What is Informed Consent?
Informed consent is the process of learning about a clinical trial before deciding whether or not to participate. To help someone decide, the doctors and nurses involved in the trial are required to explain the details of the study. They also provide a written document that includes details about the study including the purpose, risks and potential benefits, duration, required procedures, and important contact information. This document is called the “informed consent form.”
People who are considering participating in a clinical trial can ask the doctors and nurses any questions about the trial until they feel comfortable about joining. They can also talk with family, friends, or their personal doctor before they choose to participate. No one should pressure or influence their decision in any way.
Each person decides whether or not to sign the form to enroll in the trial. If the participant is a child, then the parent or guardian will determine whether or not to sign the form and enroll the child in the trial. Informed consent is not a contract and the participant may withdraw from the trial at any time for any reason.
Your rights in a clinical trial
All clinical trial participants have the right to:
- Clearly understand the risks, possible benefits, tests that will be done, and other information about the trial that is outlined in the informed consent
- Receive a signed and dated copy of the informed consent form
- Ask the doctors and nurses any questions about the trial at any time
- Leave the trial at any time and for any reason
- Ask to receive the results of the trial after it is done
All clinical trial participants have the responsibility to:
- Provide truthful answers to the questions that the doctors and nurses ask
- Follow the rules of the clinical trial that are explained in the informed consent