医学科学数据共享与使用的伦理要求和管理规范(八)审核委员会职责和高效的审核机制探讨

Ethical Requirements and Management Standards for the Sharing and Re-use of Scientific Data in Healthcare and Medicine(Ⅷ)The Responsibility of DAC and Exploration of a Potential Efficient Review Mechanism

伦理审核是保障负责任的医学科学数据共享应用实践的路径之一。对于同一机构除了IRB是否成立专门的数据访问审核委员会存在一定争议。IRB和DAC在医学科学数据共享应用的管理中相互补充,但在职责、审核内容、审核依据和标准均有不同。对于综合医疗机构或专门提供数据服务的机构建议成立专门的DAC。此外,为了适应日益增长的数据共享使用审核工作,建议应探索更加高效的数据共享应用审核机制,并提出了一些潜在可行的建议。

Ethical review is one of the pathways to ensure responsible scientific data sharing practice in healthcare and medicine.There are some disputes about whether need to set up a special Data Access Committee(DAC)except to IRB in a related institute.IRB and DAC are complementary to each other in the management of scientific data sharing practice.However,it is different of their responsibility,review content,decision basis and standards.Suggestions to setting up a DAC was provided for the comprehensive medical institutions and special service institutions and platforms of data sharing.In addition,the author described of the responsibilities of the DAC members in detail.Moreover,the author believed that more efficient review mechanism for data sharing and re-use should be explored in order to adapt to the growing data sharing work;and some potential suggestions were also provided.