CEMARC

The University of Leeds is the sponsor for this study based in the United Kingdom. We have used information from you and your medical records in order to undertake this study and act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. The University of Leeds will keep identifiable information about you for a minimum of 5 years after the study has finished.

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 If you have withdrawn from the study, we will keep the information about you that we have already obtained.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.

You can find out more about how we use your information at http://www.leeds.ac.uk/secretariat/data_protection.html

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.

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.

The NHS hospital which recruited you (your hospital) will have collected information from you and your medical records for this research study in accordance with our instructions.

Your hospital will have used your name, NHS number and contact details to contact you about the research study, and to make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from the University of Leeds and regulatory organisations may look at your medical and research records to check the accuracy of the research 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 in the University of Leeds who will have had access to information that identifies you will be people who needed to contact you to send you questionnaires at 6 months and 1,2 and 3 years or audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.

Your hospital will keep identifiable information about you from this study for a minimum of 5 years after the study has finished.

The University of Leeds has collected information about you for this research study from NHS Digital. This information included your NHS number, date of birth and health information, which is regarded as a special category of information. We used this information to cross check against information supplied by your hospital regarding trial participant mortality. We have completed the cross check and have now destroyed the NHS digital data.

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, NHS 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.

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.

This webpage was created by the CEMARC study team at University of Leeds.

We have been carrying out the CEMARC study, which is ethically approved research in the public interest. We are collecting information from NHS Digital to find out about the long-term health of CEMARC study participants after they have taken part in the study. This will help us understand more about how good the different tests involved in CEMARC are at predicting people’s long-term health. If you would like to know more about what the study has found out so far then the main results have been published in the medical journal called the Lancet and are available below.

As part of you consenting to us obtaining further health data from NHS Digital about you, we securely sent them your first name, surname, NHS number, date of birth, gender, post code and trial number to NHS Digital so that they can identify the people we would like information about. NHS Digital then send health data to us about participants who had died and the reason for their death without any extra identifying information.

Collecting information from NHS Digital means less burden for trial participants to give time to trial visits. It is also more efficient and cost-saving for the NHS, compared with asking people to make extra hospital visits. NHS Digital have strict rules about sharing their data for research projects like CEMARC. You can find out more on the NHS Digital transparency notice.

Collection of this data has been approved by an independent research ethics committee and NHS Digital. University of Leeds is responsible for what data is collected, what it is used for and making sure it is used correctly and legally, (this means they are called the ‘data controller’).

The data we collect will be stored securely at University of Leeds. Only people have need to access the data for analysis purposes will have access to it. When our agreement to hold the NHS Digital data expires in November 2022, we will securely destroy the data.

We will only collect data that we need for the study, and will not use it for any other purpose. We will not share the data with anyone else.

This data is being used for approved research in the public interest. Research in the public interest has special protection in the law to make sure it is reliable. People who the data is about cannot ask us to delete, remove, access or amend their data, because this might make the research less reliable. We will nonetheless treat all data we have extremely carefully, and make sure we comply with all aspects of the laws about data protection.

If you have any questions about how your data are used, or would like to report a problem, please contact the University of Leeds Data Protection Officer:
– 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

For more about how data are used at the Leeds Institute of Clinical Trials Research and who to contact in case of a problem, go to https://ctru.leeds.ac.uk/privacy/.