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[急诊医学研究。伦理要求]

[Research in emergency medicine. Ethical requirements].

作者信息

Steinbereithner K

机构信息

Ludwig Boltzmann-Institut für Experimentelle Anästhesiologie und Intensivmedizinische Forschung, Wien-Linz.

出版信息

Anaesthesist. 1993 Apr;42(4):240-5.

PMID:8488997
Abstract

Having pointed out some curriculum goals in medical ethics, a plea is made for extensive animal experimentation, especially in emergency medicine in order to minimize necessary investigations in human beings. Although certain groups of patients (persons in custody, minors) are protected nowadays against unjustified research activities by legal restraints, well-designed therapeutic (even nontherapeutic) investigative projects can be facilitated under certain conditions. The same attitude might be adopted for "special" populations (e.g., HIV patients), which are very often excluded for various reasons. Research protocols and statistical evaluation should not be permitted to differ in these groups in comparison to "normal" patients. The issue of "informed consent" in emergency research with the main emphasis on resuscitation cannot be considered as resolved since many patients are unconscious or at least incompetent. Irrespective of the number of legislative constructions proposed mainly in the USA ("proxy consent", "substitute decision making," "deferred consent"--the latter being already declared a misnomer by its "inventor", ethical standards might better be adapted to the respective situations guided by competent ethical committees. As for the particulars of research protocols, randomization combined with a blind or double-blind study design is now considered to be ethically desirable by a majority of authors, the same holding true for risk stratification and sequential test procedures in order to reduce the number of patients required. The "theory of intuitive thinking" is briefly touched upon as a futuristic investigative method and/or decision strategy.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

在指出医学伦理学的一些课程目标后,有人呼吁进行广泛的动物实验,尤其是在急诊医学领域,以便尽量减少对人类进行的必要研究。尽管如今某些患者群体(被拘留者、未成年人)受到法律限制的保护,免受不合理的研究活动影响,但在某些条件下,精心设计的治疗性(甚至非治疗性)研究项目仍可得到推动。对于因各种原因经常被排除在外的“特殊”人群(如艾滋病患者),也可采取同样的态度。与“正常”患者相比,这些群体的研究方案和统计评估不应有差异。由于许多患者昏迷不醒或至少无行为能力,以复苏为主要重点的急诊研究中的“知情同意”问题不能被视为已得到解决。不管美国主要提出了多少立法构想(“代理同意”“替代决策”“延迟同意”——后者已被其“发明者”称为不恰当的名称),伦理标准最好由主管的伦理委员会根据各自情况进行调整。至于研究方案的细节,大多数作者现在认为,随机化结合单盲或双盲研究设计在伦理上是可取的,风险分层和序贯测试程序也是如此,以便减少所需患者的数量。“直觉思维理论”作为一种未来主义的研究方法和/或决策策略被简要提及。(摘要截于250字)

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