Informed Consent

FDA requires that potential participants be given appropriate information about the study to enable them to decide whether to enroll in the clinical trial . This process is known as "informed consent," and it must be in writing.

The informed consent process provides an opportunity for the researcher and patient to exchange information and ask questions. Patients invited to enter a trial are not obligated to join, but can consent to participate if they find the potential risks and benefits acceptable. A consent form must be signed by the participant prior to enrollment and before any study procedures can be performed.

This is when researchers:

1. provide all the important information about the study, so that potential participants can decide whether to enroll (or if enrolled, to continue participating);
2. ensure that potential participants understand the risks and potential benefits of participating in the study, and the alternatives to the research being conducted; and
3. stress that enrolling in (and staying in) a clinical study is completely voluntary. Because giving consent to participate in research is not a contract, participants can leave a study at any time.