New England Journal of Medicine · 2014 · 170 citations · 9 references
Public HealthHealth PolicyEvidence-based PracticeMedical EthicsResearch EthicsClinical Trial EthicsClinical Trial Protocol ReviewClinical TrialsConsentRandomized Controlled TrialsCommunication Of Treatment OptionsConsent In Clinical ResearchConsent In HealthcareEthical Informed ConsentInformed ConsentRandomized Controlled Trial EthicsRoutine Practice Integration
The authors argue that informed consent is ethically necessary in pragmatic trials that randomly assign individual patients to treatments, even when treatment options are within the standard of care. They propose integration of a streamlined consent process into routine practice.
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Pragmatic randomised trials using routine electronic health records: putting them to the test
Tjeerd van Staa, Ben Goldacre, Martin Gulliford et al. · BMJ · 2012 · 173 citations · Full text