Participant Information Sheet
To return to the LOLIPOP Hearing Study Welcome Page click here.

Investigation of factors underlying hearing loss – a LOLIPOP sub-study
REC Ref: 11/NW/0633. Version 2. 11th September 2011.

We would like to invite you to take part in a research study. Before you decide you need to understand why the research is being done and what it would involve for you. Please take time to read the following information carefully. Talk to others about the study if you wish. Part 1 tells you the purpose of this study and what will happen to you if you take part. Part 2 gives you more detailed information about the conduct of the study. Please contact us if there is anything that is not clear or if you would like more information.

Part 1

1. What is the purpose of the study?
Hearing impairment is a major health problem that currently affects more than 580 million people worldwide.  We know some of the reasons why hearing loss occur - for example loud noises and some illnesses. However, many people develop hearing loss without having any clear reason. This study aims to improve our understanding of the causes of hearing loss. The results may allow us to better identify which people are at risk of hearing loss, and may ultimately lead to the development of new treatments for hearing conditions. 
 
2. Why have I been invited?
We have contacted you because you previously agreed to participate in this research study (the LOLIPOP study). We are now contacting the 30,000 people who participated in the LOLIPOP study, so that we can get an additional assessment of their hearing. We will use the information and samples previously collected on you, to investigate the differences between people in their hearing that we find now.

3. Do I have to take part?
Not if you don’t want to. It is up to you to decide. You are free to withdraw at any time, without giving a reason. This would not affect the medical care you receive.

4. What will happen to me if I take part?
We will ask you to log-on to our dedicated, secure research website for a single session lasting about 20 minutes. You will need a computer with speakers or headphones. The website will take you through a questionnaire about your hearing and a standardised test of your hearing using speech recognition. You can do the test from your computer at home, from an internet cafe or you can use one of our computers at Ealing Hospital.

5. Expenses and Payments
If you have the test done at Ealing Hospital, we will reimburse any travel expenses to and from the hospital.

6. What are the possible disadvantages and risks of taking part?
There is a small chance that your results will show a hearing abnormality of which you were unaware. In such circumstances we will refer you to the appropriate specialist in consultation with your GP, if that is what you would like. Detection has the benefit of starting treatment early, but may have implications for employment and insurance.

7. What are the side-effects of any treatment received when taking part?
There are no treatments involved in this study.

8. Harm to the unborn child.
Women of child-bearing age or who are pregnant may participate in this study without risk.

9. What are the possible benefits of taking part?
The tests may reveal hearing problems about which you were previously unaware. Such detection has the benefit of starting treatment early. We cannot promise the study will help you personally, but the information we get from this study will help improve the prevention and treatment of hearing problems in the wider community, in the future.

10. What happens when the research study stops?
Once the research is completed the data and results will be made fully anonymous (i.e. all personal information removed), and available for use by other researchers. 

11. What if there is a problem?
Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. The detailed information on this is given in Part 2.

12. Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information about you will be handled in confidence. 

If the information in Part 1 has interested you and you are considering participation, please read the additional information in Part 2 before making any decision.

Part 2

More detail – information you need to know if you still want to take part.

1. What will happen if I don’t want to carry on with the study?
You are free to withdraw from the study at any time and without giving a reason. If you wish to talk to a researcher about your reasons for withdrawal, please contact either Dr Chambers or Professor Kooner on 020 8967 5000. Understanding your concerns or reasons for leaving will be of help to us when designing future studies.

2. What if there is a problem? 
If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions (Dr John Chambers and Professor Kooner can both be contacted on 020 8967 5000). If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details can be obtained from the hospital. In the event that something does go wrong and you are harmed during the research and this is due to someone’s negligence then you may have grounds for a legal action for compensation against Ealing Hospital NHS Trust, but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you.

3. Will my taking part in this be kept confidential?
We will keep your information in confidence, and in a way that meets the security criteria set by the Data Protection Act 1988. Dr John Chambers will act as the custodian of the data. Your research data will be anonymised (all personal information removed). Only your research doctors will have access to the key matching anonymous numbers with personal information. This means we will only tell those who have a need or a right to know (eg authorised persons such as research regulatory authorities). Wherever possible, we will only send out information that has your name and address removed.

4. Involvement of your GP.
We would like to inform your GP that you have taken part in the study, but will only do this if you agree. We will also provide you with a copy of your key test results for you to give to your GP if you wish. 

5. What will happen to any samples that I give?
There are no new samples collected in this study. 

6. Will any genetic tests be done?
Some of the research will be genetic in nature as this can be the most powerful way to discover the causes of disease. Specifically , we will be trying to find genetic factors that protect against or increase the risk of hearing loss. This will be done using samples that you donated to the LOLIPOP study previously. All these analyses will be done using anonymised data, so that no individual can be identified.

7. What will happen to the results of the research study?
If you wish, you will receive an individual report of medically relevant results from your tests. If you would rather not know, you have the option not to be told.  We plan to publish the overall results of the completed study in medical journals. You will not be identified in any publications.

8. Who is organising and funding the research?
The research is organised by Professor Kooner and Dr Chambers. Our research is funded by the RNID, British Heart Foundation, Medical Research Council, Wellcome Trust and the National Institute for Health Research. Your doctors will not receive any payment for including you in the study.

9. Who has reviewed the study? 
All research in the NHS is looked at by independent group of people, called a Research Ethics Committee to protect your safety, rights, well-being and dignity. This study has been reviewed and given favourable opinion by the Research Ethics Committee.

10. Further information and contact details.
For general information about research, please click here to go to the MRC Clinical Trials Unit's website. This provides useful advice for potential participants in research.



For further information about this research project, or if you are unhappy with any aspect of the study, please contact Dr John Chambers or Professor Jaspal S Kooner (Dept Cardiology, Ealing Hospital, Uxbridge Road, Middx UB1 3HW, telephone 020 8967 5000, fax 020 8967 5007).

To return to the LOLIPOP Hearing Study Welcome Page click here.