Smith-Tyler June
Schulman Associates Institutional Review Board, Inc., 4290 Glendale-Milford Road, Cincinnati, OH 45242, USA.
Proc Am Thorac Soc. 2007 May;4(2):189-93; discussion 193. doi: 10.1513/pats.200701-008GC.
The informed consent process is designed to inform the subject of the risks, rights, and benefits of participation in a clinical research trial. Informed consent, while not always necessary, is a critical component of ethical research involving human subjects. This article includes an overview of two sets of regulations regarding informed consent found in the Code of Federal Regulations (CFR) Titles 21 and 45: 21 CFR 50 and 56, the Food and Drug Administration Regulations, and 45 CFR 46, where applicable, the Department of Health and Human Services Regulations. Also included in this discussion are the general requirements of informed consent; challenging issues regarding informed consent; determining and obtaining informed consent in research involving vulnerable subjects (e.g., children, critically ill patients); the use of genetic information; confidentiality and privacy of subject information; and compensation for injury during a research study. Examples of acceptable and unacceptable (exculpatory) informed consent language are also provided as they may pertain to commercial gain, confidentiality, and compensation for injury. The goal of this article is to provide the clinical researcher with an explanation of the legal requirements for informed consent in clinical research. The researcher faces many challenges in implementing effective informed consent beyond the federal regulations.
知情同意程序旨在让受试者了解参与临床研究试验的风险、权利和益处。知情同意虽并非总是必要，但却是涉及人类受试者的伦理研究的关键组成部分。本文概述了联邦法规（CFR）第21编和第45编中关于知情同意的两套法规：适用时，21 CFR 50和56（食品药品监督管理局法规）以及45 CFR 46（卫生与公众服务部法规）。本讨论还包括知情同意的一般要求；关于知情同意的具有挑战性的问题；在涉及弱势受试者（如儿童、重症患者）的研究中确定并获得知情同意；遗传信息的使用；受试者信息的保密和隐私；以及研究期间受伤的补偿。还提供了可接受和不可接受（免责）的知情同意语言示例，因为它们可能涉及商业利益、保密和受伤补偿。本文的目的是向临床研究人员解释临床研究中知情同意的法律要求。研究人员在实施超越联邦法规的有效知情同意方面面临诸多挑战。
