White Michael G
Department of Pediatric Cardiology, Ochsner Clinic Foundation, New Orleans, LA and The University of Queensland Faculty of Medicine, Ochsner Clinical School, New Orleans, LA.
Ochsner J. 2020 Spring;20(1):16-33. doi: 10.31486/toj.20.5012.
Institutional review boards (IRBs), duly constituted under the Office of Human Research Protection, have the federally mandated responsibility of reviewing research involving human subjects to ensure that a proposed protocol meets the appropriate ethical guidelines before subjects may be enrolled in any study. The road leading to the current regulations and ethical considerations has been long and checkered. This paper reviews the history of human subjects participating in research, including examples of egregious events, and the ethical analyses that precipitated the evolution of the mandated protections afforded participants in research under current federal regulations. Key documents-from the Nuremberg Code in 1947 to the Belmont Report in 1978 to in 2011-that have informed the ethics debate regarding human subjects protection in research activities are presented in light of their historic significance, highlighting the complexity of the issues surrounding protection of human subjects in research. The examples from history and the scarcity of contemporary examples demonstrate that the regulations for the protection of humans participating in research have evolved in a way that minimizes the probability that subjects will be harmed when they choose to participate in research. The examples also reinforce the importance of individual responsibility. Failure of IRBs to provide appropriate review and oversight can lead to severe consequences, as can abrogation by the investigator to place the well-being of the subjects as the primary responsibility in any research protocol. Understanding how we arrived at the current approach and some of the failures that directed this course can support efforts to continually reevaluate and improve the safety of subjects who are willing to participate in research activities.
根据人类研究保护办公室正式组建的机构审查委员会（IRB），负有联邦政府规定的职责，即审查涉及人类受试者的研究，以确保在受试者被纳入任何研究之前，拟议的方案符合适当的伦理准则。通向当前法规和伦理考量的道路漫长且波折。本文回顾了人类受试者参与研究的历史，包括恶劣事件的例子，以及引发当前联邦法规所规定的研究参与者保护措施演变的伦理分析。介绍了从1947年的《纽伦堡法典》到1978年的《贝尔蒙报告》再到2011年的关键文件，根据它们的历史意义阐述了有关研究活动中人类受试者保护的伦理辩论，突出了围绕研究中人类受试者保护问题的复杂性。历史例子和当代例子的稀缺表明，保护参与研究的人类的法规已经以一种方式演变，即当受试者选择参与研究时，将他们受到伤害的可能性降至最低。这些例子也强化了个人责任的重要性。IRB未能提供适当的审查和监督可能会导致严重后果，研究者在任何研究方案中未能将受试者的福祉作为首要责任也会如此。了解我们如何形成当前的方法以及导致这个过程的一些失败情况，可以支持不断重新评估和提高愿意参与研究活动的受试者安全性的努力。
