Before participating in a study, participants are provided information about the study and are given the chance to ask questions. This process is called Informed Consent. The purpose of the Informed Consent process is to make sure participants are adequately informed of important details about the clinical study so they can make an informed choice about their participation. Informed Consent begins before a research volunteer agrees to participate in a trial and continues throughout the study.
The Informed Consent document describes the study to research participants. It includes details about the study’s purpose, length, procedures, risks and benefits, and other information that all participants should know. Participants sign the document before they enter the study, but only after having read and discussed it with the research team and demonstrating an understanding of the information provided. In some cases, there will be multiple Informed Consent documents throughout the study as changes are made to the study protocol or new safety information becomes available. Signing the document(s) and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.