Frequently Asked Questions (FAQ)
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial
before deciding whether or not to participate. It is also a continuing process throughout
the study to provide information for participants. To help someone decide whether or not
to participate, the doctors and nurses involved in the trial explain the details of the
study. If the participant's native language is not English, translation assistance can be
provided. Then the research team provides an informed consent document that includes details
about the study, such as its purpose, duration, required procedures, and key contacts. Risks
and potential benefits are explained in the informed consent document. The participant then
decides whether or not to sign the document. Informed consent is not a contract, and the
participant may withdraw from the trial at any time.
