Investigating the association between prenatal exposure to air pollution and maternal and child health outcomes

University College London requires access to NHS England data for the purpose of the following research project:

The Baby Biome Study

The following is a summary of the aims of the research project provided by the controller:

Air pollution remains one of the leading public health issues facing the UK today. The mortality burden of air pollution in England is estimated to be between 26,000-38,000 a year,1 and, in London, 3,600-4,100 deaths were estimated to be attributable to anthropogenic particulate matter (PM)2.5 and NO2 in 2019.

The importance of air pollution has been highlighted by the Chief Medical Officer in England, who urged the government to take strong action to reduce air pollution and its impact in their 2022 annual report.

University College London's engagement with members of the public, including representatives of mothers and pregnant women, demonstrated that the impact of air pollution on health is a growing concern but awareness and understanding about potential long-term effects of prenatal exposure is lacking.

University College London propose to apply state of the art air pollution assessment to a UK mother-child cohort, the Baby Biome Study, to assess the effects of exposure on multiple pregnancy, birth, and child health outcomes, and further investigate the role of microbial and molecular mediators in this relationship.

The work will provide up-to-date high-quality information to meet the needs of public health policy and address widespread public concern.

The following NHS England Data will be accessed:

• Hospital Episode Statistics

• Admitted Patient Care – Necessary because one of the primary outcomes of this study is respiratory infections, many of which will require inpatient care (e.g., bronchiolitis caused by RSV).

• ECDS – Necessary because atopic conditions and mild respiratory infections may result in A&E attendances but not hospital admission.

The level of the Data will be:

· Identifiable-necessary to enable linkage of the data with data collected from other sources, including the participants themselves and the testing laboratories contracted to process swab blood and stool data.

The Data will be minimised as follows:

· Limited to a study cohort of 3500 patients who consented to participate.

· Limited to data between 2016 to 2025. For each individual patient, data will only be provided from the date they joined the trial.

The lawful basis for processing personal data under the UK GDPR is:

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.

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 Academy of Medical Sciences. The funding is specifically for the study described. Funding is in place until August 2025.

The funder will have no ability to suppress or otherwise limit the publication of findings.

A Public and Patient Involvement and Engagement group helped refine the purpose of the research. The group supported the collection of the data for the purposes described above. PPIE groups representing women from disadvantaged backgrounds were engaged, who are exposed to high levels of air pollution and will help disseminating findings (the Bridge, Global Black Maternal Health, Mothers and Others for Clean Air).

University College London will transfer data to NHS England.

The data will consist of identifying details (specifically NHS Number and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES datasets to University College London The Data will

• contain directly identifying data items including NHS Number, unique person ID & Postcode, which are required to link the Data at record level with data already held by the recipient.

The Data will not be transferred to any other location other than as described below.

The data will be stored on servers at University College London.

University College London uses offsite back-up services provided by VIRTUS Data Centres.

University College London. stores data on the Cloud provided by Amazon Web Services.

The Data will be accessed by authorised personnel via remote access.

The Controller must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations England/Wales. The data will not leave England/Wales at any time.

Access is restricted to employees or agents of University College London who have authorisation from Chief Investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will be linked at person record level with maternity and demographic data already available for study participants. These data linkages will be completed by NHS number.

Air pollution data will be linked by postcode for the registered address at the time of registration with the study.

Identifiable information will only be accessed by the researcher carrying out the data linkages.

Data will then be pseudonymised prior to analysis.

All subsequent users will conduct analyses using a pseudonymised dataset. Identifiable information will be kept in a separate dataset that will not be accessible to all researchers and will have restricted access with additional password protection.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Researchers from University College London will process the Data for the purposes described above.

The expected outputs of the processing will be:

• Submissions to peer reviewed journals at the end of the study.

• Presentations at appropriate conferences

• A database to be utilised as a resource for health research

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals

• Webinars open to policy makers in local councils and Public Health organisations (e.g., UKHSA)

• Webinars open to members of the public

• Social media

• Briefing documents provided to local councils

• Press/media engagement.

The Data Controller expect to produce and disseminate outputs at the end of the study approximately 3 years from when the data controller get access to the NHS England Data.

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers around the regulation of air pollution. The benefits this would produce would apply to patients as the findings are expected to inform best practice to improve the care, treatment and experience of health care users, in this case pregnant women, relevant to the influence of pollution on mother and child.

The use of the data could:

• help the system to better understand the health and care needs of populations.

• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

• advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as obesity and diabetes.

• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

• inform decisions on how to effectively allocate and evaluate funding according to health needs.

• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

This research has the potential to influence public policy and regulation to the benefit of patients in regards to care around air pollution by central and local governments. For instance, it may help identifying thresholds of air pollution levels that are likely to be harmful to fetus, which may be different from those to children and adults and could change the care offered as a result.

The research may also help identifying strategies to reduce exposure to air pollution that will directly benefit patients, such as offering information and guidance to pregnant women, free travel passes to pregnant women off peak, offering support to the implementation of low/zero emission zones in residential areas or other policies related to decreasing emissions.

The findings are expected to be beneficial for giving advice to pregnant women on how to minimise their exposure to air pollution and adopt strategies to mitigate against its harmful impacts on their health and the health of their children (e.g., wearing masks when outdoors in polluted areas).

More indirectly this research will benefit other researchers who will be able to access the data to explore other hypotheses considering the in-depth characterisation of this birth cohort. For instance, mechanistic studies exploring the role of epigenetics and metabolomics will be possible. These studies can ultimately produce benefits for mothers and children.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

University College London organised focus groups with PPIE reps from maternal health charities to help design the research, especially with women who experience the worst maternal health outcomes. The group strongly supported the use of maternal and child’s health data for research as findings can be very important to support policies that will protect their health and the health of their children.

Yielded Benefits is not a requirement for new applications.