RESUMO
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.
