Policy Brief: Ensuring Future Pandemic Preparedness and Supporting Maternal and Child Health Research in the Republic of Ireland - Recommendations for Policy

1. Introduction

The need to understand the risks of COVID-19 infection and vaccination during pregnancy was identified in the early stages of the pandemic to allow for targeted public health action in this vulnerable group.¹ In the Irish context, we identified three data sources on COVID-19 infection and vaccination during pregnancy.² These included the national computerized infectious disease reporting (CIDR) system, the national dataset of all COVID-19 vaccinations for all residents (COVAX), and the regional maternal and newborn electronic health record called the Maternal and Newborn Clinical Management System (MN-CMS). We previously published research regarding availability, data access processes and feasibility of conducting research into COVID-19 infection and vaccination during pregnancy using these data.^2,3 Our research showed that the necessary data were not available to conduct population-based studies in Ireland. Urgent change is necessary as part of pandemic preparedness because:

Here, we outline recommendations to policy that would ensure future pandemic preparedness while also facilitating maternal and child health research in the ROI. An executive summary of this paper is available here: https://doi.org/10.5281/zenodo.18847965.

2. Need to optimise research governance processes

First, the current data access processes are complex and often fragmented, and information on data access procedures is not always publicly available. This leads to several challenges for researchers, including delays to project timelines and an over-reliance on informal networks to identify appropriate data access processes. Second, as data can quickly become outdated, particularly in the context of a pandemic, data access timelines are crucial. We estimate that current COVID-19 pregnancy data access procedures can take up to 14 months.² Third, applying for ethical approval to access anonymised MN-CMS data is cumbersome, and involves a separate ethics application submitted to each maternity unit’s local ethics committee, each with varying local standard procedures.³

Recommendations: 1). Strengthening research support services within the health service including the implementation of transparent, publicly available guidelines and support mechanisms such as Frequently Asked Questions (FAQs) and help desks would expedite data access processes and keep researchers informed and up-to-date regarding the status of any application.⁴

2). Clearer expected timelines from initial data request to data access would facilitate timely research, reduce project setbacks, and help manage funders’ expectations.⁴

3). The introduction of a single National Ethics Review Board for maternal and child health research, specifically for anonymised secondary data requests, would facilitate a more streamlined data access approach and reduce the need to interact with all maternity units separately.

3. Linkage between different data sources

The MN-CMS captures data related to pregnancy and delivery as well as information on demographics, lifestyle factors, medical history, and data relating to the newborn. During the pandemic, limited data on COVID-19 infection and vaccination status at the time of the booking appointment was also collected.²

The implementation of Individual Health Identifier (IHI) numbers to uniquely identify individuals engaging with health services is currently underway in the ROI and was successfully employed during the COVID-19 pandemic to facilitate the vaccine schedule.⁵ However, it is not yet possible to link the MN-CMS to other health data sources using the IHI.

Recommendation: 1). Accelerated rollout of the IHI to maternity settings would have several advantages during an emergency response to a pandemic. First, different data sources would not need to collect the same data. Instead, data in one area (e.g., COVID-19 infection or vaccination) could be linked to MN-CMS data to examine the impact of COVID-19 exposures on maternal and child health. Second, it is both an efficient and cost-effective method to conduct real-time population-based research.⁶ This is of particular importance during a pandemic when primary research studies and clinical trial activities face significant disruptions, and where timely insights on disease prevention, transmission dynamics, or sequelae are of critical importance.⁷ Third, studies examining COVID-19 exposures during pregnancy would not be impeded by unknown pregnancy status or early pregnancy, as the pregnancy status would be possible to obtain from the maternity records, and the gestational age could be accurately estimated, which is essential for subsequent safety studies.

