New EU regulation on clinical trials: the impact on ethics and safeguards for participants.

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.

Page turning solutions for musicians: a survey.

Musicians have long been hampered by the challenge in turning sheet music while their hands are occupied playing an instrument. The sight of a human page turner assisting a pianist during a performance, for instance, is not uncommon. This need for a page turning solution is no less acute during practice sessions, which account for the vast majority of playing time. Despite widespread appreciation of the problem, there have been virtually no robust and affordable products to assist the musician. Recent progress in assistive technology and electronic reading devices offers promising solutions to this long-standing problem. The objective of this paper is to survey the technology landscape and assess the benefits and drawbacks of page turning solutions for musicians. A full range of mechanical and digital page turning products are reviewed.