Informed consent is voluntary agreement after receiving and understanding relevant information about an intervention or participation in research. In a clinical trial, the participant is informed about the study procedures, potential benefits and risks, alternatives and the option to decline or withdraw. Consent precedes randomization.
Communicating the nature, probability and uncertainty of benefits and harms in a form suitable for the decision. Absolute frequencies with explicit denominators, balanced framing and plans for responding to symptoms support comprehension without suppressing material information.
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