Ballantyne Angela, Style Rochelle
Department of Primary Health Care and General Practice, University of Otago, Wellington.
Independent Researcher, Wellington.
N Z Med J. 2017 Oct 27;130(1464):64-71.
Demand for health data for secondary research is increasing, both in New Zealand and worldwide. The New Zealand government has established a large research database, the Integrated Data Infrastructure (IDI), which facilitates research, and an independent ministerial advisory group, the Data Futures Partnership (DFP), to engage with citizens, the private sector and non-government organisations (NGOs) to facilitate trusted data use and strengthen the data ecosystem in New Zealand. We commend these steps but argue that key strategies for effective health-data governance remain absent in New Zealand. In particular, we argue in favour of the establishment of: (1) a specialist Health and Disability Ethics Committee (HDEC) to review applications for secondary-use data research; (2) a public registry of approved secondary-use research projects (similar to a clinical trials registry); and (3) detailed guidelines for the review and approval of secondary-use data research. We present an ethical framework based on the values of public interest, trust and transparency to justify these innovations.
在新西兰乃至全球，二次研究对健康数据的需求都在不断增加。新西兰政府建立了一个大型研究数据库——综合数据基础设施（IDI），以促进研究工作，还设立了一个独立的部长级咨询小组——数据未来伙伴关系（DFP），与公民、私营部门和非政府组织（NGO）合作，以促进可信赖的数据使用，并加强新西兰的数据生态系统。我们对这些举措表示赞赏，但认为新西兰仍缺乏有效的健康数据治理关键策略。具体而言，我们主张设立：（1）一个专门的健康与残疾伦理委员会（HDEC），以审查二次使用数据研究的申请；（2）一个已批准的二次使用研究项目公共登记册（类似于临床试验登记册）；以及（3）二次使用数据研究审查与批准的详细指南。我们提出了一个基于公共利益、信任和透明度价值观的伦理框架，以证明这些创新举措的合理性。