4. Improving documentation of data sources

The arrival of the European Health Data Space (EHDS) places a requirement on the ROI to facilitate access to large-scale health data. Under the EHDS Regulation Framework, researchers should have access to information on what data is available in their member state, where, and of what quality.⁸ Moreover, a Health Research Board (HRB) report which outlines recommendations for the roll-out of a DASSL model (Data Access, Storage, Sharing and Linkage of data) to support research and innovation in Ireland further outlines the need for national data dictionaries and standardised metadata (examples of which are outlined in the DASSL report) to facilitate use of existing data resources for public benefit.⁹

Recommendation: 1). A catalogue of definitions and attributes about variables, data collection processes, and the size of the data is essential to ensure data are effectively managed. For example, metadata is needed to examine consistency between variables across datasets, to inform computational and storage capacity requirements, and to assess the feasibility of different analytical approaches.¹⁰ This will help to guide interpretation of research findings, and to inform decision-making in a pandemic situation.

5. Timely release of data, as the pandemic progresses

The MN-CMS data are collected during routine delivery of maternity care. Therefore, new data are being generated continuously. As the cumulative number of pregnancies and deliveries captured by the MN-CMS increases each year, this may lead to an increase in data requests.

Recommendation: 1). The creation of a data warehouse or national birth register (that could be linked to other data sources through the IHI) to manage and safely store anonymised data would facilitate data-driven discovery. These data could be used to answer research questions where large sample sizes are needed and create opportunities for randomised controlled trials using routinely collected data.

Alternative models of data storage, processing and extraction include the transferring of data to a single data provider or other national agency such as the Central Statistics Office (https://www.cso.ie/en/databases/). This is similar to Northern Ireland’s system where the Honest Broker Service (HBS), within the Health and Social Care system (https://bso.hscni.net/) provides approved researchers with access to linked, de-identified health data in a safe setting, resulting in a more streamlined data access system.²

6. Prioritisation of pregnancy data collection

The Northern Ireland Maternity System (NIMATS) adapted data collection methods during the pandemic to ensure data regarding the timing of COVID-19 infection and vaccination in pregnancy was recorded. In June 2020, data relating to infection at booking, during pregnancy, at delivery or discharge, and any admissions for COVID-19 infection during pregnancy and infant COVID-19 status, were added to NIMATS. In March 2021, the woman’s COVID-19 vaccination status at booking and the time of delivery, including the number and dates of vaccines, was also added to the system.² However, the availability of this information is limited in the ROI.

CIDR (which is proposed to be replaced by a new Outbreak, Case, Incident Management and Surveillance (OCIMS) Programme)¹¹ collected data on pregnancy status and gestational age at the time of COVID-19 infection. However, pregnancy information was poorly completed on CIDR. Resource constraints within the HSE’s Contract Management Programme meant that certain types of data collected were ‘switched off’ during periods of case surges.

Similarly, in the COVAX system, while data on pregnancy status at the time of COVID-19 vaccination was collected, data on gestational age was not systematically recorded.

Recommendations: 1). Data on pregnancy timing, particularly gestational age during the time of infection and vaccination, is vital to distinguish the impact of any future infectious disease threats at different trimesters. For example, the first trimester is the most susceptible period to teratogenesis.¹² Therefore, accurate information on gestational age at the time of infection and vaccination should be incorporated in the national OCIMS and National Immunisation Information System’s (where relevant) going forward.

2). Future pandemic planning should take an all-island perspective because many complex outbreaks span border areas. Therefore, inter-operable data systems, or at a minimum, greater consistency of available data across both sides of the border is needed.

7. Increased supports and funding needed

Currently, there are no direct costs for researchers to access the ROI health data discussed in this paper.² As suggested by the HRB DASSL report; sharing, linking, and preparing datasets usually incurs a charge in other settings.⁹

Recommendations: 1). The introduction of a nominal fee-based model, similar to Northern Ireland and Scotland, to support researcher requests, and to carry out data processing functions may warrant consideration in the ROI.

2). Increased support from funding agencies such as the Department of Health, Health Research Board and Taighde Éireann (Research Ireland) is necessary to achieve significant improvements to data access systems in the ROI. For example, a fully funded data science team (embedded in organizations such as the National Perinatal Epidemiology Centre) to handle data requests and perform data extraction and anonymisation procedures would enhance the provision of pregnancy data for secondary use.