EASi-KIDNEY

The Study of Heart and Kidney Protection with BI 690517 in combination with empagliflozin

Part 2. Detailed information about the study

Alder Hey Children’s NHS Foundation Trust is the Sponsor of this study and is responsible for managing it. They have asked that the day to day running of the study is carried out by a team based at the Clinical Practice Research Datalink (CPRD), part of the Medicines for Healthcare Regulatory Agency. A paediatric respiratory doctor, based at Alder Hey Children’s Hospital, is leading the study supported by a team from across the UK, including GPs, asthma specialists, statisticians from the University of Liverpool, and health economics researchers from Bangor University.

The study has been reviewed by the Medicines and Healthcare Products Regulatory Authority, the Health Research Authority and the National Research Ethics Service to make sure that the study is scientifically and ethically acceptable. This study is funded by National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme.

Your child’s doctor will not receive any personal payment for including your child in this study but the GP practice will be reimbursed for the time staff spend on the study

How will you collect and use information about my child?

Alder Hey Children’s NHS Foundation Trust, The University of Liverpool, and Bangor University are the joint Data Controllers for this study and will need to use information from you or from your medical records for this research project. Clinical Practice Research Datalink (CPRD) are data processors and will only use your information in a way approved by the Data Controllers.

Individuals from Alder Hey Children’s NHS Foundation Trust, the University of Liverpool, Bangor University and CPRD and regulatory organisations may look at your child’s medical and research records to check the accuracy of the research study. People who do not need to know who you and your child are will not be able to see your or your child’s name or contact details.

Your child’s data will have a code number instead. We will keep all information about you and your child safe and secure in accordance with the General Data Protection Regulation (GDPR). Once we have finished the study, we will keep the data for 15 years, so we can check the results. Your child’s data will be anonymised in any published reports, and no readers will be able to identify that they took part in the study.

What are my choices about how my child’s information is used?

Your child can stop being part of the study at any time, without giving a reason, but we will keep information about your child that we already have unless you tell us that you want the information removed. If you choose for your child to stop taking part in the study, by stopping their treatment, we would still like to continue to follow up your child using their electronic health records, and to ask you to complete the surveys. This information is still important for the study. But, if you do not want this to happen you can tell your GP and we will stop.

Although the risk of side effects is low in this study, if your child did experience any and you decide to stop taking part we may still need to collect limited information about the side-effects from your medical record. We will stop doing this as soon as we have all of the information about the side effect that we are required to report, by law, to the Medicines for Healthcare Regulatory Authority.

We need to manage your child’s records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you or your child.

Information sharing for other research

Information that identifies your child will never be shared for other research purposes. However, anonymised information about your child’s health and care may be beneficial 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 child’s anonymous 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, or equivalent standards.

Where can I find out more about how my information is used?

You can find out more about how we use information relating to you and your child:

• on the HRA website
• in the Health Research Authority leaflet available here
• by contacting the Alder Children’s Hospital NHS Trust Data Protection Officer on info.gov@alderhey.nhs.uk
• by contacting the University of Liverpool Data Protection Officer on LegalServices@liverpool.ac.uk
• by contacting the University of Bangor Data Protection Officer on info-compliance@bangor.ac.uk
• by contacting the Clinical Practice Research Data Link Data Protection Officer on dataprotection@mhra.gov.uk
• by asking your child’s GP

What if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak to your GP or practice nurse who will do their best to answer your questions.

If you remain unhappy and wish to complain formally, you can do this by contacting your local NHS Patient Advice and Liaison Service (PALS) or equivalent. Your GP practice should be able to provide this information to you. Every care will be taken in the course of this clinical study to protect your child’s safety. However, in the unlikely event that your child is harmed by taking part in this research project, there are no special compensation arrangements.

If your child is harmed due to someone’s negligence, then they may have grounds for legal action for compensation against the NHS Trust where they are being treated (you may have to pay legal costs).

If you wish to raise a complaint on how any research organisation has handled personal data pertaining to your or your child, you can contact the relevant Data Protection Officer who will investigate the matter.

The details of the Data Protection Officer for each organisation in the study are listed on page 10. If you are not satisfied with their response or believe they are processing your or your child’s personal data in a way that is not lawful you can complain to the (Information Commissioner's Office (ICO)).

Thank you for reading this information sheet.