Stamer Ulrike M, Naef Nadja, Porz Rouven, Stuber Frank, Leva Brigitte, Meissner Winfried, Fletcher Dominique
From the Department of Anaesthesiology and Pain Medicine, Inselspital and Department of Clinical Research (UMS, NN, FS), Unit for Clinical Ethics, Inselspital, University of Bern, Bern, Switzerland (RP), Clinical Trial Network, European Society of Anaesthesiology, ESA Office Bruxelles, Brussels, Belgium (BL), Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany (WM), and Service d'Anesthésie Réanimation, Hôpital Raymond Poincaré, Garches, France (DF).
Eur J Anaesthesiol. 2015 Feb;32(2):126-31. doi: 10.1097/EJA.0000000000000206.
Research ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation.
To evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial.
Survey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires.
Twenty-four hospitals in 11 European countries.
From the 24 hospitals, 23 local investigators responded; 23 answers were analysed.
Comparison of research ethics procedures and committee requirements from the perspective of clinical researchers. Comparison of the institutions' procedures regarding patient information and consent. Description of further details such as costs and the duration of the approval process.
The approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 &OV0556;. In 20 hospitals, a patient information sheet of variable length (half page up to two pages) was provided. Requirements for patients' informed consent differed. Written informed consent was mandatory at 12, oral at 10 and no form of consent at one hospital. Details such as enough time for consideration, possibility for withdrawal and risks/benefits of participation were provided in 25 to 30% of the institutions.
There is a considerable variation in the administrative requirements for approval procedures by research ethics committees in Europe. This results in variation of the extent of information and consent procedures for the patients involved.
euCPSP in Clinicaltrials.gov identifier: NCT01467102; PAIN-OUT in Clinicaltrials.gov identifier: NCT02083835.
不同国家以及不同类型的组织，其机构研究伦理委员会的研究伦理审批、程序及要求差异很大。
基于一项欧洲多中心试验，评估研究伦理委员会的要求与程序、患者信息详情及知情同意情况。
采用电子问卷对参与慢性术后疼痛前瞻性观察研究（euCPSP）的欧洲医院进行调查。
11个欧洲国家的24家医院。
24家医院中有23位当地研究者做出回应；对23份回答进行了分析。
从临床研究者的角度比较研究伦理程序和委员会要求。比较各机构在患者信息和同意方面的程序。描述费用及审批过程时长等更多细节。
审批过程持续时间从不到2周至超过2个月不等，财务费用在0至575欧元之间。20家医院提供了长度不一（半页至两页） 的患者信息表。对患者知情同意的要求各不相同。12家医院要求书面知情同意，10家要求口头知情同意，1家医院不要求任何形式的同意。25%至30%的机构提供了诸如足够考虑时间、退出可能性以及参与的风险/益处等细节。
欧洲研究伦理委员会对审批程序的管理要求存在很大差异。这导致了所涉患者信息及同意程序程度的差异。
euCPSP在Clinicaltrials.gov的标识符：NCT01467102；PAIN - OUT在Clinicaltrials.gov的标识符：NCT02083835。
