The information published here applies to the use of your personal information (also known as ‘personal data’) by the POPStar project, which is being sponsored by the University of Cambridge. You can find out more about the privacy policies of the University through the viewing or use of its main website (www.cam.ac.uk). For more information about how the University handles personal information, and your rights under data protection legislation, please see https://www.information-compliance.admin.cam.ac.uk/data-protection/general-data.
Who will be responsible for the data for this project?
The data controller is the University of Cambridge.
The project team are happy to answer any questions you have regarding how data will be held or used in the project. You can contact us on:
POPStar Study Team
University Department of Obstetrics and Gynaecology
The Rosie Hospital
The Principal Investigator for the project is Professor Gordon Smith, who can be contacted via the details above.
2.) What is the purpose of the project?
The POP study, which recruited pregnant women between 2008 – 2012, looked at ways to predict which women will have complicated pregnancies. The information collected during POPS pregnancies (from interviews, blood samples and extra scans), is unique and has been used to draw important conclusions about health of mothers and babies during pregnancy.
The POPStar study is a further research project following up the long-term health outcomes of the mothers and children who participated in the POP study. The aim of POPStar is to understand how factors before and during pregnancy (e.g. genes, hormones, baby’s growth in the womb) and childbirth affects mothers’ long-term health as well as children’s health, growth and development.
The POPStar study participants were all part of the POP Study during pregnancy. Unless participants opt out, we will collect additional information from records that the NHS and other public organisations already hold about the POPS mums and babies. Participants can opt out of the project at any stage - this means that their data will not be collected or would be deleted from the project. Having access to this data allows us to look back and see if pregnancy information can be used as an early warning or predictor for any condition the mothers or children may have or develop in the future.
The processing of information in the project will be carried out in accordance with article 6(1)(e) of the General Data Protection Regulations (GDPR), and section 251 of the Health and Social Care act. The processing of this information is necessary for the University to perform a task in the public interest. The information processing that will be carried out by POPStar has been reviewed and approved by a research ethics committee, independent confidentiality advisory group, and the organisations that hold the data. The information we collect will be kept confidential at all times.
The information from the POPStar project will lead to a better understanding of the links between genes, pregnancy, environmental factors, and disease. The aim of POPStar is to contribute to improving healthcare provision and long-term prevention of a number of different diseases, which is in the public interest.
3.) What information will be used?
In order to access information about participants, we will provide minimum necessary personal details (name, date of birth and NHS number) to initially to NHS Digital. These details are already held by the POPS project, and will be provided to the POPStar study only for the purposes of identifying participants and updating their contact information via the NHS Spine. The NHS Spine will be used by NHS Digital to access the latest information on your opt-out status for research studies, whether mother and child are both still alive, and to find the last known contact address of the mother. NHS Digital will then automatically remove any participant who has previously registered an objection to their data being used for research purposes and no data processing related to these individuals will occur. For everyone else, if the mother and baby are both alive, then we will directly contact potential participants at the last known address of the mother. We will then send full study information including opt-out details, directly to that address. This ensures that all participants have the opportunity to opt-out of their data being included in POPStar.
Participants have a right to access the data held about them by the POPStar project (which they can do on request to email@example.com). Participants can have their data rectified by the project team if it is inaccurate or incomplete. Identifiable data will be stored and used only to identify and allow opt-out for participants, but will not otherwise be processed. All analyses will be performed on pseudonymised data only. No participant will be subject to any decisions made based on automated processing.
After participant notification and making study information visible in the public domain, there will be a period of one month during which no data processing will be made.
This period is in place to ensure that:
(i) Any participant who wishes to exercise their right to opt out of data linkage has ample opportunity to do so.
(ii) Participants have time to consider their position with respect to opting out of POPStar
During the period prior to the initial data linkage, opt-out information received will be checked and actioned by the research team at least weekly.
Thereafter, the opt-out option will remain available to participants via email or post at all times.
