Taking part in this straight forward health research study will help us to develop new lung disease screening tests that may help you and your community in the future. We simply need a urine sample.
Your name has been put forward by your GP for the Targeted Lung Health Check and it seems that you have not yet taken up the invitation (which we encourage you to do). However, we also want to provide you with a new-exciting way of being involved through a research study associated with the Targeted Lung Health Check.
This research study aims to develop better ways of identifying lung disease at a very early stage to improve outcomes by using a new urine test. If you have any questions, please telephone a member of the P4LHC team on +44 (0)151 600 1876 (between the hours of 9am and 5pm), or email Research.LHCH@lhch.nhs.uk.
If you decide to take part, you can change your mind or withdraw from the study at any time and without giving a reason.
Any clinical care you receive will not be affected.
What will happen to me if I take part in P4-LHC?
You will provide consent and a urine (pee) sample, that’s it.
- Complete the enclosed paper Consent Form.
- Collect one sample of your urine using the easy to use enclosed device and post the urine sample tube back to the Liverpool University Biobank, in the packaging provided, along with your completed paper Consent Form.
Postage is pre-paid and you can post in any Post Office post-box.
Do I have to take part?
No, this is entirely voluntary and the research is separate from the Targeted Lung Health Check.
What happens to the sample?
The Liverpool University Biobank will receive your urine sample; some of your urine will be transferred to Elypta in Sweden to run the new urine lung disease test. The remainder of your urine sample will be kept by the Liverpool University Biobank.
As this is a research study, your urine sample test result will not be fed back to you personally, or placed in your medical records, as the tests are for research only. The urine test is not currently able to diagnose lung disease, so a test result will not accurately indicate if you have lung disease or not. The aim is to help us find new, less invasive ways to track lung health and assist in developing new diagnostic tests.
Will my taking part in P4-LHC be kept confidential?
Yes. Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules. To make contact with you we have obtained your name and address from the NHS, but people who do not need to know who you are will not be able to see your details.
We will need to use information from your medical records for this research project. If you consent to take part in this study, your medical records may be reviewed by the NHS TLHC study team and shared with the University of Liverpool using a code number to keep your medical information anonymous.
Further details about what information we will use and how we will use it, is available in our P4-LHC Privacy Notice.
Who is co-ordinating and funding the P4-LHC study?
The study will be co-ordinated by the University of Liverpool, in collaboration with the Targeted Lung Health Check team at Liverpool Heart and Chest Hospital. The study is funded by Elypta (the Swedish company developing the new test for lung disease).
Who has reviewed the study?
The P4-LHC study has been reviewed by an NHS Research Ethics Committee and by the Liverpool Heart & Chest Hospital Research Committee.
Who should I contact if I have a concern or a complaint?
Please contact the study team in the first instance. If this is not resolved, you can contact The Liverpool Heart and Chest Hospital Patient & Family Support team by telephone +44 (0)151 600 1517 or the patient family support website.
What happens when the P4-LHC study ends?
If you have consented “that left over urine samples will be stored in the Liverpool University Biobank”, your consent record, urine sample and any related data will be under the care of the University of Liverpool for as long as it is considered they will be useful for research. Liverpool University Biobank, will be responsible for keeping your samples and information safe and confidential. All samples and data will be anonymous if used in future research projects with ethical approval to investigate use of urine samples in healthcare. Anonymous urine samples will also be retained for future research by Elypta.
How will we use information about you?
We will need to use information from your GP, or that you provided to the Targeted Lung Health Check for this research project. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.
The University of Liverpool is the sponsor of this research, and is responsible for looking after your information. We will keep all information about you safe and secure by:
- Only holding anonymous data unless you have provided consent
- Keeping all data on secure data systems, accessed by trained, authorised staff.
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. You have the right to ask us to remove, change or delete data we hold about you for the purposes of the study. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.
International transfers
Your personal data will not be shared outside the UK.
What should I do now?
If you would like to take part in P4-LHC research project, please return the consent form and a urine sample (as per enclosed instructions).
Additional information on confidentiality and how we handle your personal data can be found in the P4-LHC Privacy Notice and a copy of the Consent Form.
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