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1 Information about the research Health beliefs in OCD participants with OCD information sheet (non-nhs participants version) We would like to invite you to take part in our research study. The study is being undertaken as part of a PhD project for Rebecca Pedley. Before you decide whether or not to participate, we would like you to understand why the research is being done and what it would involve for you. This information sheet explains the purpose of the study and what will happen if you take part. Ask us if anything is not clear. Talk to others about the study if you wish. What is the purpose of the study? Obsessive compulsive disorder (OCD) is a common mental health problem which can have a considerable impact on both the person experiencing OCD and their family members. Research into other health conditions has found that the way we understand health problems that affect us can affect how we cope with them. We want to find out about how people with OCD and their family members understand their diagnosis. We plan to do this by carrying out individual interviews with people who have OCD and also with family members of people experiencing OCD. We hope this work will contribute to improved treatments that could potentially help the whole family to cope better. Why have I been invited? You have been invited because you currently have symptoms of OCD. Alternatively, you may have responded to an advertisement because you believe that you are experiencing symptoms of OCD. We expect to interview around 15 people who have OCD and 15 family members of people with OCD. Do I have to take part? It is up to you to decide to take part. If you agree to take part, we will then ask you to sign a consent form. This consent form will allow you to indicate which parts of the study you are happy to take part in. You are free to withdraw at any time, without giving a reason. Leaving the study will not affect the standard of care you receive.
2 What will happen to me if I take part? There are two parts to this study, Parts A and B you can choose whether you are happy to take part in Part A or Part B, or both: Part A Consent to take part in an interview with you about your OCD. Part B Consent for the researcher to interview a family member (consent will also be sought from the family member) People who are interested in taking part in the study will be contacted by the researcher, who will check if you can take part by asking you some brief questions. At this point you can ask more questions you might have about the study. You will then be given some time to think about whether you want to take part or not. You do not have to take part unless you feel completely happy with the study. If you decide that you are happy to participate, the researcher will ask you to sign a consent form indicating which parts of the study you would like to participate in. Part A If you agree to take part in part A, we will ask you to complete some basic information about yourself (e.g. date of birth) and your symptoms of OCD (e.g. the types of symptoms that you have been experiencing). Some of these questions will tell us whether you meet the study criteria. If you meet the study criteria, we will ask permission to turn the audio recorder on. The researcher will then have a discussion with you about your personal experience and understanding of OCD. We expect this to take around an hour. The information that you provide during this interview will remain confidential. However, if we become worried about risk of harm to yourself or others during your interview, we may need to discuss this with your GP or other health professional involved with your care. We will of course discuss this with you first. Part B If you agree to take part in part B, we will ask you to agree the name of the relative who you are happy for us to interview. We will take some basic information about you (e.g. date of birth), as well as your symptoms of OCD (e.g. the types of symptoms that you have been experiencing). If we find that you meet our study criteria, we will then contact the family member that you have agreed for us to interview in order to conduct the interview.
3 Expenses and payments You will not receive any payment for taking part. However, to prevent you from incurring expenses as a result of your participation, the researcher will usually meet at your home or other preferred location close to your home. What will my relative need to do if they agree to take part? If both you and your relative agree to take part in Part B, we will contact your relative and arrange to meet them at a convenient time. We will ask your relative to provide some general details about themselves (e.g. their age, the length of time they spend with you in a typical week). Following this, the researcher will ask permission to turn the audio recorder on. The researcher will then ask some questions about your family member s personal understanding and experiences of having a family member with OCD. We expect this to take around an hour. Please note that for reasons of confidentiality, we will not share what you have told us with your relative. Similarly, we will not share information your relative provides, with you. To ensure that participants feel able to speak openly, it is preferable for family members to be interviewed individually. What are the possible disadvantages and risks of taking part? We do not think there are any disadvantages of taking part in the study. However, some individuals could find it difficult to talk about their experiences of living with OCD. Participants can refuse to answer any questions that they feel uncomfortable with. If you do experience any distress in discussing these issues, we will put you in touch with people who can help you. What are the benefits of taking part? The study is not intended to offer any treatment for OCD. However, the information that we gain during the study will help us to learn about the way in which people affected by OCD think about the health problem. This could lead to improved treatments which could help suffers and family members supporting people with OCD to cope better. What happens when the study stops? Following your/your relatives interview, all recordings will be typed up so that it is easy to analyse the responses given. We will analyse the transcripts, looking for similarities and differences between the way in which different participants understand OCD. The results of the analysis will be written up for publication, taking care to preserve the identity of participants.
4 What if there is a problem? Complaints 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. If they are unable to resolve your concern or you wish to make a complaint regarding the study, please contact a University Research Practice and Governance Co-ordinator on or or by to research.complaints@manchester.ac.uk. Harm In the event that something does go wrong and you are harmed or suffer loss as a result of taking part in the research you may have grounds for claiming compensation from The University of Manchester. In order to protect you, the University of Manchester has insurance in place that provides: compensation for non-negligent harm to research subjects occasioned in circumstances that are under the control of the University, cover for legal liabilities for injury, loss of or damage to property, or financial loss arising from the University s actions or those of its staff or supervised students. If you make a claim in respect of legal liability you may have to pay your legal costs. What will happen to information about me collected during the study? All information will be held securely and in strict confidence. Only authorised people working on the study will have access to your information. We will destroy all personal details 5 years after the end of the study. We keep the health information we collect about you separate from your personal details. We will use the information we collect to look at how best to help people with OCD. We will keep it 15 years and then destroy it securely. Some of the information that we collect from you could be used for other education, such as teaching students about OCD and research methods. It may also be looked at by other researchers interested in OCD. Only information that has been made anonymous would be made available. This means that nobody outside of the research team will have access to your name or address, nor will they have access to any other data that may identify you. You will be asked to consent to your data being used for educational and research purposes outside of the study. You are
5 free to refuse, and this will not affect your health care. You can still take part in the study. To help protect your identity, we will ask you to use a pseudonym to refer to any individuals you discuss during the recorded part of the interview. The audio recording will be stored on a password protected university computer. The transcription of the recording may be conducted by a research team member or by an approved university transcription service, who have signed university confidentiality agreements. Any transcribers used from outside the research team will not be given any personal information about you such as name, address etc. Involvement of your GP We will not inform your GP of your involvement in the study, or of any information you provide to us during the study. However, if we become worried about risk of harm to yourself or others during your interview, we may need to discuss this with your GP. What will happen to the results of the study? When the study is completed, the results will be published in a scientific journal so health care professionals can see the results. Your identity and personal details will be kept confidential and no named information about you will be published in any reports. Who is organising and funding the study? The study is organised by the University of Manchester as part of a PhD qualification. Who has reviewed the study? This study has been reviewed by an independent group of people, called the Research Ethics Committee, to protect your safety, rights, well being and dignity. The study has been given a favourable opinion by NRES Committee North West - Lancaster (Ref: 13/NW/0506). Who is the study researcher? The study researcher is Rebecca Pedley. They can be contacted by telephone on: (0161) / Alternatively, you can write to the study coordinator at:
6 Rebecca Pedley School of Nursing, Midwifery & Social Work The University of Manchester Room Jean McFarlane Building Oxford Road Manchester M13 9PL Thank your for taking time to read this information sheet
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