知情同意（IC）不仅仅是一个签名或文件，需要确保患者有足够的信息，以便在知情的情况下做出参与临床研究的决定。本次培训的目标是了解 FDA 对知情同意的期望、审查在知情同意中促进参与者理解的方法等。
50.20知情同意的一般要求：FDA法规要求调查人员在极少数例外情况下，在受试者参加FDA监管的医学产品临床试验之前，必须获得受试者的知情同意。知情同意必须是前瞻性的、可理解的，并且不包括排斥性语言。同意程序也不得造成不适当的影响或胁迫。
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§ 50.20 General requirements for informed consent.
Except as provided in §§ 50.22, 50.23, and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
[46 FR 8951, Jan. 27, 1981, as amended at 64 FR 10942, Mar. 8, 1999; 88 FR 88248, Dec. 21, 2023]
• 一份声明：
-说明目的/预期期限
-程序/研究干预的说明
• 可预见的风险
• 对受试者或他人的合理预期收益
• 披露适当的替代品
• 保密性/FDA可能会检查
赔偿和与研究有关的伤害
提问的联系人
参与是自愿的。
• 声明特定的治疗或程序可能对受试者(或胚胎或胎儿)造成不可预见的危险
• 终止研究的情况
• 研究的成本
• 退出研究的后果
• 将发表一份声明，说明与该研究对象是否愿意继续进行有关的重大新发现。
• 研究中受试者的大约数量
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