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What is Meant by “Informed Consent”?

*August 2022* By EGFR Resisters Co-founder Ivy Elkins for

Unless you have participated in a clinical trial, you might not be familiar with the term “informed consent,” commonly used to refer to the document that patients are given when they are considering signing up for a trial. This document contains information about the trial, discusses risks of participating, and includes details about the experimental treatment and required tests. Patients need to sign the document before beginning a clinical trial.

What is informed consent?
The National Cancer Institute (NCI), however, defines informed consent as “a process in which patients are given important information, including possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This is to help them decide if they want to be treated, tested, or take part in the trial. Patients are also given any new information that might affect their decision to continue. Also called consent process.”1 This leads to an important question: Is informed consent a process, as the NCI definition indicates, or is it merely a document? Read more.