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The third vignette was an emergency trial with a drug already registered for another indication.
The third imaginary research project (vignette 3, Additional file 1) was an emergency trial with a licensed drug given by ambulance personnel without informed consent.
An exception is a study of an African emergency trial, FEAST, which incorporated a preliminary and brief verbal assent stage before administration of the investigatory interventions, as well as deferred consent following the intervention.
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to explore women's and their partners' views of recruitment to emergency trials in severe postpartum haemorrhage (PPH).
We improve our understanding of the community consultation process for acute neurologic emergency trials conducted under the federal regulations for Exception From Informed Consent (EFIC) for emergency research.
Here we present our experience in two emergency trials [ 1].
We also explored the views of parents who had experienced prospective consent within CATCH about the wider application of deferred consent in children's emergency trials.
However, they spoke of how, in other emergency trials, staff refusal to take additional blood samples before seeking deferred consent could invalidate a trial's results if this introduced bias or led to missing data.
Analysis of questionnaires completed by parents after their CATCH consent discussion indicated that their decisions had been made voluntarily, while in the latter part of interviews, parents described their support for deferred consent in CATCH and for other emergency trials.
We further explored this acceptance of deferred consent in CATCH by asking parents about their views on the potential use of deferred consent in other emergency trials, which might not always involve investigational treatments already used as a routine part of emergency treatments.
The ESCAPE (effectiveness and safety of chest pain evaluation to prevent emergency admission) trial was a randomised controlled trial and economic evaluation of CPU versus routine care that showed that CPU care was associated with reduced hospital admission [ 15], improved health utility [ 15] and improved patient satisfaction [ 16], and was likely to be considered cost-effective [ 15].
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com