Lemaire François
Délégation à la recherche clinique, AP-HP, et Université Paris 12, France.
Curr Opin Crit Care. 2008 Dec;14(6):696-9. doi: 10.1097/MCC.0b013e328315a62.
Critical care is a special area in which research needs to take place, because of the severity of the diseases which are treated there, but it is also a place where research faces a lot of hurdles and difficulties. The main cause of difficulties is the consent issue, as most patients cannot consent for themselves. Recently, all national legislations in the countries of the European Union have been modified to include the provisions of directive 2001/20.
This review article provides a summary of the recent literature concerning the issue of consent for clinical care research such as how the surrogate consent reflects the view of the patient and how time consuming and inaccurate can be the consultation of a community before the start of a trial with a waiver of consent. Another hurdle to research is the rigidity of our legislations concerning clinical research, especially the absence of a simplified way for low or no-risk research. This article shows how this situation is potentially deleterious and how it could ultimately forbid low-risk research.
Critical research remains a domain in which research on patients is difficult and controversial. Regulation can be difficult to implement, largely inadequate or uselessly complicated. Intensive care physicians need to keep pressure on politicians and lawmakers to constantly explain the necessity and specificities of critical care research.
重症监护是一个需要开展研究的特殊领域，这是因为在此处治疗的疾病十分严重，但它也是一个研究面临诸多障碍和困难的地方。困难的主要原因是同意问题，因为大多数患者无法自行做出同意表示。最近，欧盟各国的所有国家立法都已修改，纳入了2001/20号指令的条款。
这篇综述文章总结了近期有关临床护理研究同意问题的文献，比如替代同意如何反映患者的观点，以及在启动一项放弃同意的试验之前，咨询社区会多么耗时且不准确。研究的另一个障碍是我们有关临床研究的立法过于僵化，尤其是缺乏针对低风险或无风险研究的简化方式。本文展示了这种情况可能如何有害，以及它最终可能如何禁止低风险研究。
重症监护研究仍然是一个对患者进行研究既困难又有争议的领域。监管可能难以实施，在很大程度上不够充分或复杂得毫无用处。重症监护医生需要不断向政治家和立法者施压，持续解释重症监护研究的必要性和特殊性。
