You will not need to provide your written consent to be involved in the study. The study will use information that is already routinely collected by the NHS about your pre-eclampsia risk, your pregnancy, labour, birth, your baby’s health and other general characteristics. There will be no additional data collected specifically for this study and only information needed for the care of you/your baby will be collected during your care.

In order for us to see if there is a difference between the two screening tests, the results of your pre-eclampsia screening, along with your NHS number, date of birth and a number to identify your pregnancy created by your hospital will be entered onto the STARshiP online database, which is managed by the Nottingham Clinical Trials Unit at the University of Nottingham. Access to this database is carefully controlled; your information will not be visible to people outside your pregnancy care team and the research team at the Nottingham Clinical Trials Unit. This data will be kept confidential, and your data will not be shared outside of the research study.

At the end of the study, the information on this database will be linked to information about your health and the health of your baby during pregnancy and shortly after birth. Hospitals already collect and share this information with NHS England and other health care providers (which we refer to as “routine data”). We will link all this information together in a database called a “Trusted Research Environment”. This is a secure database where trained researchers from the University of Nottingham, Manchester and Oxford can access the research data. The data will have all information that identifies you removed and replaced with a unique study ID (it will be pseudonymised) once it is linked. 5 years after the study analysis has been completed, your identifiable data will be permanently deleted. Anonymised data may be retained indefinitely for use in future research. This data cannot be linked back to you. This information is vital to fully understand which pre-eclampsia risk test is better at helping pregnant women/people avoid preterm birth due to pre-eclampsia.

In addition, at least 200 pregnant women/people at your hospital will have a small amount of extra non-sensitive information collected from medical records which is not routinely shared with NHS England. This will include information about the number of pregnant women/people who have blood tests and ultrasounds taken, how many pregnant women/people choose to decline specific aspects of their usual care treatment such as the blood tests, and whether aspirin was recommended or not.  This extra information will help us to understand any changes to pregnancy care that could happen after pre-eclampsia risk screening (that cannot be checked through the routinely shared data). If you are selected as part of this group, you will be assigned a study identity code and your NHS number, date of birth and a number to identify your pregnancy created by your hospital will be entered into the study database and then linked with the screening information and routine data.

All aspects of this study, including what information is collected and how it is stored, have been discussed with the STARshiP Patient and Public Involvement (PPI) Group. This group are parents with experience of pregnancy, some of whom have had pre-eclampsia, from across the country. Permission to use routinely collected data for the purposes of this study has been approved by the Health Research Authority based on the advice provided by the Confidentiality Advisory Group. These steps have been taken to ensure that this study is run to the highest standards, that your information is kept confidential and secure, and that no unnecessary data is being collected. The use of your information for the purpose of this study has the potential to bring great benefits to future pregnant women/people and their babies.

If you do not want your data (or your baby’s data) to be used in this study, you have the right to opt out and your care will not be impacted in any way. You can do this using a STARshiP study specific opt-out form or by using the national data opt-out service.

Routinely collected data will be requested from NHS England at three timepoints in the study. If you do not want your data to be used in the study, please opt-out using either the STARshiP study specific opt-out form or the National Data Opt-Out form by 01.08.2029. Please find more information on these forms below.

The STARshiP Study Specific Opt-out Form

You can tell us that you do not wish your data to be used for the STARshiP study by completing this form : [The study has not officially started and so this form is not yet available].

You will need to provide your NHS number and date of birth for us to identify your information and remove this from the study. You can find your NHS number here [https://www.nhs.uk/nhs-services/online-services/find-nhs-number/].

If you need any help completing this form, please ask your midwife or doctor.

What happens to my opt out request?

If your booking appointment was less than 1 week ago at the time you complete this form, your opt out request will go directly to your NHS Trust. They will make sure that your data is not shared with the STARshiP study team, and it will not leave the NHS. If you have another pregnancy, or if you transfer your pregnancy care to another hospital you will need to repeat this request so that the new NHS Trust are aware of your wishes.

