Research without consent: Current status, 2003
Research without consent: Current status, 2003
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DOI：
10.1067/s0196-0644(03)00490-6
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发表时间：
2003-10-01
影响因子：
6.2
通讯作者：
Biros, MH
中科院分区：
文献类型：
--
作者：
Biros, MH
1996年11月，美国食品和药物管理局（FDA）和卫生与人类服务部（HHS）制定的条例生效，允许某些紧急和复苏人体受试者研究无需事先知情同意即可进行。这些新规定统一了负责研究监督的两个联邦机构的要求，结束了近4年来基本上关闭复苏研究的暂停。然而，FDA对知情同意的紧急例外和HHS对知情同意的放弃很少被使用。已经描述了执行条例的许多障碍，包括调查员和机构审查委员会的额外管理负担，额外的费用和时间。需要充分满足监管要求，机构审查委员会不愿允许这些研究向前推进，因为担心潜在的法律后果。无论提出的论点如何，这些规定基本上是目前唯一未经同意就为研究提供的监管选择。本文简要介绍了FDA最终规则的发展历史，总结了其要求和迄今为止的使用情况，并提出了实施建议。一些策略允许复苏研究界建议对法规进行微调，希望允许需要知情同意例外的研究以监管机构可接受的方式进行，严格保护患者，同时对实施复苏研究的实际方面敏感。
In November 1996, regulations developed by the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) went into effect to allow certain emergency and resuscitation human subjects research to proceed without prospective informed consent. These new regulations brought harmonization to the requirements of the 2 federal agencies charged with research oversight and ended a moratorium that had essentially shut down resuscitation research for almost 4 years. However, the FDA's emergency exception from informed consent and the HHS's waiver of informed consent have been used infrequently. Many perceived obstacles to implementation of the regulations have been described, including the additional regulatory burden for investigators and institutional review boards, the extra expense and time. required to adequately fulfill the regulatory requirements, and the reluctance of institutional review boards to allow these studies to move forward because of concerns about potential legal ramifications. Regardless of the arguments advanced, these regulations are essentially the only current regulatory options that have been provided for research without consent. This article presents a brief history of the development of the FDA's Final Rule, a summary of its requirements and its use so far, and suggestions for its implementation. Some strategies to allow the resuscitation research community to suggest fine tuning of the regulations are suggested in hopes that research requiring an exception from informed consent is allowed to proceed in a manner acceptable to regulators, is stringent in patient protection, and yet is sensitive to the practical aspects of performing resuscitation research.