Boer Annelies Den, Schipper Irene
Senior Health Advocate, Wemos Foundation, Ellermanstraat 15-O, PO Box 1693, 1000 BR Amsterdam THE NETHERLANDS. e-mail:
Indian J Med Ethics. 2013 Apr-Jun;10(2):106-9. doi: 10.20529/IJME.2013.032.
The European Commission has proposed a new regulation to replace the current clinical trials directive. The proposed regulation aims at accelerating the application procedure and simplifying and harmonising the administrative requirements for multi-centre trials across the European Union. One striking feature of the proposed regulation is a two-tiered assessment, one at the central level, to be carried out by a reference member state, binding on all concerned member states; and one at the national level, where the ethics aspects will be assessed. Second, the proposal no longer requires the approval of the clinical trial application by a separate ethics committee. Third, it introduces the concept of "low intervention" trials that will undergo a "light" approval procedure. The proposed regulation may stimulate clinical trials that yield substantial public health benefits. However, it is a step back in terms of protection of the rights and safety of trial participants. It undermines current frameworks for ethical review by not requiring the involvement of an ethics committee, and by insufficiently integrating the Declaration of Helsinki into assessment procedures at the national and European levels. The introduction of the riskbased approach needs more preparation as there is no consensus yet on key issues, such as how to define risk, and who is going to define it.
欧盟委员会已提议制定一项新法规，以取代现行的临床试验指令。拟议中的法规旨在加快审批程序，简化并统一欧盟范围内多中心试验的行政要求。拟议法规的一个显著特点是采用两级评估：一级是由参考成员国在中央层面进行的评估，对所有相关成员国具有约束力；另一级是在国家层面进行的评估，将对伦理方面进行评估。其次，该提案不再要求由单独的伦理委员会批准临床试验申请。第三，它引入了“低干预”试验的概念，这类试验将接受“简化”审批程序。拟议中的法规可能会刺激那些能带来重大公共卫生效益的临床试验。然而，在保护试验参与者的权利和安全方面，这却是一种倒退。它削弱了当前的伦理审查框架，既不要求伦理委员会参与，也未充分将《赫尔辛基宣言》纳入国家和欧洲层面的评估程序。基于风险的方法的引入需要更多准备工作，因为在一些关键问题上尚未达成共识，比如如何定义风险，以及由谁来定义风险。
