This privacy notice is provided in compliance with the General Data Protection Regulation 2018 and Data Protection Act 2018. It relates to the use of personal identifiable data in the context of research conducted at the National Perinatal Epidemiology Unit, and specifically, the conduct of the Neonatal Complications of Coronavirus Disease (COVID-19) Study.
Coronavirus is a new virus that has come from China where it was first recognised as a causing a new infection in late 2019. The virus has crossed the world and in the UK we started to see people with the virus in February 2020. Since Coronavirus is a completely new virus no one has any immunity to it. So far we have very little information about how the virus affects newborn babies and it is not clear how best to care for the mothers and babies affected.
Why are we doing this study?
This study has been designed to identify all newborn babies receiving care in hospital in the first month after they are born who are infected with Coronavirus so that we can better understand its impact and what is the best treatment for infected babies. The study also includes newborn babies whose mothers are infected with Coronavirus. These two groups of babies are called the 'eligible' babies for the study. In this study we will collect information about the eligible babies and their mothers. This information will help us to understand:
- How babies get infected by Coronavirus
- What happens to babies when their mother is infected with Coronavirus
- What treatments are effective in helping babies to get better
- What happens to babies in the longer term when they have been treated
We are also carrying out a separate study of mothers who are infected with Coronavirus during pregnancy. Carrying out the two studies together means that we will be able to understand how babies get the Coronavirus infection, whether it transmits from mothers to their babies while they are still pregnant, whether it is transmitted during labour and birth, or whether the infection occurs following birth. Understanding this will mean that we can give the best advice to pregnant women about the effects of Coronavirus on their baby.
Who is carrying out this study?
The study is being co-led by Prof Jenny Kurinczuk and Dr Chris Gale. Dr Gale is a research doctor and neonatal consultant (doctor who specialises in the care of newborn babies), from Imperial College London, who looks after newborn babies who are sick. Prof Jenny Kurinczuk is a clinical epidemiologist who works at the University of Oxford. The study is being co-ordinated through the National Institute for Health Research (NIHR) Policy Research Unit in Maternal and Neonatal Health and Care (PRU-MNHC) based at the National Perinatal Epidemiology Unit, University of Oxford, which is funded by the Policy Research Programme at the Department of Health and Social Care (England). Dr Gale is a research collaborator with the PRU-MNHC. Other researchers involved come from the Universities of Leicester and Nottingham, Public Health England and the British Association of Perinatal Medicine (BAPM).
The study is being conducted through the British Paediatric Surveillance Unit (BPSU) which is based at the Royal College of Paediatrics and Child Health in London.
How will we carry out the study?
Every doctor across the UK looking after newborn babies in hospital will be asked by the BPSU each week if they have looked after a baby infected with Coronavirus or whose mother is infected with Coronavirus. If they have, they will be sent a questionnaire to collect information about the baby and their mother. As well as medical information about the baby and the care provided, we will also collect identifiable information about the mother (her NHS/CHI number) and her baby (their NHS/CHI number, date of birth, sex, partial postcode, ethnicity and date of death, if they have died). The completed questionnaire will be sent by the doctor to the BPSU-COVID-19 study team at the National Perinatal Epidemiology Unit at the University of Oxford where the information will be stored electronically and analysed.
Why do we need to collect identifiable information?
We need to collect identifiable information about each baby and their mother so that we can:
- Check that we have information about all the eligible babies
- Check if babies have already been notified to us so that we can make sure that we don't 'double count' information
- Link the information we collect about infected mothers and babies to other information collected, including:
- The National Neonatal Research (NNRD)
- The Paediatric Intensive Care Audit Network (PICANet)
- The national surveillance of maternal and perinatal deaths (MBRRACE-UK)
- National in-patient information in Scotland (SMR02) collected by the Information Services Division Scotland (ISD)
- Cross check our information with the study of pregnant women and mothers with COVID-19 who have recently given birth. This study is being carried out using the UK Obstetric Surveillance System (UKOSS)
Cross checking between all of these different information systems will ensure that we get a complete picture of what happens to all mothers and babies affected by Coronavirus, so that we can give the best advice about the risks of Coronavirus during pregnancy and how to treat mothers and babies who are infected with the virus. You can read more about these systems by following these links:
We will also share the information we receive about babies in England with Public Health England to support their legal duty to collect information about all 'notifiable diseases', of which COVID-19 is one. They collect this information under Regulation 3 of the Health Service (Control of Patient Information) Regulations 2002.We will also share the information we receive about babies in Scotland, Wales and Northern Ireland respectively to similarly support their legal duties. This sharing will also enable us to be sure that we have identified all the eligible babies.
