2624: Blood Doners Studies BioResource Research Database
The INTERVAL, COMPARE and STRIDES BioResource studies (collectively known as the Blood Donors Studies) are multi-purpose, multi-stage research projects involving blood donors recruited in England.
About the project:
What the project aims to do
The INTERVAL, COMPARE and STRIDES BioResource studies (collectively known as the Blood Donors Studies) are multi-purpose, multi-stage research projects involving blood donors recruited in England. The primary aim of these studies is related to blood donation research aiming to improve NHS Blood and Transplant’s (NHSBT) core services (for example, safety and efficiency of blood donation).
A longer-term purpose of these studies is related to the creation of a comprehensive bioresource that will enable detailed studies of health-related questions. This will be enabled by combining data generated during the initial studies and subsequent research with information from participants’ health-related records. Participants in the Blood Donors Studies gave informed consent for access to their health records and long-term storage and use of their health data for health-related research purposes.
The University of Cambridge holds a rich set of data for the INTERVAL and COMPARE participants including genetic and biomarker data, demographic information and data from electronic health records (EHR) such as Hospital Episode Statistics obtained from NHS Digital. The University of Cambridge has also obtained the COVID-19 test results data for INTERVAL and COMPARE participants from the UK Health Security Agency (UKHSA) (data sharing agreement reference: PHE 2019-nCoV National Blood Donor Cohorts).
The University of Cambridge is requesting to continue to receive the COVID-19 test results dataset for the INTERVAL and COMPARE participants as well as adding the STRIDES BioResource study to the data request.
The COVID-19 test data will enable research to;
- understand the risk factors for COVID-19, clinical trajectory and associated health outcomes
- evaluate the long-term impact of COVID-19 infection, vaccination and antibody levels in participants that have been hospitalised due to COVID-19 infection or chronic diseases
This will be achieved through linking genetic and biological data of the INTERVAL, COMPARE and STRIDES BioResource participants with the COVID-19 test results from the UKHSA and other electronic health records such as Hospital Episode Statistics and Vaccination Status data from NHS Digital. The TRACK-COVID study, which is a recall study recruiting participants from INTERVAL, COMPARE and STRIDES BioResource, will also provide data specific to COVID-19 for these participants, through questionnaires on symptoms and by assaying of SARS-CoV-2 antibodies.
Why this project is important
The results from the analyses will help provide more information on factors that are associated with COVID-19 diagnosis, severity of disease and recovery from disease, as well as the long-term impact of COVID-19 infection, vaccination and antibody levels in participants that have been hospitalised due to COVID-19 infection or chronic diseases. The results will be disseminated to key stakeholders (for example, policymakers, healthcare organisations and the scientific community) as well as to members of the public.
Who the data is about
Whole blood donors in England, aged 18 years or older who were recruited into one of the following studies and provided their consent for data linkage:
- INTERVAL study (REC ref: 11/EE/0538)
- COMPARE study (REC ref: 15/EE/0335)
- STRIDES BioResource study (REC ref: 18/EE/0284)
How the data will be used
For analyses, the researchers will link socio-demographic, lifestyle, genetic and other biological data recorded in INTERVAL, COMPARE and STRIDES BioResource participants with data obtained from electronic health records, for example, the COVID-19 test results from the UKHSA and Hospital Episode Statistics and Vaccination Status data from NHS Digital.
Socio-demographic, lifestyle, and genetic information have been collected and generated during study recruitment. Molecular data have been generated afterwards using blood samples collected from participants at baseline recruitment.
Obtaining COVID-19 test results from the UKHSA:
- the University of Cambridge will transfer personal identifiers for participants in the INTERVAL, COMPARE and STRIDES BioResource studies to the UK Health Security Agency (UKHSA) for linkage to the UKHSA datasets
- UKHSA will ensure all NHS numbers are present and validated
- UKHSA will link the Data Recipient data to the Second Generation Surveillance System (SGSS) and securely transfer the data for all matched participants
- UKHSA SGSS data will be downloaded using SFTP from the UKHSA site and stored in the Secure Data Hosting Service (SDHS) at the University of Cambridge
Subject to approval by the Univesity’s Data Access Committee (DAC), these data will be shared with approved researchers. The committee includes senior members from the organisations involved in the studies: the University of Cambridge, NHS Blood and Transplant (NHSBT), the Wellcome Sanger Institute and the University of Oxford, and public members. The DAC has overall responsibility for the data access procedures and decisions, and works according to the guidelines set out in the Data Access Policy.
Data will be released to approved researchers following review of a detailed statistical analysis plan by senior statisticians, involving details about analytical models (for example, time-to-event analysis, survival analysis, linear mixed models) that will be performed using standard statistical softwares (for example, STATA, R).
How often data is needed
Annual release
How this project will benefit public health and the public
The results of analyses will help provide more information on factors that are associated with COVID-19 diagnosis, severity of disease and recovery from COVID-19 (which has caused severe disease and high mortality rates worldwide). This information can help inform public policy with respect to the COVID-19 (and potentially other) pandemics in the future.
The results can also provide information on the long-term impact of COVID-19 infection, vaccination and antibody levels on development and outcome of non-communicable diseases in participants that have been hospitalised due to COVID-19 infection. This information will have the potential to help the development of preventive strategies, advancement of medicine and inform policy and public health decisions.
The researchers at the University of Cambridge are also working as part of national and international COVID-19 consortia to increase biological understanding of the virus and disease. For example, results from the analyses of INTERVAL study participants with the COVID-19 testing data from the UKHSA and information on pre-existing conditions and new diagnoses based on Hospital Episode Statistics from NHS Digital contributed to the international COVID-19 Host Genetics Initiative. Work by this consortium identified areas in the genome that are associated with SARS-CoV-2 infection or severe COVID-19 disease and this has the potential to inform the development of therapeutics for patients (The COVID-19 Host Genetics Initiative, Nature 2021).
The initial results from the TRACK-COVID study (an epidemiological investigation of SARS-CoV-2 virus infection in the population) are expected to be published at the end of 2022.
Planned project outputs and communication
- peer-reviewed scientific journals
- internal report (publication not intended)
- conference presentation
- website
- press release
- newsletters to participants
Lawful processing of personal and special category personal data
Under the UK General Data Protection Regulation (UK GDPR), the data required for this project is classified as special category personal data. This means that, in order for the processing of this data to be lawful, there must be both a lawful basis for processing under Article 6 and a separate condition for processing under Article 9 of the UK GDPR.
Legal basis for using personal data (Article 6)
UK GDPR Article 6(e): processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the Controller
Legal basis for using special category personal data (Article 9)
UK GDPR 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.
Common law duty of confidentiality
The data needed for this project includes Confidential Patient Information — meaning data that can both identify an individual and relate to their health or care, shared in a context where confidentiality is expected and protected.
Confidential Patient Information is subject to a strict duty of confidentiality. It can only be used with the patient’s explicit consent or under specific legal provisions that permit its use — for example, for medical research or public health purposes.
How is the duty of confidentiality set aside
Explicit informed consent.
National Data Opt-Out
Opt-out preferences will not be applied.
This is because the national data opt-out does not apply to anonymised data.