Understanding the consequences of congenital cytomegalovirus infection: a feasibility study

Of an estimated 3000 children born with congenital CMV infection each year in England, ≈500 are expected to have long-term adverse sequelae, most commonly sensorineural hearing loss; fewer than half will have clinically-apparent symptoms at birth. Currently, babies are not routinely screened for CMV infection at birth in the UK and better information is needed about the consequences of congenital CMV infection to inform decisions around neonatal screening and treatment.

This project will inform future studies on the consequences of congenital CMV for child health. Its objectives are to explore how best to ascertain outcomes relevant to questions on congenital CMV in a future study (e.g. hearing, neurodevelopment), including whether (or which) routine data sources in the UK have data of sufficient quality on these outcomes; to explore appropriate comparison group(s), ethical implications and acceptability of different study design options; and to synthesise findings and input from an interdisciplinary collaborative research network to develop a proposal for a future study.

CMV Springboard Privacy Notice

Understanding the consequences of congenital cytomegalovirus infection: a feasibility study

This research is being conducted at UCL Institute for Global Health and is being led by Dr Heather Bailey. The study is supported by the Academy of Medical Sciences/the Wellcome Trust/ the Government Department of Business, Energy and Industrial Strategy/the British Heart Foundation/Diabetes UK Springboard Award [SBF003\1170].

1.1 What is this Privacy Notice about? 
This privacy policy outlines the purpose of the research and explains how we will collect and use the data for this study. It also describes how to get further information and what to do if you (or your child) do not want to be part of the study.

1.2 What is this study about?
The purpose of this feasibility study is to inform the design of a future study on congenital cytomegalovirus (CMV) infection. Around 1 in 200 children are thought to be born with CMV infection in England, with around 1 in 1000 likely to have lifelong disability caused by the infection. The most common problem is hearing loss, but this may not be apparent at birth. There are many unanswered questions about the consequences of congenital CMV infection for child health and more research is needed to inform decisions around neonatal screening and treatment.

In order to design future research studies, we are investigating what relevant information on child health is already captured as part of routine care or in administrative datasets, and how best this could be used. This study uses de-identified healthcare data from the Newborn Hearing Screening Programme and other clinical data sources along with survey data from healthcare professionals to inform the design of a future study.

1.3 What is the lawful basis for using this information?

The lawful basis for using information collected through the Newborn Hearing Screening Programme for this research project at UCL is ‘public task’, which falls under Article 6(1)(e) of the General Data Protection Regulation. It also falls under Article 9(2)(j), “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”.

Work with the Newborn Hearing Screening Programme data has received ethics approval from the South West - Cornwall & Plymouth Research Ethics Committee (reference 22/SW/0091). The clinic surveys being conducted as part of this study meet the definition of audit, and as such do not require ethics approval; no individual patient data will be collected in these clinic surveys.

1.4 What information will we collect about you (or your child) for the study?
Our study uses de-identified data collected within the Newborn Hearing Screening Programme on sociodemographics, audiological investigations, hearing outcomes and other clinical information for all children who were screened or received audiology assessment from 1 January 2018 to 1 January 2022, and all children with confirmed permanent childhood hearing impairment recorded from when the screening programme was established in 2006 up to 2022. Part of the planned work is to explore quality of these data, and to do this we need to evaluate data for the whole of England to take into account variations between sites. The research team will not have access to personal information that could identify you or your child from the Newborn Hearing Screening Programme or other clinical data sources used for this research. Personal identifiers (such as name and postcode) have been removed before transfer of any data to UCL researchers. The researchers cannot identify individual patients under any circumstances.   

If you are a healthcare professional and respond to a clinic survey being conducted as part of this study, you will be asked to provide your name, job title, clinic site and contact details so that researchers at UCL can contact you about the possibility of taking part in a future study.

1.5 How will the information be used? 
The data from the Newborn Hearing Screening Programme will be used by the study in the following ways:

1) To describe the population undergoing screening and/or audiological assessment and quality and completeness of data, including on children with hearing loss identified at older ages – e.g. after 6 months of age – and progressive loss

2) To prepare resources that will help other researchers to make use of this data source for research

Other clinic data sources may be used to understand availability of existing congenital CMV test results and whether it is feasible to link this information with data on hearing loss or other outcomes, e.g. on education and development.

Clinic survey data will be analysed to investigate use of the Newborn Hearing Screening database and relevant policies and practice. Summary information from the surveys on number of patients in different groups will be compared with other data sources to explore how complete those data sources are. Surveys will also be used to collect the details of clinicians who may be interested in participating in a future study.

The findings of the different components of this feasibility study will be used to inform the design of a future study to address gaps in our knowledge of child health outcomes of children with congenital CMV. We will publish results in open access journals so that they can be read online and downloaded for free. We will announce these publications on our website: https://www.ucl.ac.uk/global-health/understanding-consequences-congenital-cytomegalovirus-infection-feasibility-study

It will not be possible to identify any individual patients in the study publications.

1.6 Where will the data be stored?

The study data will be securely transferred and stored in the UCL Data Safe Haven. The UCL Data Safe Haven, is a registered data processor under the terms of the Data Protection Act 1998.

The research team have permission to keep the data for 3 years after which time its retention will be reviewed. It will not be used for marketing purposes, shared with or transferred to any third parties. The data provided to the team for research will not be transferred to other countries.

1.7 Your rights

Patient records held for this research study are de-personalised: researchers are not able to identify which records may belong to individual patients. As a consequence, it is not possible for researchers themselves to grant usual data protection rights, and nor is automated decision (including profiling) making applicable.

However, the government department providing access to the records (‘NHS England’) is able to uphold some of your rights, such as your right to request access to your data. For more information on your rights, please consult NHS England’s privacy notice at the link below: https://www.england.nhs.uk/contact-us/privacy-notice/

1.8 What if I do not want my data (or child’s data) to be used in this study?
The UCL research team will not be able to identify you and cannot remove your records from the study directly at your request. You have the right to tell NHS Digital that you do not want the information you provide to the NHS to be used beyond the purpose of providing healthcare. This is known as a ‘patient objection’ and ‘opting out’.  Opting out of your information being used for research cannot be applied to this study’s historic data. Please visit the NHS website for further details: https://www.nhs.uk/your-nhs-data-matters/manage-your-choice/

 Your choice will not affect the health care or the educational resources you receive.

If you are a healthcare professional and would like your name and contact details to be removed from any survey response you submit for this study, please contact the research team at the contact details below.

1.9 Access to your (or your child's) information in the study? 

If you or your child are a patient, it will not be possible to access your study data from the University research team data because all the personal information will removed. If you are a healthcare professional and want to access the information that we hold about you from your survey response (e.g. your job title and contact details) then you can contact Dr Heather Bailey at the contact details below.

1.10 How do I contact the Research team (or Data Controller)?
If you have questions or concerns about the study please contact Dr Heather Bailey:

Mortimer Market Centre

Off Capper Street

London WC1E 6JB

Email: heather.bailey@ucl.ac.uk
 

You may also contact the UCL Data Protection Officer:
Data Protection and Freedom of Information (FOI) Officer
University College London
Legal Services, 6th Floor
1-19 Torrington Place
London
WC1E 7HB

Email: data-protection@ucl.ac.uk

You also have the right to complain directly to the Information Commissioner’s Office, which is an independent regulatory authority set up to uphold information rights.