A limited number of medicines pragmatic trials had potential for waived informed consent following the 2016 CIOMS ethical guidelines
European regulations do not allow modification or waiver of informed consent for medicines randomized controlled trials (RCTs) where the three 2016 Council for International Organizations of Medical Sciences (CIOMS) provisions are met (consent would be impractical or unfeasible, yet the trial would have high social value and pose no or minimal risk to participants). We aimed to identify whether any such trials of medicines were being conducted in Europe.
Source: Journal of Clinical Epidemiology - Category: Epidemiology Authors: Rafael Dal −Ré, Cristina Avendaño−Solà, Anthonius de Boer, Stephan K. James, Frits R. Rosendaal, Richard Stephens, John PA Ioannidis Tags: Original Article Source Type: research
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