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Health Services Research Unit Participant Information Sheet (version 26.6.2018) Health Services Research Unit Nuffield Department of Population Health Richard Doll Building, Old Road Campus, Headington, Oxford OX3 7LF Telephone 01865 289432 or email [email protected] Telephone 01865 289424 or email [email protected] Pretesting new items for the Parkinson’s Disease Questionnaire (PDQ) (ETHICS APPROVAL REFERENCE R58649/RE001) 1. What is the purpose of the study? The Parkinson’s Disease Questionnaire (PDQ) was developed in 1997 to measure the effects of Parkinson’s on every day life. Researchers in the Health Services Research Unit (HSRU) at the University of Oxford have recently conducted a series of interviews with people with Parkinson’s in order to explore whether additional questions for the PDQ are required in light of changes in the management of Parkinson’s over the last 20 years. Between 1 August and 30 October 2018 we will be conducting interviews with a small number of people with Parkinson’s to test a pool of newly generated PDQ questions. This is to ensure that the proposed questions are relevant, acceptable, unambiguous and usable. 2. Why have I been asked to take part in the study? You are being approached because you are a member of Parkinson’s UK and your local branch or the Research Support Network is helping to promote the project. We are looking for between 12 and 20 adults with Parkinson’s to take part. You must be over 18 years old, live in the UK, have access to the internet and use your computer or other electronic device to complete the proposed new questions online. 3. Do I have to take part? No. You can ask questions about the study before deciding whether or not to participate. If you do agree to participate, you may withdraw yourself and your data from the study at any time up to two weeks from the date of interview without giving a reason and without penalty, by advising the researchers of this decision. If you decide to withdraw, please let us know within two weeks of the interview so any data you have contributed can be destroyed before the data is anonymised. 4. What will happen to me if I take part in the research? If you are happy to take part, please email [email protected] to arrange a time for a researcher to visit you (ideally at your home) for a one-off meeting during which you will complete the new PDQ questions online. Ahead of the meeting you will be emailed a link to the proposed questions. You will be asked to wait until the researcher is with you before accessing the questions. On arrival, we will outline what we are doing and give you the chance to ask any questions. This may take up to 10 minutes. You will be asked if you are willing to have the discussion audio recorded as this will provide an accurate record of what you say about the proposed new PDQ questions. If you are still happy to take part, you will be asked to sign a consent form before answering the new PDQ questions online while the researcher is with you. When you have finished we will ask some questions about your answers. You can choose not to discuss your responses to the questions if you feel that it may make you uncomfortable. We expect the whole process will take approximately one hour in total, depending on how much you have to say. Participation is voluntary. All the information you give will remain strictly confidential and will be seen only by members of the research team. 1 Participant Information Sheet (version 26.6.2018) 5. Are there any potential risks in taking part? No, there are no risks in taking part. However, if you feel that issues have been brought up that need to be addressed, contact your GP, Parkinson’s nurse or telephone NHS Direct on 111. 6. Are there any benefits in taking part? There will be no direct benefit to you from taking part in this research, but you will be helping the researchers to check that the proposed new questions are suitable for use in a larger survey of people with Parkinson’s. 7. What happens to the data provided? The research data will be confidential. It will be stored in password protected computer files in a secure place at the Health Services Research Unit at the University of Oxford. Access to data will be restricted to members of the research team. Your personal details (name, email address and telephone number) will be used only for this study and will be kept only until the conclusion of the study so that a lay summary can be forwarded to you. The audio files will be confidential. They will be downloaded to password protected computer files and deleted from recording devices immediately.. A member of the research team will then listen to and transcribe the audio files before deleting them from the computer. Your responses will be anonymised two weeks after the interview. The transcript will be stored in a locked cabinet in a locked private office at the HSRU at the University of Oxford. Data will be accessed only by members of the research team and will be destroyed after 5 years. 8. Will the research be published? The study is likely to lead to an international conference presentation. Results will be published online and in an updated copy of the PDQ User Manual. You will be able to find the results on the HSRU website if you wish to read them. 9. Who is organising and funding the research? The research is internally funded by the Health Services Research Unit (HSRU), Nuffield Department of Population Health, University of Oxford. The members of the research team at the HSRU are Dr David Morley, Dr Laura Kelly and Mrs Sarah Dummett. The HSRU is led by Professor Crispin Jenkinson. 10. Who has reviewed this study? This study has been reviewed by, and received ethics clearance through, the University of Oxford Central University Research Ethics Committee (reference number R58649/RE001). 11. Who do I contact if I have a concern about the study or I wish to complain? If you have a concern about any aspect of this project, please speak to the relevant researcher (Dr David Morley, telephone 01865 289432) who will do his best to answer your query. The researcher should acknowledge your concern within 10 working days and give you an indication of how they intend to deal with it. If you remain unhappy or wish to make a formal complaint, please contact the relevant chair of the Research Ethics Committee at the University of Oxford who will seek to resolve the matter in a reasonably expeditious manner: Chair, Medical Sciences Inter-Divisional Research Ethics Committee; Email: [email protected]; Address: Research Services, University of Oxford, Wellington Square, Oxford OX1 2JD 12. Further Information and Contact Details If you would like to discuss the research with someone beforehand (or if you have questions afterwards), please contact: Primary Researcher Name: Dr David Morley Department: HSRU, Nuffield Department of Population Health Department address: Richard Doll Building, Old Road Campus, Oxford OX3 7LF Telephone 01865 289432 Email [email protected] 2 Participant Information Sheet (version 26.6.2018) 13. Data Protection The University of Oxford is the data controller with respect to your personal data, and as such will determine how your personal data is used in the study. The University will process your personal data for the purpose of the research outlined above. Research is a task that we perform in the public interest. Further information about your rights with respect to your personal data is available from http://www.admin.ox.ac.uk/councilsec/compliance/gdpr/individualrights/. 3 .
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