临床研究数据共享:从道德责任到负责任的实践

Clinical Research Data Sharing:From Moral Responsibility to Responsible Practice

近年来,临床研究数据共享作为道德责任得到越来越多的关注,成为确保研究质量、提升研究效率的又一最佳实践。对临床研究数据共享的内涵进行澄清,探讨了临床研究数据共享自身的伦理意义及其应遵循的伦理原则。强调临床研究数据共享应在遵循社会获益及其价值最大化,风险、获益和负担合理分配,确保尊重以及公众信任和参与的伦理框架下,从伦理审查、知情同意、数据质量控制、数据共享基础设施建设和数据伦理治理等操作层面推进负责任的临床研究数据共享实践。

Being part of moral responsibility,clinical research data sharing draws increasing attention in recent years,and it grows to be a best practice on ensuring research quality and improving efficiency.This article clarifies the definition of clinical research data sharing,illustrates its intrinsic values and related ethical norms.An ethical framework,including maximizing the benefits and social value,equitable distribution of risks,benefits and burdens,respect for people,as well as public trust and engagement,was reaffirmed for promoting responsible data sharing.Concrete suggestions,for instance,ethical review,informed consent,data quality control,data sharing infrastructure construction and data ethical governance are proposed for consideration.