Security and privacy requirements for a multi-institutional cancer research data grid: an interview-based study

Frank J Manion; Robert J Robbins; William A Weems; Rebecca S Crowley

摘要

Background Data protection is important for all information systems that deal with human-subjects data. Grid-based systems – such as the cancer Biomedical Informatics Grid (caBIG) – seek to develop new mechanisms to facilitate real-time federation of cancer-relevant data sources, including sources protected under a variety of regulatory laws, such as HIPAA and 21CFR11. These systems embody new models for data sharing, and hence pose new challenges to the regulatory community, and to those who would develop or adopt them. These challenges must be understood by both systems developers and system adopters. In this paper, we describe our work collecting policy statements, expectations, and requirements from regulatory decision makers at academic cancer centers in the United States. We use these statements to examine fundamental assumptions regarding data sharing using data federations and grid computing. Methods An interview-based study of key stakeholders from a sample of US cancer centers. Interviews were structured, and used an instrument that was developed for the purpose of this study. The instrument included a set of problem scenarios – difficult policy situations that were derived during a full-day discussion of potentially problematic issues by a set of project participants with diverse expertise. Each problem scenario included a set of open-ended questions that were designed to elucidate stakeholder opinions and concerns. Interviews were transcribed verbatim and used for both qualitative and quantitative analysis. For quantitative analysis, data was aggregated at the individual or institutional unit of analysis, depending on the specific interview question. Results Thirty-one (31) individuals at six cancer centers were contacted to participate. Twenty-four out of thirty-one (24/31) individuals responded to our request- yielding a total response rate of 77%. Respondents included IRB directors and policy-makers, privacy and security officers, directors of offices of research, information security officers and university legal counsel. Nineteen total interviews were conducted over a period of 16 weeks. Respondents provided answers for all four scenarios (a total of 87 questions). Results were grouped by broad themes, including among others: governance, legal and financial issues, partnership agreements, de-identification, institutional technical infrastructure for security and privacy protection, training, risk management, auditing, IRB issues, and patient/subject consent. Conclusion The findings suggest that with additional work, large scale federated sharing of data within a regulated environment is possible. A key challenge is developing suitable models for authentication and authorization practices within a federated environment. Authentication – the recognition and validation of a person's identity – is in fact a global property of such systems, while authorization – the permission to access data or resources – mimics data sharing agreements in being best served at a local level. Nine specific recommendations result from the work and are discussed in detail. These include: (1) the necessity to construct separate legal or corporate entities for governance of federated sharing initiatives on this scale; (2) consensus on the treatment of foreign and commercial partnerships; (3) the development of risk models and risk management processes; (4) development of technical infrastructure to support the credentialing process associated with research including human subjects; (5) exploring the feasibility of developing large-scale, federated honest broker approaches; (6) the development of suitable, federated identity provisioning processes to support federated authentication and authorization; (7) community development of requisite HIPAA and research ethics training modules by federation members; (8) the recognition of the need for central auditing requirements and authority, and; (9) use of two-protocol data exchange models where possible in the federation.

机译：背景技术数据保护对于处理人类数据的所有信息系统都很重要。基于网格的系统（例如癌症生物医学信息网格（caBIG））寻求开发新的机制来促进与癌症相关的数据源的实时联合，包括受各种监管法律保护的数据源，例如HIPAA和21CFR11。这些系统体现了用于数据共享的新模型，因此对监管机构以及将要开发或采用它们的人提出了新的挑战。系统开发人员和系统采用人员都必须理解这些挑战。在本文中，我们描述了我们收集美国学术癌症中心监管决策者的政策声明，期望和要求的工作。我们使用这些语句来检查有关使用数据联合会和网格计算进行数据共享的基本假设。方法从美国癌症中心的样本中对主要利益相关者进行基于访谈的研究。访谈是有条理的，并使用了针对本研究目的开发的工具。该工具包括一组问题情景-困难的政策情况，这些情况是由一组具有不同专业知识的项目参与者在全天讨论潜在问题的过程中得出的。每个问题场景都包含一组开放式问题，旨在阐明利益相关者的观点和担忧。访谈被逐字记录，用于定性和定量分析。为了进行定量分析，根据特定的访谈问题，将数据汇总到个人或机构分析单位。结果与六个癌症中心的三十一（31）个人进行了联系。在三十一（24/31）个人中，有二十四个人对我们的要求做出了回应，总回应率为77％。受访者包括IRB主任和决策者，隐私和安全官，研究办公室主任，信息安全官和大学法律顾问。在16周内进行了19次面试。受访者提供了所有四种情况的答案（共87个问题）。将结果按广泛主题进行分组，其中包括：治理，法律和财务问题，伙伴关系协议，取消身份识别，用于安全和隐私保护的机构技术基础设施，培训，风险管理，审计，IRB问题以及患者/受试者同意。结论研究结果表明，通过额外的工作，可以在规范的环境中进行大规模联合数据共享。关键的挑战是为联合环境中的身份验证和授权实践开发合适的模型。身份验证（识别和确认一个人的身份）实际上是此类系统的全球属性，而授权（访问数据或资源的权限）则模仿了在本地级别最好地服务于数据共享协议。这项工作产生了九项具体建议，并进行了详细讨论。其中包括：（1）必须建立单独的法律或公司实体来管理这种规模的联合共享计划; （2）关于如何对待外国和商业伙伴关系的共识; （3）风险模型和风险管理流程的开发; （4）发展技术基础设施，以支持与研究相关的认证过程，包括人类受试者; （5）探索开发大规模，联合的诚实经纪人方法的可行性; （6）开发适当的联合身份提供过程以支持联合身份验证和授权; （7）由联邦成员在社区中开发必要的HIPAA和研究道德培训模块; （8）认识到需要中央审核要求和授权，并且; （9）在联盟中尽可能使用两种协议的数据交换模型。

Security and privacy requirements for a multi-institutional cancer research data grid: an interview-based study

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