YOUNG PERSON with HAEMOPHILIA (12-15Yrs) PARTICIPANT INFORMATION SHEET

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YOUNG PERSON with HAEMOPHILIA (12-15Yrs) PARTICIPANT INFORMATION SHEET [Emi + Me Young Persons with Haemophilia PIS (12-15yrs) v7 Dated 16 April 2020: IRAS number 248511] Oxford Haemophilia & Thrombosis Centre Churchill Hospital Old Road Headington Oxford OX3 7LE YOUNG PERSON WITH HAEMOPHILIA (12-15yrs) PARTICIPANT INFORMATION SHEET Study Title: Emi and Me: An Exploration of Emicizumab on the lives of people with haemophilia and inhibitors and their families Study Sponsor: Haemnet Protocol Number: Version 4 dated 26 November 2019 Principal Investigator: Simon Fletcher Co-investigators: Dr Kate Khair, Luke Pembroke Introduction This study is talking to people about what it is like to use Emicizumab (Hemlibra®) in people with haemophilia and inhibitors. We also want to find out about impact of Emicizumab use on the lives of your close family members (parents and sisters). We will get this information through talking to you all. The study will also form part of a body of work given as evidence for a PhD currently being undertaken by the Principal Investigator Please read this information carefully and talk to your mum, dad, carer or hospital haemophilia team if you have any questions. Please ask us if there is anything that is not clear or if you would like more information, our contact details are at the end of this information sheet. If you don’t want to take part that is fine. Why are we doing this study? From this study we want to find out what it is like to use Emicizumab for you and your close family members. We also want to understand what you think about your haemophilia care now and how it might be in the future. Why have I been chosen? You have been asked to take part in this study because you have haemophilia and an inhibitor and are treated with Emicizumab. Do I have to take part? 1 [Emi + Me Young Persons with Haemophilia PIS (12-15yrs) v7 Dated 16 April 2020: IRAS number 248511] No. It is entirely up to you. If you do decide that you would like to take part: - You will be asked to sign a form to say you agree to take part (an assent form). - You will be given this information sheet and copy of the assent form you signed to keep. We will also ask your close family members who participate in the interview to sign a consent form after they have read an information sheet designed for them. What will happen to me if I take part? The Emi and Me study will be one face-to-face interview with the researchers. If you agree to take part one of our research team will contact you and your parents/guardian to organize a convenient time to do the interview. We can do the interview at the hospital, your home or other another place that works for you. You will only take part in one interview for this study. During the interview, notes will be taken and the conversation will be recorded. The recording will then be written down and reviewed by the study research team. The interview can be done either face to face or over the internet using ZOOM®. If you tell us about any untoward experiences from using Emicizumab we will have to report these either the MHRA (Medicines and Healthcare products Regulatory Agency) or to Roche (the company that makes Emicizumab). Any information provided to the manufacturer will be fully anonymised and they will have no access to any of your personal information and we will talk with you and your parents before we send any information. How will we use information about you? We will need to use information from you for this research project. This information will include your: name initials age sex contact details current treatment o how long you have been taking Emiczumab o how frequently you are taking Emicizumab previous treatment o what factor product you were on o how frequently you took that product 2 [Emi + Me Young Persons with Haemophilia PIS (12-15yrs) v7 Dated 16 April 2020: IRAS number 248511] People will use this information to do the research or to check your records to make sure that the research is being done properly. 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. We will keep all information about you safe and secure. We will write our reports in a way that no-one can work out that you took part in the study. What are your choices about how your information is used? You can stop being part of the study at any time, without giving a reason, but with your permission we will keep information about you that we already have. Where can you find out more about how your information is used? You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/ by asking one of the research team by sending an email to [email protected], or by ringing us on 01865 225316 What are the possible disadvantages, risks and possible benefits of taking part? Doing the interview may not help you directly, but it may help you and others in the future. You will receive a thank you gift voucher for participating. Taking part in the interview will mean giving up some of your time. Although we do not think that answering the questions during the interview will be upsetting, but if it is we can stop. If you want to talk to someone about it this can be arranged by your GP, who will be informed of your participation in the study, or through your haemophilia centre. What if I change my mind? If you agree to take part in the study you can stop at any time without giving any reason. If you choose to stop your doctors and nurses will look after you in exactly the same way as before. Who is organising and funding the study? The study is sponsored by Haemnet. Haemnet is a charity that supports nurses and Doctors to make sure that excellent care becomes is an everyday experience for you. The overall study is funded by Roche Products Limited (who make Emicizumab) – they will not have access to any data other than the side effect reports if these happened to you. They will also get a final report which may use anonymised quotes from interviews. The lead researcher doing the interviews is Simon Fletcher who is a specialist haemophilia nurse. 3 [Emi + Me Young Persons with Haemophilia PIS (12-15yrs) v7 Dated 16 April 2020: IRAS number 248511] Will my taking part in this study be kept confidential? Yes! No personal information such as your name and address will be included in the records. All audio-recordings will be transcribed word for word by a person who does this as a job – they will be unknown to you. They will have signed an agreement to keep the information safe. The paper records and recordings will be kept in locked cupboards by Haemnet. Recordings will be deleted by Haemnet once the study has been analysed. All personal information will be kept for 12 months following the end of the study, after which it will be shredded. Paper records, including the written down interviews will be kept for 15 years after the study, after which they will be shredded. Any data on computers will be password protected in line with NHS data protection procedures. You have the right to ask to see the data that has been collected about your health and if you think anything is incorrect, to have it corrected. Who has reviewed the study? Before any research goes ahead it has to be checked by a Research Ethics Committee. This is a group of people who make sure that the research is ok to do. This study has been reviewed by the London and Chelsea Ethics Committee and the reference number is 19/LO/1592. They have said that we are able to do the study. What happens if there is a problem? You should not suffer any harm or injury by being in this study. If you wish to complain or have any concerns about the way you have been treated during the study then you can talk to your parents, your haemophilia team or contact the Patient Advice and Liaison Service (PALS) at the Oxford University Hospitals NHS Foundation Trust (TEL: 01865 235855; Email: [email protected]). Will I be Informed of the results of the Study? This study will be reported in both specialist haemophilia publications and at international conferences. Each participant will receive a final report from the study team. How can I find out more about the study? If you would like any more information, please do ask any of the nurses or doctors looking after you. You can also ask question about the study with a member of the research team by calling or emailing: 4 [Emi + Me Young Persons with Haemophilia PIS (12-15yrs) v7 Dated 16 April 2020: IRAS number 248511] Simon Fletcher: 01865 225316 or [email protected] Dr Kate Khair: 07515 900812 or [email protected] Thank you for taking the time to read this information sheet 5 .
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