NHS Digital Data Release Register - reformatted
Young Epilepsy projects
19 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
Turning6 - A Clinical and Neurodevelopmental follow up of EPIPEG participants at 60 months — DARS-NIC-700125-B2Z7J
Type of data: information not disclosed for TRE projects
Opt outs honoured: Identifiable, No (Section 251 NHS Act 2006)
Legal basis: Health and Social Care Act 2012 - s261(2)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Purposes: No (Charity)
Sensitive: Non-Sensitive
When:DSA runs 2023-06-16 — 2024-06-15 2023.07 — 2024.04.
Access method: One-Off
Data-controller type: YOUNG EPILEPSY
Sublicensing allowed: No
Datasets:
- Demographics
Objectives:
Young Epilepsy requires access to NHS England data for the purpose of the following research project: Turning6 - A Clinical and Neurodevelopmental follow up of Epilepsy in infancy: relating phenotype to genotype (EPIPEG) participants at 60 months.
The following is a summary of the purpose for accessing NHS England data:
Establish up-to-date address information of children who participated in the EPIPEG study to enable Young Epilepsy to send parents/carers invitations for their children to participate in the Turning6 study.
Establish whether any children who participated in the EPIPEG study have died, so parents/carers of those children are not invited to participate in the Turning6 study, therefore reducing the likelihood of causing potential distress to those parents/carers.
The following is a summary of the aims of the research project provided by Young Epilepsy. These objectives will not be met through use of the data provided under this agreement, but explain the broader purpose of the Turning6 study:
Undertake comprehensive psychological assessments of children who developed epilepsy in the first year of life as they reach 6 years of age.
Characterise the neurodevelopmental (cognition, autism and ADHD status, sleep, health related quality of life) status of children who developed epilepsy in the first year of life.
Examine the association between initial neurodevelopmental and clinical assessments, and performance at follow-up.
The following NHS England data will be accessed:
Demographics necessary because the study team plan to contact parents of children in the EPIPEG cohort with an invitation to participate in the Turning6 study. Access to the demographics data enables the study team to assign up-to-date address information to the correct patient in preparation for invitations to be distributed. The demographics dataset contains a Fact of Death variable indicating whether a patient has passed away. This helps the study team identify patients who should not be invited to participate.
The level of the data will be Identifiable. This is necessary to obtain up-to-date address data for each patient in the EPIPEG cohort. Identifiable data will enable the study team to send letters of invitation to parents/carers of patients at their latest recorded address and exclude any patients who have died since participating in the EPIPEG study.
The data will be minimised as follows:
Limited to a study cohort identified by Young Epilepsy The cohort consists of the remaining 112 EPIPEG participants who developed epilepsy in the first year of life and were recruited to the EPIPEG study in 2016-2017.
Young Epilepsy is the research sponsor and the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party, unless there is a good reason to protect the individuals personal data which overrides those legitimate interests.
Young Epilepsy, as part of their Legitimate Interests, will use the data to invite surviving participants of the EPIPEG study to participate in the Turning6 study which aims to improve knowledge for healthcare professionals and deliver better healthcare to citizens. The provision of mortality data from NHS England will mitigate the impact of contacting a parent whose child has sadly passed away.
The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients treatments or care.
The funding is provided by the George Neville Foundation Trust. The funding is specifically for the study described. Funding is in place until May 2024.
The funders will have no ability to suppress or otherwise limit the publication of findings.
No other organisations are involved as data processors.
University College London (UCL) were the sponsors and joint Data Controllers for the EPIPEG study. UCL are part of a wider steering committee for the Turning6 study but will not have access to the data. UCL are not the sponsors, and do not make decisions about the manner and means of conducting the Turning6 study.
Great Ormond St Hospital (GOSH) were involved in the EPIPEG study as a patient identification centre. GOSH have no involvement in the Turning6 study.
Data will be accessed by substantive employees of Young Epilepsy only.
Expected Benefits:
The expected benefits from the use of NHS England data for the purposes described in this agreement are:
Letters of invitation to participate in the Turning6 study will be delivered to parents/carers at the most recent record of address.
The likelihood of causing distress to parents/carers of children who participated in the EPIPEG study but have since died, will be reduced.
The following is a summary of expected benefits of the Turning6 project. These benefits will be an indirect result of the purpose of this application:
The Turning6 project will allow Young Epilepsy to characterise the neurodevelopmental (cognition, autism and ADHD status, sleep, health related quality of life) status of children who had epilepsy,and examine the association between initial neurodevelopmental and clinical assessments, and performance at follow-up. The follow-up study of this unique cohort will, therefore, significantly enhance understanding of neurodevelopmental course in children with early onset epilepsy. Additionally, understanding factors associated with impairments will help direct prognosis and management.
It is hoped that through access to up-to-date address information for each EPIPEG participant, the study team will recruit a sufficient number of participants to enable the Turning6 study to produce meaningful outputs that meet the Turning6 project objectives.
Outputs:
The expected outputs of the processing will be:
Mailing Turning6 letters of invitation to parents/carers of surviving children who participated in the EPIPEG study.
There will be no published outputs from the use of the Demographics Data.
Dissemination of letters to parents/carers is expected to be complete by September 2023.
Processing:
Young Epilepsy will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, and Postcode) for the cohort to be linked with NHS England data.
NHS England will provide the relevant records in the Demographics dataset to Young Epilepsy. The data will contain directly identifying data items including NHS Number and Date of Birth, which are required to link the data at record level with data already held by the study team. Address, and Postcode will be provided to enable Young Epilepsy to invite caregivers of patients to participate in the Turning6 study. The data will indicate the Fact of Death Status of patients, facilitating identification of patients who should not be invited to participate in the study, therefore reducing the possibility of causing distress to parents or carers of children who have died.
The data will not be transferred to any other location.
The data will be stored on servers at Young Epilepsy only.
The data will be accessed by authorised personnel via remote access. The data will remain on servers at Young Epilepsy at all times.
The data will not leave England/Wales at any time.
Access is restricted to employees of Young Epilepsy who have authorisation from the Chief Investigator.
University College London and Great Ormond St Hospital are not permitted to access the data.
All personnel accessing the data have been appropriately trained in data protection and confidentiality.
The data will be linked at person record level with EPIPEG data already held by Young Epilepsy.
Analysts from Young Epilepsy will process the data for the purposes described above.