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Informed consent is a process by which people learn the important facts about a
clinical trial to help them decide whether to participate. This process is used
in every imaging clinical trial and in clinical trials in general. This
information includes details about what is involved, such as the purpose of the
study, the tests and other procedures used in the study, and the possible risks
and benefits. In addition to talking to the doctor or nurse, people receive a
written consent form explaining the study. People who agree to take part in the
study are asked to sign the consent form. However, signing the form does not
mean people must stay in the study. People can leave the study at any time -
either before the study starts or at any time during the study or follow-up
period.
The informed consent process continues throughout the study. If new benefits,
risks, or side effects are discovered during the study, the researchers must
inform the participants. They may be asked to sign new consent forms if they
want to stay in the study.
You should feel free at any time to discuss questions or concerns with the
doctors and nurses in charge of the study. To find out more about informed
consent, go to A Guide to Understanding Informed Consent.
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