MiFoot RCT DATA PROCESSING ACTIVITY

Information you need to know:

The Leicester Diabetes Centre is part of the University of Leicester. Further information on the institution can be found here: https://le.ac.uk/ . The University of Leicester is the Data Controller for your information. You can find more information about how we use your information at the Leicester Diabetes Centre here: https://www.leicesterdiabetescentre.org.uk/privacy-policy

The Data Protection Officer is: Parmjit Singh Gill, Data Protection Officer, University Of Leicester, and University Road, Leicester, LE1 7RH. Email: dpo@leicester.ac.uk.

This privacy notice explains how we use your personal information and your rights regarding that information. The information in this privacy notice is intended to supplement specific information provided to research participants, for example, through participant information sheets or consent forms, with regard to their participation in research studies carried out by the University of Leicester.

The UoL conducts research activity which has obtained appropriate ethical and legal approvals. Data collected as part of our research activity is processed and stored strictly in the public interest. The UOL is able to assure compliance by following the UK Policy Framework for Health and Social Care Research.

What information are we collecting?

This information will include:

  • Name and Initials

  • Contact details including address, post code, email address and phone numbers

  • Vehicle identifiers to reimburse parking costs

  • Date of Birth

  • Sex

  • Ethnic Group

  • NHS number

  • Medical records

  • Clinical data obtained during the study

  • Unique study code

We may collect information about you directly from you or on some occasions we may collect from third parties such as GPs or hospitals, when you have provided consent. The information collected will be proportionate to achieve the research objectives and our researchers will not collect more information than is actually needed. 

Why are we collecting your data?

We will collect your personal data:

  • For research, auditing and monitoring purposes

  • To check your eligibility for the study

  • To contact you regarding study visits

The MiFoot trial is a consortium of leading researchers and clinicians from across the UK, working together to investigate the effect of the complex intervention (MiFoot) with usual care for preventing CVD events in people with T2D and current or previous DFUD in a randomised controlled trial.

How we will use this data?

Clinical data will be used to check whether you are eligible to take part in this study. Your contact details and some basic information about you will be stored on your Trust Research Volunteer’s database and may be used to contact you in the future about our other research studies. Your contact details will be shared with the University Hospitals of Leicester NHS Trust for the purpose of Leicester site to contact you at month 0 and for the remote follow up visits at month 12 and 24. Identifiable information will not leave the NHS Organisation for the purpose of monitoring and auditing because any monitoring/auditing activity has to take place at the Trust.

What is the legal basis for processing the data?

The legal basis for the processing of participant information that we are collecting and using for the trial is Public Task as set out in the Data Protection Act 2018 and UK GDPR Article 6.1(e). Research is a public task that the University of Leicester performs in the public interest and is part of its core functions as a University. Where special category data will be collected, our additional conditions for processing information relies on; Article 9.2(i); and that it is necessary for ‘scientific research or statistical purposes’ as set out in the Data Protection Act 2018 and GDPR Article 9.2(j).

If we are sharing your data with others who are we sharing it with?

We will share your personal data within University of Leicester and the University Hospitals of Leicester NHS Trust, this information will be accessed by the research team. If you would like to have further details about how your personal data is shared, please contact the research team. Identifiable data will only be accessed by the relevant approved members of the research team. Any data dissemination will use non-identifiable data. Research information is often coded (pseudonymised or anonymised) and this means all identifiers such as NHS number, name, data of birth etc., are removed from the records. In this case, for reporting purposes your personal data will be pseudonymised. We will share your coded data within University of Leicester, University of Sheffield and University Hospitals of Leicester NHS Trust this information will be accessed by the research team.

Leicester Diabetes Centre will manage a research repository which is a collection of information from the health and medical records of trial participants and can sometimes include identifiable information (like name, address, date of birth). The repository includes codes that identify each person whose information is collected. However, the repository does not share your personal information with researchers.

Relevant sections of your medical notes and/or research data may be looked at by individuals from the research and clinical team, the Sponsor, The University of Leicester, regulatory authorities or other NHS host organisations where it is relevant to your taking part in the MiFoot trial.

How long we will process your data for?

Personal identifiable data collected during the trial will be kept by each participating site for a maximum of 12 months following the end of the study, after which it will be destroyed, unless you have expressed an interest in receiving a copy of the trial results. All other paper and electronic data will be retained for at least 6 years after completion of the trial, in accordance with the University of Leicester standard operating procedures. The data will be stored at a University of Leicester approved archiving facility which will ensure that it is stored securely and accessed only by authorised individuals.

You will be able to find more specific information about the retention period in the participant information sheet or consent form the research team provided when you joined the trial in which you are a participant.

What are your rights and how to enforce them?

Where data is identifiable you have the following rights,

  • The right to be informed - which is met by providing you with this notice

  • The right of access – you can request access to the data held about you.

  • The right of rectification – you can ask us to correct inaccurate data

  • The right to object to processing your personal data

  • The right to restrict your personal data

Please note: some of the above rights are no absolute, where personal data is no longer identifiable (pseudonymised or anonymise), the rights can no longer be enforced.

If you wish to exercise any of these rights please contact the University’s Information Assurance Service by email ias@leicester.ac.uk

How to complain to the Information Commissioner’s Office?

The Information Commissioner can be contacted on:

Post: Information Commissioners Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK95AF.

Tel: 0303 123 1113.

Email contact can be made by accessing www.ico.org.uk