The identifiable information we collect will only be used for the purposes of this study and shared in the way described above. We will not pass the identifiable information to anyone else unless they have a legal basis to receive the data or if, in the case of research, they have the relevant regulatory research approvals.
We will store the identifiable information in a separate database from the medical information. We will reduce the identifiable data used during analysis, for example, the information relating to dates will be converted into time periods and any dates required will have the day of the month removed for analysis. For example, a date of birth of 3rd March 2020 will be converted to the first week of March 2020. All the information will be stored on the secure servers in the Nuffield Department of Population Health, University of Oxford, where the National Perinatal Epidemiology Unit is based.
During the course of the pandemic we will share information from the study with the organisations who are responsible for deciding on the measures to control the pandemic, those organisations responsible for providing advice to pregnant women and mothers about Coronavirus and is effects and how doctors should treat affected mothers and babies, and those organisations responsible for ensuring that the care provided for mothers and babies meets their needs. These organisations include the Westminster Government and the Devolved Governments, the Royal College of Obstetricians and Gynaecologists (RCOG), the Royal College of Paediatrics and Child Health (RCPCH), the British Association of Perinatal Medicine (BAPM), the Care Quality Commission (England) and equivalent organisations in Scotland, Wales and Northern Ireland.
When we publish the findings of the study we will ensure that no individual babies and mothers are identifiable.
Who do we share the data we have collected with?
To be able to investigate what has happened to babies affected by Coronavirus we will share the data we have collected with the National Neonatal Research Database at Imperial College London. This will allow us to receive more detailed clinical information about how babies affected by Coronavirus have been looked after and what treatments they have received.
We will also plan to share the data for babies in England with NHS Digital to enable the information we have collected to be linked together, for those babies who are admitted to hospital again later, with hospital information collected as part of 'Hospital Episode Statistics' (HES) data. We will do the same with for babies in Scotland with the Information Services Division (ISD). This will enable us to investigate whether babies affected by Coronavirus have further health problems in the first two years after they are born.
The sharing of this information involves sharing identifiable information so that the different datasets can be linked together.
Collecting information without consent
Because we need to include all the eligible babies and need to collect this information very quickly we will not be asking parents for their consent for their information or their baby's information to be included in the study. In order to collect this information without consent our study has been reviewed and approved by:
Identifiable information will not be collected from Northern Ireland as privacy legislation there does not allow this information to leave Northern Ireland. Instead staff in the Northern Ireland Maternal and Child Health office will help us to ensure we have identified all eligible mothers and babies and connect the information together.
More information about the legal basis for this study is given below.
Is it possible for parents to opt out of this study?
We hope that parents will understand the benefit of this research and wish to participate. However, if parents do not wish the information about their baby to be included in the study, whilst they cannot opt out of the notification of their baby, they can opt out of the data collection. Parents can do this by either letting their baby's doctor (who is looking after them in the neonatal or paediatric intensive care unit) know they want to opt out, or by getting in touch with the study team by email: email@example.com or telephone: 01865 617774. If we have received the data collection form already, we will delete the information we have received and this information will not be included in the study.
You can also write to us at the address below to ask to opt out:
BPSU COVID-19 study
National Perinatal Epidemiology Unit
Nuffield Department of Population Health
Richard Doll Building
University of Oxford Old Road Campus
Headington, Oxford OX3 7LF
Information about data processing rights under GDPR, including the rights of parents to object to the use of their information and that of their baby can be found on the University website.
How long will we keep the study information for?
At present it is unclear how long the Coronavirus pandemic will continue or how long we will continue to see babies and mothers infected with the virus in the UK. We will carry on with the study for as long as the pandemic continues. During the course of the study we will analyse the data so that we can provide information to support the Government's Coronavirus control efforts. When the study is completed, most likely when the pandemic is over, we will analyse and publish the complete data.
