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Information and Consent for Parents, Children and Young People

Name of Researcher(s): Dr Aimee Aubeeluck, Professor Christine Moffatt, CBE and Professor Isabelle Quéré

We would like to invite you to take part in our research study. Before you decide we would like you to understand why the research is being done and what it would involve for you.

What is the purpose of the study?
 
This study aims to explore the Quality of life of children and young people with Lymphoedema and to validate a Lymphoedema specific quality of life tool (LYMPHOQOL) for use with children and young people with Lymphoedema.
Why have I been invited?

You are being invited to take part because you or your child are living with Lymphoedema.

Do I have to take part?

It is up to you to decide whether or not to take part. When you have read this information and if you decide to take part please read the consent form below and tick your agreement to take part.

You are still free to withdraw at any time while filling in the questionnaires without providing any reason. This would not affect your legal rights.

It is important for the children and young people to answer the questionnaires themselves whenever possible, however parents can assist children to complete the questionnaires if they feel it is helpful.

What will happen to me if I take part?

You will be asked to complete 2 online questionnaires (LYMPHOQOL and KIDSCREEN) that are written in your own language and according to your age. These questionnaires aim to measure your quality of life and understand any worries you may be experiencing.  You will also be asked to tell us what you think about the new LYMPHOQOL questionnaire and how long it took you to complete the online survey.

Expenses and payments

Participants will not be paid to participate in the study.

What are the possible disadvantages and risks of taking part?

There are no anticipated disadvantages to taking part in this study although it may prompt you to think about aspects of living with Lymphoedema that are distressing to yourself. If you are upset by taking part in any aspect of the study, we will provide an email for you to contact us for help.

What are the possible benefits of taking part?

We cannot promise the study will help you but the information we get from this study may help provide us with a better understanding of how it feels to live with Lymphoedema and how we may better support children and young people who have the condition in the future.

What happens when the research study stops?

When the study stops, we will take 6 months to analyse the findings before we present them. We will provide a summary of the findings on the International Lymphoedema Framework website www.Lympho.org and will keep everyone updated this way. We will publish the results in medical journals and make the questionnaires that come out of this study widely available for use.  The study results will further be published via social media. This will help you to see how your contribution has helped the Lymphoedema Community.

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.  The researcher’s contact details are given at the end of this information sheet.
Will my taking part in the study be kept confidential?

We will follow ethical and legal practice and all information about you will be handled in confidence.

If you join the study, the data collected for the study will be looked at by authorised persons from the University of Nottingham and the University of Montpellier Hospital who are jointly organising the research.

Under UK Data protection laws the University of Nottingham is the data controller (legally responsible for the data security) and the chief investigators of this study are the data custodians who manage access to the data. This means we are responsible for looking after your information and using it properly. Your rights to access, change or movement of your information are limited as we need to manage your information in specific ways to comply with certain laws and for the research to be reliable and accurate. To safeguard your rights we will use the minimum personally identifiable information possible. You can find out more about how we use your information and to read our privacy notice at https://www.nottingham.ac.uk/utilities/privacy.aspx/

The data could be looked at by authorised people to check that the study is being carried out correctly. All will have a duty of confidentiality to you as a research participant and we will do our best to meet this duty.

What will happen if I don’t want to carry on with the study?

Your participation is voluntary, you are free to withdraw at any time, without giving any reason, and without your legal rights being affected. If you withdraw then any anonymous information collected so far cannot be erased and this information may still be used in the project analysis. Any identifiable data already collected will be withdrawn at your request. 

All information which is collected about you during the course of the research will be kept strictly confidential and stored on a password protected database. 

You will have a choice of whether you provide your name and contact details for us. This would only be used with your consent and if you wished us to contact you to participate in future studies using the questionnaires.

All other data (research data) will be kept securely for 7 years and then safely disposed of. During this time all precautions will be taken by all those involved to maintain your confidentiality, only members of the research team will have access to your personal data.

Involvement of the General Practitioner/Family doctor (GP)

There will be no involvement of your GP / Family doctor.

Who is organising and funding the research?

This research is being organised by the University of Nottingham and is being sponsored by the the Centre de Reference des maladies Lymphatiques Primaires, University Hospital of Montpellier and supported by the International Lymphoedema Framework (ILF), a UK registered charity.

Who has reviewed the study?

This study has been reviewed and given favourable opinion by The University of Nottingham, Faculty of Medicine and Health Sciences Research Ethics Committee

Further information and contact details

Professor Christine Moffatt CBE Emeritus Professor, University of Nottingham,
International Professor of Nursing,
Nottingham Trent University,
Shakespeare Street,
Nottingham, NG1 4FQ

Email: christine.moffatt@ntu.ac.uk

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