Privacy Notice: ASCEND
This Privacy Notice is being provided in compliance with the General Data Protection Regulation (GDPR) 2018. Before you joined the ASCEND trial, you were sent an ASCEND Participant Information Leaflet providing you with details about the study. In that leaflet, we informed you that “The coordinating centre would seek information from participants’ own doctors and from NHS and other central registries about any serious illnesses (such as heart attacks, strokes, cancers etc) that occur. All such information would be used, in confidence, only for medical research purposes and for routine regulatory and audit purposes.” The following questions and answers give you more detail about how information collected about you as part of the study is handled and processed.
Information about people taking part in ASCEND comes mainly from the questionnaires you have completed on a regular basis. In addition, we may ask for information from your GP or your hospital records about serious illnesses such as heart attacks, cancers or severe bleeding episodes. Information is also received from NHS Digital which holds information nationally from the records that health and social care providers keep about the care and treatment they give; this information received by ASCEND includes information about hospital attendances or admissions (called Hospital Episode Statistics or HES). For patients in Scotland, similar information is requested from the electronic Data Research and Innovation Service (eDRIS), and from the NHS Wales Informatics Service for patients in Wales. Finally, we also obtain information about your eye health from the NHS Diabetic Eye Screening Service.
We send information that identifies you (name, date of birth, NHS number, or CHI number in Scotland, and postcode) to NHS Digital and other NHS data repositories in England, or equivalent service in Scotland or Wales, who have a record of all hospital admissions and outcomes data from the Hospital Episode Statistics (HES) dataset and will link this information to individual participants in the study. NHS Digital also provide us with information relating to cancer registrations on behalf of Public Health England (PHE). In addition NHS digital, or the similar body in Scotland, provide us with information about people who may have passed away. This information includes date and cause of death supplied on behalf of the Office for National Statistics (ONS) and is sourced from civil registration data.
The processing of the NHS registry data will allow accurate coding of the medical events experienced by the people taking part in the study, ensuring high quality information (data) are available for any analyses.
Types of analyses
The data collected from central NHS registries during the Long–Term Follow-up phase of the study, will be used to assess whether the balance of benefits versus hazards of aspirin observed within the trial, relating to major vascular events such as heart attack or stroke, continue long-term or whether additional benefits emerge during longer-term follow-up.
It had been suggested that low-dose aspirin might protect against cancer and ASCEND provides one of the first opportunities to test this hypothesis. The analyses based on the study treatment phase showed no reduction in any cancers during the (up to) 9 years of follow-up available so far. However, the main focus of the analyses will be after longer-term post-trial follow-up has been collected, when the study team will be much better position to assess whether there is any benefit.
Dementia and cognitive impairment are increasing globally with increasing lifespan. Diabetes is associated with an increased risk of developing these conditions and so the study team are investigating whether taking aspirin provides any benefit.
Diabetic retinopathy and diabetic maculopathy are among the most common causes of registerable blindness among working-age adults in the UK. The eye sub-study is assessing the impact of aspirin and omega-3 fatty acids on various eye outcomes including diabetic retinopathy, macular degeneration and cataracts by allowing linkage to diabetic screening registry information. Visual loss impacts significantly on the quality of life for those people affected, as well as generating financial costs to the NHS ophthalmology services. Therefore the preservation of vision is extremely important.
The information that we receive is stored securely by Oxford University on a study database. When we analyse the information, your personal details (name, date of birth, NHS number and address), will be removed and replaced by a unique trial ID number. Your data is treated in the strictest confidence and is used solely for academic research purposes. Access to the study database is by unique combinations of usernames and passwords and only authorised study personnel can access information about participants. The University building is also secure with authorised swipe card access only. Importantly no individuals will be identified in any publications arising from this work.
Information will continue to be gathered about you from NHS registries beyond the end of the study treatment period so that any long term effects of taking aspirin or fish oils can be discovered. If you do not wish to have further health information collected about you then you should inform the study team using the contact details below. Anonymised information about study participants, which would not identify you, may be shared in the future with other approved medical researchers. Sharing of information with other researchers helps ensure that research is open to scrutiny and that best use is made of the information collected. Researchers at Oxford University will remain responsible for the security and validity of the information held.
The University of Oxford will keep the information collected about you until the end of the study in 2037 and perhaps longer if required by the law or other research needs. The “end of the study” is when the last health information is collected about study participants and will be many years after everyone stops the study medications.
The University of Oxford, as sponsor, is the data controller. This means that we, as University of Oxford researchers, are responsible for looking after your information and using it properly.
The University of Oxford is using your personal data for research purposes and will only process personal data as necessary to undertake research that is being carried out in the public interest. This is known under data protection law as our “legal basis”. The legal basis for the processing and storage of your personal data for ASCEND and its sub-studies is that it is ‘a task in the public interest’ (Article 6 (1) (e) EU General Data Protection Regulation (GDPR)). In addition, a required condition under GDPR to process your special category (sensitive) personal data is met as it is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes (Article 9 (2) (j) GDPR).
Data protection regulation provides you with control over your personal data and how it is used. When you agree to your information being used in research, however, some of those rights may be limited in order for the research to be reliable and accurate.
Further information about your rights with respect to your personal data under the General Data Protection Regulation is available on the University of Oxford's Compliance webpage. If you would like to contact us directly for more information about how we process and protect data collected for research, please email: firstname.lastname@example.org or call Freephone: 0800 585323 or you can write to: ASCEND study, Clinical Trials Service Unit, NDPH, University of Oxford, Richard Doll Building, Old Road Campus, OX3 7LF
If you wish to raise a complaint on how we have handled your personal data, you can either contact the ASCEND study team via the contact details above or the University of Oxford's Data Protection Officer via email at: email@example.com or by telephone on +44 (0) 1865 270285, who will investigate the matter. If you are not satisfied with our response or believe we are processing your data in a way that is not lawful you can complain to the Information Commissioner's Office (ICO) or call their helpline on 0303 123 1113.
Your participation by taking study treatment in ASCEND finished during 2017. The results of the main ASCEND trial were published in 2018 and can be accessed from this website clicking on the following link: Publications. As described above we are continuing to collect information about hospital admissions and other outcomes of interest from NHS datasets, which will allow us to compare the long-term effects of the study medications.
It helps ASCEND to produce reliable results if we are able to follow-up as many participants as possible by accessing their electronic NHS records. If you decide you do not want your study data to be linked in this way you can withdraw from this follow-up without affecting your current medical care. This can be done by contacting the study team who would require your identifiers to then inform NHS Digital and other data sources that you no longer wish to be included. You are free to do this at any time and don’t have to give us a reason. If you have any questions, please contact the study team using the details below:
Clinical Trial Service Unit
Richard Doll Building
University of Oxford
Old Road Campus
(the firstname.lastname@example.org e-mail will continue to work)
Freefone: 0800 585323
Office telephone: 01865 743888
Office fax: 01865 743981
The ASCEND trial and its sub-studies have been reviewed and approved by the North West – Haydock Research Ethics Committee (03/8/087).
Reference number: 03/8/087