The questionnaires will be deleted one year after publication of the complete findings. Electronic data containing limited identifying information will be stored for five years after the end of the study to enable us to answer any questions which arise after publication. After this the identifying information will be deleted completely and the anonymised electronic data will be stored in perpetuity on the secure servers at the Nuffield Department of Public Health at the University of Oxford.
How will we keep this information secure?
We ensure that we protect all the data that we hold against unauthorised access, unlawful use, accidental loss, corruption or destruction. To do this we use 'technical measures' such as encryption and passwords to protect the individual databases as well as to protect the computer systems in which the databases are held. We also use 'operational measures' to protect the data, for example, by limiting the number of people who have access to the databases in which personal data is held.
Who is responsible for the data we collect?
The data controller for this study is the University of Oxford (University Offices, Wellington Square, Oxford OX1 2JD). Under the General Data Protection Regulation the data controller is responsible for what happens to data which is collected. The data protection officer for the University of Oxford can be contacted by email at: firstname.lastname@example.org. For more information you can read the University Policy on Data Protection.
The National Perinatal Epidemiology Unit (NPEU) is the data processor. The data processor is responsible for holding the data and processing it. On a day to day basis Professor Jenny Kurinczuk, who is the director of the NPEU, is responsible for the data.
If you wish to contact us with a question about the handling of personal data please get in touch with Professor Jenny Kurinczuk: email@example.com
What is the lawful basis for conducting this study?
The legal basis for holding and processing personal and sensitive data for this study without consent is as follows:
General Data Protection Regulation:
- Article 6 (1) (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.
- 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.
The collection of the study data is in the public interest so that we can provide the best advice and care to babies and mother infected with Coronavirus.
Common Law Duty of Confidence:
- We applied for and have received section 251 support under the 2006 NHS Act from the Confidentiality Advisory Group at the Health Research Authority to collect and process identifiable data about individuals without their consent for the purposes of this study (20/CAG/0058). This approval covers England and Wales.
- In Scotland we are carrying out this study against the test of public interest.
- In Scotland we approval from the Public Benefit and Privacy Panel for Health and Social Care.
- In Northern Ireland doctors will seek parental consent for participation in the study.
Research ethics committee approval
- Our study protocol was reviewed and approved by North East – Newcastle and Tyneside 2 Research Ethics Committee: Reference number 20/NE/0107
Do you have any questions about the study?
If you have any questions about the study please email the BPSU-COVID-19 study team and we will endeavour to answer your questions as quickly as possible: firstname.lastname@example.org
Email contact is preferable currently but you can also telephone us on: 01865 617774.
How does a parent find out what data is held about them or their baby?
Parents have the right to know what personal data the University of Oxford hold about them and their baby and to have a copy of that data. Parents also have the right to correct wrong or outdated personal data and request the deletion of data. However, the study may be obliged by law to keep data to ensure consistency and reproducibility of the results and we cannot delete data that has already been used in analyses (note that analyses will be run regularly throughout this study).
Parents also have the right to restrict or object to what we do with their data, or to request that their data be transferred elsewhere. However, sometimes the data controller (University of Oxford) may not to be able to (or have grounds not to) follow a request, for example, if we consider that deleting data would seriously harm the research.
If parents wish to have a copy of the data from this study which is held about them and their baby please email Professor Jenny Kurinczuk at: email@example.com
What should I do if I have a complaint about the study?
The individuals whose data we hold have the right to complain. If you believe you are one of the individuals whose information is part of this study and you wish to raise a complaint about how we have handled your personal information, you can contact our Data Protection Officer, firstname.lastname@example.org, who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner's Office (ICO).
If you would like to contact us directly for more information about this study or how we use and protect data collected for research conducted at the NPEU more generally, please contact Professor Jenny Kurinczuk preferably by email at present:
Or by mail or telephone (we cannot guarantee anyone will be in the office at present):
Professor Jenny Kurinczuk
Director, National Perinatal Epidemiology Unit
Director, NIHR Policy Research Unit in Maternal and Neonatal Health and Care
Nuffield Department of Population Health
University of Oxford Old Road Campus
Headington, Oxford OX3 7LF
Tel: 01875 617909