024 · pRCT compares clinically relevant alternative interventions, recruits participants from diverse practice settings, and collects data on various health outcomes.
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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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