Petrini Carlo
Drug Metabol Drug Interact. 2014;29(1):61-3. doi: 10.1515/dmdi-2013-0055.
During the last century a large number of documents (regulations, ethical codes, treatises, declarations, conventions) were published on the subject of ethics and clinical trials, many of them focusing on the protection of research participants. More recently various proposals have been put forward to relax some of the constraints imposed on research by these documents and regulations. It is important to distinguish between risks deriving from direct interventions on human subjects and other types of risk. In Italy the Data Protection Authority has acted in the question of research using previously collected health data and biological samples to simplify the procedures regarding informed consent. The new approach may be of help to other researchers working outside Italy.
在上个世纪，大量关于伦理与临床试验主题的文件（法规、道德准则、论文、宣言、公约）得以发表，其中许多聚焦于对研究参与者的保护。最近，人们提出了各种提议，以放宽这些文件和法规对研究施加的一些限制。区分源于对人类受试者直接干预的风险与其他类型的风险很重要。在意大利，数据保护局已就使用先前收集的健康数据和生物样本进行研究的问题采取行动，以简化有关知情同意的程序。这种新方法可能会对在意大利境外工作的其他研究人员有所帮助。
