How your information is used in the LOTUS Clinical Study

LOTUS: An international multi-centre long term follow up study of the long term outcomes and impact of cancer treatments in “triple negative” breast cancer

LOTUS entry on the international clinical trials registry: http://www.isrctn.com/ISRCTN43423520
UK Research Application System ID: 158206

This web page explains how we at the Clinical Trials Research Unit at the University of Leeds in the UK use the information we collect about you in the LOTUS clinical study. Your information is protected by data protection laws in the United Kingdom. These laws mean that you must have clear information about how information about you is collected and used.

This web page provides some more information about how the data we collect from you is used, in addition to the patient information sheet you were given before you joined the LOTUS study.

General information

The University of Leeds is the sponsor of this study, and is based in the United Kingdom. The Clinical Trials Research Unit (CTRU) is part of the University of Leeds, and is responsible for day-to-day management of the LOTUS study.

The University of Leeds uses information from you and your medical records in order to undertake this study and acts as the “data controller” for this study. This means that we are responsible for looking after your information and using it properly. CTRU will keep identifiable information about you for at least 15 years after the study has finished. As the University of Leeds is in the United Kingdom, your information will need to be sent from the country where you live to the UK.

As a university we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have 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 means that when you agree to take part in a research study, we will use your 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. We do this by following the UK Policy Framework for Health and Social Care Research.

We make sure we follow the data protection principles in everything we do:
• Data are used lawfully: all our use of personal data has a clear ‘lawful basis’ as per UK law, which in this case is both ‘task in the public interest’ and ‘necessary for scientific research purposes’.
• Data are used fairly and transparently: before we use people’s data, we make clear to them what the data will be used for, how it will be handled, what their rights are and how they can act on those rights.
• We only collect and use data for clear and specific purposes: for our research or for further, similar research in the public interest (see below), or to support the work of our organisation.
• We only collect as much data as we need for these purposes, and no more.
• We spend a lot of time and effort making sure the data are accurate, as this is vital to the reliability of our research.
• We only keep data as long as we need it. Once a research project is over, we need to store data for a certain length of time in order to comply with laws and policies around research data (at least 15 years in the case of LOTUS). We sometimes ask other organisations to store this data for us, away from the CTRU or the University of Leeds. When we do this, the data is held very securely and the organisation storing the data is not able to access the contents of the data or identify any individuals from the data.
• We ensure data are stored and used in ways that keep it secure and confidential, and only accessible to people who need to access it for specific, valid reasons.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. 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.

If you wish to raise a complaint about how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter.

Our Data Protection Officer can be contacted using the following details:
• 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

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 relevant data protection supervisory authority in your country of residence.

How your information is used

Your hospital collects information from you and your medical records for this research study in accordance with our instructions.

Your hospital uses your name, hospital number, date of birth to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from CTRU and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Your hospital will pass these details to CTRU along with the information collected from you and your medical records. The only people in CTRU who will have access to information that identifies you will be people who need to audit the data collection process.

CTRU will collect information about you for this research study from your hospital. This information will include your name, date of birth and hospital number and health information, which is regarded as a special category of information. We will use this information to run the study and analyse the results.

Your hospital will keep identifiable information about you from this study for at least 15 years after the study has finished.

Using your information for further research

When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, UK National Health Service organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-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.

We would like to take this opportunity to thank you again for taking the time to read this information, and for your participation in the LOTUS study.

On behalf of the LOTUS team.

Date: 25th September 2020