As per ICH-GCP Guidelines, Informed Consent is “A process by which a subject 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 subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.”
A process in which researchers communicate with potential and enrolled participants about a clinical study. This is when researchers:
- provide all the important information about the study, so that potential participants can decide whether to enroll (or if enrolled, to continue participating);
- ensure that potential participants understand the risks and potential benefits of participating in the study, and the alternatives to the research being conducted; and
- stress that enrolling in (and staying in) a clinical study is completely voluntary. Because giving consent to participate in research is not a contract, participants can leave a study at any time.
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 until the study ends. 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 document to enroll in a study.