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医学伦理委员会和知情同意书是受试者参与药物临床试验的主要保护措施。临床试验中知情同意的完整性主要包含知情同意书和知情同意过程。知情同意(Informed Consent)已成为国际上生命法学和生命伦理学的核心问题之一，无论是在医学界还是医学伦理学界对知情同意的认识，都存在一些不同的看法。本文主要试图对知情同意的完整性方面的内容作简要介绍、评述和探讨。“,”Medical ethics commit ee and informed consent is the main protection of subjects involved in drug clinical trials.The integrity of the informed consent in clinical trial mainly include informed consent and informed consent process.Informed consent (Informed Consent)has become the one of the core issue ofbioethics and international life jurisprudence,in both medical and medical ethics educational world understanding of informed consent,there are some dif erent opinions.This paper at empts to discuss the completeness of informed consent.