Informed Consent (IC)

Process by which a participant voluntarily confirms their willingness to participate in a study, after having been informed of all aspects of the study that are relevant to the participants’ decision to participate. Informed consent is documented by means of a written, signed and dated Informed Consent Form (ICF). ICH GCP, 1.28

The active sharing of information between the researcher and the participant (or the participant’s Legally Authorized Representative (LAR)/parent/guardian) begins with the first information exchange with the participant about the study to make an informed and voluntary decision about whether to participate (or not) and continues beyond study termination to ensure that the participant has information about the research to make an informed and voluntary decision about whether to continue participation in the study (or not). All interactions with study participants are opportunities for education and support with the process of informed consent. In addition, any new information or findings about the study that may affect a participant’s willingness to continue participation must be communicated to the participants, and former participants in some cases, as part of the ongoing informed consent discussion.