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What is informed consent



Informed consent, a key part of a good trial, is required in studies that are federally regulated or funded, as well as by many state laws. Informed consent means that as a patient, you are given information so you can understand what is involved in a trial, including its potential benefits and risks, and then decide freely to take part in it or not. The nature of treatment is explained by the doctors and nurses in the trial. You are given an informed consent form to read and consider carefully. Ask any questions you may have. Then, if you agree to take part, you can sign the form. Of course, you can also refuse.

The informed consent process is an ongoing process. If you enter a trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial. Signing the consent form does not bind you to the study. You can still choose to leave the study at any time.

The above information is taken from "What Are Clinical Trials All About?" published by the National Institutes of Health, National Cancer Institute