Informed Consent

Informed consent explains the risks and potential benefits associated with a clinical study before someone decides whether to participate. This is the process by which a participant (or legal guardian) voluntarily confirms his/her willingness to participate in a particular study (after learning about all aspects of the study relevant to his/her decision to take part). Informed consent is usually documented by means of a written, signed, and dated informed consent form, which has been approved by an Institutional Review Board, Independent Ethics Committee, or Human Subjects Protection Review Board. (NIH)