知情同意 Informed Consent

　　知情同意：指受试者被告知可影响其做出参加临床试验决定的各方面情况后，确认同意自愿参加临床试验的过程。该过程应当以书面的、签署姓名和日期的知情同意书作为文件证明。¹⁾

　　Informed Consent: 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.²⁾

　　1. FDA: 知情同意指南（Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors）