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This Privacy Notice is being provided in compliance with the General Data Protection Regulation (GDPR) 2018. At the end of the ASCEND trial you were sent a Participant Information Leaflet which described a sub-study called ASCEND-Eye. The following questions and answers give you more information about how information collected about you as part of the ASCEND-Eye study is handled and processed.

Diabetic retinopathy and age-related macular degeneration are among the most common causes of registerable blindness among adults in the UK. The ASCEND-Eye study is assessing the impact of aspirin and omega-3 fatty acids on various eye conditions including diabetic retinopathy, age-related macular degeneration and cataracts by obtaining information about eye health from the NHS Diabetic Eye Screening Programme registry, and via a one-off Visual Function Questionnaire. Visual loss impacts significantly on the quality of life for those people affected, as well as incurring significant financial costs to the NHS ophthalmology services. Therefore research into measures which may preserve vision is extremely important.

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The information we collect about your eye health comes from three main places:

  1. From the follow-up questionnaires you completed every 6 months during the main ASCEND trial (this activity is now complete)
  2. From your completion of the one-off ASCEND-Eye Visual Function Questionnaire that was posted to you at the end of ASCEND (this activity is now complete)
  3. From the NHS Diabetic Eye Screening service that individuals with diabetes are invited to attend on a regular basis (this activity is ongoing

In order to obtain results from your eye screening appointments, we send information that identifies you (including your NHS number and unique ASCEND participant ID number), to the NHS Diabetic Eye Screening Programme you attend. They link this information to their records of your diabetic retinopathy grades since you began the ASCEND trial, and then return the results to us via a secure route.

Each screening programme holds data for the geographical area that they serve. Some screening programmes do not have staff with the required computer skills to perform this type of data linkage. They have the option to allow the company which provides the software used during the screening, to perform this task on their behalf.

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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.

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Any personal data that identifies you are collected and managed by the ASCEND team at the Clinical Trial Service Unit (CTSU) and will not be shared with anyone else, except to obtain health information about you from the NHS Diabetic Eye Screening Programme (as described above). Data shared between CTSU and the NHS Diabetic Eye Screening Programmes or their software provider, will be performed under data sharing agreements and by secure methods of electronic data transfer. It will be used only to allow us to carry out the ASCEND-Eye study and to send you a summary of the results.

At the end of the ASCEND-Eye study, de-identified data (from which you cannot be identified) may be shared with other research groups who are doing similar research. This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.

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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 law or if used solely for research purposes under the provisions of Article 5(1)(e) EU General Data Protection Regulation (GDPR). The “end of the study” is when the last health information is collected about study participants and will be many years after everyone has stopped the study medications.

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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.

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Data protection regulation requires that we state the legal basis for processing information about you. In the case of research, this 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).

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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: ascend@ctsu.ox.ac.uk 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

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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/process information from the one-off Visual Function Questionnaire and NHS Diabetic Eye Screening service, which will allow us to compare the effects of the study medications on eye health.

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It helps ASCEND-Eye to produce reliable results if we are able to obtain information about eye health on as many participants as possible by accessing their NHS Diabetic Eye Screening Programme data. If you decide you do not want your study data to be linked in this way you can withdraw from this exercise without affecting your current medical care. This can be done by contacting the study team who would require your identifiers to then inform the screening programme 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:

 

ASCEND

Clinical Trial Service Unit

Richard Doll Building

University of Oxford

Old Road Campus

Headington

Oxford

OX3 7LF

 

E-mail: ascend@ndph.ox.ac.uk (the ascend@ctsu.ox.ac.uk 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 (Reference number: 03/8/087)

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