As soon as an opt-out notification is received either via post or via email, the research team will match the name of the opting-out participant to the list of POPS mothers and babies. Both the electronic and hard copy mail received by the project will be checked at least weekly in the period prior to data linkage by a member of the research team and any new opt-outs actioned. The details of any opting out mother and their child will be erased from the securely held list of participants whose personal data will be provided to NHS Digital or the Department for Education, for linkage. The participant’s study ID will be identified from the list at the time of erasure, and matched to any previously linked data. As opt-out can be exercised at any time during POPStar it may be the case that we have already received and have analysed pseudononymised data relating to that participant. In this case we will erase any such data. Opting out of POPStar does not affect in any way the status of the participant’s data in the original POPS dataset, for which explicit consent is in place, unless the participant also contact the POPS team.
If you wish to opt out you can do this via email (firstname.lastname@example.org) or by contacting the study team at:
POPStar Study Team
University Department of Obstetrics and Gynaecology
The Rosie Hospital
So that we can be sure to remove the correct participant, please provide your full name, your child’s name and the date that your child in the POP study was born. Please provide a return address so that we can acknowledge receipt.
Personal details will be used to contact participants to ensure fair processing and to identify the correct participant information on NHS Digital and Department for Education databases. NHS Digital will retrieve health status information, and return this to the POPStar project identified only by study number. The Department for Education will do the same with educational information. The POPStar study will not hold identifiable information linked to health or educational information. We will use the anonymous study number to link pregnancy research data (from the POP study) with current health status. It will not therefore be possible for the study team to know what information relates to each individual. The data will be analysed only using anonymous study numbers.
4.) How will information be handled?
None of the research information previously collected in the POP Study will be disclosed to other NHS or government departments for any purpose.
All data received from NHS Digital will be held in the University of Cambridge secure data storage area, known as the Safe Haven. For more information about the Safe Haven see: https://www.medschl.cam.ac.uk/research/information-governance/the-secure-data-hosting-service/.
All researchers who have direct access to the data will be substantive employees of the University of Cambridge. All our protocols for data-handling have been scrutinised and approved by an independent review panel. No data will be transferred to, or shared with any third parties. The information will remain securely stored only on servers located at the University of Cambridge. There will be no international transfer of information. All linked data will be stored and analysed in anonymised form.
Information will be linked to routinely collected health records for POPS participants until the child reaches 16 years of age. Beyond this time, personal information will be stored for a further two years, and the fully anonymised research data will be retained for a longer period.
Information about how long different types of information are retained by the University of Cambridge is published at https://www.information-compliance.admin.cam.ac.uk/records-management.
5.) What options are available to individuals with respect to their data in POPStar?
POPStar participants are restricted to mothers and children who participated in POPS only, who gave permission for their samples and data to be used in future projects. These participants will be contacted directly at their last known address to ensure that they are aware of their freedom to opt out of data processing and exactly how this can be done. They will also be automatically excluded if they have previously registered any objection to their health data being used in research.
Participants are free to opt out or stop access at any point. Withdrawal from POPStar will mean that all the information held regarding the participant will be destroyed using the standard procedures employed by Cambridge University Hospitals NHS Trusts for confidential information.
Opting-out can be done via telephone, email, via our website or by post. The study team would be happy to hear from anyone who would more information or has specific questions about the study (email@example.com). You can also request phone or email contact from the University of Cambridge about any information governance questions via our online form https://www.medschl.cam.ac.uk/research/information-governance/the-secure-data-hosting-service/
No-one is obliged to provide any data or to allow their data to be used in the POPStar project. The POPStar project will obtain personal data provided to the POPS project and available on the NHS Spine only for the purposes of participant identification and contact. All other data accessed via NHS Digital or the Department for Education will be supplied in pseudononymised form only. No research data will be held in identifiable form. The study does not use any automated decision-making or profiling of individuals.
6.) Who can I contact?
If you have any questions about the condictionn of the project, the study team would be pleased to hear from you (firstname.lastname@example.org).
If you have any questions about how your personal information is used, or wish to exercise any of your rights, please consult the University’s data protection webpages at https://www.information-compliance.admin.cam.ac.uk/data-protection. If you need further assistance, please contact the University’s data protection team (email@example.com) or its Data Protection Officer (firstname.lastname@example.org).
If you are not happy with the way your information is being handled, or with the response received from us, you have the right to lodge a complaint with the Information Commissioner’s Office at Wycliffe House, Water Lane, Wilmslow, SK9 5AF (https://ico.org.uk/).
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