Informed consent process

The process by which potential participants in a study receive the information needed to decide whether or not to participate. As a first step, a potential participant meets one of the researchers, usually a doctor, who explains, in a one-to-one talk, the details of the study (aims, process, interventions, procedures), and the possible benefits and risks associated with participation. After this discussion, the doctor provides the same details in a written form (see Information sheet). If the patient decides to participate in the study, she/he has to sign the informed consent form.

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