What is Informed Consent in respect of research?
Informed consent is a process by which a participant voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the individuals decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. (ICH GCP 1.28) Before a participant is involved in any study specific procedure or investigation that is part of a research protocol their written consent must be obtained. The consent is valid only if it has been given freely, with no coercion from the investigator or trial staff. Individuals must be fully informed about the study so that they understand the nature and consequences of their participation prior to giving their consent.
