informed consent form
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informed consent formEBM
The document used in a clinical trial that explains to potential participants the risks and potential benefits of a study, and the rights and responsibilities of the parties involved. The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. It is designed to begin the informed consent process, which consists of a dialogue between the subject and the research team; if the individual then decides to enter the trial, he or she gives his or her official consent by signing the document.