Gonzalez Stephanie K, Helling Thomas S
Department of Surgery, Conemaugh Memorial Medical Center, Johnstown, Pennsylvania, USA.
J Trauma. 2008 Jun;64(6):1665-72. doi: 10.1097/TA.0b013e31817156ce.
The development of life-saving techniques in medical emergencies often requires enrollment of patients into clinical trials without the opportunity for informed consent. The Food and Drug Administration had designated such exemptions from informed consent for the purpose of emergency research as "the Final Rule." In the decade following the Final Rule for emergency research, little progress has been made in the study of therapies for acute, life-threatening conditions with high mortality rates. The potential for significant change in accepting research without consent begins with a level of public knowledge, trust, and credibility in the healthcare delivery system. This review seeks to address the Final Rule and its ramifications and issues that undermine the provisions of emergency research. In understanding the complexities of emergency research and its potential, there are opportunities for improvement for the scientific community to develop a greater understanding of the general public's attitudes and perceptions concerning research without consent.
在医疗紧急情况中，挽救生命技术的发展往往需要在患者无法获得知情同意的情况下将其纳入临床试验。美国食品药品监督管理局已将这种出于紧急研究目的而免于知情同意的情况指定为“最终规则”。在紧急研究最终规则发布后的十年里，针对高死亡率的急性、危及生命病症的治疗研究进展甚微。在未经同意的情况下接受研究方面实现重大变革的可能性始于公众对医疗保健提供系统的了解程度、信任度和可信度。本综述旨在探讨最终规则及其影响以及破坏紧急研究规定的问题。在理解紧急研究的复杂性及其潜力时，科学界有机会进行改进，以更深入地了解公众对未经同意的研究的态度和看法。
