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who is eligible to take part in ORION-4 and how are they identified?

People are potentially able to take part in ORION-4 if they have had a heart attack, stroke or an operation or procedure to unblock or bypass one of the arteries to their legs, and they are at least 55 years old. In England and Wales these patients are identified by NHS Digital or the NHS Wales Informatics Service. NHS Digital holds information from the records that health and social care providers in England keep about the care and treatment they give and are able to run an electronic search to find patients who have had one of these conditions or procedures. Details, including name, date of birth, address, NHS number and registered general practice, for these patients are securely transferred to the ORION-4 researchers at the University of Oxford so that invitations to take part in the study can be sent on behalf of the local ORION-4 clinic. For people living in Wales, individual Health Boards run a similar search and securely transfer the information to the ORION-4 researchers.

Some patients living in the Manchester area may be identified and invited by their General Practitioner. For more information about this visit the NorthWest EHealth website.

How is personal data about potentially eligible patients processed by the ORION-4 researchers?

Personal data about potentially eligible patients are used to mail a letter inviting them to attend a study visit at their local ORION-4 clinic. Invitation letters may be produced, printed and mailed on behalf of the University of Oxford by Paragon Customer Communications Ltd who also handle patient letters for the NHS. Names and addresses of potentially eligible patients may, therefore, be passed securely to Paragon Customer Communications Ltd who will not use this personal data for any other purpose and will delete the data once the invitation letters have been sent out.

People who decide to take part in the study are asked to provide written consent at their first study visit. For details about how information about study participants is collected and processed see the Data protection information for ORION-4 participants section of this website. Information about people who decide not to take part (or do not reply) is kept securely by the ORION-4 researchers until 2024 to ensure those people are not invited again and to produce reports about the study (for example how many people were invited). After that, information about potentially eligible patients who did not take part in the study is deleted. ORION-4 is coordinated by the Clinical Trial Service Unit at the University of Oxford and is co-sponsored by the University of Oxford and The Medicines Company. Information about patients who are to be invited to take part in ORION-4 may be shared with the NHS Hospital Trust in which it was originally recorded, but will not be shared with any other organization. No information identifying any individuals will be transferred to The Medicines Company.

The University of Oxford is the “data controller” for this information which means that it is responsible for looking after this information and for ensuring it is used properly. Information about potentially eligible patients is stored securely using encryption and password protection and access is limited to only those members of staff who need to use the information.

If people have requested that their NHS data is not used for research and planning, then their details are not transferred to the ORION-4 researchers for this study. You can find out more about how the NHS uses your data for research and planning by visiting the NHS website.

The University of Oxford is using information about people who are potentially eligible to take part in ORION-4 for research purposes and it will only process “personal data” (information about someone where that individual could be identified) in order to undertake research carried out in the public interest. This is known under data protection law as our “legal basis” for processing personal data.

The Confidentiality Advisory Group, an independent body which provides expert advice on the use of confidential patient information in England and Wales has provided support for details about potentially eligible patients to be provided to the ORION-4 team at the University of Oxford under section 251 of the National Health Service Act 2006.

Rights and complaints

If you would like to find out whether the ORION-4 team holds information about you then contact us via our website, by e-mail at orion4@ndph.ox.ac.uk, or telephone 0800 585323. If you do not wish to receive an invitation to take part in ORION-4 or do not want the ORION-4 team to hold information about you then please contact us.

You have the right to access any personal information that is held about you by the ORION-4 team, the right to ask us to correct any inaccurate personal information we hold about you, to delete personal information, or otherwise restrict processing or object to processing or to receive an electronic copy of the personal information we hold about you. If you would like to discuss this further please contact the ORION-4 team using the details above or alternatively you can contact the Data Protection Officer, data.protection@admin.ox.ac.uk.

If you are not happy with the way your data has been handled by the ORION-4 team you have the right to lodge a complaint with the Information Commissioner’s Office (0303 123 1113 or www.ico.org.uk).