The personal cost of health conditions in childhood

信息治理背景：重要的卫生和社会科学研究受到研究人员个人遵守为保护个人隐私而制定的必要保障措施的能力的限制。大学作为政府资助的机构，有法律的依据使用数据进行研究（2018年数据保护法第6（1）条）;然而，寻求联合收割机从不同数据集的个人信息的研究需要在组织之间共享更敏感的信息，如姓名和出生日期，这具有更高的保密门槛（普通法保密义务）。共享此类机密数据的一种方法是征求数据中所代表的个人的同意。然而，当考虑到包含整个人口的行政数据集时，它变得不可行，并且由于自我选择而导致的偏倚降低了基于人口的方法的价值。这在健康研究中尤其重要，因为那些最受关注的人可能不去诊所，因此甚至无法接触到要纳入的选项。卫生研究管理局提供了一套替代批准，在无法获得同意的情况下分享机密信息（称为“第251条”，2006年《国家卫生服务法》的一部分）。通常情况下，研究人员寻求这样的豁免来回答一组特定的研究问题（称为“项目特定部分251”），就像我们在目前的项目中所做的那样，将糖尿病审计与威尔士的教育数据集联系起来。然而，在本提案中，我们将其扩展到一个特殊的豁免情况，称为“研究数据库部分251”。实质性背景：关于患有慢性疾病（如糖尿病，癫痫和哮喘）的儿童在健康以外的领域中的表现的证据是有限的，部分原因是由于上述行政数据的合并面临的挑战。为了解决糖尿病问题，我们与国家儿科和成人糖尿病审计，HESA和威尔士政府合作，为威尔士流动和链接这些健康和教育数据集。这是一个艰苦的过程，涉及与数据提供者、健康研究管理局和医学研究理事会监管支持中心合作，以确保信息治理达到最高标准，并得到数据提供者和其他各方的充分理解和支持。目标1信息治理框架：我们项目的中心任务是建立信息治理框架（以研究数据库第251节批准为骨干），将英格兰和威尔士的儿科健康数据与教育数据联系起来。这包括起草链接协议，为希望使用链接数据集的外部研究人员规划和起草申请流程，发布研究人员使用我们的研究数据库批准将其自己的疾病特定数据集链接到研究数据库的申请流程;发布所有针对患者的公平处理文件，包括专门针对儿童、父母的修改版本，目标2概念联系的证明：为了证明该框架的有效性，我们将把儿科（0至16岁）及成人使用DfE作为标识符和ONS的处理器，对英格兰的学校（NPD）和大学（HESA）数据进行糖尿病（16至30岁）审计-SRS作为安全存储库。目标3扩展到其他疾病：虽然使用治理框架添加其他健康状况数据的可能性是目标1的基本组成部分，但我们将与其他研究人员合作，主要是癫痫研究人员，以确保他们能够使用该框架添加数据。

Information governance background: Important health and social science research is limited by the capacity of individual researchers to adhere to the necessary safeguards which are put in place to protect the privacy of individuals. Universities, as publicly funded organisations, have a legal basis to use data for research (Article 6(1) of the Data Protection Act 2018); however, research that seeks to combine information for individuals from different datasets requires the sharing of more sensitive information - such as name and date of birth - between organisations, which has a higher threshold of confidentiality (common law duty of confidentiality). One way to share such confidential data is to seek consent from the individuals represented in the data. However, when considering administrative datasets containing entire populations, it becomes infeasible, and bias due to self-selection into a study diminishes the value of a population-based approach. This is particularly important in health studies, where those individuals of most concern may not be attending clinics and so cannot even be approached for the option to be included. The Health Research Authority offer an alternative set of approvals to share confidential information where consent cannot be obtained (known as 'Section 251', part of the National Health Service Act 2006). Typically, researchers seek such an exemption to answer a specific set of research questions (known as 'Project Specific Section 251'), as we did in our current project linking the diabetes audits to education datasets for Wales. However, in this proposal we extend this to a special case of the exemption known as 'Research Database Section 251'.Substantive background: Evidence on how children with chronic conditions such as diabetes, epilepsy, and asthma fare in spheres beyond health is limited, in part due to the challenges in combining administrative data described above. To tackle this for diabetes we worked with the national paediatric and adult diabetes audits, together with HESA and Welsh Government, to flow and link these health and education datasets for Wales. This was a gruelling process involving working with data providers, the Health Research Authority, and the Medical Research Council Regulatory Support Centre to ensure the information governance was of the highest standard and was well understood and supported by the data providers and other parties. Objective 1 Information governance framework: The central task of our project is to set up the information governance framework (with the Research Database Section 251 approval as the backbone) for the linkage of paediatric health data to education data for England and Wales. This includes drafting linkage protocols, planning and drafting an application process for external researchers that wish to use the linked datasets, publishing the application process for researchers to use our Research Database approvals to link their own disease specific datasets into the research database; publishing all fair processing documentation for patients including modified versions specifically for children, for parents, in other languages etc. Objective 2 Proof of concept linkages: To demonstrate the efficacy of the framework we will link the paediatric (aged 0 to 16) and adult (aged 16 to 30) diabetes audits to the schools (NPD) and university (HESA) data for England using DfE as the processor for the identifiers and ONS-SRS as the secure repository. Objective 3 Extensions to other conditions: While the potential to use the governance framework to add data for other health conditions is a fundamental part of objective 1, we will work with other researchers, primarily for epilepsy, to ensure they are able to use the framework to add their data.