ResearchOne enables ongoing engagement between clinical practice and research, through clinical and administrative information from SystmOne. Here are the answers to some FAQs about ResearchOne, and more information can be found in the system summary.
What does ResearchOne do?
Health and social care organisations using SystmOne can contribute non-identifiable information for research. Research teams use this real-world data to develop innovative ways to support patients. As well as being openly available, these innovations can improve the way that SystmOne supports organisations to deliver care. You can watch an overview of ResearchOne and read further documentation.
Has ResearchOne been reviewed?
The NRES Committee North East – Newcastle and North Tyneside 1 are a Research Ethics Committee that reviews the establishment of research databases. They provided a favourable opinion for the ResearchOne database. The REC reference number is 11/NE/0184.
The National Information Governance Board (NIGB) reviewed the data that can be held in the ResearchOne database and deemed it non-identifiable.
What is the consent model?
The project is based around a “provider opt-in” model. It is the data controller at each provider organisation who must opt-in to ResearchOne. This can be done from the Organisation Preferences screen in SystmOne. Should a provider subsequently decide to opt-out, the data will be removed from ResearchOne within 7 days.
The model includes a “patient opt-out” mechanism should a patient not want their de-identified data used for research purposes. This follows the model for existing GP data research databases such as CPRD, QResearch and THIN. The data has been deemed by the NIGB and the Secretary of State to be non-identifiable but nonetheless we think it is very important to include an opt-out in the design.
In order to opt-out, a patient just needs to inform any of their care providers on SystmOne. There is a button in SystmOne for recording a dissent flag on the patient record and the data will be removed from ResearchOne within 7 days.
Let’s look at how this works for a patient who is seen at more than one organisation (e.g. GP Practice and Out of Hours): the data controllers can opt in the parts of the record that their organisation has entered, and the patient can opt out the entire record.
Is identifiable data taken from SystmOne?
The ResearchOne database only has non-identifiable data from the organisations that have opted in.
The data is all de-identified on SystmOne before being extracted into the ResearchOne database. This process includes the removal of all hard identifiers (such as NHS Number), the reduction of soft-identifiers to less specific values (such as only taking sector-level postcodes) and a K-anonymisation procedure to ensure that the rarity of a data item does not make it identifiable.
Some projects may have consent from patients and care providers and the National Research Ethics Service, or legal approval under Section 251, to receive identifiable data. The non-identifiable ResearchOne database cannot be used for such projects. Subject to approval and explicit consent, TPP may be able to provide such data from SystmOne. This data is pseudonymised, which means that only that project team can re-identify it.
Is all SystmOne data taken?
Only non-identifiable data items, that have been reviewed by the NIGB and REC, are extracted to ResearchOne, as outlined above. This includes coded data such as drugs and diagnoses, for example in Read Code CTV3 or ICD10. No narrative text from consultation is extracted and records containing rare cases are excluded.
This non-identifiable information is only extracted from SystmOne where it has been entered by an organisation that has opted in to ResearchOne. It is not taken if the patient has opted out.
Where does ResearchOne hold the data?
The database is held in secure NHS-accredited data centres, subject to the same security protocols as the TPP SystmOne production environment. ResearchOne leverages the existing TPP infrastructure which has allowed us to implement very high security measures for data storage and processing.
Are patients informed?
We are committed to trying to inform patients about ResearchOne all the latest information is posted on this website. There is an FAQ section for patients, and posters and patient information leaflets are available in SystmOne F1 Help. We are also exploring using social media, such as Twitter, to inform people about the database and projects we are supporting.
We are always keen to hear other ideas of how we can keep informing everyone about the project on both local and national levels.
Are clinicians and patients involved?
As well as contributing to the development of ResearchOne and research proposals, clinicians and patients have representation on the ResearchOne Database Committee. We have given annual updates at the SystmOne National User Group Conference. In such ways include patient and clinician views on what ResearchOne does, the projects it supports, and how we address any privacy concerns.
Where do I go next further information?
You can find a lot of information on this website and can navigate by the tabs at the top of each page. For example, under the Research tab you can find out what data is available, how it is being used and how to request data. The Information tab includes FAQs and the Ethics tab has the Protocol and the letters of ethical approval. Under Publications you can find documents including information leaflets, watch presentations, and read papers about ResearchOne and projects that have analysed data from ResearchOne. You can also find out more on SystmOne or by contacting us.
What is the cost?
ResearchOne is run as a non-for-profit enterprise between TPP and the University of Leeds. We help researchers to access quality clinical data as cost-effectively as possible. To support the growth of research in the UK, we provide data for free to Masters and PhD students. Each year TPP cover ResearchOne costs for research in an area of national importance.