How will PIONEER be managed, and is there an accountability structure in place?
PIONEER will be carefully managed with clear governance and accountability. All processes have been approved by the Health Research Authority (HRA) and PIONEER will report all data access requests to the East Midlands-Derby Regional Ethics Committee that approves PIONEER on an annual basis.
Each data request is reviewed by the Data Trust Committee, which is made up of patient and public members who ensure data access is the public’s interest. If the Data Trust Committee approves a data access request, it will be bound by a specific data licence agreement which sets out how data can be used, by who, for what purpose, and for how long. The data license will only be granted if the Five Safes can be met, and restricts the use of the data to the specific purpose for which it was requested.
The PIONEER leadership team is responsible for how the project is run and managed. To ensure there is transparency around how data has been used, PIONEER will publish lay summaries for all data projects, followed by results once the data has been used. Patient and public involvement will be a key part of PIONEER, with patient and public members helping make decisions about how the data is used.
What requirements are in place to access data?
Data access will be under license and will need to meet the ‘Five safes’ criteria, which are:
- Safe projects – is the requested use of the data appropriate?
- Safe people – can the researchers be trusted to use the data appropriately?
- Safe data – is there a risk that a person could be identified from the data and how can this be minimised?
- Safe setting – is the data stored in a safe manner which limits the possibility for unauthorised use?
- Safe outputs – could the results of the analysis cause any individual to be identified and how can this be minimised?
Will data be shared with industry, technology or commercial organisations?
Yes, but we will only share de-identified data and decisions will be made following the principles of the Five Safes. Data will not be shared with any external organisation (including NHS, academic or industry) unless approved by the Data Trust Committee. This way, all decisions will be reviewed by patients and members of the public, and only those considered to be in the best interests of patients and the public will be provided with licensed data access.
Some commercial parties (such as Microsoft and ENSONO) have donated time and expertise to build PIONEER’s world-class digital research platform, meeting the most stringent governance and cyber security regulations. These companies will not be permitted to access the data on the platform.
What is HDR UK?
HDR UK is a non-profit-making body, independent of the government, and funded by 10 organisations including the NHS’s National Institute for HealthResearch and the Wellcome Trust. HDR UK is the national institute for health data science and our mission is to unite the UK’s health data to enable discoveries that improve people’s lives.
Its vision is that every health interaction and research endeavour will be enhanced by access to large scale data and advanced analytics.
PIONEER datasets, tools, papers and other related resources can be viewed on the HDR UK Innovation Gateway.