Screen and Treat with Aspirin to Reduce Pre-eclampsia (STARshiP)
Study Specific Privacy Notice
Final Version 1.3 – 24-Oct-2025
Why we collect your personal data
We collect personal data under the terms of the University of Nottingham’s Royal Charter in our capacity as a teaching and research body to advance education and learning. Data is being collected on this occasion to conduct a randomised clinical study to compare two screening tests in clinical practice. Particularly, the study will look at whether using a new pre-eclampsia screening test from the Fetal Medicine Foundation (FMF) reduces the risk of preterm birth (birth before 37 weeks gestation) compared to the current NICE screening strategy in place in the UK (National Institute for Health and Care Excellence).
What data are we collecting?
To help us answer the study question, your routine first trimester pre-eclampsia screening details will be entered into a secure research database (called REDCap) located at the Nottingham Clinical Trials Unit (NCTU) at the University of Nottingham. Minimal identifiable data (NHS number, date of birth and a pregnancy ID generated by the hospital) will be used to link all the relevant datasets before being removed in the final dataset used for the analysis (to pseudonymise the data). Pseudonymising the data means that your data will no longer be able to be linked back to you.
Other relevant data will, additionally, be obtained from different sources such as, NHS England, and National Neonatal Research Dataset (NNRD). Maternal, pregnancy and delivery characteristics will also be looked at together with the pre-eclampsia risk score, to assess the ability of the new test to reduce preterm births. Postcodes will also be received from NHS England to look at the indices of deprivation (the index of deprivation tells us if an area in England is more deprived than another).
Pseudonymised data (for example, your NHS number which is replaced with a STARshiP unique identifier), will be stored on secure servers that are only accessible by authorised individuals and will not be shared at a participant level outside of the study team.
Approval for the disclosure of confidential data without individual consent
Under the common law duty of confidentiality, confidential information such as names, NHS numbers and date of births or other information that could be used to identify an individual cannot normally be disclosed except for the purposes of clinical care without patient consent.
However, there are certain circumstances when confidential patient information can be used for the benefit of research and other important activities without patient consent. An alternative legal basis is required to do this, which is commonly Section 251 of the NHS Act 2006 support.
This study has received approval from the Health Research Authority (HRA), following advice provided by the Confidentiality Advisory Group (CAG), to enable the common law duty of confidentiality to be temporarily lifted under section 251 of the NHS Act 2006. This means that confidential patient information can be disclosed by the person responsible for the information (data provider) without being in breach of the common law duty of confidentiality.
More information on section 251 support and the common law duty of confidentiality can be found here: https://www.hra.nhs.uk/about-us/committees-and-services/confidentiality-advisory-group/confidential-patient-information-and-regulations/
Legal basis for processing your personal data under GDPR
The legal basis for processing your personal data for this study is under Article 6(1e) of the General Data Protection Regulations "processing is necessary for the performance of a task carried out in the public interest". Providing high risk pregnant women/people with an appropriate treatment reduces the risk of preterm births and all the adverse maternal and child outcomes associated with preterm birth and pre-eclampsia.
Special category personal data
In addition to the legal basis for processing your personal data, the University must demonstrate a further basis when processing any special category data, including: personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person’s sex life or sexual orientation.
The basis for processing your sensitive personal data for this study is under Article 9(2j) "processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes".
Storage and retention periods for the personal data
All electronic databases will be encrypted and hosted on a University of Nottingham secure server, or the Trusted Research Environment (TRE) located at University of Nottingham. All data is accessed by authorised research staff only using individual usernames and passwords to access the secure platforms.
The University may store your data for up to a period of no more than 5 years after the research project finishes and is published. The researchers who collected or processed your data may also store the final dataset (“research data”) used for the analyses (that contains processed data, anonymised, not raw data) indefinitely for use in future research. You will not be identifiable in any data used in this way. Measures to safeguard your identity in stored data include encryption, pseudonymisation and full anonymisation, whichever is applicable to this particular research study. Identifiers such as NHS numbers, date of births and postcodes will be safely stored in a separate location.
The University of Nottingham also works with suppliers and partners who may make use of Cloud and/or hosted technologies. We undertake data security due diligence on our partners, ensure that suitable contracts are in place and that these partners conform to appropriate accreditations.
Wherever these transfers take place, the University of Nottingham will have an appropriate contract in place and there are strict rules regarding the confidentiality and security of your information in place to safeguard it.
Who we share your data with
The data team at NCTU will be managing the data transfer between the TRE and each data provider, the data processing and the data storage therefore, University of Nottingham is one of the data processors for this study.
Economic analysis on the anonymised dataset will be carried out by University of Oxford (data processor) researchers who are appropriately GDPR trained, through safe access of the data. Results from each study analysis will be published in aggregate format (not at individual level), for use by the scientific community. Your anonymised data may also be stored indefinitely (as explained above) on external data repositories (for example, the UK Data Archive) and be further processed for archiving purposes in the public interest, or for historical, scientific or statistical purposes, following further ethical approvals.
Transfers of your data outside Europe
Data will not be shared outside the European Economic Area (EEA).
Right to withdraw
You are not under a statutory or contractual obligation to provide personal data. As the study will use routine hospital data, obtained for all pregnant women/people accessing maternity services in participating NHS Trusts during the study period, you can request that your data is removed via a study specific opt-out process or via the national data opt-out process.
A study specific local opt-out will be available so that you can opt-out of your data being used in the STARshiP study, without the need to opt-out of all research (as would be the case with the national data opt-out). A detailed explanation of the study specific opt-out is available on the study specific website. This will be displayed within the information for your NHS Trust. Please got to [Information for Women/People] and select your NHS Trust to find out more.
If you prefer to opt out of your data being used in any research or for any non-clinical purpose within the NHS, please use the NHS National Data Opt-Out via: <https://digital.nhs.uk/services/national-data-opt-out>.
If you use either of the data opt-out processes, this will not affect your future care, but a national data opt-out request will be applicable for all future research and not solely for the STARshiP study. The withdrawal request, via either study-specific or national opt-out, will be applicable if the request is received before your routine data has been transferred to the NCTU from the national routine data sources at the end of the study. This withdrawal request must be completed by 01/08/2029. After this date, your routine data will have been received and processed at NCTU, your data will have been pseudonymised, and it will not be possible to withdraw the data from the analysis. https://starship.ac.uk/
You have the right to lodge a complaint with the Information Commissioner’s Office at University of Nottingham on the ICO's website(https://ico.org.uk/).
You can also find the University of Nottingham and University of Manchester research privacy notices for all research conducted by such parties on the NCTU website.
Data Controller and Data Protection Officer
The University of Manchester (Oxford Road, Manchester, M13 9PL, United Kingdom) and the University of Nottingham (University Park, Nottingham, NG7 2RD (0115 951 5151)) are the Data Controllers for the study (legally responsible for the data security) and are registered as a Data Controllers under the Data Protection act 2018 (Nottingham registration No.Z5654762). The University of Nottingham has appointed a Data Protection Officer. Their postal address, email address and telephone number can be found here: https://www.nottingham.ac.uk/utilities/privacy.aspx
Notice Review
We will keep this privacy notice under regular review and will place any updates on this web page. This privacy notice was last updated on 24-Oct-2025.