Utilising the National Neonatal Research Database
The National Neonatal Research Database (NNRD) has been created through the collaborative efforts of neonatal services across the country to be a national resource. The NNRD was developed and is maintained and managed at the Neonatal Data Analysis Unit (NDAU) at the Chelsea and Westminster NHS Foundation Trust campus of Imperial College London, led by Professor Neena Modi.
Researchers, clinicians, managers, commissioners, and others are welcome to utilise the NNRD. The NDAU receives no core funding to support the NNRD. For this reason a charge is necessary to cover the costs of maintaining and developing the NNRD, data transfer, extraction, cleaning, and storage, and any analyses requested.
A Steering Board provides oversight of the NNRD. The Steering Board does not provide peer review but ensures the request is legitimate, feasible and in the interests of patients or the public. If the request is approved, the applicant is notified and asked to obtain necessary regulatory approvals. Applicants are asked to confirm that research findings will be published. On confirmation of regulatory approval, all eligible neonatal units are sent a copy of the research protocol, inviting them to participate. In the case of nationally commissioned service evaluations, all neonatal units are notified of the request by the lead organisation. These processes ensure that neonatal units are able to decline participation in research if they wish and are fully informed about national initiatives.
Accessing the National Neonatal Research Database
If you are thinking of using the NNRD for research or health services audit or evaluations, please first read the following information carefully, follow the process shown and complete the HDR UK data access request https://web.www.healthdatagateway.org/dataset/67020745-9def-4c6e-b5ac-bb273bd0a20e
Please note that if you only need access to your own neonatal unit data you should contact your Electronic Patient Record supplier directly.
Step 1 Define your question
- Please define your research question clearly; i.e. what exactly are you trying to show/prove/disprove? What information/variables will you require to answer the research question? Specify the population (e.g. gestational age; birth weight; sex; condition), the time period, and the geographical regions of interest
- Please note that the NNRD only contains data on admissions to NHS neonatal units, not data on all births
- Data from neonatal units in England are available from 2010 when 96% of units contributed data; from 2012 there has been 100% contribution from English neonatal units
- All Welsh neonatal units contributed to the NNRD from October 2012, 13 Scottish neonatal units from June 2014 and 3 from May 2018
- No data from Northern Irish neonatal units are included in the NNRD to-date; discussions are currently underway about the regulatory permissions required
Step 2 Check the data variables you require are included in the Neonatal Data Set ISB1595 (pdf)
- Check that the data you require are available in the NNRD by looking through the list of variables that comprise the Neonatal Data Set
- We recommend you define the type of analysis you wish to conduct as you may find you require additional variables (e.g. for confounder adjustment)
Step 3 Consider whether you only require a data extract, or whether you will require data analysis and/or statistical support
- Data extraction from the NNRD to meet specific needs is undertaken on a purpose-by-purpose basis by the NDAU data analysts
- Please feel free to discuss your needs with us
Step 4 Consider how you intend to fund your requirements
- We recommend you contact us in advance so that you are able to include any NNRD related costs in your grant applications
- We are required to submit all research related costs to the Department of Public Health and Primary Care, Imperial College London for approval
Step 5 Prepare your summary research protocol and data extraction request and submit there to the steering board
- The Steering Board is not a peer review committee but is happy to consider proposals at an early stage to be certain that the research question can be answered using the NNRD
Step 6 Obtain all regulatory approvals
- If the proposal is approved by the Steering Board, obtain the necessary regulatory permissions
- All research projects involving the NNRD require National Research Ethics Committee approval
- To use Scottish neonatal data you must also obtain approval from the Public Benefit and Privacy Panel for Health and Social Care
- HRA approval (“R&D approval”) is only required from Chelsea and Westminster NHS Foundation Trust as the host organisation of the NNRD, and is not required from each NHS Trust contributing data to the study
- If you require patient identifiers without patient consent you will require specific additional approval from the Health Research Authority Confidentiality Advisory Group
Step 7 Notifying neonatal units
- No research utilising the NNRD is undertaken without the agreement of each neonatal unit contributing data using an opt-out approach (unless the Research Ethics approval specifically mandates an opt-in approach)
- We will notify neonatal units on your behalf, in order to invite participation and request agreement
- NHS trusts contributing data through the NNRD for research studies that are adopted onto the National Institute for Health Research portfolio may list participation in their Research Quality Account returns, register their involvement through the Central System for Processing, and may be eligible for support through the appropriate Research Network
Step 8 Data sharing agreement
- Once all approvals are received we will ask you to sign a Data Sharing Agreement; this specifies the purpose for which the data are to be used, and the acknowledgements to be made
- We ask that contributing Trusts, Networks, Lead Clinicians, and other contributing members of the UK Neonatal Collaborative, as appropriate are acknowledged in all outputs
- On receipt of the Data Sharing Agreement, we will proceed with data extraction and analyses if requested
- We will provide you with an estimate of the time to completion
We recognise that this process can seem daunting. If you would like to discuss your project or are unsure about any of the above points we will be happy to help. Please contact the NDAU manager who will put you in touch with an appropriate member of the team.
Health services evaluations and audits
If you have a health services evaluation or audit to undertake, the NDAU team can also help. The first step is to clarify your needs. Please refer to questions 1-4 posed to researchers above. We recommend you then contact us for an informal discussion.
Once your proposal is complete send this to the NDAU manager. This will be considered by the Steering Board. You will be provided with confirmation if your analysis is possible, the estimated length of time required, and the cost. Please note you will need to inform all neonatal units that will be included about the audit or evaluation. We can notify neonatal units on your behalf if you wish.
If you decide to go ahead you will be contacted by Imperial College Consultants (ICON) to draw up a contract setting out the services the NDAU will provide, the time frame for completion, and the cost. As this is a consultancy, VAT will apply and a 10% fee will be levied by ICON.