在20世纪的过程中，知情同意的概念发展了很多，导致其在美国生物医学研究中被确立为基础伦理原则。尽管它现在是癌症研究中一个高度规范化的部分，但获得知情同意的过程通常受到系统性、临床医生和患者因素的阻碍，需要进行小规模和大规模的干预。由于临床试验设计的创新、基因组测序的使用增加以及基因组编辑和人工智能的进展，新的挑战和考虑不断出现。我们在临床试验中知情同意这一核心伦理准则的历史、政策、实用挑战和不断发展的角色提供了一篇综述。Copyright © 2023 Elsevier Inc. All rights reserved.

The concept of informed consent has evolved considerably over the course of the 20th century, leading to its establishment as a foundational ethical principle for the conduct of biomedical research in the United States. Even though it is now a highly regulated part of cancer research, the process of obtaining informed consent is often impeded by systemic, clinician, and patient factors that require both small- and large-scale intervention. New challenges and considerations continue to emerge due to innovations in clinical trial design, increases in utilization of genomic sequencing, and advances in genomic editing and artificial intelligence. We present a review of the history, policy, pragmatic challenges, and evolving role of the central ethical tenet of informed consent in clinical trials.Copyright © 2023 Elsevier Inc. All rights reserved.