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About 80% of the survey questions were taken from previously designed informed consent assessment tools; the Quality of Informed Consent (QuIC) questionnaire [ 6] and the Deaconess Informed Consent Comprehension Test (DICCT).[ 15] The survey was anonymous.
As this study was retrospectively designed, informed consent was waived by the IRB.
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The study design, informed consent and ethics procedures, and clinical results have been reported elsewhere.
The consequence is that scientific design, informed consent, and ethical oversight can be short circuited by patient led "disobedience".
The Ethics Committee of Garcia de Orta Hospital approved the study design; informed consent was waived as there was no need for additional blood samples.
The ethics committee at the Aichi Medical University School of Medicine approved the JACC Study, including study design, informed consent procedure, and data collection and analysis.
These community structures should work together with ethics committees to facilitate the study design, informed consent process, and study implementation.
Their involvement in research may greatly improve the study design, informed consent process, and study implementation, particularly those targeting vulnerable populations.
Due to the protocol design, informed consent was obtained from the patients' next of kin at the time of ICU admission.
It was critical to work collaboratively with our UAEU colleagues, receive guidance, and respond to feedback in designing our informed consent approach.
The goal of this study was to better understand family and community concerns and decision-making about post-mortem needle biopsies in this low-income, predominantly Muslim country in order to design an informed consent process.
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