Rose Carlos D
Division of Rheumatology, Nemours Alfred I. duPont Hospital for Children, Thomas Jefferson University, Wilmington, Delaware; and Chair, Nemours Wilmington Institutional Review Board, Nemours Office of Human Research Protection, Wilmington, Delaware
Pediatrics. 2017 Jun;139(6). doi: 10.1542/peds.2016-3650. Epub 2017 May 11.
In part 1 of this series, we discussed the historical, ethical, and legal background that provides justification for the current system of protection of subjects of human experimentation. We also discussed briefly the implementation of those principles in institutional review board (IRB) operations. In part 2, we focus on legislation dealing with pediatric research, the rules and ethics of assent, and then turn our attention to minimal-risk studies. To that end, we discuss the minimal-risk threshold and the process of balancing benefit and risk in IRB decisions for pediatric studies. We define the notion of consent waiver as well as the procedures for expedited review, management of adverse events, and amendments to approved protocol. Finally, we mention some miscellaneous issues, including central and commercial IRB, reliance agreements, biobanks, and sample shipping regulations.
在本系列的第1部分中，我们讨论了为当前人体实验受试者保护体系提供正当理由的历史、伦理和法律背景。我们还简要讨论了这些原则在机构审查委员会（IRB）运作中的实施情况。在第2部分中，我们重点关注涉及儿科研究的立法、同意的规则和伦理，然后将注意力转向最低风险研究。为此，我们讨论了最低风险阈值以及IRB在儿科研究决策中平衡利益和风险的过程。我们定义了同意豁免的概念以及快速审查、不良事件管理和批准方案修订的程序。最后，我们提及一些杂项问题，包括中央和商业IRB、信赖协议、生物样本库和样本运输规定。
