Sanders Arthur B, Hiller Kathy, Duldner John
Department of Emergency Medicine, University of Arizona, Tucson, AZ, USA.
Acad Emerg Med. 2005 Nov;12(11):1045-9. doi: 10.1197/j.aem.2005.06.013.
The survival of patients who present to the emergency department with severe injury or illness is dismal. Resuscitation researchers are interested in advancing the science of resuscitation, and clinical studies must be conducted to determine the best treatment protocols. These studies must reflect good science and must balance individual patient autonomy and safety with scientific progress that benefits society as a whole. Researchers find the present federal guidelines on waiver of and exception from informed consent to be time consuming and expensive. They see variability in the requirements as interpreted by institutional review boards. There is confusion regarding the requirements for public notification and response to community consultation. They believe that the majority of the public, as well as health care professionals, want resuscitation research to progress, but a minority of people and governmental regulators are uncomfortable with waiver of and exception from informed consent for research studies. There is concern and some evidence that the federal guidelines have impeded the advancement of resuscitation science. Several strategies have been suggested to improve the situation. These include 1) better education of resuscitation researchers regarding the federal guidelines, 2) a toolbox for resuscitation researchers clarifying the guidelines, 3) advocacy for the advancement of resuscitation science as a public good, and 4) a national research advisory board that provides unbiased reviews of clinical studies and guidelines for local institutional review boards regarding risks, benefits, and communication strategies for waiver of and exception from consent proposals.
因重伤或重病而被送往急诊科的患者生存率很低。复苏研究人员致力于推动复苏科学的发展，必须开展临床研究以确定最佳治疗方案。这些研究必须反映良好的科学依据，并且必须在尊重患者个体自主权和安全的同时，兼顾有利于整个社会的科学进步。研究人员发现，现行联邦关于知情同意豁免和例外的指导原则费时且昂贵。他们发现各机构审查委员会对这些要求的解释存在差异。在公众通知要求和对社区咨询的回应方面存在混乱。他们认为，大多数公众以及医疗保健专业人员都希望复苏研究取得进展，但少数人和政府监管机构对研究中知情同意的豁免和例外感到不安。有人担心并且有证据表明，联邦指导原则阻碍了复苏科学的发展。已经提出了几种策略来改善这种情况。这些策略包括：1）对复苏研究人员进行更好的关于联邦指导原则的教育；2）为复苏研究人员提供一个阐明指导原则的工具箱；3）倡导将复苏科学的进步视为一项公益事业；4）设立一个国家研究咨询委员会，该委员会对临床研究进行公正审查，并就同意书豁免和例外提议的风险、益处及沟通策略，为地方机构审查委员会提供指导方针。
