Informed Consent and Human Subject Trial

Informed Consent, served as an effective measure to protect the subjects and patients, has enjoyed the wide recognition in the fields of the Law of Life and the Law of Medical Ethics, and has become the paradigm of consent in human body trials and clinical practices internationally. It involves two essential parts: a document and a process. The informed consent document provides the participant with purpose, procedures, schedule, potential risks and benefits of human trials and the rights of participants. The informed consent process provides participants with ongoing explanations that will help the subjects make the educated decisions about whether to participate in a trial. The article reviews the origin and evolution of informed consent, and approaches the essence of informed consent, the informed range and autonomy of decision-making.