If you decide to opt-out later than 1 week after your booking appointment), your data will have left the NHS and will have been received by the STARshiP study team at the Nottingham Clinical Trials Unit (NCTU) at the University of Nottingham. However, you are still able to opt out of your data being used in the STARshiP study. Your opt out request (including NHS number and date of birth) will be sent directly to the NCTU. They will use it to remove your data from our study records for this pregnancy and any other pregnancies during the STARshiP trial. These details will be kept confidential. Once the study team has confirmed that all your data has been removed, your NHS number and date of birth will be deleted at the end of the study before the data is analysed.

If, during your pregnancy, or any future pregnancies, you decide to transfer your care to another hospital in a different trust participating in the STARshiP study, you will need to complete this form again to tell the trust or NCTU team that you do not want to share your data. If you do not transfer your care to another trust participating in the STARshiP study, you do not need to complete this opt out form again.

The National Data Opt-out Form

The national data opt-out service is a is a national service that allows you to ‘opt out’ of all your health information being used for all future research and NHS planning, (not just for this study). For more information or to ‘opt out’, go to: https://www.nhs.uk/your-nhs-data-matters/ .

If you opt out of your data being used after it has been processed, unfortunately it cannot be erased as it will have already been used in analysis and included in the study findings. It will not be possible to link the data back to you.

If you have previously 'opted out' of having all your health information used for all research and planning in England and you have changed your mind, then you will need to 'opt in'. The process of 'opting in' is clearly set out on the:  https://www.nhs.uk/your-nhs-data-matters/ website.

If you 'opt in' then all your health information could be used for this study, and all future studies who are approved to do so.

Under UK Data Protection laws, the Universities of Manchester and Nottingham are joint Data Controllers (legally responsible for data security). The Chief Investigator of this study (Professor Jenny Myers) is the Data Custodian (manages access to the data). This means that we are responsible for looking after your information and using it properly. Your rights to access, change or move your information are limited as we need to manage your information in specific ways to comply with certain laws and for the research to be reliable and accurate. To safeguard your rights, we will use the smallest amount of personally identifiable information possible.

You can find out more about how we use your information and read the University of Manchester privacy notice. You can also read the STARshiP study specific privacy notice at [Privacy Notice]. Please also find the link for the Health Research Authority (HRA) webpage where you can find more information about how we use your information <www.hra.nhs.uk/patientdataandresearch>.

The data collected for the study will be looked at and stored by authorised persons from the Universities of Manchester and Nottingham who are organising the research. They may also be looked at by authorised people from regulatory organisations to check that the study is being carried out properly. All members of the research team have a duty of confidentiality to you as a research participant, and we will do our best to meet this duty.

All research data will be kept securely for 5 years after the analysis is done.  After this time, the data will be disposed of securely.  During this time, precautions will be taken by all those involved to maintain your confidentiality. Only members of the research team who have been given permission by the data custodian will have access to your personal data and any identifiable personal data will be deleted by the end of the study. They will keep your information private. 

In accordance with the University of Manchester, University of Nottingham, the Government and our funders’ policies we may share our research data with researchers in other Universities and organisations, including those in other countries, for research in health and social care. Sharing research data is important to allow our findings to be checked by others, avoid duplication of research and to understand the bigger picture in particular areas of research. Only completely anonymous data will be shared in this way and will not include your routine clinical data. This means that it will not be possible to identify you or your baby from any information shared.

If you have any concerns or questions relating to the care you have received, you should speak to your local maternity unit or midwife.

A link to your hospital trusts’ contact page can be found here:
<Link>

If you have any questions related to the study and how your data is used and managed, please contact the STARshiP team at starship@nottingham.ac.uk.

If you remain unhappy and wish to complain formally, you can do this through the National Health Service (NHS) Complaints Procedure via your local Patient Advisory and Liaison Service (PALS) <insert Local PALS details>.