Straight Timothy M
Department of Clinical Investigation, Brooke Army Medical Center, San Antonio, TX 78234-6315, USA.
Clin Dermatol. 2009 Jul-Aug;27(4):375-83. doi: 10.1016/j.clindermatol.2009.02.012.
The system in place to ensure the ethical conduct of human subject research in accordance with federal regulations has drawn great criticism from all sides, to include clinical investigators, administrators, research subjects, and legislators. The administrative requirements associated with clinical trials has changed dramatically in the last several decades, as has the complexity of the science being regulated. The institutional review board (IRB) system, however, appears to be struggling to keep pace, and has even been labeled a "system in jeopardy" by a national committee of experts. This contribution outlines the current obstacles and critique of IRBs, providing a discussion of the structure of the IRB system and strategies to meet these challenges.
为确保按照联邦法规开展人体研究的道德行为而设立的体系受到了各方的严厉批评，包括临床研究人员、管理人员、研究对象和立法者。在过去几十年里，与临床试验相关的行政要求发生了巨大变化，受到监管的科学的复杂性也同样如此。然而，机构审查委员会（IRB）系统似乎难以跟上步伐，甚至被一个国家专家委员会称为“处于危险中的系统”。本文阐述了IRB目前面临的障碍和受到的批评，讨论了IRB系统的结构以及应对这些挑战的策略。
