LupusTrials.org The goal of the informed consent process is to protect participants. It begins when a potential participant first asks for information about a study and continues throughout the study. The researcher and potential participant have discussions that include answering the participant’s questions about the research. All the important information about the study must also be given to the potential participant in a written document that is clear and easy to understand. This informed consent document is reviewed and approved by the human subjects review board for a study before it is given to potential participants. Generally, a person must sign an informed consent form to enroll in a study.
Source: ClinicalTrials.gov