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A limited number of medicines pragmatic trials had potential for waived informed consent following the 2016 CIOMS ethical guidelines.

08:00 EDT 15th June 2019 | BioPortfolio

Summary of "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.

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This article was published in the following journal.

Name: Journal of clinical epidemiology
ISSN: 1878-5921
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