Sensitive data: legal, ethical and secure storage issues

Slides from the introduction to a panel session at eResearch Australasia (Melbourne, October 2016). <br>Panellists: Kate LeMay (Australian National Data Service), Gabrielle Hirsch (Walter and Eliza Hall Institute of Medical Research), Gordon McGurk (National Health and Medical Research Council) and Jeff Christiansen (Intersect).<br><b>Short abstract</b>Human medical, health and personal data are a major category of sensitive data. These data need particular care, both during the management of a research project and when planning to publish them. The Australian National Data Service (ANDS) has developed guides around the management and sharing of sensitive data. ANDS is convening this panel to consider legal, ethical and secure storage issues around sensitive data, in the stages of the research life cycle: research conception and planning, commencement of research, data collection and processing, data analysis storage and management, and dissemination of results and data access. The legal framework around privacy in Australia is complex and differs between states. Many Acts regulate the collection, use, disclosure and handling of private data. There are also many ethical considerations around the management and sharing of sensitive data. The National Health and Medical Research Council (NHMRC) has developed the Human Research Ethics Application (HREA) as a replacement for the National Ethics Application Form (NEAF). The aim of the HREA is to be a concise streamlined application to facilitate efficient and effective ethics review for research involving humans. The application will assist researchers to consider the ethical principles of the <i>National Statement of Ethical Conduct in Human Research (2007) </i>in relation to their research. National security standard guidelines and health and medical research policy drivers underpin the need for a national fit-for-purpose health and medical research data storage facility to store, access and use health and medical research data. med.data.edu.au is an NCRIS-funded facility that underpins the Australian health and medical research sector by providing secure data storage and compute services that adhere to privacy and confidentiality requirements of data custodians who are responsible for human-derived research datasets.

本数据集为2016年10月于墨尔本举办的澳大利亚电子研究大会（eResearch Australasia）专题小组开场环节的演示幻灯片。
专题小组嘉宾包括：凯特·勒梅（Kate LeMay，澳大利亚国家数据服务中心（Australian National Data Service，ANDS））、加布里埃尔·赫希（Gabrielle Hirsch，沃尔特与伊丽莎·霍尔医学研究所）、戈登·麦卡克（Gordon McGurk，澳大利亚国家健康与医学研究理事会（National Health and Medical Research Council，NHMRC））以及杰夫·克里斯蒂安森（Jeff Christiansen，Intersect）。
【简短摘要】
人类医疗、健康与个人数据属于敏感数据的重要类别，此类数据在科研项目管理阶段与计划发布阶段均需得到特殊规范与照料。澳大利亚国家数据服务中心（ANDS）已围绕敏感数据的管理与共享制定专项指南。本次专题小组由ANDS牵头，旨在探讨科研全生命周期各阶段中敏感数据相关的法律、伦理与安全存储问题，覆盖科研构思与规划、研究启动、数据采集与处理、数据分析存储与管理，以及成果发布与数据访问环节。
澳大利亚当前的隐私法律框架较为复杂，各州规定存在差异，多部法案对私人数据的采集、使用、披露与处理作出规范。敏感数据的管理与共享亦涉及诸多伦理考量。澳大利亚国家健康与医学研究理事会（NHMRC）已推出人类研究伦理申请（Human Research Ethics Application，HREA），以替代原《国家伦理申请表》（National Ethics Application Form，NEAF）。HREA旨在打造简洁高效的申请流程，为涉及人类受试者的研究开展高质高效的伦理审查提供支持。该申请工具将协助研究人员对照《人类研究伦理行为国家声明（2007年版）》（National Statement of Ethical Conduct in Human Research (2007)）审视自身研究的伦理合规性。
国家安全标准指南与健康医学研究政策导向，共同催生了构建适配国家实际需求的健康医学研究数据存储设施的必要性，该设施需可用于存储、访问与使用健康医学研究数据。med.data.edu.au 是由国家合作研究基础设施战略（National Collaborative Research Infrastructure Strategy，NCRIS）资助的设施，其通过提供符合人类来源研究数据集负责人隐私与保密要求的安全数据存储与计算服务，为澳大利亚健康医学研究领域提供核心支撑。