ELF to Uncover Cirrhosis as an Indication for Diagnosis and Action for Treatable Events
(ELUCIDATE)

For participants
This information is for the attention of participants of the ELUCIDATE trial and describes how the data you provided during your participation in the trial is being used and protected. This information has been put together by the team of researchers responsible for the ELUCIDATE trial.

Who is responsible for your data?
The University of Leeds is sponsor for this study based in the United Kingdom. The University of Leeds has shared the data with the Royal Free London NHS Foundation Trust as this is where the doctors who are in charge of the study are based. Both University of Leeds and Royal Free London NHS Foundation Trust have used information from you and your medical records in order to undertake this study and act as the data controllers for this study.

What information do we collect about you?
The NHS hospital which recruited you in to the research study (your hospital) will have collected information from you and your medical records needed for the research study from your medical records.

Your hospital will have used your name, NHS number and postcode to make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Your hospital will have passed these details to the University of Leeds along with the information collected from you and your medical records. The only people at the University of Leeds who will have access to information that identifies you will be people who received, reviewed and entered your data on to the study database, the people who analysed your data or people who audit the data collection process.

The University of Leeds has also sent your Initials, NHS number, Data of Birth and Postcode to NHS Digital and in return they will inform us if you have died, have been diagnosed with liver cancer, or have been admitted to hospital due to a liver-related complication.

How we use your personal data
The University of Leeds and Royal Free London NHS Foundation Trust uses personally-identifiable information to conduct research to improve health, care and services. It is the duty of both organisations to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This provides the legal basis for our use of your data; GDPR Article 6(1)(e) and Article 9(2)(j). This means that when you agree to take part in a research study, we will use your data (including your health data) in the ways needed to conduct and analyse the research study. Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. To ensure we can carry out the research to the highest standards we comply with the UK Policy Framework for Health and Social Care Research.

You can find out more about how the University of Leeds uses your information at
http://www.leeds.ac.uk/info/5000/about/237/privacy_and_cookies
https://ctru.leeds.ac.uk/privacy/

You can find out more about how the Royal Free London NHS Foundation Trust uses your information at https://www.royalfree.nhs.uk/patients-visitors/privacy-notice/

How long we keep your data
The University of Leeds and Royal Free London NHS Foundation Trust will keep identifiable information about you for a minimum of 10 years after the study has finished.

How we protect your data
We protect your data against unauthorised access, unlawful use, accidental loss, corruption and destruction.
We use technical measures such as encryption and password protection to protect your data and the systems they are held in. We also use operational measures to protect the data, for example, but limiting the number of people who have access to the study database in which your data is held and using unique reference numbers to identify participants rather than names wherever possible.
We keep these security measures under review and refer to University security policies to keep up to date with current good practice.

Who is my data shared with?
The University of Leeds has worked closely with expert researchers at the Royal Free London NHS Foundation Trust to develop and run the study. The University of Leeds will share data collected about you as part of ELUCIDATE and from NHS Digital with these researchers to help analyse the results of the study. Information about your health and care may also be shared with researchers running other research studies within the University of Leeds or other organisations. These other organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad.

Any information which is shared with other organisations 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.

Your rights
Under the General Data Protection Regulation (GDPR), which came into effect on 25 May 2018, you have the following rights in relation to the information that we hold about you (your ‘personal data’):

  • The right to request access to your data (commonly known as a “subject access request”). This enables you to receive a copy of your data and to check that we are lawfully processing it.
  • The right to request correction of your data. This enables you to ask us to correct any incomplete or inaccurate information we hold about you.
  • The right to request erasure of your data. This enables you to ask us to delete or remove your data in certain circumstances for example, if you consider that there is no good reason for use continuing to process it. You also have the right to ask us to delete or remove your data when you have exercised your right to object to processing (see below).
  • The right to object to the processing of your data, where we are processing it to meet our public tasks of legitimate interests (or the legitimate interests of a third party) and there is something about your particular situation which makes you want to object to processing on this ground. You also have the right to object where we are processing your data for direct marketing purposes.
  • The right to request that the processing of your data is restricted. This enable you to ask us to suspend the processing of your data, for example, if you want us to establish its accuracy or the reason for processing it.
  • The right to access, change or move your data. Depending on the circumstances, we may have grounds for not complying with your request, for example, where we consider that deleting your information would seriously harm the research or where we need to process your data for the performance of a task in the public interest.

If you wish to exercise any of these rights, please contact the study at ELUCIDATE@leeds.ac.uk.
If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Complaints
If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (https://ico.org.uk).

Our Data Protection Officer can be contacted as follows:
Email: DPO@leeds.ac.uk;
General postal address: University of Leeds, Leeds LS2 9JT, UK;
Postal address for data protection issues: University of Leeds, Room 11.72 EC Stoner Building, Leeds, LS2 9JT;
Telephone number: +44 (0)113 243 1751.

Contact us
If you would like to contact us directly for more information about how we process and protect data collected for research, please email elucidate@leeds.ac.uk or you can write to the study team at: ELUCIDATE Trial, Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT.

Top