What is a clinical trial?
A clinical trial is an organized study involving a group of healthy volunteers or patients (people with the condition being studied). The goal of the
trial is to obtain clinical data so that the treatment(s) being studied can be evaluated in a scientific manner.
Why Participate in a Clinical Trial?
Participants in clinical trials can play an active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
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.
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