Title: The personal cost of health conditions in childhood
Funder: Economic and Social Research Council

Abstract: 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.

Lay abstract: 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.

Research activity codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: METABOLIC AND ENDOCRINE;NEUROLOGICAL